Cholesterol-Slashing Drug Does Not Harm Brain

Evolocumab and clinical outcomes in patients with CVD

Cholesterol-Slashing Drug Does Not Harm Brain

They were taking optimal doses of affordable, cholesterol-lowering statins, which gave them an average LDL of 92, well within the range - an LDL of under 100 - that has been advised for high-risk patients.

The recommended LDL level by the doctors is below 100 milligrams per decilitre. Now, the new phase 2 clinical trial has confirmed the effectiveness of injecting inclisiran for reducing cholesterol that can be taken alone or potentially combined with statins for maximum effect. It is too soon to know if the drug is saving lives.

Bad cholesterol is the villain in heart world.

Repatha could be an important drug for some high-risk patients, in spite of the cost, he said.

Given that many patients at risk of a heart attack or stroke have little else to try, he says, this is "absolutely an advance in cardiovascular medicine".

Amgen hoped the FOURIER study results would help it win the debate over the cost-benefit of Repatha.

The results of a two-year clinical trial on the drug sold as Repatha by Amgen Phamaceuticals that costs more than $14,000 a year were released at the American College of Cardiology annual conference in the United States capital.

The results should loosen the purse strings of insurers reluctant to pay for a drug with a list price of over $14,000 a year before discounts, given the high cost of treating strokes and heart attacks.

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.

Half of the patients were asked to take optimal quantity of statins along with Repatha.

The study was conducted on 27,564 patients and almost 80 percent of them had suffered from a heart attack.

Benefits continued to accrue through the median 2.2 years of the study and the risk reduction grew over time, from 16% in the first year to 25% beyond the first year. The agency authorized its use when accompanied by a healthy diet and a statins treatment in patients with Homozygous Familial Hypercholesterolemia (HoFH), Atherosclerotic Cardiovascular Disease, and people in need of reducing their LDL cholesterol levels.

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.

As for safety, "patients who achieved the lowest levels of LDL, the lowest quartile, saw levels of 19 or less", Levy said, "and the safety profile in those patients was also pristine".

"A promising new approach is blocking the action of PCSK9, a molecule which reduces the breakdown of LDL-cholesterol in the liver".

Millions of people consume drugs called statins to minimize the amount of bad cholesterol.

Overall 325,000 in Britain are eligible, although only a few have yet been given the drugs.

Among them, is a relatively new drug named Repatha which was cleared by the FDA in 2015.

Price could provide a stumbling block however. We think stronger uptake will follow guideline and prescribing label changes (which should push payers to open access), as well as new risk-sharing contracts with payers (which will likely imply a lower net price).

"These Repatha results are disappointing", said Dr. Ethan Weiss, a cardiologist and associate professor of medicine at the Cardiovascular Research Institute, University of California San Francisco.

Excitement about Repatha - also called evolocumab - has been building in the past three years, with scientists predicting it could "switch off" heart disease. Cardiologists not associated with Amgen had flagged two key indicators to watch: rates of neurological side events (1.6 percent for evolocumab patients, 1.5 percent for statin-only), and the onset of diabetes (8.1 percent for evolocumab, 7.7 percent for statin-only).

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