Researchers presented post-hoc findings regarding the effect of evinacumab on changes in apheresis eligibility. Apheresis eligibility was determined via the 2019 US Food and Drug Administration threshold criteria in patients with HOFH. The single-arm, open-label, phase 3 study (ClinicalTrials.gov Identifier: NCT03409744) enrolled patients aged 12 years or older with HOFH and assessed the long-term tolerability and safety of evinacumab.

The study included a run-in period of up to 10 weeks, a 2-week screening period, an open-label treatment period, and a 24-week follow-up after the last dose of evinacumab. The participants received intravenous evinacumab 15 mg/kg every 4 weeks. The primary endpoint was the severity and incidence of treatment-emergent adverse events (TEAEs) during the open-label treatment period.

A total of 106 patients (mean age, 39 [SD, 16.4] years; 50% men; 71% White) were included. At baseline, 67.9% of patients qualified for lipoprotein apheresis and 32.1% of patients did not per the US eligibility criteria. At week 56, the mean decrease in low-density lipoprotein cholesterol was 130.6 (SD, 109.3) mg/dL from baseline.

Among the 72 patients who qualified for apheresis at baseline, 39 out of 63 patients (data were missing for 9 patients) no longer qualified for apheresis after 56 weeks of treatment. The decrease in the proportion of patients who qualified for apheresis was maintained to week 184 and through the follow-up per protocol. Evinacumab was generally well tolerated, and no new safety signals were observed.

At least 1 TEAE was reported in 81.1% of patients and 19.8% of participants had 1 or more serious TEAE. A TEAE leading to death occurred in 2 patients, and 3 patients had 1 or more TEAE leading to treatment discontinuation. Nasopharyngitis (24.5%) and headache (18.9%) were the most common TEAEs.

Disclosure: This analysis was funded by Regeneron Pharmaceuticals, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The prospective, cross-sectional study evaluated use of the Healthy Eating Assessment Tool (HEAT) in meeting dietary fat and cholesterol restriction cut points of CHILD-2 and its association with adiposity and lipid variable markers. The study enrolled patients aged 2 to 18 years from a pediatric dyslipidemia clinic over 2 years.

The researchers assessed the association between individual HEAT scores and HEAT score categories (poor, 0-4.5; fair, 5-6.5; good, 7-8.5; and excellent, 9-10; analysis of variance) and factors such as nutritional analysis findings of 7-day food records, body mass index (BMI) z-score, waist-to-height ratio, and lipid variables.

Participants who had the highest HEAT scores (good, 43%; excellent, 64%) met the CHILD-2 cut point of less than 25% total fat calories (P =.03), with a nonsignificant trend (P =.08) for saturated fat to less than 8% of total daily calories (excellent, 64%).

Having a lower HEAT score was associated with an increased BMI z-score (r = -0.31, P <.01) and waist-to-height ratio (r = -0.31, P <.01).

No association was observed between HEAT score and any lipid variable after adjustment for age, sex, amount of moderate to vigorous physical activity, hours of screen time, use of lipid-lowering medications, BMI z-score, and waist-to-height ratio.

“HEAT score associations with meeting CHILD-2 fat targets were modest, with more consistent associations with markers of adiposity, and no independent association with lipid levels,” wrote the study authors. “While fat-restricted diets are safe, they are not particularly effective for treatment of dyslipidemia or for weight management alone. The HEAT may be a more useful and simplified way of assessing and tracking broader dietary goals in clinical practice.”

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Investigators sought to assess if system-wide educational modules offered to providers would eliminate implicit biases and health inequities in lipid lowering therapy in adults at the University of Louisville health clinics.

This retrospective analysis included data for 18,757 patients (40-75 years of age; 71.9% White; 26% Black) seen in the family medicine, internal medicine, or cardiology clinics at the University of Louisville, Louisville, KY, in 2019. From 2019 to 2022, follow-up data was collected for statin prescriptions, obesity, diabetes mellitus (DM), hypertension (HTN), lipid profiles, socioeconomic status, and race. System-wide educational modules were presented to providers over 3 years with intention to reduce racial disparities in HLD screening and treatment.

They found that 73% of all patients received lipid screening in 2019 (75% Black; 73% White; P <.0001). Comorbidities were more prevalent in Black patients vs White patients (elevated LDL-C levels, 31% vs 26%; DM, 38.1% vs 29.5%; HTN, 85.7% vs 79.1%; obesity, 57% vs 51%; all P <.0001).

Patients with certain risk factors were more likely to receive lipid screening compared with patients without certain risk factors (DM, 82.9% vs 74%; HTN, 79% vs 68.1%; obesity, 81.3% vs 79.6%; all P <.0001), and they were more likely to receive statins (DM, 64% vs 0%; HTN, 24.5% vs 3.4%; obesity, 26% vs 12.6%; all P <.0001). Overall, a higher percentage of Black patients vs White patients received statins (23.7% vs 11.1%; P <.0001).

“Patients from different racial and socioeconomic groups had equal access to care after educational intervention in 2018…” the study authors wrote.

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Researchers aimed to validate use of dried blood spot testing for multiple ASCVD risk markers, including thyroid and kidney function. They enrolled 249 participants who, after fasting for longer than 8 hours, did fingerstick testing which collected 4 to 6 drops of capillary blood on ADX-100 cards. Cards were sealed in pouches containing desiccant after being dried at room temperature for at least 30 minutes. Serum and red blood cell samples were subsequently analyzed and results compared with analysis results of serum collected after venipuncture.

The researchers evaluated 42 parameters including 11 genotyping tests, 7 lipids and apolipoproteins, 7 hormones, 6 fatty acid parameters, 3 diabetes markers, and 2 inflammation markers. They found a high correlation (Pearson r≥0.95; P <.00001) between dried blood spot-derived concentrations for hormones, kidney function, vitamins, diabetes, inflammation, and lipids compared with standard venipuncture results. The intra-assay and inter-assay coefficient of variation was less than 5% for all assays.

There was a high correlation (r>0.90; P <.0001) between dried blood spot measurements for monounsaturated fat index, omega-6 index, omega-3 index, arachidonic acid, dcosahexaenoic acid, and eicosapentaenoic acid compared with standard venipuncture values.

The researchers noted a 100% correlation for genotyping results between dried blood spot and standard phlebotomy results.

The study authors wrote, “Our data demonstrate that DBS [dried blood spot]-derived measurements had excellent correlations with results obtained with venous blood for 31 biomarkers and 11 genetic variants.”

Disclosure: This research was supported by Boston Heart Diagnostics. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The ongoing VICTORION-INCEPTION trial (ClinicalTrials.gov Identifier: NCT04873934) is planned to be completed in 2024. It is a phase 3b, randomized, parallel-group, open-label study that includes 384 patients aged at least 18 years from more than 60 locations across the United States.

Researchers aim to examine the effect of inclisiran added to usual care vs usual care alone on low-density lipoprotein cholesterol (LDL-C) concentrations among patients recently hospitalized for ACS who have LDL-C concentrations equal to at least 70 mg/dL despite statin therapy. Percentage change from baseline to Day 330 in LDL-C concentration and proportion of patients at Day 330 achieving LDL-C of less than 70 mg/dL are the primary endpoints.

Secondary outcomes of the study will be changes in intensity of lipid-lowering therapy from baseline to Day 330, the proportion of patients discontinuing statins at Day 330, the proportion of patients achieving prespecified LDL-C targets after Day 90 and Day 330, and absolute changes from baseline to Day 330 in LDL-C.

Inclusion criteria include ACS within 5 weeks (inpatient/outpatient) of enrollment and LDL-C concentration of at least 70 mg/dL or non-high-density lipoprotein cholesterol of at least 100 mg/dL despite statin therapy. Additionally, patients will have fasting triglyceride concentrations of less than 4.52 mmol/L at screening and estimated glomerular filtration rate of greater than 20 mL/min.

Patients will be randomly assigned in a 1:1 ratio to inclisiran plus usual care (n=192) or usual care alone (n=192). Inclisiran therapy will be inclisiran sodium 300 mg subcutaneously twice yearly after initial doses at baseline and 3 months. The researchers plan to discontinue inclisiran in patients with unexplained creatinine kinase values, changes in liver parameters meeting study drug interruption criteria, or with intolerable adverse events. Statin therapy and usual care will continue among patients in both groups.

