Cholesterol drug drops heart risks, but ignites new price debate

by Jared Lewis March 21, 2017, 0:32
Cholesterol drug drops heart risks, but ignites new price debate

About 10% of patients taking the drug had a heart attack or stroke, or died of heart disease during the trial. Repatha and a similar drug, Praluent, called PCSK9 inhibitors, were approved in 2015 for people with inherited risk for high cholesterol, or heart disease that had already caused a problem such as a heart attack.

"The data from our trial provide insight into the benefit of decreasing LDL cholesterol levels to median levels lower than those in previous trials", wrote the researchers, led by Marc Sabatine of Brigham and Women's Hospital in Boston. Therefore, in order to find out if the claims held some truth, a study was conducted to note the effects of this new drug sponsored by Amgen, the maker of Repatha. Given the low cost of statin treatment, payers could still limit coverage for Repatha to higher risk patients.

"It is probably the most important trial result of a cholesterol-lowering drug in over 20 years".

The announcement came during the American College of Cardiology annual meeting in Miami. Kaiser Health News noted that insurers aren't quite sure whether they would cover the drug, citing issues with its price and its then-unproven benefits.

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

In addition, Amgen noted that there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed - the secondary endpoints. The price of the drug is so high that even most of the medical insurances do not wish to pay for it.

It was observed that administering the drug reduced average low-density lipoproteins (LDL) from 92 to 30.

It establishes that maximally reducing LDL-C levels with Repatha, beyond what is possible with the current best therapy alone, further reduces major cardiovascular events, including heart attacks, strokes and coronary revascularisations.

According to a statement published in The New England Journal of Medicine, the study included 27,564 patients between 40 and 85 years old with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter or higher.

Unfortunately, evolocumab did not reduce a person's overall risk of death, or their risk of dying from heart disease, noted Dr. Gregg Stone, director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Medical Center. The rest of the patients, due to narrowed arteries, were suffering from pain in their legs and had a stroke.

Safety-wise, Repatha patients didn't see some of the side effects that other lipid therapies produce, he said. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said. The researchers found an average decline of 59 percent in LDL levels among the 14,000 people in 49 countries who were put on the drug for 48 weeks, when compared with an nearly identical number of patients who received a placebo.

Stubbornly high cholesterol is a key risk factor.

The investigation arose after the drug was approved by the U.S. Food and Drug Administration before making a deep study including real patients. However, the high cost of treatment has already started a debate on the drug and ever increasing drug prices.

Reacting to the offer, multiple doctors were mostly critical about the deal, stating that it may be a lose-lose situation for both the patient and their insurance provider.

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