Powerful heart drug sharply cuts risk for cardiac patients on statins

Judith QuinnMar 21, 2017

The recommended LDL level by the doctors is below 100 milligrams per decilitre.

The investigation analyzed data from 27,000 patients, part of whom found that their low-density lipoprotein (LDL) cholesterol levels went down by around 60 percent.

Experts said the findings were the most important since the first statins trials were published two decades ago. Repatha showed a measurable-if modest-benefit in reducing cardiovascular events such as heart attacks and stroke. The sanction was done without any evidence it showed great results in reducing cholesterol. More cautious doctors insisted they needed proof that it prevents heart attacks and strokes. In a study conducted by Amgen 27,000 patients were observed.

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.

Millions of people consume drugs called statins to minimize the amount of bad cholesterol. However, it has been created to target a protein in the liver with the name PCSK9.

"This is a game changer for high-risk patients".

Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington.

Patients either took statins alone, or took Repatha - also known as evolocumab - alongside their statins.

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. Many doctors wondered if such low levels would be unsafe, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.

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.

According to a report from Kaiser Health News, Repatha is a man-made antibody with the generic name evolocumab.

"A promising new approach is blocking the action of PCSK9, a molecule which reduces the breakdown of LDL-cholesterol in the liver". The data from Amgen's "Fourier" study are meant to prove to insurers and clinicians that evolocumab is worth its $14,000 per month list price, which was met with major resistance.

The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year.

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.

"As a practicing cardiologist who sees a lot of patients with severe dyslipidemia and/or statin intolerance, I am very excited by these data because I need all the tools I can get to reduce CVD risk, especially for patients with severe dyslipidemia or who can't tolerate statins, " Stein wrote in an email.

Prof Sir Nilesh Samani, medical director at the British Heart Foundation, said: "Coronary heart disease is the single biggest killer in the United Kingdom and worldwide and "bad" LDL-cholesterol is a major cause".

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.

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