The researchers noted that usual care may include anti-PCSK9 monoclonal antibodies in the usual care group only, or inclisiran in the usual care group if the treating physician prescribes it (acquired through commercial outlet). The discretion of the treating physician will be used for adjustments in therapy during the study other than for inclisiran in the inclisiran arm. LDL-C values obtained as part of the study will not be accessible by treating physicians, however at their discretion, physicians can perform these assessments.

Study limitations include patients in the usual care only arm receiving inclisiran by treating physicians.

Disclosure: This research is supported by Novartis Pharmaceuticals Corporation. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The investigators conducted a meta-analysis after searching Cochrane, PubMed, and Embase databases from inception to October 2022 for randomized clinical trials (RCTs) and cohort studies evaluating statin use effects on incidence of lung, colorectal, prostate, and breast cancers. Pooled risk ratios (RRs) were calculated using a fixed effects model.

The investigators found no statistical significance in RCTs between statin use and increased incidence of lung cancer (RR, 0.91; 95% CI, 0.76-1.09; P =.32), colorectal (RR, 0.96; 95% CI, 0.81-1.13; P =.61), prostate (RR, 1.08; 95% CI, 0.93-1.25; P =.31), and breast cancer (RR, 1.08; 95% CI, 0.83-1.42; P =.56).

There was no statistical significance in cohort studies between statin use and increased incidence of lung cancer (RR, 0.76; 95% CI, 0.69-0.84; P ≤.00001), colorectal (RR, 0.89; 95% CI, 0.72-1.12; P =.26), prostate (RR, .70; 95% CI, 0.47-1.04; P =.08), and breast cancer (RR, 0.65; 95% CI, 0.30-1.38; P =.26).

“We found no apparent evidence to support the use of statins to prevent cancer,” the investigators concluded.

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Investigators aimed to characterize pathogenic and probable pathogenic variants, reduced penetrance risk alleles, and variants of unknown significance across 7 LPL pathway genes among patients with suspected familial chylomicronemia.

Investigators performed DNA next generation sequencing and copy number variant analysis among 127 patients residing in Canada and the United States. They analyzed deidentified genetic variant data of LPL, APOA5, APOC2, CREB3L3, LMF1, GPD1, and GPIHBP1 genes for associated FCS symptoms, zygosity, and allele frequency.

Among patients included in the analysis, the median age at onset of severe hypertriglyceridemia was 33 (range, 4-60) years, 77.9% were European, and 81.1% had at least 1 comorbid condition. Comorbidities among the patients included pancreatitis, lipemia retinalis, xanthomata, hepatosplenomegaly, and plasma lactescence. Of note, 11.8% of patients had atherosclerotic cardiovascular disease.  

Investigators found at least 1 variant in LPL, APOA5, APOC2, CREB3L3, LMF1 genes of 86 (68.7%) patients, of whom 32.3% had no genetic cause determined for the variation. Oligogenic variants in multiple genes (including 5 homozygotes) were noted among 14 (11%) patients, and 57% had monogenic variants (including 5 homozygotes).

There were 66 patients with 93 APOA5 variants identified, of whom 65 had at least 1 risk allele, 2 pathogenic variants, and 2 likely pathogentic heterozygotes. There were 29 LPL variants, 6 LMF1, 2 APOC2, and 2 CREB3L3 identified, which accounted for 22% of variants overall. In both APOC2 and LMF1 genes, there was 1 likely pathogenic variant identified. The investigators identified 16 variants of unknown significance in LPL, APOA5, APOC2, CREB3L3, and LMF1 genes overall, whereas no variants were identified in GPD1 and GPIHBP1 genes.

The investigators noted 11 patients with pathogenic LPL variants (3 homozygous for classic FCS variants). There were 9 additional patients in whom the LPL risk allele was found (triglyceride level, ≤13,000 mg/dL). They also identified 1 LPL variant that was likely pathogenic. Among all patients, 18.1% had classic familial chylomicronemia syndrome with LPL heterozygotes and 2.4% had LPL homozygotes.

Study limitations include potential ascertainment bias and a population that may not reflect all patients with severe hypertriglyceridemia. In addition, some genetic variants may not have been identified, and data were unavailable for genotype and phenotype correlations.

 According to the investigators, “Given these allele frequencies in an enriched population, genetic testing for patients suspected of FCS [familial chylomicronemia syndrome] is warranted to further characterize FCS associated variants.”

Disclosure: This research was supported by Ionis Pharmaceuticals. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Metabolic syndrome has been associated with increased risk for cardiovascular disease. Researchers assessed whether patients with metabolic syndrome experienced higher rates of mortality, thrombosis, acute kidney injury, cardiogenic shock, cardiovascular accident, intraoperative and postoperative complications, ventricular tachycardia, and ventricular fibrillation after undergoing PCI compared with the general population.

Of the 432,764 patients who underwent PCI, 0.04% had a history of metabolic syndrome. At baseline, patients with a history of metabolic syndrome were younger compared with the general population (age, 61 years [95% CI, 60-62] vs 66 year [95% CI, 66-66]). When undergoing PCI, patients with a history of metabolic syndrome did not experience statistically significant higher rates of mortality (P =.7726), coronary artery thrombosis (P =.1309), acute kidney injury (P =.4399), cardiogenic shock (P =.3925), cardiovascular accident (P =.1443), intraoperative and postoperative complications (P =.1498), ventricular tachycardia (P =.7298), or ventricular fibrillation (P =.4869) compared with the general population.

While metabolic syndrome increases the risk for coronary artery disease, “there is no significant difference in in-hospital mortality between patients with metabolic syndrome and the general population who underwent PCI,” the study authors concluded.

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Researchers used data from the National Inpatient Database of 2020 to identify prediabetic patients who had PCI. Outcomes included in-hospital mortality, acute kidney injury, cardiogenic shock, cerebrovascular accident (CVA), coronary artery thrombosis, intraoperative and postoperative complications, hospital length of stay, and total hospital charges.

A total of 432,765 patients received PCI, of whom 3% were prediabetic. Outcomes were compared in 11,515 prediabetic patients and 239,395 nondiabetic patients. The patients with prediabetes were younger (mean age, 63 years [95% CI, 63-64] vs 65 years [95% CI, 65-66]).

The patients with prediabetes had a lower rate of in-hospital mortality (n=145) compared with nondiabetic patients (n=7659; P <.0001), which was statistically significant.

Prediabetic patients also had a lower rate of acute kidney injury (P =.0207), cardiogenic shock (P =.0001), ventricular fibrillation (P =.0378), length of hospital stay (3.1 days [95% CI, 3.0-3.2] vs 4 days [95% CI, 3.5-4.0]), and total hospital charges ($114,222.8 [95 % CI, $109,026.4-$119,414.3] vs $125,877.7 [95% CI, $122,393.2-$129,363.2]).

No difference was observed in the 2 groups regarding coronary artery thrombosis (P =.1834), CVA (P =.5974), intraoperative and postoperative complications (P =.1071), and ventricular tachycardia (P =.6320).

“More research is needed to identify factors that increase mortality in patients who undergo PCI,” wrote the researchers.

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Investigators sought to analyze all lipoprotein fractions (except lipoprotein[a]) for particle number and lipid apolipoprotein content and validate use of specialized NMR software for measurement of triglycerides (TG), serum total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apoB, and apoA-I concentrations. Outcomes between men and women were compared.

Fasting serum (≥8 hours) from 1076 individuals (53.2% women) was analyzed. The investigators used 600 MHz NMR and Bruker B.I.LISA analytical software, as well as New York State testing criteria, for the analysis. They compared LDL-particle (P) and HDL-P via 600 MHz NMR and Numares analytical software; ApoB and apoA-I by immunoturbidimetric assays; and HDL-C, small dense LDL-C, TG, total cholesterol by standardized enzymatic methods.

There was a high correlation (r>0.95) with standardized enzymatic and immunoturbidimetric values for HDL-C, directed LDL-C, TG, total cholesterol, apoB, and apoA-I in the NMR-derived concentrations (P <.00001). There was a high correlation (r=0.920) between LDL-P values derived by Numares software analysis and values derived by Bruker software analysis (P <.0001).

Women had significantly higher large buoyant LDL1-P and LDL2-P and total LDL-P and significantly lower very low-density lipoprotein (VLDL)-P and LDL3-P (P <.00001). They had slightly higher small dense LDL6-P (P =.046), trending towards lower LDL6-C concentration (P =.071).

