That means about 74 high-risk patients would have to be treated for two years to prevent one heart attack or stroke or death from heart disease, and that at three years 50 would have to be treated.
The drugs, evolocumab (Repatha) and inclisiran, both work by targeting PCSK9, an enzyme that regulates the liver's ability to remove "bad" LDL cholesterol from the bloodstream. And the biotech emphasizes that the absolute benefit of Repatha will likely be higher outside of trials, noting the cardiovascular event rate in clinical practice is higher than in the controlled environment of an outcomes study.
The new trial of 27,500 patients, led by Harvard Medical School and Imperial College London, finally provides that evidence.
"It is probably the most important trial result of a cholesterol-lowering drug in over 20 years".
Amgen presented the detailed results from EBBINGHAUS at a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C.
However, the new drug would be unlikely to replace the current treatment, statins, Prof Sever said.
It also decreased the risk of heart attack or stroke or cardiovascular death by 15 percent in the first year and 25 percent in the second year.
Some health care experts weren't impressed by Amgen's offer. There was no question that Repatha, an antibody drug developed by Amgen, could provide stunning drops in cholesterol for people who have already maxed out the benefits of decades-old statin drugs.
For the study, the team looked at the protective effect of evolocumab on 27,564 patients, aged 40-85 from 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol. These events include sudden heart death, heart attack, stroke, hospitalization for angina, or surgery to reopen a blocked artery.
Heart disease and stroke are the number one killers worldwide, taking 15 million lives in 2015, according to the World Health Organization. However, at more than $14,000 a year, Repatha still has insurers balking, especially without proof it actually reduces heart incidents, not just cholesterol numbers.
Fourier-as well as the SPIRE-2 trial of Pfizer's now-defunct PCSK9 inhibitor candidate bococizumab-have "laid the groundwork like a typical phase 2 trial would; issues raised/identified (e.g. dose (s), endpoint (s), and trial duration) are expected to increase the probability of delivering a more robust outcomes data in support of inclisiran", write the analysts.
Yet Repatha's high cost could burden the USA health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager.
Stubbornly high cholesterol is a key risk factor. The cost of prescription drugs has become a growing source of concern with doctors and patients, but it's not a factor considered by an independent committee used by Express Script to determine coverage of a new drug, Chief Medical Officer Dr. Steve Miller said. A similar drug to Repatha, called Praluent, costs about as much.
However, Prof Sever said: "They will probably not [replace statins], there are an very bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".
"You have a treatment regimen that gives you on average, with an initial starting dosing regimen, a 50 percent (LDL) reduction through to nine months", said Ray.