Faculty Opinions recommendation of Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial.
The major cause for statin discontinuations reported by patients is perceived adverse events. Non-statin low-density lipoprotein (LDL) cholesterol-lowering therapies have been evaluated in patients who report statin-associated muscle symptoms (SAMS). In this study, the ODYSSEY ALTERNATIVE trial, the authors showed that alirocumab reduced LDL cholesterol by 45% compared to 15% with ezetimibe. Additionally, the trial included a single-blind placebo run-in and excluded participants who reported SAMS with placebo. In the second phase, continuing participants were randomized to double-blind treatment (2:2:1) with alirocumab, ezetimibe 10mg daily, or atorvastatin 20mg daily. On re-exposure to statin therapy, nearly 50% tolerated atorvastatin. SAMS were 39% less frequent with alirocumab versus atorvastatin. This Recommendation is of an article referenced in an F1000 Faculty Review also written by Robert S. Rosenson.