Women also had higher LDL-C (median percent difference [MPD], +8.89), LDL-TG, LDL-apoB, and LDL6-C (P <.01) and lower VLDL-TG, VLDL-C, and VLDL-apoB (P <.00001) compared with men. This corresponded to LDL and VLDL particle number; lower serum TG concentrations (MPD, -6.99; P =.016); and significantly higher serum apoB, apoA-1, apoA-II, and total cholesterol concentrations (P <.01).

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Investigators sought to assess the efficacy and safety of statin therapy in individuals with and without baseline kidney disease. Secondary endpoints included evaluation of changes in estimated glomerular filtration rate (eGFR) and proteinuria, and beneficial effects of statins on low-density lipoprotein cholesterol (LDL-C) concentrations.

The investigators conducted a pair-wise random effects meta-analysis including articles from Cochrane, PubMed, and Embase from inception to October 2022. They found 48 studies (33 used hydrophobic statins; 15 used hydrophilic statins) that included 6668 individuals with CKD at baseline (mean age, 58±9.3 years; mean eGFR in statin group 68±31mL/min/m² vs mean eGFR in placebo group 70±30.8mL/min/m²). There were 45 studies evaluating baseline and post-treatment eGFR and 16 studies examining proteinuria changes.

Investigators found the statin group vs placebo group showed significant improvement in eGFR (mean difference [MD], 0.067; 95% CI, 0.055-0.079; P ≤.00001), significant reduction in proteinuria (MD, -0.643; 95% CI, -1.002 to -0.285; P ≤.00001), and significant reduction in LDL-C (statin group, 143±32mg/dL to 100±21; vs placebo group 141±39 mg/dL to 140±42).

“Statin use significantly attenuated the progression of kidney function decline and proteinuria,” the investigators wrote. Statin type and baseline CKD status may alter the renoprotective effect of a statin. They added, “These results should spur RCTs [randomized controlled trials] that use CKD progression as one of the primary endpoints in patients with CKD and ASCVD, which will inform future guidelines about the potential for statin use in preventing CKD progression while also reducing major adverse cardiac events.”

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Researchers assessed the long-term efficacy and safety of twice-yearly subcutaneous (SC) inclisiran in patients aged 18 years or older with clinical ASCVD (or high-risk primary prevention) and increased LDL-C despite use of maximally tolerated statins or other oral lipid-lowering therapy. Patient data are from the ORION-3 (ClinicalTrials.gov Identifier: NCT03060577) trial, which is a long-term, open-label extension to the phase 2 ORION-1 study.

ORION-3 included 2 treatment arms, an inclisiran-only arm and a “switching” arm in which patients received SC evolocumab in year 1. The exploratory subgroup analysis only included data of patients with clinical ASCVD.

The primary endpoint in ORION-3 was the percentage change in LDL-C from baseline in ORION-1 to day 210 of ORION-3 (570 days of inclisiran exposure) in the inclisiran-only arm.

The analysis included 253 participants (mean age, 65.0 [SD, 9.3] years; 72.7% men) with clinical ASCVD. The inclisiran-only arm intention-to-treat (ITT) and modified ITT (mITT) populations included 190 and 181 participants, respectively, and the switching arm included 63 participants. A total of 206 patients completed the 4-year study (150 in the inclisiran-only arm and 56 in the switching arm).

The mean percentage decrease in LDL-C from baseline to day 210 in the inclisiran-only arm was 49.5% (95% CI, -53.0 to -45.9; P <.0001). The mean time-averaged decrease in LDL-C during the 4-year study period was 46.2% (95% CI, -49.8 to -42.6). For the switching arm, the time-averaged mean percentage decrease in LDL-C with evolocumab (year 1) was 63.0% (95% CI, -67.2 to -58.9), and for inclisiran (years 2-4) it was 45.2% (95% CI, -50.5 to -39.9).

In the inclisiran-only arm, about 83% of patients met LDL-C levels of less than 70 mg/dL at any point after day 1 of ORION-1, and 74.1% of patients achieved LDL-C levels of less than 55 mg/dL.

Patients in the inclisiran-only arm had a cumulative exposure to inclisiran (ORION-1 through ORION-3) of 794.3 patient-years. In the switching arm, cumulative exposure to inclisiran was 176.8 patient-years (ORION-3).

In the inclisiran-only arm (n=185), 96.2% of patients had 1 or more treatment-emergent adverse event vs 91.9% in the switching arm (n=62). In the inclisiran-only arm, 20.5% of patients had 1 or more drug-related treatment-emergent adverse event vs 29.0% in the switching arm.

Limitations of the study include the small population and potential selection bias owing to the voluntary enrollment of patients from ORION-1. Also, the study is not powered to provide formal efficacy comparisons between evolocumab and inclisiran.

“In this exploratory post-hoc analysis of ORION-3, including patients with clinical ASCVD and elevated LDL-C, twice-yearly health care professional-administered inclisiran provided consistent and effective long-term LDL-C lowering when added to maximally tolerated statins,” the researchers wrote.

Disclosure: This investigation was sponsored by Novartis Pharmaceuticals Corporation. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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The study was aimed at improving identification, adherence, and education in primary care among adult patients with MetS.

The researcher conducted a lifestyle intervention quality improvement program in Southeast Texas at a primary care nurse practitioner clinic in 2021 that included adult patients enrolled in the Model for Improvement Framework — Plan Do Study Act.

The program included a chart review and written and verbal education, along with the method and content of education, accurate diagnosis of MetS, and frequency of waist circumference documentation. The researcher assessed anthropometric patient measurements and survey of physical activity and dietary habits, and conducted a survey of provider and staff measurement processes, self-perceived efficacy, and satisfaction, as well as health literacy.

The National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII) definition was used for MetS (defined as ≥3 blood glucose >100; blood pressure >130/85; high-density lipoprotein cholesterol <40 [men] or <50 [women]; waist circumference >40 inches [men] or >35 inches [women]; and triglycerides >150).

Results showed, at baseline screening, 7 of 25 participants had the presence of 3 or more of the diagnostic criteria. After the completion of the project, 23 of the 25 participants had 3 or more of the diagnostic criteria.

Changes before vs after the project were noted (mean weight, 233.13±58.75 vs 228.28±59.32 pounds; waist circumference, 47.1±6.51 vs 45.5±6.42 inches; BMI, 37.69±8.13 vs 36.83±8.24; health literacy, 73±21.79 vs 98±6.16, respectively; P =.000 for all). Reductions in weight, waist circumference, and BMI were found to be statistically significant. The mean health literacy increased 25% and diagnostic accuracy 64%.

“Early diagnosis and implementation of lifestyle intervention programs are effective at reducing markers of MetS,” the researcher concluded, with “patient reporting of progress [improving] adherence.”

Some of the key takeaways from the study were that providers must assess MetS and metabolic dysfunction, and waist circumference, of their patients, and must enable patients to self-report progress, if they are enrolled in a lifestyle program. In addition, clinicians should recognize the importance of early diagnosis and implementation of lifestyle changes, and that verbal, along with written, education may improve health literacy.

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Researchers aimed to assess the safety and efficacy of evinacumab in young pediatric patients with HOFH. During Part B of the study, among the intent-to-treat (ITT) population, mean percent change in LDL-C to week 24 from baseline was the primary efficacy endpoint.

The researchers conducted an open-label, multicenter, 3-part study (ClinicalTrials.gov Identifier: NCT04233918) that included 6 patients in Part A (mean age, 8.8±1.7 years; 67% girls), 14 patients in Part B (mean age, 9.1±1.9 years; 57% girls), and all 20 of these patients in an ongoing Part C. Inclusion criteria included the patients being aged 5 to 11 years, with LDL-C greater than 130 mg/dL while being treated with lipid-lowering therapy.

Part A (16-week Phase 1b, open-label, single dose intravenous (IV) evinacumab 15 mg/kg) aimed to evaluate pharmacokinetics, pharmacodynamics, and safety of evinacumab. Part B (24-week Phase 3, open-label, evinacumab 15 mg/kg IV every 4 weeks [Q4W]) aimed to evaluate the efficacy and safety of evinacumab in 14 patients who did not participate in Part A. Part C (48-week Phase 3 on-going, open-label extension with 24-week follow-up, evinacumab 15 mg/kg IV Q4W) aimed to evaluate long-term efficacy and safety of evinacumab and included all 20 patients from Parts A and B.

