Adding the 'investigational biologic' evolocumab to statin therapy works better, study says
WebMD News from HealthDay
By Kathleen Doheny
SUNDAY, March 15, 2015 (HealthDay News) -- Adding an experimental new biologic drug to conventional cholesterol-lowering drugs may result in better cholesterol control and reduced risks of heart attack and stroke, according to a new study.
Compared to patients on conventional therapy alone, those who also got the experimental drug evolocumab were half as likely to die, suffer a heart attack or a stroke or be in the hospital to have a procedure to open blocked arteries during the one-year follow-up, said lead researcher Dr. Marc Sabatine.
The combined therapy ''basically halves the rate of cardiovascular events," said Sabatine, a senior physician in cardiovascular medicine at Brigham and Women's Hospital in Boston.
"It's a very impressive risk reduction," added Sabatine, who's due to present the study findings Sunday at the American College of Cardiology annual meeting in San Diego. The findings were published simultaneously in the New England Journal of Medicine.
The study was funded by the drug's maker, Amgen.
Sabatine's group looked at 4,465 patients who had already completed one of the 12 phase II or III trials to evaluate the drug. The patients were offered an opportunity to join a one-year extension trial. The researchers randomly assigned patients to either standard treatment -- usually with cholesterol-lowering drugs known as statins -- or to standard treatment as well as the new drug. The evolocumab was injected under the skin either every two or four weeks.
"This is a new class of drugs. They are being reviewed by the U.S. Food and Drug Administration now, but they are not available yet," Sabatine said.
The new drug isn't meant to replace statins, Sabatine said. "Statins will always be the foundation of therapy. These [new drugs] will be an additional medicine for patients who aren't getting appropriate control of their cholesterol on a statin alone," he said.
Those on the biologic were about half as likely to have a heart attack or stroke over the one-year follow-up. While 2.18 percent of those in the standard treatment group had a heart attack, stroke or other cardiovascular problem, less than 1 percent of those in the combination group did, the findings showed. Over the follow-up, there were 60 heart attacks, strokes or other such events.
source : Experimental Drug Shows Promise in Lowering Cholesterol, Heart Attack Risk