Experimental LDL-lowering drugs Repatha and Praluent effective, but raises certain questionsChris Middlebrooks (Author) Published Date : Mar 16, 2015 10:29 IST
Manufactured by Amgen Inc.(NASDAQ: AMGN), Repatha, better known as evolocumab, together with Praluent, made by Sanofi SA and Regeneron Pharmaceuticals Inc., have both shown encouraging results in latest clinical trials as very effective at lowering bad cholesterol or LDL and also reduce by half associated risks of heart attack, stroke, and death among others.
These drugs have been found effective in patients that are predisposed to bad cholesterol or intolerant of statins and other statin-related medications. The drugs were designed as PCSK9 inhibitors, and the findings obtained by the researchers were presented at the meeting of the American College of Cardiology which holds annually.
About 4,500 patients were tested after experimenting with Repatha over the course of a year, and the researchers found that only 0.95% of participants that took the medication alongside conventional therapy suffered cardiovascular event, as against 2.18% of participants that took only conventional therapy that included statins and even diet changes.
According to Amgen, a cardiovascular event is defined as death, heart attack, stroke, or unstable chest pain or heart failure that required necessary hospitalization, or any procedure to restore bloodflow to the heart.
Participants in the study reported rare cases of side effects that included neurocognitive problems like confusion among others with Amgen s Repatha, and the FDA called for analysis into these reported side effects. But Scott Wasserman, Amgen's head of cardiovascular and metabolic therapies, said there is no such thing with Repatha.
The second bad cholesterol-lowering drug, Praluent, also reported certain side effects after 2,300 patients were tested on the drugs over an 18-month period. It was found to reduce cardiovascular risks from 3.3% for placebo patients to 1.7% for treatment group.
Some of the endpoints in these trials are kind of soft, and they aren't prospective studies, said Dr. Anthony DeMaria, director of the cardiovascular center at the University of California San Diego. It's encouraging that the larger trials are likely to succeed, but we still need those trials.
And Dr. Marc Sabatine, lead investigator of the Repatha study, said data for both drugs are very consistent. It appears that cutting LDL by 61 percent translates to a roughly 50 percent reduction in cardiovascular events.
Consisting of antibodies and delivered by injection, both experimental drugs target PCSK9 protein which regulates LDL protein the bloodstream. Unlike statin pills that are now available in low-cost generic forms, Praluent and Repatha work much differently from others by blocking the liver s ability to produce LDL cholesterol in the blood.
The FDA has given August 27 to decide on Amgen s application for Repatha, and July 24 to rule on Praluent for the US markets.
Experimental LDL-lowering drugs Repatha and Praluent effective, but raises certain questions