There was a mean maximum LDL-C reduction of 41.6% (SD, 18.3%) after 8 weeks among all 6 patients in Part A. Of patients in Part B, 78.6% experienced at least a 50% reduction in LDL-C after 24 weeks. At week 24, among the 14 patients in Part B, there was a mean percent change from baseline of -48.3%±10.4%. Additional mean percent changes from baseline to week 24 occured (total cholesterol, -49.1%±8.1%; non-high-density lipoprotein cholesterol, -48.9%±9.8%; apolipoprotein B, -41.3%±9.0%).

There was a -43.0%±12.8% mean percent change in LDL-C for patients with a defective/negative low-density lipoprotein receptor (LDLR) variant (LDLR activity >15%) and -67.7%±6.5% for patients with a negative/negative LDLR variant (LDLR activity ≤15%).

The researchers noted that 10 of the 14 patients in Part B experienced treatment-emergent adverse events (TEAEs). There were 2 of these patients in whom TEAEs were treatment-related (abdominal pain and nausea). Additionally, patients experienced oropharyngeal pain (n=3), diarrhea (n=2), vomiting (n=2), headache (n=2), and nasopharyngitis (n=2). There was 1 patient who experienced a serious TEAE (tonsilitis), not considered treatment-related. There were 3 patients who experienced at least 1 severe TEAE. They reported no deaths or treatment discontinuations due to TEAEs.

A limitation of this study is the small sample size.

“In very-young pediatric patients with HOFH (aged 5–11 years) and inadequately controlled LDL-C despite optimized lipid-lowering therapy (including apheresis and lomitapide), evinacumab rapidly and durably lowered LDL-C, with considerable reductions of 48% by week 24,” the researchers wrote. “Evinacumab was generally well tolerated, and the safety profile remained consistent with that observed in adult and adolescent patients, with no new safety signals observed.”

Disclosure: This research was supported by Regeneron Pharmaceuticals, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers sought to assess patient and provider characteristics regarding patients who initiated inclisiran in a real-world setting. The retrospective analysis was conducted in adult patients who initiated inclisiran from Komodo Health, a nationally representative longitudinal database of patients enrolled in a US health care plan.

Participants were adults who received an initial dose of inclisiran from January 2022 to October 2022 and had 12 months of continuous enrollment in a health plan before the index date.

A total of 465 patients were identified from closed claims and 905 from open claims. The mean (SD) age was 67.8 (10.7) years for patients from closed claims and 71.6 (8.7) for those from open claims. A majority of participants were aged 65 years or older (68.4% closed claims; 83.7% open claims), and more than half were women (52.3% closed claims; 57.2% open claims).

Patients were most frequently enrolled in commercial insurance plans (47.3% closed claims, 42.5% open claims), followed by Medicare Advantage for closed claims (42.4%), and Medicare for open claims (38.2%).

Among the cohort, 83.9% of patients in closed claims and 86.3% in open claims had clinical atherosclerotic cardiovascular disease at baseline. Most participants had hypertension (83.7% in closed claims and 79.1% in open claims), and 43.4% in closed and open claims had diabetes. In addition, a little more than half of the patients had received statins before starting inclisiran (56.3% for closed claims and 51.0% for open claims).

Regarding primary specialties of the providers who administered inclisiran, for closed claims, 29.9% were nurse practitioners (NP) or physician assistants (PA) and 16.1% were cardiologists. In open claims, 33.9% were NP/PA, and 22.5% were cardiologists.

Limitations of the study include the use of administrative claims data for nonresearch purposes with limited details on clinical variables and the potential for missing data and coding-related errors. Also, clinical characteristics and medication data were obtained during the 12 months before the initiation period, and the study focused on describing the characteristics of patients who successfully initiated inclisiran.

“Though not observable in the administrative claims database, a large proportion of patients may have been statin intolerant,” wrote the researchers. “No notable difference was observed between patients identified in open vs closed claims based on this descriptive analysis. Additional evidence generation is ongoing to fully characterize the real-world effectiveness of inclisiran beyond the immediate postapproval period in the United States and worldwide.”

Disclosure: This study was conducted by Komodo Health and funded by Novartis Pharmaceuticals Corporation. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Researchers developed a diabetes risk prediction model and assessed its ability in accurately identifying individuals with prediabetes and diabetes who would benefit from lifestyle modifications.

Data for the model were sourced from the longitudinal Framingham Offspring Study. The study included 2414 patients (mean age, 58 years) who were diabetes-free at baseline. Variables entered into the model included cholesterol-lowering medication use, parental history of diabetes, body mass index; and high-density lipoprotein cholesterol, triglycerides, total cholesterol, glycated serum albumin, insulin, adiponectin, and glucose levels. The researchers assessed the occurrence of new diabetes during a mean follow-up period of 10 years.

Diabetes risk models were subsequently developed using step-wise multivariate analysis and applied to a large fasting population (N=133,764) along with lifestyle modification. Homeostasis model assessment of insulin resistance (HOMA_IR) and insulin sensitivity and production (HOMA_β) were calculated in all patients.

Among the fasting population, 2017 (7.5%) were diabetic (predicted 10-year diabetes risk rate, 100.0%), 9738 (36.2%) were prediabetic (10-year risk rate, 5.5%), and 56.3% were neither (10-year risk rate, 0.3%).

There were significant differences in the degree of insulin resistance and insulin production among patients with diabetes indicated via HOMA evaluations. Further analysis showed that some patients with diabetes required insulin therapy due to markedly decreased insulin production.

For patients with diabetes, 10.7% received a lifestyle modification plan. Following receipt, 8.2% of patients were no longer diabetic vs 3.4% of control patients (P <.001). For patients with prediabetes, 12.0% requested a lifestyle modification plan. After receipt, the risk for diabetes among these patients decreased from 5.7% to 3.1%, with no change in diabetes risk observed in control patients (P <.001).

Overall, lifestyle modifications were associated with reduced insulin resistance but did not result in significantly increased insulin production. In addition, both HOMA-IR and HOMA_β were effective for identifying patients who require insulin therapy due to reduced insulin production.

According to the researchers, “Our biochemical model was useful in targeting pre-diabetic and diabetic subjects for lifestyle change.”

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Rates of dyslipidemia were observed to increase with higher socioeconomic status (SES), despite lower rates of obesity and diabetes, according to results of a study presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

SES, according to ZIP code, may have important implications for access to healthcare and dietary options. Investigators from Memorial Healthcare System in Florida sought to evaluate the relationship between SES and dyslipidemia in the United States. Data were sourced from the 2016 to 2018 Nationwide Inpatient Sample. Univariate and multivariate analyses were performed to evaluate relationships.

Patients were divided into the first (n=27,090,614), second (n=23,576,000), third (n=21,133,731) and fourth (n=17,468,777) SES quartiles, with the first quartile having the lowest SES. The first quartile, compared with the fourth, was younger (aged mean 56.3 vs 59.5 years) and associated with higher rates of hypertension (34.8% vs 33.7%), diabetes (29.8% vs 21.8%; P <.001), and obesity (17.6% vs 14.3%; P <.001), but lower rates of dyslipidemia (28.5% vs 32.0%; P <.001).

Compared with the first quartile, the second (odds ratio [OR], 1.06; 95% CI, 1.05-1.06; P <.0001), third (OR, 1.10; 95% CI, 1.10-1.10; P <.0001), and fourth (OR, 1.12; 95% CI, 1.12-1.12; P <.0001) SES quartiles were associated with increased risk for dyslipidemia.

Compared with the fourth quartile, the third (OR, 1.10; 95% CI, 1.07-1.08; P <.0001), second (OR, 1.16; 95% CI, 1.15-1.16; P <.0001), and first (OR, 1.19; 95% CI, 1.18-1.20; P <.0001) SES quartiles were associated with increased risk for coronary heart disease among the subset of patients with dyslipidemia.

Similarly, the third (OR, 1.12; 95% CI, 1.10-1.15; P <.0001), second (OR, 1.20; 95% CI, 1.17-1.22; P <.0001), and first (OR, 1.26; 95% CI, 1.24-1.29; P <.0001) SES quartiles were associated with increased risk for peripheral artery disease among the subset of patients with dyslipidemia.

Stroke in dyslipidemia was associated with the fourth (OR, 1.04; 95% CI, 1.03-1.05; P <.0001) and third (OR, 1.02; 95% CI, 1.01-1.03; P =.001) SES quartiles.

