This Cholesterol Drug Can Reduce Risk Of Heart Attacks but Costs $15000

20 March, 2017, 12:40 | Author: Oscar Goodwin

In the research paper, the scientists show how one heart attack or stroke was prevented for every 74 patients taking the drug in the two-year trial. 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".

The larger reductions in heart attacks and strokes drove the drug's performance on the MACE measure, and on the primary endpoint, which comprised the MACE numbers as well as hospitalization for unstable angina and coronary revascularization procedures, Levy said.

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 data also show similar clinical benefit with evolocumab when analyzed according to baseline LDL levels, even in patients in the lowest quartile of baseline LDL cholesterol, in whom evolocumab reduced LDL cholesterol from 73 to 22 mg/dL. 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. All of them were already receiving statin therapy. They followed-up these people for two years, from 2013 to 2015.

Stubbornly high cholesterol is a key risk factor. Instead, it had only been tested in laboratory trials.

The much anticipated study, titled ORION-1, was presented March 17 at American College of Cardiology's 66th Annual Scientific Session.

Repatha cut the combined risk of heart attacks, strokes and heart-related death by 20 per cent compared with a placebo in patients already on high doses of cholesterol-lowering statins, such at Lipitor.

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

And with a price tag of $15,000 per patient per year, that question for third-party payers will be significant.

This treatment has not been approved for all kind of patients.

Patients report few side effects from Repatha, which acts differently than statins and does not cause the muscle pain and weakness that some statin users experience.

Those benefits are clinically significant, not just statistically significant, and in a conference call hosted by Mizuho Securities USA Inc.'s senior biotech analyst Salim Syed, James Underberg, a clinical assistant professor of medicine at New York University Medical School and president-elect of the national lipid association, stressed the good news about the results.

The FOURIER trial (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk) was created to determine whether evolocumab, when added to statin therapy, would reduce adverse cardiovascular events. Evolocumab is a monoclonal antibody created to inhibit proprotein convertase subtillsin-kexin type 9 (PCSK9) and lower low-density lipoprotein (LDL) cholesterol levels to approximately 60%.

The company said it plans to begin enrolling patients in a pivotal Phase III study for the drug, inclisiran, later this year. The drugs work by blocking a protein that affects the liver's ability to remove cholesterol from the blood.

Evolocumab is part of a new class of drugs called PCSK9 inhibitors, which are monoclonal antibodies that help lower cholesterol.

Another study focused on evolocumab's effects on the cognitive function showed that there was no difference between the placebo group and the patients receiving evolocumab in the working memory, memory function and psychomotor speed.

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