Just weeks after the US government declared it safe to eat more cholesterol, a new study published in yesterday’s issue of the New England Journal of Medicine reports that two new drugs, Repatha (evolocumab) from Amgen Inc., and Praluent (alirocumab) under development by Sanofi SA and Regeneron Pharmaceuticals, both cut cholesterol levels by more than 62 %, vastly reducing the risks of cardiovascular disease such as heart attacks. In fact, it was reported that clinical trials showed that patients given Repatha orally or injected with the Praluent were “48% as likely to die or suffer a major cardiac complication after 1-1.2 years of treatment.” Those participating in the studies (funded by each drug company respectively) had already reached the tolerance limit for statins.
Researchers who presented results of the Repatha study at the American College of Cardiology meeting in San Diego, stated that they found “just under 1% of patients on the medication for a year experienced a heart complication, compared with 2.18% on standard treatment. The Repatha trial involved 4,465 patients with a median LDL of 120 milligrams per deciliter. Under 100 milligrams is considered good for an adult. It was also announced that Amgen intends to continue its research with a multiyear trial involving 27,500 patients, while Sanofi and Regeneron will include 18,000 patients in their own multi-year trials, both of which are expected to conclude by the end of 2017.
In the meantime, the FDA has requested further investigation into some side effects, including mild cognitive problems and forgetfulness, as well as eye problems and muscle pain (more common with Repatha) before its makes its final decision to approve (or not) the drugs this coming July.