This study found that dyslipidemia was increased among individuals with higher SES, despite lower incidences of obesity and diabetes. Among individuals who developed dyslipidemia, coronary heart disease and peripheral artery disease rates were higher among individuals with low SES and stroke risk was increased among individuals with high SES.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Park K, Konindala N, Aung P.  Socioeconomic Disparities in Dyslipidemia and Associated Complications. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #64.

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When patients with rheumatoid arthritis (RA) with an elevated erythrocyte sedimentation rate (ESR) were compared with patients with RA and a normal ESR, lipid profiles were no more likely to be evaluated and patients were no more likely to be prescribed lipid-lowering medication, according to research presented at the National Lipid Association (NLA) Scientific Sessions 2022 from June 2^nd through 5^th, in Scottsdale, AZ. These findings add to the paradox in RA patients of LDL inversely correlated with inflammation.

The leading cause of early death among patients with RA is cardiovascular disease (CVD), and while decreased inflammation and better CVD outcomes are associated with lipid-lowering therapies in these patients, increased inflammation has been associated with low HDL, LDL, and total cholesterol levels making treatment options problematic. In RA patients, researchers sought to investigate the association between lipid markers and inflammation by ESR and to document lipid management and monitoring practices in these patients.

To accomplish this, they conducted a retrospective cross-sectional study of 756 patients (mean 54.1 years of age; 80.7% female; 43.4% non-Hispanic Black) with RA and an electronic medical record (EMR) of ESR (elevated defined as ≥20mm/hr), seen at least 2 times at a minority-serving metropolitan outpatient rheumatology clinic. Of these patients, 200 (26.5%) also had a lipid panel in the EMR, and rates of obtaining lipid profiles were statistically similar between those patients with high vs normal ESR (29.5% vs 23.5%; P =.06).

A significant difference between high vs normal ESR was seen in LDL-C (94.6mg/dl vs 105.4mg/dl; P =.03). No difference was seen between high vs normal ESR in triglycerides (P =.67), HDL-C (P =.87), and total cholesterol (P =.09). Also, in high vs normal ESR, there was no difference in the prescription rate of lipid-lowering medications (9.9% vs 8.1%; P =.38).

Researchers concluded that, “Among patients with elevated ESR, only 29.5% of patients were evaluated with a lipid profile, and 9.9% of patients were prescribed a lipid-lowering medication.” These results add credence to the lipid paradox among RA patients — LDL being inversely correlated with inflammation. Researchers suggest, “specialized risk evaluation and rigorous management of atherosclerotic CVD with a lipid specialist or preventive cardiologist,” for patients with RA and elevated ESR.

Reference

Aronov A, Kim YJ, Nazir NT. Association of systemic inflammation with lipid profiles and management in patients with rheumatoid arthritis. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #50.

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Estrogen, but not testosterone, was found to inhibit expansion of cholesterol during the crystallization process, according to results of a study presented at the National Lipid Association Scientific Sessions in Scottsdale, Arizona, from June 2nd to 5th, 2022.

Estrogen and testosterone hormones are formed by a cholesterol-based molecule, and the 2 hormones only differ by one OH side branch and methyl group. However, despite their similar chemical structures, their effects differ greatly.

Cholesterol crystallization has been implicated in atherosclerotic plaque destabilization and can lead to rupture and cardiovascular events. Estrogen has been associated with protective effects against cardiovascular events among premenopausal women.

In order to evaluate the potential mechanisms behind estrogen’s beneficial effects, investigators from Michigan State University performed a scanning electron microscopy study. Graded concentrations of estradiol or testosterone of 13, 130, and 1300 mg were mixed with 3 g of cholesterol power in 1 mL of water. The mixtures were allowed to crystalize at room temperature (22°C). Changes in volume expansion between liquid and crystalline phases were compared against water alone.

The change in cholesterol volume expansion decreased significantly with greater estradiol concentrations (P <.01). This trend was not observed for testosterone (P =.64), in which the change in volume expansion was similar to water alone regardless of the concentration of testosterone.

Scanning electron microscopy imaging demonstrated the cholesterol crystals that were exposed to estrogen to be dissolving compared with intact crystals in the absence of estrogen.

This study found that the volume expansion with cholesterol crystallization from liquid to solid was inhibited with the addition of estrogen. This pattern was not observed with testosterone. These findings are consistent with clinical observations that support the protective effect of estrogen in decreasing the frequency of cardiovascular events among premenopausal women.

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Wang E, Al-Abcha A, Osman H, Oladeji A, Boumegouas M, Abela GS. The effect of estrogen and testosterone on cholesterol crystallization. Presented at: National Lipid Association 2022 Scientific Sessions; June 2-5, 2022; Scottsdale, Arizona. Abstract #56.

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Outside of regular atherosclerosis risk factors, there is a significant association between low HDL cholesterol (HDL-C) and a rising total cholesterol to HDL (TC/HDL) ratio with increasing coronary plaque volumes, according to research presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

Previous studies have shown HDL-C levels and the TC/HDL ratio are useful predictors of cardiovascular risk, but not how or why that is. Researchers sought to examine the association between HDL-C level and the TC/HDL ratio with coronary artery plaque volumes.

To accomplish this, they conducted a cross-sectional study that included 190 participants (aged 58.9±9.8 years; 37% women; 83% had hypertension; 78% had hyperlipidemia; 57% had diabetes) with stable coronary artery disease who participated in quantitative plaque analysis and lipoprotein level analysis. Evaluation of the association of HDL-C and TC/HDL ratio with coronary plaque volumes was achieved with multivariate regression models adjusted for cardiovascular risk aspects.

HDL-C (>40 mg/dl) is inversely associated with fibrous plaque (P =.003), fibrous fatty plaque (P =.009), low attenuation plaque (LAP) (P =.014), total noncalcified plaque (TNCP) (P =.003) and total plaque (TP)(P =.005) volume, but is not associated with dense calcified plaque (P =.229), after adjustment for cardiovascular risk factors.

The TC/HDL ratio (>4.0) is associated with LAP (P =.024), but statistically not associated with the fibrous, fibrofatty, TNCP, and TP volumes.

“There is a strong association between low HDL-C and increasing TC/HDL ratio with increasing coronary plaque volumes, independent of traditional risk factors of atherosclerosis,” the study authors noted. “The findings of this study suggest mechanistic evidence supporting the protective role of HDL-C in coronary artery disease.”

Reference

Manubolu VS, Verghese D, Alalawi L, et al. Coronary computed tomography angiography evaluation of plaque morphology and its relationship to HDL and total cholesterol to HDL ration. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #67.

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High 30-day readmission rates exist among patients with acute congestive heart failure (aCHF) and underlying metabolic syndrome (MetS) but with no statistical significance with a slightly higher mortality rate seen during readmission, according to research presented at the National Lipid Association (NLA) Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

A greater risk for heart failure with preserved ejection fraction (HFpEF) may be indicated in patients with type 2 diabetes mellitus (type 2 DM), atrial fibrillation (AF), atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD); a greater risk for hypertensive heart failure in patients with aCHF and MetS was also found.

Patients with heart failure (HF) often have MetS, a cardiovascular disease independent risk factor whose significance for HF outcomes lacks full understanding, the study authors wrote. They sought to investigate the 30-day readmission rate (30-DRr) for aCHF with co-existing MetS, the outcomes, and health care consumption.

To accomplish this, they conducted a retrospective analysis of data from the 2016 and 2017  National Readmission Database  of patient discharges with aCHF and coexisting MetS that included 530 index hospitalizations (mean age, 62.2 years; 48.4% women) for aCHF with MetS, and 71 readmissions (mean age, 60.6 years; 38.9%women) within 30 days. The primary end point was 30-DRr, and secondary end points included readmission death rate, reason for readmission, and resource consumption.

Analyses revealed that the 30-DRr was 13.6%. The index admission in-hospital mortality rate was 1.7% and the readmission in-hospital mortality rate was 2.2%, a statistically insignificant difference, the investigators noted. The health care in-hospital cost was more than $1 million, and the patient economic load more than $3.5 million.

Researchers concluded that among patients with aCHF and underlying MetS, there was a significant 30-DRr, and although the readmissions were associated with an increased mortality rate, there was no statistical significance. They added, “A higher risk for hypertensive heart failure among MetS patients and a greater proportion of patients with CKD, ASCVD, AF, Type 2 DM and other comorbidities may indicate a higher risk for HFpEF.”

