New Cholesterol Drug Lowers Risk of Heart Attack and Stroke

Mar 21, 2017, 00:47
New Cholesterol Drug Lowers Risk of Heart Attack and Stroke

Peter Bach, for instance, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering, emphasized that the number of CV events prevented would be too small for payers to save much money.

"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.

One major barrier is its high cost - it has a USA list price of $14,000 a year per patient.

The patients in the trial were already taking statins, and their risk was cut further by the new therapy.

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"Investors have grown more cautious on the PCSK9 space following the less-than-stellar Fourier data from Amgen", said the analysts in a research note. Rind also was not involved in the study. In clinical trials, both Repatha and its competitor, a drug called Praluent developed by Sanofi and Regeneron, reduced LDL cholesterol by about 60% in patients already taking statins. "However, for lower risk patients this study still leaves payers with significant ammunition to restrict access". But in the Mizuho Securities conference call, participants agreed that a reasonable estimate of the direct hospital cost of treating a stroke is around $20,000 to $40,000, while the total lifetime costs are about $100,000 for an elderly patient, and up to $500,000 for a young patient. People with naturally-occurring mutations in the gene encoding PCSK9 have lower levels of LDL cholesterol, and are protected from heart disease, strongly suggesting that an antibody against the PCSK9 protein should have the same beneficial effects - a story that remains the poster-child for exploiting human genetics to understand the biology of common diseases (such as heart disease) in the same way it revolutionised the discovery of new treatments for rare diseases a decade earlier.

Some doctors are less impressed with the new study, which was funded by Amgen.

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.

The benefit of Repatha was seen on those tested within six months.

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Professor Naveed Sattar, an expert in metabolic medicine at the University of Glasgow, said: 'Can we realistically afford to extend the guidelines to bring these drugs to more people? If a patient has a heart attack or stroke while taking Repatha as prescribed, Amgen will refund the cost of treatment. However, it has been created to target a protein in the liver with the name PCSK9. Patients took either statins alone, or Repatha with their statins.

Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, Patterson said.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins. The implication, he said, is that larger benefit is "probably a true reflection of what patients will experience if they take the drug over time".

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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While Amgen said in a statement that those differences weren't notable, Topol disagreed, and said that the increase in instances of diabetes partially offsets evolocumab's reduction in heart attacks. Pfizer, the drug's manufacturer, halted development of bococizumab in November.

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