Safety and efficacy of ETC-1002 in hypercholesterolaemic patients: a meta-analysis of randomised controlled trials
Abstract
Background: Due to the myopathic adverse events of statins, safer alternatives are being studied. Bempedoic acid (ETC-1002) is a novel low-density lipoprotein cholesterol (LDL-C)-lowering agent, currently under trial in hypercholesterolaemic patients.
Aims: To investigate the tolerability and efficacy of ETC-1002 in hypercholesterolaemic patients through a systematic review of published randomised controlled trials (RCTs).
Methods: Five databases were searched for RCTs that investigated the safety and efficacy of ETC-1002 in hypercholesterolaemic patients. The retrieved search results were screened, and then data were extracted and analysed (as mean difference [MD] or odds ratio [OR]) using the RevMan software.
Results: Five RCTs (625 hypercholesterolaemic patients) were identified. ETC-1002 was superior to placebo in terms of percentage changes from baseline in serum levels of LDL-C (MD –26.58, 95% confidence interval [CI] –35.50 to –17.66, p < 0.0001), non–high-density lipoprotein cholesterol (MD –21.54, 95% CI –28.48 to –14.6, p < 0.00001), and apolipoprotein-B (MD –15.97, 95% CI –19.36 to –12.57, p < 0.0001). When compared to ezetimibe, ETC-1002 was superior in reducing LDL-C (–30.1 ± 1.3 vs. –21.1 ± 1.3). Regarding safety, ETC-1002 did not increase the risk of all adverse events (OR 0.58, 95% CI 0.37–0.91, p = 0.02) and arthralgia (OR 0.32, 95% CI 0.13–0.81, p = 0.02) compared to placebo. All other adverse events including myalgia, headache, and urinary tract infections were similar between ETC-1002 and placebo groups. The evidence certainty in the assessed outcomes was moderate to high except for lipoprotein(a), free fatty acids, and very low-density lipoprotein particle number (very low certainty).
Conclusions: ETC-1002 is a safe and effective lipid-lowering agent and may be a suitable alternative in statin-intolerant patients. Well-designed studies are needed to explore the long-term safety and efficacy of ETC-1002 in these patients.
Keywords: bempedoic aciddyslipidaemiaETC-1002hypercholesterolaemiameta-analysis