Reference

Fatuyi M, Pereira L, Khoklov L, et al. Rate of 30-day readmission and economic burden of patients with acute congestive heart failure with coexisting metabolic syndrome. Presented at: National Lipid Association (NLA) Scientific Sessions 2022; June 2-5, 2022; Scottsdale, AZ. Abstract #69.

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Considerable overlap exists between barriers and facilitators related to care for familial hypercholesterolemia (FH), according to study results presented at the National Lipid Association Scientific Sessions, from June 2 to 5, 2022, in Scottsdale, Arizona.

FH is associated with premature cardiovascular disease. Although effective diagnostic criteria and therapies are available, FH is vastly underdiagnosed and undertreated. In order to evaluate barriers to FH care, investigators at the Geisinger Commonwealth School of Medicine searched publication databases through December 2021 for studies regarding barriers and facilitators of FH.

A total of 26 articles were evaluated for determinants at the individual, clinician, health system, and research levels.

The investigators found that at the individual level, cost, lack of awareness, absent or limited insurance coverage, nonadherence, side effects, competing family or personal demands, stigma and health anxiety, familial social dynamics, education, privacy concerns, discrimination, access to health care or patient support organizations, relationship with physicians or the health care system, and not achieving target low-density lipoprotein cholesterol levels with current therapies were significant barriers.

At the clinician level, lack of awareness, belief in lack of evidence, perception, other clinical demands, inadequate record keeping, legal concerns, poor insurance reimbursement, education, and skill comfort with genetic disorders were endorsed as barriers.

For the health system, gaps in access to care, lack of focus on prevention, cost, genetic testing resources, and lack of formal screening programs were barriers.

At the research level, the barriers included difficulty in identifying FH probands and paucity of data on ideal treatments.

In general, barriers affected treatment more than identification or cascade testing.

The study authors concluded there was substantial literature on barriers and facilitators to FH care that could help inform interventions.

“Future interventions should target barriers reported across several studies or address combinations of identification, cascade testing, and treatment,” the study authors noted. “Facilitators that have positively impacted multiple aspects of FH care should be promoted and incorporated into care delivery.”

Reference

Rodriguez G, Calvo EM, Walters NL, et al. Barriers and Facilitators to Identification, Cascade Testing, and Treatment for Familial Hypercholesterolemia: A Scoping Review. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Poster 24.

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Lipoprotein(a) [Lp(a)] levels were negatively correlated with increased total and monosaturated fat consumption, according to results of a study presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

Lp(a) is an established risk factor for atherosclerotic cardiovascular disease (ASCVD). The association between dietary fat consumption and ASCVD has not been fully elucidated.

In order to better establish the relationship between dietary fat intake and Lp(a), data for this study were sourced from the National Health and Nutrition Examination Survey (NHANES III). Twenty-four-hour dietary recall data were compared with results from a Lp(a) enzyme-linked immunosorbent assay.

The study population comprised 8722 individuals who were mostly women (56.3%) and over a third were White (38.5%).

The change in Lp(a) per 24-hour intake of fat was significantly associated with total fat intake (mean change, -0.05; 95% CI, -0.09 to -0.01 mg/dL; P =.01), total monosaturated fat intake (mean change, -0.10; 95% CI, -0.19 to -0.02 mg/dL; P =.02), C18:1 monosaturated fat intake (mean change, -0.11; 95% CI, -0.20 to -0.02 mg/dL; P =.02), C18:3 polyunsaturated fat intake (mean change, -1.21; 95% CI, -2.11 to -0.32 mg/dL; P =.01), and C14:1 monosaturated fat intake (mean change, -5.4; 95% CI, -10.7 to -0.01 mg/dL; P =.05).

In addition, intake of C16:0 saturated fats was trending toward significance (mean change, -0.18; 95% CI, -0.36 to 0.00 mg/dL; P =.052).

The major limitation of this study was the reliance on 24-hour dietary recall and not prospectively collected dietary information.

This study found that Lp(a) was negatively correlated with high total and monosaturated fat consumption and that the size of the fatty acid chain length may be important. The lack of a significant association between Lp(a) and saturated fat consumption conflicts with previously published data. Additional research is needed to understand how dietary components impact Lp(a) phospholipid content and ASCVD risk.

Reference

Patel N, Brandt E. Association Between Dietary Fat Content and Serum Lipoprotein(a) Level. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ.  Abstract #18.

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Patients with ST-elevated myocardial infarction (STEMI) should be evaluated for lipoprotein (a) [Lp(a)] and given additional, aggressive therapy if needed, according to results of a retrospective, single-center study presented at the National Lipid Association Scientific Sessions in Scottsdale, Arizona from June 2 to 5, 2022.

Previous studies found that 10% to 35% of patients with STEMI were on some lipid-lowering medication. Investigators at the University of Colorado Anschutz Medical Campus in Aurora sought to evaluate the proportion of patients presenting with STEMI at their facilities who were on lipid-lowering therapies. The researchers also assessed whether patients presenting with STEMI had been evaluated for cholesterol levels or other lipid disorders during their hospitalization.

A total of 50 patients with STEMI were evaluated during the 12-month study period. Of those, 16% were already receiving lipid-lowering medications at the time of their STEMI. Most patients who were receiving therapy were on atorvastatin. Nearly a third of patients (30%) met the criteria for receiving lipid-lowering medication. Two patients met the criteria for likely familial hypercholesterolemia.

Patients receiving lipid-lowering therapy had decreased low-density lipoprotein cholesterol (LDL-C) compared with patients not on therapy (mean, 89.4 vs 109.8 mg/dl).

Among patients receiving therapy, additional lipid lowering therapy was given to 2% of patients and Lp(a) was evaluated among 1% of patients.

No patients were evaluated for homocysteine or hypobetalipoproteinemia or other metabolic measures.

At follow-up, LDL-C decreased from 106.6 to 51.8 mg/dl and high-density lipoprotein cholesterol (HDL-C) increased from 39.5 to 42.3 mg/dl.

The study authors concluded that patients presenting with STEMI were rarely evaluated for metabolic levels, despite the fact that 30% of patients met the criteria to receive lipid-lowering medications, and few received therapy. The study authors recommended that aggressive, additional lipid lowering therapy should be given to patients who are in need of additional therapy.

This study was limited because it involved only one site and thus findings may not be generalizable to other sites.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Gill EA, Zirille FM, Morcos M, Simon S, Saxon D. Why are patients presenting with STEMI already on statin not treated with additional aggressive lipid lowering agents? Presented at: NLA Scientific Sessions 2022; June 2-5, 2022; Scottsdale, Arizona. Abstract 70.

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Bempedoic acid was generally well tolerated and led to glycemic parameter improvement and greater low-density lipoprotein cholesterol (LDL-C) reduction in patients with metabolic syndrome (MetS), according to a poster presented at the National Lipid Association (NLA) Scientific Sessions 2022, held in Scottsdale, Arizona, between June 2nd and June 5th, 2022.

The findings are based on a pooled analysis of 4 phase 3 studies of 3623 patients, of whom 1114 with diabetes were excluded. The participants were randomized 2:1 to bempedoic acid or placebo and were grouped by baseline metabolic status. MetS was defined according to modified International Atherosclerosis Society guidelines with body mass index as a proxy for waist circumference.

Among the 936 patients with MetS, 648 received bempedoic acid and 288 received placebo. Of the 1573 patients without MetS, 1037 received bempedoic acid and 536 received placebo.

The participants were assessed for the percentage change in LDL-C at week 12, as well as changes in total cholesterol (TC), non–high-density lipoprotein cholesterol (HDL)-C, apolipoprotein B (Apo B), high-sensitivity C-reactive protein (hsCRP), triglycerides (TG), and changes in fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) at week 12. Safety assessments were investigator-reported.

Of the patients with MetS, those who received bempedoic acid had a mean age of 63.7 ± 9.1 years, and 67.3% were male; those who received placebo had a mean age of 64.2 ± 9.0 years and 67.7% were male. Of the participants without MetS, those who received bempedoic acid had a mean age of 65.8 ± 9.7 years and 65.8% were male; those who received placebo had a mean age of 66.2 ± 9.3 years and 64.2% were male. More than 90% of participants in all groups were White.

The placebo-corrected least squares mean in LDL-C percentage change at week 12 was significant for bempedoic acid (P <.0001) regardless of MetS status and was significantly more pronounced (interaction P = .0472) in patients with MetS compared with those without MetS.

