Medicines Co drug shows long-term cholesterol lowering in study

Medicines Co drug shows long-term cholesterol lowering in study

The study showed that one heart attack or stroke was prevented for every 74 patients taking the drug in the two-year trial. "Why not just reduce the price of the drug and make it more broadly available?"

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

The drug, Repatha, is called a PCSK9 inhibitor and can make cholesterol tumble to levels nearly never seen naturally in adults, or even in people taking cholesterol-lowering statins. By blocking the enzyme, the medications spur the body to screen out more cholesterol.

Following this data, Amgen hopes that payers will expand access and reduce the hurdles that have been preventing the majority of patients with prescriptions from initiating therapy, and it plans to offer an option that would provide a refund if a patient has a stroke or heart attack while taking Repatha (this is only expected to lower net pricing if the drug does not perform as it has in clinical trials). Repatha showed a measurable-if modest-benefit in reducing cardiovascular events such as heart attacks and stroke.

The study has focused on the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death.

Those who took both were less likely to suffer a heart attack or stroke than if they took statins alone.

"The disappointing thing to me was there was absolutely no difference in mortality", Stone said.

But it comes at a hefty price tag of more than $14,000 per year, raising concerns about how many patients could benefit. It works by using artificial antibodies to block the receptors for PCSK9 in the liver. Statins cost only £20 a year per patient.

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.

"It's three or four injections a year versus what we're currently doing now, which is 24 or 12 injections a year", Underberg said. The fresh evidence could mean many more patients become eligible.

Cholesterol reducing drugs are used by millions of heart patients in the United States. These patients came into the trial with established atherosclerotic CV disease or peripheral artery disease, or having had a heart attack or stroke.

Some doctors hailed the results as major progress against heart disease. A study testing whether Praluent also lowers heart risks will wrap up later this year.

The best dose turned out to be 300 mg given three months apart, which cut LDL-c by around 45% at nine months, and there have been no additional concerns about safety after the fatal heart attack in one patient reported previous year.

"It sounds like the patient gets harmed and the payer has its financial risk reduced", said New York-Presbyterian Hospital/Weill Cornell Medical Center cardiologist Cam Patterson.

Cardiologists have always been taught that CV patients have three risk factors that can be handled with treatment: high blood pressure, smoking and high LDL cholesterol, Levy said.

Amgen believes that multiple components go into the analysis, namely quality of life, lifespan, baseline event rate, efficacy of the drug, and cost (medical and drug).

Amgen and Sanofi/Regeneron have been hoping that new data showing that reductions in LDL cholesterol (LDL-c) are mirrored by significant reductions in the cardiovascular complications of high cholesterol will drive uptake, and Amgen reported the results of its outcomes trial-Fourier-at the American College of Cardiology (ACC) meeting over the weekend.

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