RCT | Bempedoic acid shows modest reduction in cardiovascular events for statin-intolerant patients

Summary:

Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol levels and is associated with a low incidence of muscle-related adverse events. The study enrolled 13,970 patients at increased cardiovascular risk, with 6,992 randomized to bempedoic acid and 6,978 randomized to placebo, with a median duration of follow-up of 40.6 months.

The study found that bempedoic acid was associated with a statistically significant 13% reduction in the primary endpoint of major adverse cardiovascular events, which included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. However, the absolute risk reduction of events was modest, at 1.6% over nearly four years.

The study also reported higher incidences of gout and cholelithiasis with bempedoic acid compared to placebo, as well as small increases in serum creatinine, uric acid, and hepatic-enzyme levels.

Article: Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

CLEAR Positives and Cautions With Bempedoic Acid for Statin Intolerance – Medscape (recommended reading – free registration required)

Cardiovascular Outcomes After “Statin-Intolerant” Patients Take Bempedoic Acid – NEJM Journal Watch (free for a limited period)

Commentary on Twitter

Bempedoic acid showed a modest absolute reduction in CV outcomes, relative to placebo, in patients “unable or unwilling” to take a statin. https://t.co/hQUfvFwz68 #ACC23 @hmkyale @NEJM #CardioTwitter pic.twitter.com/YMoNsce8MI

— NEJM Journal Watch (@JWatch) March 7, 2023