english.prescrire.org > Spotlight > Archives : 2019 > Secondary cardiovascular prevention: dubious benefits of evolocumab (Repatha°) and alirocumab (Praluent°)

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Secondary cardiovascular prevention: dubious benefits of evolocumab (Repatha°) and alirocumab (Praluent°)

In patients who have already had a cardiovascular event, the addition of evolocumab or alirocumab to a statin does not reduce mortality but does expose to adverse effects, although these are not well known.

In patients who have had a previous cardiovascular event (myocardial infarction, stroke) or peripheral artery disease, cholesterol-lowering therapy aims to reduce the risk of premature death and further cardiovascular events. Only pravastatin and simvastatin have been proved to reduce mortality in some patients. Adding another cholesterol-lowering agent whose efficacy is dubious has an uncertain or even unfavourable harm-benefit balance.

Evolocumab and alirocumab are authorised as cholesterol-lowering agents in secondary cardiovascular prevention. One trial compared evolocumab with placebo in nearly 27 500 patients at low cardiovascular risk taking a statin. After more than two years' follow-up, total mortality and cardiovascular mortality were close in both groups. One trial also evaluated alirocumab in the same situation and showed no difference in cardiovascular mortality compared with placebo. The main adverse effects of these two drugs are injection site reactions, hypersensitivity reactions and infections, but their long-term effects are poorly known.

Further independent trials are needed to better evaluate the efficacy of these drugs. They should include patients at higher risk, and should use mortality as the primary endpoint.

Given the evidence of their poor efficacy, there is no justification at present for offering evolocumab or alirocumab to patients with a cardiovascular history and cholesterol levels poorly controlled by a statin, outside clinical trials.

©Prescrire 1 October 2019

"Evolocumab (Repatha°) in secondary prevention of cardiovascular disease. No reduction in either all-cause or cardiovascular mortality" Prescrire Int 2019; 28 (208): 234-237. (Pdf, subscribers only).

"Alirocumab in secondary prevention of cardiovascular disease: conflicting mortality data" Prescrire Int 2019; 28 (208): 236. (Pdf, subscribers only).

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Download the full reviews:

Evolocumab (Repatha°)
Pdf, subscribers only

Alirocumab (Praluent°)
Pdf, subscribers only

See also:

Statins in secondary
cardiovascular prevention
(September 2017)
Free