Amgen's Repatha lowers heart attack, stroke risk

Cheryl Sanders
March 17, 2017

Researchers found that Amgen Inc.'s new cholesterol-lowering drug Repatha reduced the risk of deaths, heart attacks and strokes by 20% compared with standard treatment with statin drugs, a benefit that the biotech hopes will persuade health insurers to pay the more than $14,500 yearly list price.

PCSK9 inhibitors and statins start lowering LDL cholesterol nearly right away, but the beneficial effects on harder outcomes like heart attack and stroke take longer to emerge in clinical studies. The new drug, Amgen's Repatha, is given as a shot once or twice a month and is part of a novel class of medicines that drop LDL to unprecedented levels.

"It is probably the most important trial result of a cholesterol lowering drug in over 20 years".

In an interview Thursday, Harper pointed to additional evidence from the study - adjusted for what he calls a "treatment lag" - showing Repatha reduced the risk of heart attack and stroke by 33%. His study focused on patients with underlying heart disease, most of whom had already had a heart attack. Patients who had had an acute heart attack or stroke within the previous four weeks and those with advanced heart failure, uncontrolled heart rhythm disorders, upcoming cardiac surgery and end-stage kidney disease were excluded. "But if you look at it, there are still a lot of people having troubles".

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

"A 15% relative reduction in risk for the primary endpoint is much lower than predicted based on prior trials".

Roxana Mehran, professor of medicine at Mount Sinai School of Medicine in NY, described the findings as "probably the most important trial here" at the ACC meeting, which is the largest annual gathering of cardiologists in the United States. Sixty-nine percent of patients were on a high-intensity statin and 30 percent were on moderate-intensity statin. It also proved safe - side effects were similar to those from a dummy drug.

Around 15m people die each year from heart attacks or stroke and Yorkshire has the highest levels of cardiovascular disease in the country. That happened to almost 6 percent of people on Repatha versus more than 7 percent on the dummy drug. However, we can say with certainty that the long-running debate over the cost-to-benefit ratio of using PCSK9 inhibitors like Repatha will continue to rage on.

As a result, insurers may balk at covering the huge cost.

"That's the biggest issue - whether they're worth all the money", Hlatky said of the drugs. Researchers also saw a 25 percent reduction in the study's more serious secondary endpoint-cardiovascular death, heart attack or stroke-after the first year. "I don't think so".

Results of FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) are highly anticipated as the first large, long-term randomized clinical trial created to rigorously assess whether evolocumab, given along with statin therapy, can improve outcomes among high-risk patients.

Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn't involved in the study.

Dr. Seth Baum, president of the American Society for Preventive Cardiology, said records from IMS Health, an information services company, show 83 percent of patients had claims rejected in the first year Repatha and Praluent were sold, and 26 percent of them won on appeal. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone.

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