Evolocumab, added to statins may help lower cholesterol

The randomized, double-blind, placebo-controlled clinical trial included 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter.

Needham analyst Chad Messer said in a note to clients that Esperion's drug, bempedoic acid, has a different method of reducing "bad" LDL cholesterol.

In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30.

Some doctors hailed the results as major progress against heart disease.

A year and a half after its feted approval, a new cholesterol drug has passed a key test.

In addition, high-risk populations appear the most relevant for delivering benefit from PCSK9 drugs, Meanwell said.

The latest trial, involving 27,500 patients and led by Harvard Medical School and Imperial College London, provides that evidence.

The company hinted at price flexibility when evolocumab launched, and already uses payment schemes that link the drug's net price to cholesterol reductions and "anticipated appropriate patient utilization".

Overall, the risk reduction was less than what might have been expected based on how much evolocumab reduces the amount of LDL cholesterol in the body, says Krumholz.

A landmark study revealed that the cholesterol-lowering drug evolocumab (Repatha) also reduces the risk of death and hospitalization.

Last May it was made available on the NHS for 325,000 people at high risk.

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. "There are an very bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".

A new class of cholesterol lowering drugs, PCSK9 inhibitors, effectively lower LDL cholesterol levels beyond current treatment targets and new research showed that these lower levels result in a reduction in adverse cardiovascular events, making these drugs attractive treatment options for patients who do not achieve their target cholesterol level with statin therapy alone. It was also published online today in The New England Journal of Medicine. Almost all were taking modest or large doses of statins. Most patients (81 percent) had a history of heart attack, 19 percent had suffered an ischemic stroke, which happens when a blood clot blocks an artery supplying blood to the brain, and 13 percent had symptomatic peripheral artery disease, which is when blood flow to the limbs is limited.

"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". That longer duration in between doses means a clean side effect profile is crucial because the effects couldn't be reversed if there was a problem.

Evolocumab is a human monoclonal antibody that works by blocking a protein that reduces the liver's ability to remove LDL cholesterol from the blood, called PCSK9.

"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". A year-long supply of evolocumab costs $14,100, while alirocumab goes for $14,600.

Perry Colangeli, a 51-year-old from Calgary has been taking evolocumab as part of the study.

"With this trial, we now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely", said Marc S. Sabatine, MD, the Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine at Brigham and Women's Hospital in Boston, chair of the Thrombolysis in Myocardial Infarction (TIMI) study group and the study's lead author.

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