March 30, 2017

Amgen's Repatha Reduces Cholesterol and Cuts Risk of Cardiovascular-related Deaths

20 March 2017, 12:38 | Kevin Scott

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The injectable medication, usually taken alongside statins, cuts the risk of heart attacks by an extra quarter.

Prof Sever said: "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". Reviews of evolocumab have been mixed, with some physicians hailing the results as major progress against heart disease, while others expected more from the expensive drug.

The drug cut by 15 percent a broader set of problems - the ones above plus hospitalization for chest pain or an artery-opening procedure.

Data from the first successfully completed dedicated outcomes trial of a PCSK9 inhibitor show that, in patients with cardiovascular disease, evolocumab reduced LDL cholesterol by 59 percent and reduced the risk of adverse cardiovascular outcomes with greater benefit the longer the duration of therapy. Millions of people in the United States and other parts of the world take statins regularly to reduce their cholesterol level.

Around 15m people die each year from heart attacks or stroke and Yorkshire has the highest levels of cardiovascular disease in the country.

"The disappointing thing to me was there was absolutely no difference in mortality", Stone said. For that reason, Sabatine said the P values for outcomes should be considered "exploratory". PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL from the blood. Kaiser Health News noted that insurers aren't quite sure whether they would cover the drug, citing issues with its price and its then-unproven benefits.

The inclisiran dosage that produced the best results would require a person to get an initial shot followed by a booster three months later, Ray said.

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The antibody is given by injection into the skin every two to four weeks.

"Now we have more confidence that not only are we are helping on the biochemistry reports numbers, but also helping keep patients out of emergency rooms and cardiac operating theatres".

The safety data showed no serious ill effects from either drug, which may have even fewer side effects than statins, researchers reported. The price tag for evolocumab is $14,000 per year, while a generic statin costs only $250 per year. But researchers didn't have evidence then that the drug could also protect against heart attacks or strokes.

"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 now offered", said Lloyd-Jones. In an exploratory analysis, the relative risk reduction for fatal and nonfatal heart attack or stroke was 19% in the first year (P = 0.003) and 33% beyond the first year (P 0.00001). These results are likely to make their way into all-important treatment guidelines published by medical societies, Levy said: Preventing "1 in 5 or 1 in 4 strokes and heart attacks, with no offsetting safety concerns", should be plenty to turn Repatha into the standard of care for the type of high-risk patients Fourier enrolled.

"This is a game changer for high-risk patients. Creating new treatments which use this approach could prove life-saving for patients with high cholesterol and those who can't tolerate statins".

Amgen, Inc. says that it is willing to bargain with insurance companies in an effort to get them to offer Repatha to their customers. After 2 years, 9.8% of patients in the treatment group had at least one such event, versus 11.3% in the placebo group, the team revealed today in The New England Journal of Medicine and at a meeting of the American College of Cardiology in Washington, D.C.

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