The placebo-corrected least squares mean in percentage change at week 12 for TC, non–HDL-C, TG, and Apo B was significant (P ≤.02) for patients with and without MetS (interaction P =.523, P =.451, P < 0.0001, and P =.530, respectively).

The median difference at week 12 for hsCRP was significant for patients with and without MetS (with MetS, –17.9 [–25.1, –10.7], P <.0001; without MetS, –19.9 [–26.5, –13.2], P <.0001; interaction P =.965 in the log scale).

The placebo-corrected least squares mean percentage change at week 12 for HbA1c and FPG was significant for patients with MetS (HbA1c, −0.07 [−0.10, −0.04], P < .0001; FPG, −2.4 [−4.0, −0.9], P =.002) and insignificant for patients without MetS (interaction P =.0003 and P =.002, respectively).

The bempedoic acid safety profile was similar in patients with or without MetS. The incidence of treatment emergent adverse events (TEAEs) were comparable between the placebo and bempedoic acid groups. Nasopharyngitis was the most common TEAE in all 4 groups.

“Bempedoic acid was associated with significant decreases in LDL-C, TC, non–HDL-C, Apo B, and hsCRP regardless of the presence or absence of MetS,” stated the investigators. “Bempedoic acid lowered LDL-C levels to a greater extent in patients with MetS compared with patients without MetS.”

Disclosure: Clinical trials included in this analysis were funded by Esperion Therapeutics, Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Shapiro MD, Taub PR, Louie MJ, Lei L, Ballantyne CM. Efficacy and safety of bempedoic acid in patients with metabolic syndrome. Poster presented at: National Lipid Association (NLA) Scientific Sessions 2022; June 2-5, 2022; Scottsdale, Arizona.

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Individuals with familial combined hyperlipidemia (FCHL) and familial hypercholesterolemia (FH) have a significantly greater risk of incident coronary artery disease (CAD) compared with control patients, according to research presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

These findings are based on an analysis of participants in the UK Biobank cohort. Using modified versions of 5 different diagnostic criteria, the researchers identified individuals with an FCHL phenotype from 349,222 unrelated participants of European ancestry. Discovery, case-control, genome-wide association studies were conducted for the different criteria.

The investigators then evaluated the association of clinical and genetic risk factors with FCHL and examined the risk for incident CAD compared with participants with monogenic FH.

The FCHL phenotype prevalence was 11.44%, 5.01%, 1.48%, 1.10%, and 0.48% per modified versions of the Consensus, Dutch, Mexico, Brunzell, and Goldstein criteria, respectively.

According to the Mexico criteria, the researchers identified 64 lead single-nucleotide variants (SNVs) associated with FCHL at P <10^-8. All lead SNVs were previously associated with triglyceride levels, low-density lipoprotein-cholesterol, or total cholesterol.

The participants with FCHL (odds ratio [OR], 2.72 [2.33-3.18]) and FH (OR, 2.38 [1.75-3.24]) had a significantly greater risk of incident CAD compared with the control cohort.

“FCHL phenotype represents a polygenic susceptibility to dyslipidemia in combination with metabolic abnormalities,” the study authors wrote. “The cardiovascular risk associated with an FCHL phenotype is similar to that of monogenic FH, despite being [approximately] 5x more common.”

Reference

Trinder M, Vikulova D, Mancini GBJ, Brunham LR. Genetic architecture and cardiovascular risk of familial combined hyperlipidemia. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #6.

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Metabolic syndrome was found to be associated with a higher risk for developing pulmonary arterial hypertension (PAH) but did not affect in-hospital mortality, length of stay (LOS), or complications, according to study results presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, Arizona.

For the study, researchers conducted a retrospective analysis of the 2016 to 2018 Nationwide Inpatient Sample for patients chosen with the appropriate ICD-10 diagnosis code. Recognizing that the effect of metabolic syndrome on the pulmonary arterial system has yet to be elucidated, the researchers sought to identify the outcomes among patients with metabolic syndrome and PAH.

A total of 90,902,481 patients were hospitalized during the study period. Overall, the sample included 0.17% (150,095 of 90,902,481) of participants with metabolic syndrome and 99.83% (90,752,386 of 90,902,481) of those without metabolic syndrome.

Patients who had metabolic syndrome compared with those without tended to have obesity (64.0% vs 16.5%, respectively), hypertension (46.1% vs 34.4%, respectively), and diabetes (58.5% vs 26.4%, respectively). The mean age of the 2 groups was similar (57.7±0.09 vs 57.9±0.005 years, respectively). Overall, 53.1% of those with metabolic syndrome and 57.8% of those without metabolic syndrome were men.

Following adjustment for sex, age, and burden of comorbidities, the presence of metabolic syndrome was associated with a significantly increased risk for PAH (odds ratio [OR], 1.8; 95% CI, 1.2-2.8; P =.006). Further, among individuals who developed PAH, metabolic syndrome was linked to a significantly higher risk for major adverse cardiac events (OR, 3.6; 95% CI, 1.0-12.5; P =.04).

In contrast, in-hospital mortality (P =.9), LOS (P =.4), acute coronary syndrome (P =.1), acute respiratory failure (P =.6), and acute heart failure (P =.8) were all not statistically significantly affected by the presence of metabolic syndrome in patients with PAH.

“Further studies are needed to explicate the association of metabolic syndrome and PAH as well as to develop potentially effective therapies,” the study authors wrote.

Reference

Aung P, Park K, Konindala N, Nge H. Association between metabolic syndrome and  pulmonary arterial hypertension. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Poster 61.

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Sex disparities have been reported with respect to the treatment of and outcomes among patients with heterozygous familial hypercholesterolemia (HeFH). These findings were presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

A longitudinal registry analysis was conducted in patients with HeFH at the McGill University Health Centre, located in Montréal, Québec, Canada. The researchers sought to identify sex inequalities in the treatment of and lipid target achievement levels among patients with HeFH. All data used in the study were obtained from the FH Canada Registry. This registry includes patients who are diagnosed as having “definite,” “probable,” or “possible” FH, based on the Simon-Broome criteria, the Dutch Lipid Criteria, or the Canadian FH definition.

HeFH has a prevalence of 1 per 311 individuals in the general population. If left untreated, FH can lead to premature atherosclerotic cardiovascular disease and death. With many barriers to the care for patients with FH reported, low rates of diagnosis and subsequent suboptimal treatment and outcomes exist.

A total of 127 women and 162 men were screened. Results of the study show a sex bias in patients with FH in favor of men, with respect to the use of lipid-lowering treatment intensity. Overall, among 116 men and 85 women, 94% and 86%, respectively, received lipid-lowering therapy. The use of high-intensity statins was reported among 74% of men compared with 35% of women, a difference that was statistically significant (P =.002). Further, statin intolerance was reported among 22% of men vs 40% of women (P =.02).

Guideline-recommended lipid level achievement also differed between men and women. Overall, among 110 male participants and 81 female participants, the average percent reduction in LDL-C was –62%±20% in men vs –51%±20% in women (P =.01). A change in LDL-C levels of 2.5 mmol/L or less from baseline to the most recent visit (follow-up) was reported among 55% of men vs 32% of women (P =.02). Further, a change in LDL-C levels of more than 4.0 mmol/L from baseline to follow-up was 7% in men compared with 21% in women (P =.01).

The researchers noted that identification of imbalances among patients with HeFH will permit the breaking down of the barriers to care in this population through educational initiatives and additional training.

Reference 

Guerin A, Iatan I, Ruel I, Ngufor L, Genest J. Sex disparities in treatment and outcomes of patients with familial hypercholesterolemia. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #78.

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In patients with clinical atherosclerotic cardiovascular disease (ASCVD) and comorbid nondialysis chronic kidney disease (CKD), the use of high-intensity statin therapy is recommended to reduce the risk for cardiovascular events.

A retrospective, cross-sectional, observational study assessing prescribing patterns of statin therapy in patients with ASCVD and CKD was conducted, and the results were presented at the National Lipid Association (NLA) Scientific Sessions 2022, which were held in Scottsdale, Arizona, between June 2nd and June 5th, 2022.

Recognizing that the presence of nondialysis CKD increases the risk for ASCVD, the researchers compared prescribing practices of statin therapy among patients with ASCVD and nondialysis-dependent stage 4 and stage 5 CKD with those with stage 3a and stage 3b CKD.

