Tuesday, 28 March, 2017

Powerful heart drug sharply cuts risk for patients on statins

Endpoints News Endpoints News
Mae Harvey | 18 March, 2017, 01:40

Those who got Amgen's drug were 15 percent less likely to suffer a bad outcome, defined as heart attack, stroke, hospitalization for chest pain, placement of a stent, or death. The NLA's mission is to enhance the practice of lipid management in clinical medicine, and one of its goals is to enhance efforts to reduce death and disability related to disorders of lipid metabolism in patients. "The open question was, 'Does this way of lowering [cholesterol] reduce risk of coronary heart disease, '" says Sekar Kathiresan, a cardiologist at the Massachusetts General Hospital in Boston and the Broad Institute in Cambridge, Massachusetts, who was not involved in the study.

Meanwhile, another study is underway to test a similar drug called Praluent, and see whether it too lowers heart risks. "They asked for outcomes data and we gave them outcomes data", an Amgen spokeswoman said.

For patients like Susan Goodreds, whose insurance copay for Repatha is $356 a month, it's not an easy choice.

"The challenge for this industry is if the predecessor medicines are really good, and are now available for pennies, and are ubiquitous, it's really hard to come up with something that has sufficient incremental benefit and appeal to justify a price that is hundreds of times higher", Porges said.

Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, presented the findings today (17 March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington.

The FOURIER Trial studied 27,564 patients who had a prior MI, ischemic stroke, or symptomatic peripheral artery disease and a LDL ≥70 mg/dL or a non-HDL-C ≥100 mg/dL with optimal statin therapy. But the study was terminated after only two years because the placebo group was at a disadvantage and having a higher rate of cardiac events. Two other multi-national trials randomized 27,438 patients to either bococizumab or placebo and were created to evaluate the impact of the drug on cardiovascular outcomes, including nonfatal heart attack and stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death.

"It is much more effective than statins", said Prof Peter Sever, from Imperial College London. In addition, the data showed that using the drug for a longer period of time increases magnitude of the risk reduction. Almost 10 percent of folks on Repatha had one versus more than 11 percent on the dummy drug. Since Praluent and Repatha are so similar in terms of cost and effectiveness, the markets are likely anxious that insurers will play hardball with Regeneron and Sanofi on pricing, too.

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"That's the biggest issue - whether they're worth all the money", Hlatky said of the drugs. This raises the concern that insurers might not be willing to remove numerous restrictions that they have placed on accessing Repatha unless Amgen is willing to give in on pricing.

In a trial of more than 27,000 patients, researchers found that taking monthly or twice-monthly injections of the medication, called evolocumab, on top of statins could cut cholesterol levels by nearly 60 per cent on average in patients with an underlying risk of cardiovascular disease.

The evolocumab study was funded by Amgen, the pharmaceutical company that makes the drug, which is marketed as Repatha. The two-year trial showed one heart attack or stroke was prevented for every 74 patients taking it.

A key secondary endpoint of the study narrows the list of bad patient outcomes to cardiovascular death, heart attack and stroke.

Shares of Amgen fell, while Regeneron was down 3.4 percent and Sanofi shares closed down 0.5 percent in Paris.

"During five years as a study investigator I have been impressed with the level of enthusiasm of heart patients for this treatment". The companies also are in a patent war over the drugs.

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