Medicines Co drug shows long-term cholesterol lowering in study
- Author: Lila Blake Mar 21, 2017,
Mar 21, 2017, 0:34
Aiming to address questions about its cognitive effects, researchers at Brigham and Women's Hospital in collaboration with Brown University and the University of Geneva ran cognitive tests on almost 2,000 people enrolled in a two-year study of the drug.
"There has always been a debate that low LDL cholesterol levels could lead to negative effects on memory or other cognitive functions", saidRobert P. Giugliano, M.D., S.M., Brigham and Women's Hospital, Boston and lead study investigator.
What the study hasn't yet proven is that people were less likely to die while on the drug.
Investors greeted the trial results with initial disappointment and appeared to assume that insurers would continue to restrict access to the drug, in part because it did not show a benefit in overall death rates from cardiovascular causes.
"It is probably the most important trial result of a cholesterol-lowering drug in over 20 years".
Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington. The new drugs have a list price of $14,523 a year. "It's remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years", stated Sean E. Harper, M.D., EVP of R&D at Amgen. In the recent years, cost of many drugs has been increased by pharmaceutical companies and those drug price increases have been contested by insurance companies, politicians and consumer groups.
In FOURIER, 27,500 patients were enrolled into the trial and randomly allocated to treatment with either an optimised regimen of statin drugs or statins plus Repatha.
An worldwide trial of 27,000 patients found that those who took the drug evolocumab saw their bad cholesterol levels fall by around 60% on average. On a more narrow basis looking at just cardiovascular death, heart attack or stroke, treatment with Repatha reduced risk by 20%.
The study involved 27,564 men and women.
Heart disease and stroke are the number one killers worldwide, taking 15 million lives in 2015, according to the World Health Organization. That trial is expected to read out sometime this year and will give a better sense of how high of a bar Amgen has set with Repatha.
In an op-ed for NPR, cardiologist and Yale-New Haven Hospital Center for Outcomes Research and Evaluation director Harlan Krumholz wrote that the benefits of Repatha as a cholesterol drug may not be all that they're cracked up to be.
While diet guides and medical textbooks aimed at the general reader aim to lower cholesterol, there is a difference, with total cholesterol, between "good" and "bad" cholesterol. The trail showed the drug lowered LDL cholesterol levels to an average of 30 miligrams per deciliter and reduced the risk of cardiovascular events for patients with atherosclerotic cardiovascular disease.
"This is a game changer", said Dr. Kausik Ray, who presented the data at the ACC meeting.
Nearly 14,000 patients were recruited to the treatment arm of the study, receiving the drug over a 48-week period.
"It would be hard for me to look a patient in the eye, if they've had a couple of heart attacks and is scared to death, and say it's not worth you taking this medication", Nissen said. Injection site reactions were "rare" in both arms of the study, but slightly higher with Repatha patients, Levy said.