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Efficacy of evolocumab confirmed in large meta-analysis

Evolocumab demonstrates favourable effects on lipid profiles with an overall acceptable safety profile in adults with cardiovascular disease or major risk factors, according to a meta-analysis.

Dr Musa Khalil (Howard University Hospital, Washington DC, USA) presented results from a systematic review and meta-analysis of randomised clinical trials and cohort studies evaluating evolocumab in adults with cardiovascular disease or major risk factors [1]. The pooled data were analysed for efficacy (effects on lipids and major cardiovascular adverse events) and safety (therapy discontinuation and injection-site reactions). In total, 10 studies comprising 67,727 patients were included.

In the overall meta-analysis, evolocumab versus control resulted in a significant reduction in low-density lipoprotein cholesterol (LDL-C), with a mean difference of -57.7 mg/dL (95% CI, -60.7 to -54.8; P<0.0001). Additionally, evolocumab reduced in total cholesterol (mean difference -52.3 mg/dL; 95% CI -66. to -37.9; P<0.0001) and triglycerides (mean difference -21.2 mg/dL; 95% CI -26.0 to -16.4; P<0.0001), increased high-density lipoprotein cholesterol (HDL-C) (mean difference 3.7 mg/dL; 95% CI 1.7–5.7; P=0.0003), and significantly reduced major adverse cardiovascular events (RR 0.53; 95% CI 0.40–0.71; P<0.0001). These results were consistent in the subgroup of patients aged >60 years.

In terms of safety, there was a non-significant trend toward increased treatment discontinuation with evolocumab in both the overall population and the subgroup aged >60 years. There was also a trend toward increased injection-site reactions, which reached statistical significance in the older age group (RR 1.32; 95% CI 1.13–1.55; P=0.0004).

“Evolocumab significantly improves lipid profiles and reduces major adverse cardiovascular events in patients with or at high risk of cardiovascular disease, while demonstrating a generally favourable safety profile,” concluded Dr Khalil. “These results support evolocumab as an effective adjunct to standard lipid-lowering therapies, particularly in patients who are unable to tolerate statins or achieve LDL targets.”

  1. Goel A, et al. Evolocumab decreases low density lipoprotein and reduces major adverse cardiovascular events – A systematic review and meta-analysis. ACC 2026, 28–30 March, New Orleans, LA, USA.

 Copyright ©2026 Medicom Education B.V.

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Obicetrapib shows favourable safety in a pooled analysis of phase 3 trials

Obicetrapib, compared with placebo, was associated with a lower risk of adverse events related to diabetes, kidney function decline, and liver function, according to a pooled phase 3 analysis presented by Dr Adam Nelson (Monash University, Australia) [1].

The pooled safety analysis was based on 2 phase 3 trials evaluating obicetrapib 10 mg/day versus placebo: BROOKLYN (NCT05425745) in patients with heterozygous familial hypercholesterolemia, and BROADWAY (NCT05142722) in patients with heterozygous familial hypercholesterolemia or a history of atherosclerotic cardiovascular disease. In both trials, patients had uncontrolled cholesterol levels despite receiving maximally tolerated lipid-lowering therapies. In total, 2,880 participants were included in the pooled analysis, of whom 1,919 patients received obicetrapib and 961 received placebo.

Rates of treatment-emergent adverse events, discontinuations due to adverse events (AEs), and serious AEs were similar between the obicetrapib and placebo groups. An analysis of AEs of special interest showed a reduced risk with obicetrapib versus placebo for new-onset diabetes mellitus or worsening glycaemic control (32.9% vs 37.6%; RR 0.88; 95% CI 0.79–0.97), decline in eGFR (6.7% vs 8.7%; RR 0.77; 95% CI 0.59–1.00), increases in bilirubin to >2 times upper limit of normal (0.1% vs 0.7%; RR 0.17; 95% CI 0.03–0.83), and increases in serum creatinine of ≥0.3 mg/dL (5.0% vs 7.3%; RR 0.69; 95% CI 0.51–0.93).

In contrast, rates of increase in transaminases and creatine kinase, as well as events indicative of heart failure and changes in heart rhythm and blood pressure, were similar between treatment groups.

Overall, the safety profile in this pooled analysis was consistent with that reported in the individual trials. Dr Nelson concluded that “this analysis supports the safety and tolerability of obicetrapib in patients with high cardiovascular risk. If confirmed in larger and adequately powered trials, the safety profile of obicetrapib with respect to hepatic, renal, muscle, and glycaemic events may favourably differentiate it from other available lipid-lowering therapies.”

  1. Nelson AJ, et al. Safety of obicetrapib: An integrated pooled phase III safety analysis. ACC, 28–30 March 2026, New Orleans, LA, USA.

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Meta-analysis confirms the impact of obicetrapib on atherogenic lipid levels

Obicetrapib, compared with placebo, reduces low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B (ApoB) levels, while increasing HDL-C levels, according to a systematic review and meta-analysis presented by Dr Prutha R. Pathak (North Alabama Medical Center, AL, USA) [1].

The systematic literature review identified 802 records, of which 9 randomised controlled trials were included in the meta-analysis, comprising more than 3,700 patients. Random-effects meta-analyses using mean differences were conducted to assess the treatment effect of obicetrapib versus placebo on LDL-C, non-HDL-C, and ApoB levels. Dose-response analyses were also performed to determine the maximally effective dose of obicetrapib.

Overall, obicetrapib significantly improved all lipid parameters compared with placebo across the included trials. Mean reductions were -38.1% in LDL-C levels (95% CI -43.0 to -33.2; P<0.00001), -32.3% in non-HDL-C levels (95%CI -33.5, -29.0; P<0.00001), and -25.9% in ApoB levels (95% CI -30.3 to -21.4; P<0.00001). In addition, obicetrapib increased HDL-C levels by approximately 150%. Dose-response analyses demonstrated an increase in LDL-C reduction up to 8 mg/day, with a plateau observed at doses up to 10 mg/day.

In terms of safety, obicetrapib was well tolerated, with no off-target toxicity signals identified. There were no significant differences compared with placebo in live or haematologic markers, or in treatment discontinuation rates (RR 1.04; 95% CI 0.7–1.9).

Dr Pathak concluded that “obicetrapib produces robust reductions in LDL-C, non-HDL-C, and ApoB, while dose-response modelling suggests near-maximal benefit at approximately 7–8 mg/day. Safety and discontinuation rates were comparable to controls.”

  1. Gill OA, et al. Efficacy and safety of obicetrapib in reducing atherogenic lipids: A systematic review and dose response meta-analysis with trial sequential analysis. ACC 2026, 28–30 March, New Orleans, LA, USA.

 Copyright ©2026 Medicom Education B.V.

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