The study assessed electronic health records of  patients between 18 and 89 years of age who received treatment within the University of Colorado Health System from January 1, 2020, through September 30, 2021.

The primary study outcome was the proportion of patients with ASCVD who were prescribed high-intensity statin therapy with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² compared with those with an eGFR ≥30 to 59 mL/min/1.73 m².

Secondary study outcomes included the proportion of patients on a US Food and Drug Administration–approved renal dose adjustment of rosuvastatin, the mean difference in low-density lipoprotein cholesterol levels between the 2 groups, and differences in prescribing patterns of low-intensity to moderate-intensity statins between the 2 groups.

Patients with eGFR <30 mL/min/1.73 m² were found to have a higher mean systolic blood pressure and were more likely to have diabetes or heart failure compared with those with eGFR ≥30 to 59 mL/min/1.73 m². Further, a lower percentage of White individuals was reported in the group with an eGFR <30 mL/min/1.73 m².

No statistically significant differences were observed between the groups with respect to the proportion of high-intensity statins that were prescribed. The researchers found that in 67.6% (25 of 37) of the patients, rosuvastatin was not renally adjusted in an appropriate manner (P =.0240).

The researchers concluded that results of the current study demonstrate that prescribers do not appear to be following the package insert dosing recommendations for rosuvastatin, based on the fact that the severity of a patient’s CKD does not affect the prescribing pattern of high-intensity statin therapy. They recommend identification of prescribing barriers for high-intensity statin therapy and incorporation of these barriers into decision pathways and/or provider education.  They also suggest that collaborative drug therapy management with a clinical pharmacist may be beneficial for initiating, titrating, and adjusting high-intensity statin therapy among appropriate patients.

Reference

Fstkchian A, Saseen J, Lowe R. Comparing prescribing practices of statin therapy in ASCVD patients with varying levels of CKD.  Poster presented at: National Lipid Association (NLA) Scientific Sessions 2022; June 2-5, 2022; Scottsdale, Arizona. Abstract #47

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Eicosapentaenoic acid (EPA) can modulate expression of cytoprotective and inflammatory proteins in pulmonary endothelial cells (ECs) when exposed to air pollution particulate matter, according to research presented at the National Lipid Association’s 2022 Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

Investigators assessed the ability of EPA to modulate expression of inflammatory proteins and related pathways, including neutrophil degranulation, in pulmonary ECs after exposure to air pollution particulate matter of different sizes.

The pulmonary ECs were pre-treated with EPA (40 µM) for 2 hours in 2% fetal bovine serum (FBS)-containing medium and challenged with urban particulate matter (50 µg/mL) for 2 hours, and proteomic analysis was conducted.

The researchers performed a bicinchoninic acid assay to quantify the total protein in each sample. Each multiplexed sample was then fractionated to increase the overall protein coverage using high pH reversed phase fractionation. Proteins with a fold change >1.0 and P <.05 for the relevant comparisons were considered significant and further analyzed.

EPA significantly modulated the expression of 205 and 347 proteins relative to fine and urban particulate matter, respectively. Neutrophil degranulation was in pathways modulated by both particulate matter, in which fine and urban particulate matter modulated 36 and 13 proteins, respectively. A total of 8 proteins were common to fine and urban particulate matter, including 1.5-fold and 1.3-fold increases in C-X-C motif chemokine 6, respectively.

EPA treatment modulated 22 and 35 proteins associated with neutrophil degranulation compared with fine and urban particulate matter, respectively. Relative to fine particulate matter, EPA increased expression of heat shock protein 90-β and decreased expression of interleukin enhancer-binding factor 2. EPA also decreased expression of C-X-C motif chemokine 6 and increased expression of glutathione S-transferase P, compared with urban particulate matter.

“EPA favorably modulated expression of various cytoprotective as well as inflammatory proteins in pulmonary ECs during exposure to multiple air pollution particulate matter,” stated the researchers. “These findings support a potential cardiovascular benefit for EPA under inflammatory conditions caused by air pollution particulate matter.”

Disclosure: This study was conducted with financial support from Amarin Pharma Inc, Bridgewater, NJ, and Elucida Research.

Reference

Sherratt SCR, Libby P, Bhatt DL, Mason RP. Eicosapentaenoic acid (EPA) modulates expression of inflammatory proteins in pulmonary endothelial cells following exposure to air pollution particle matter. Presented at: National Lipid Association (NLA) Scientific Sessions 2022; June 2-5; Scottsdale, AZ. Abstract #37.

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Hispanic patients hospitalized in the US had the highest rate of hypertriglyceridemia (HTG), and White patients with HTG had a greater risk for coronary heart disease (CHD) than other ethnicities, according to research presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, Arizona.

While HTG is a known risk factor for CHD, research has been limited regarding racial and ethnic differences in HTG and its relationship with CHD. Researchers sought to investigate the association of race and ethnicity in HTG and related clinical outcomes.

Using the Nationwide Inpatient Sample from 2016 through 2018, researchers conducted a retrospective analysis of 90,856,281 adults. Patients self-identified as White (69.7%), Hispanic (14.5%), Black (8.8%), Asian (3.4%), and Native American (0.4%). Of total study participants, 350,250 had HTG (Hispanic, 0.5%; Asian, 0.48%; Native American, 0.41%; White, 0.4%; Black, 0.22%). Among patients with HTG, White patients had the lowest occurrence of diabetes (47.4%) and the highest occurrence of hypertension (50.6%), and Asian patients had the lowest proportion of obesity (19.5%).

In comparison to the White population, after adjusting for obesity, sex, age, and comorbidities, Hispanic and Asian populations had an elevated risk for HTG (odds ratio [OR], 1.14 and 1.33, respectively; all P <.001). After adjusting for sex, age, and comorbidities but not for obesity, Hispanic, Asian, and Black populations had a lower risk for CHD (OR, 0.73, 0.75, and 0.69, respectively; all P <.001). A greater risk for stroke was also noted in Black and Asian populations. No statistical difference among ethnicities was noted for in-hospital CHD mortality.

“The incidence of HTG was the highest in Hispanic [patients] and the lowest in Black [patients],” the study authors wrote. “Also, [the] Hispanic and Asian population[s] were associated with elevated risk [for] HTG. White patients with HTG were at higher risk [for] CHD than other ethnicities.”

Reference

Park K, Konindala N, Aung P, Himed K. Racial difference in hypertriglyceridemia and its impact on coronary heart diseases. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Poster 66.

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Cholesterol crystals were found in more maternal decidua tissue samples from women with pre-eclampsia and may be important in the development of hypertensive disorders of pregnancy, according to results of a study presented at the National Lipid Association Scientific Sessions, from June 2nd through 5th, in Scottsdale, AZ.

Investigators from the University of Oklahoma and Michigan State University evaluated whether cholesterol crystals were present in the maternal decidua and whether patients with pre-eclampsia had a greater burden of cholesterol crystals than women without pre-eclampsia. Women (N=10) who were at 37 to 39 weeks’ gestation had maternal decidua tissues dissected from placental tissues and were evaluated for cholesterol crystals using scanning electron microscopy. The women were stratified by pregnancy-induced hypertensive (n=5) or normotensive (n=5) statuses. Crystal density was defined as no crystals, occasional crystals, isolated clusters, and widely distributed clusters.

The pregnancy-induced hypertensive and normotensive cohorts gave birth to babies with birth weights of 3070 to 4380 and 3010 to 4375 g, 2 babies were boys and 3 were girls in each cohort, and 1 baby in each cohort was Black and 4 were White, respectively.

Cholesterol crystals were observed in 4 out of 5 of the hypertensive and 2 out of 5 of the normotensive maternal decidua specimens.

The blind scanning electron microscopy analysis detected both needle and rhomboid cholesterol crystal forms, representing anhydrous and monohydrate cholesterol crystals, respectively.

This study was limited by its small sample size and these findings should be validated among a larger cohort.

“The presence of [cholesterol crystals] in the maternal decidua is a critical finding,” the study authors wrote. “Although preliminary, this is an important finding that could be mechanistically critical in the development of a hypertensive disorder of pregnancy.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Wild R, Salafia CM, Paneth N, et al. Pregnancy-Induced Hypertension: The Potential Role of Cholesterol Crystals in the Maternal Decidua. Presented at: National Lipid Association Scientific Sessions; June 2-5, 2022; Scottsdale, AZ. Abstract #54.

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