english.prescrire.org > Spotlight > Archives : 2016 > Evolocumab (Repatha°). A "mab" for hypercholesterolaemia: no evidence of benefits

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Evolocumab (Repatha°). A "mab" for hypercholesterolaemia: no evidence of benefits

FEATURED REVIEW In adults with hypercholesterolaemia, evolocumab has only been evaluated in terms of surrogate (i.e. non-clinical) endpoints. In addition, its long-term adverse effects are poorly documented, even though evolocumab is intended for long-term administration.
Full review (5 pages) available for download by subscribers.

Abstract

  • The cholesterol-lowering drugs of first choice for adults with hypercholesterolaemia are pravastatin and simvastatin. Colestyramine and gemfibrozil are other options.
     
  • In patients with homozygous familial hypercholesterolaemia, cholesterol-lowering drugs, even when used at high doses, seldom eliminate the need for LDL lipoprotein apheresis, a burdensome and inconvenient procedure.
     
  • Evolocumab is the first monoclonal antibody targeting PCSK9, an enzyme involved in regulating hepatic LDL cholesterol receptors, to be authorised in the European Union.
     
  • Clinical evaluation of evolocumab includes about ten trials, mainly conducted in patients with no history of cardiovascular events. These trials generally lasted only a few months and used surrogate lipid endpoints. Thus, in early 2016, there is no evidence that evolocumab is effective in reducing morbidity or mortality.
     
  • In patients with hypercholesterolaemia, the five principal randomised controlled trials showed that evolocumab, alone or in combination with other cholesterol-lowering drugs, reduced LDL-cholesterol levels by about 55% to 75% versus placebo after 12 weeks of treatment and at one year.
     
  • Two trials including a total of 145 patients with homozygous familial hypercholesterolaemia showed that evolocumab reduced LDL-cholesterol by between 17% and 30% after 12 weeks of treatment, but its impact on the frequency of apheresis sessions was not reported.
     
  • Evolocumab provokes injection site reactions, infections, hypersensitivity reactions and, possibly, muscle damage. Long-term harms are poorly documented and must therefore be a focus of post-marketing surveillance.
     
  • In practice, in early 2016, evolocumab has only been shown to provide a marked reduction in LDL cholesterol levels. Its efficacy is unknown, and its long-term adverse effects are poorly documented. It is more prudent to use better assessed drugs, pending the results of ongoing trials.

©Prescrire 1 September 2016

"Evolocumab (Repatha°). A "mab" for hypercholesterolaemia: no evidence of benefits" Prescrire Int 2016; 25 (174): 201-205. (Pdf, subscribers only)
Download the full review.
Pdf, subscribers only

See also:

Panacea-mAb
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50 years of cholesterol-
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25 (174): 205.
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