Data from Pharmawand - Curated by EPG Health - Date added 15 March 2019
Daiichi Sankyo and Esperion Therapeutics announced that results from the 2,230 patient, 52-week, Phase III long-term safety study of ETC 1002 (bempedoic acid) in dyslipidaemia were published in NEJM. The NEJM publication highlights results from the primary endpoint of adverse event rates over 52-weeks along with key efficacy endpoints at 12-weeks. It shows that bempedoic acid significantly lowered LDL-C by 18.1% (p<0.001) on background maximally tolerated statin therapy, significantly reduced hsCRP, an important marker of the underlying inflammation associated with cardiovascular disease by 22% and that treated patients showed lower rates of new-onset or worsening of diabetes compared with those on placebo (3.3% vs 5.4%). It also showed the drug did not lead to higher overall adverse events compared with placebo (78.5% vs 78.7%), and the proportion of patients with reported serious adverse events was small and similar compared with placebo (14.5% vs 14.0%). Bempedoic acid did not lead to increased discontinuation rates due to muscle-related adverse events of importance, myalgia and muscle weakness compared to placebo (2.1% vs 1.9%) and it showed fewer adjudicated major adverse cardiac events compared with placebo (4.6% vs 5.7%). Finally it was observed to be well-tolerated.
See: "Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol" Kausik K. Ray et al. N Engl J Med 14 March 2019; 380:1022-1032 DOI: 10.1056/NEJMoa1803917
Comment: Bempedoic acid is being developed as a convenient, once-daily, oral therapy for the treatment of patients with elevated LDL-C. Bempedoic acid and the bempedoic acid / ezetimibe combination are currently undergoing regulatory review for marketing authorisation by the European Medicines Agency (EMA). A decision is expected during the first half of 2020.