Drug which cuts 'bad' cholesterol can help prevent heart attacks and strokes

Pricey new cholesterol drug scrapes by in heart risk study

If they cost 50 times as much as statins, "are they 50 times better?" It cut the risk of stroke by 21%.

"They would have another 20 percent reduction in risk, and that is a big effect", Prof Sever said.

Amgen may know that insurers are unlikely to accept their money-back guarantee, Patterson said.

Longer term, Sabatine said, there could be a reduction in deaths as well.

Amgen believes it has the cardiovascular outcomes data it needs to inject some renewed momentum into its laggard cholesterol-lowering antibody Repatha, but reaction to the results has been muted.

If guidelines are changed because of the results, thousands more could benefit.

As Amgen reveals, the study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death.

Pfizer, based in New York City, abandoned a PCSK9-blocking drug called bococizumab past year after running into problems during patient trials.

Barclays analysts weren't impressed, either.

The study, also published in the prestigious New England Journal of Medicine, involved testing Repatha on patients in 49 countries, 1,500 of them in Britain. The company already has some pay-for-performance deals with payers-including arrangements with Harvard Pilgrim and Cigna-that link the net price of Repatha to expected LDL cholesterol reductions. Millions of people in the United States and other parts of the world take statins regularly to reduce their cholesterol level. The payers have been citing a lack of data quantifying their effects on cardiovascular risks. For now, "we should still probably reserve these for the highest risk patients where statins are not doing a good enough job - at least at the price they are currently offered", said Lloyd-Jones. Some cardiologists and researchers had anxious that very low LDL might have deleterious effects, just as excessively low blood pressure can. Those on the highest tier might include specialty medicines that could cost the patient hundreds of dollars even with coverage.

"The end result was cholesterol levels came down and down and down, and we've seen cholesterol levels lower than we have ever seen before in the practice of medicine".

Results from the highly anticipated 27,564-patient Fourier study should help remove some barriers to patient access from health insurers and pharmacy benefit managers, who have been rejecting some 75 per cent of prescriptions written for the costly medicine.

The group which had received evolocumab experienced fewer primary endpoint events, compared to the placebo arm of the study, with 1,344 (9.8 per cent) compared to 1,563 (11.3 per cent) respectively.

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. Amgen is ready to take on some risk for Repatha's real-world performance through financial risk-sharing agreements and outcomes-based contracts (refund the cost of Repatha for eligible patients who have a heart attack or stroke).

While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies. "Creating new treatments which use this approach could prove life-saving for patients with high cholesterol and those who can't tolerate statins".

Till now, with LDL, "no one was sure whether it was more like blood pressure and needed to be in range, or whether we want to eliminate it like tobacco", Levy said.

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