Long-Term Safety and Efficacy of Bempedoic Acid: CLEAR Harmony Open-Label Extension

Bempedoic acid is a newer cholesterol-lowering pill whose appeal is that it works through a statin-like pathway without entering muscle tissue — making it an option for patients who cannot tolerate statins. This study addressed the practical question of durability: does it keep working, and stay safe, over years rather than months?

It followed patients from the CLEAR Harmony trial into an open-label extension lasting up to 130 weeks. The LDL-lowering achieved in the original trial held steady over the long run, patients who had been on placebo got the same reduction when switched onto the drug, and no new safety problems emerged over roughly two and a half years of continuous use.

The reassurance is real but bounded. An open-label extension has no placebo comparison, so it speaks to durability and tolerability rather than to whether the drug prevents heart attacks — that question was answered later by the separate CLEAR Outcomes trial. This study is about staying power, not proof of benefit.

We rate the evidence moderate. It is a useful long-term safety follow-up that supports bempedoic acid as a durable adjunct, particularly for statin-intolerant patients, without itself demonstrating a hard clinical outcome.