Alirocumab Well-Tolerated and Effective in Patients With Statin

Red blood cells, cholesterol
Red blood cells, cholesterol
Researcher observed a much lower rate of discontinuations due to skeletal muscle events with alirocumab in the open-label extension trial compared with the double-blind parent study (3.2% vs 15.9%).

The following article is part of conference coverage from the 2018 AHA Scientific Sessions in Chicago, Illinois.The Cardiology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in cardiology. Check back for the latest news from AHA 2018.

CHICAGO — Long-term alirocumab use was well-tolerated and effective for reducing low-density lipoprotein cholesterol (LDL-C) levels in patients with a statin intolerance, according to research presented at the Scientific Sessions of the American Heart Association, held November 10-12, 2018.

This open-label extension study sample included 281 patients with complete assessment data who either completed treatment (n=216) or prematurely discontinued treatment (n=65) during the 24-week double-blind parent study. 

Of the 65 participants who discontinued treatment during the parent study, 51 reported skeletal muscle events as their reason for exiting the study. In the open-label extension trial, participants continued alirocumab therapy and were followed for approximately 3 years or until alirocumab was made commercially available.

From the baseline of the parent study until week 32 of the extension study, researchers saw a 52% reduction in mean LDL-C levels. These reductions were sustained throughout the 3-year follow-up period, with a 51.9% reduction reported at week 36, a 55.4% reduction at week 100, and a 53.7% reduction at week 148. 

During the open-label extension trial, 38.4% of the overall participants reported skeletal muscle events, but only 9 patients discontinued treatment due to extremity pain or myalgia. The mean exposure duration was 113 weeks.

Alirocumab was well-tolerated in patients with statin intolerance and was further associated with significant and reproducible LDL-C reductions over the course of the study. Safety results were consistent between the open-label extension trial and the parent study, but a lower rate of treatment discontinuations occurred due to skeletal muscle events in the open-label extension trial.

Disclosure: Multiple authors declare associations with the pharmaceutical industry. Please see original reference for a full list of authors’ disclosures.

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Moriarty PM, Thompson PD, Cannon CP, et al. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label extension of the ODYSSEY ALTERNATIVE trial. Presented at: AHA 2018; November 10-12, 2018; Chicago, lllinois. Abstract Su1240/1240.