Alirocumab was found to be well tolerated and to produce long-term reductions in low-density lipoprotein cholesterol (LDL-C) in patients who are intolerant to statins, according to a study published in the Journal of Clinical Lipidology.

Alirocumab is an inhibitor of proprotein convertase subtilisin/kexin type 9. In the 24-week randomized, double-blind ODYSSEY ALTERNATIVE trial ( identifier: NCT01709513), alirocumab was found to be superior to ezetimibe and atorvastatin in reducing LDL-C levels and eliciting skeletal muscle events, respectively, in patients with primary hypercholesterolemia and moderate to very high cardiovascular risk who were intolerant to statins.

A total of 281 participants of the ODYSSEY trial enrolled in this optional open-label treatment period of the trial, designed to evaluate the long-term safety of alirocumab. Patients in the open-label phase had primary hypercholesterolemia and moderate/high or very high cardiovascular risk and were intolerant to statin therapy because of associated skeletal muscle or other events. In the open-label period, participants were given alirocumab 75 mg or 150 mg every 2 weeks for approximately 3 years, or until it became commercially available.

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A total of 108 participants (38.4%) of patients in the open-label period reported skeletal muscle events. Fewer participants treated with alirocumab discontinued treatment during the open-label vs double-blind phase of the trial because of skeletal muscle events (3.2% vs 15.9%, respectively). At week 32, there was a 52% reduction in mean LDL-C levels from baseline. Reductions in mean LDL-C were sustained through weeks 100 (55.4%) and 148 (53.7%).

Study limitations include the lack of a washout period prior to the open-label treatment phase of the ODYSSEY ALTERNATIVE trial.

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”[T]hese results indicate that repeated long-term treatment with alirocumab was well tolerated in [patients intolerant to] statins with very high baseline LDL-C, with a safety and tolerability profile consistent with that described in the product labeling,” concluded the study authors.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. This clinical trial was supported by Sanofi and Regeneron Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.


Moriarty PM, Thompson PD, Cannon CP, et al. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020;14(1):88-97.e2.