Individuals with high "bad" cholesterol saw a greater reduction in risk of serious incidents when they took the drug Repatha in addition to statins when compared with patients who took statins alone, according to a study published Friday in the New England Journal of Medicine, the New York Times reports.
Repatha, made by Amgen, is part of a new class of cholesterol-lowering drugs known as PCSK9 inhibitors, which lower LDL, or "bad" cholesterol, differently than statins. Unlike statins, PCSK9 inhibitors are injectable biologic drugs. The drugs block the PCSK9 protein, which affects the body's ability to clear LDL.
PCSK9 inhibitors are considered breakthrough treatments that have the potential to change the course of cardiovascular treatment and result in billions of dollars in revenue for drug companies. However, the drugs have yet to gain traction amid questions about their prices and efficacy. Repatha costs more than $14,000 for a year's worth of treatment before any discounts are considered.
Amgen funded the study, and also helped design it, collect data for it, and authored a corresponding paper on the findings.
For the study, researchers followed 27,564 individuals with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter or higher who were taking statins. The participants had a median LDL cholesterol level of 92 mg per deciliter. About 80 percent of the participants had already had a heart attack, while the rest had experienced a stroke or pain in their legs and feet from narrowed arteries.
The researchers randomly assigned the participants into two groups—one that received Repatha and a statin, and one that received a placebo and a statin—and compared the outcomes.
Over the course of 2.2 years, the researchers found that individuals who took Repatha saw a 20 percent reduction in the risk of the most serious possible outcomes—death from heart disease, heart attack, and stroke—compared with patients who received the placebo. According to the researchers, 5.9 percent of patients who took Repatha and a statin had a heart attack, stroke, or died, compared with 7.4 percent of patients who received a placebo and a statin.
Further, the researchers found that the combined risk of heart attack, stroke, or death from cardiovascular disease, hospitalization for worsening chest pain, or having a stent inserted to open a blocked artery decreased by 15 percent among the group that took Repatha when compared with the placebo group. According to Amgen, the absolute reduction in the risk of heart attack was 1.3 percent at two years and 2 percent at three years among the group that received Repatha.
In addition, the researchers found that participants who took Repatha saw their LDL levels fall to an average of 30 mg per deciliter, with one-quarter reaching an LDL level of 19 or lower.
Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital, said the findings show that, "as a class," PCSK9 inhibitors "clearly have the potential to lower event rates."
However, some physicians said they had hoped the study would show greater reductions in serious complications related to cardiovascular disease. David Rind, CMO at the Institute for Clinical and Economic Review, said, "This (result) is probably a little less than we had been hoping for."
John Mandrola, a cardiologist at Baptist Health in Kentucky, called the drop in the risk of serious complications "a small reduction for a super expensive drug."
Steven Nissen—chair of cardiovascular medicine at Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past—said Repatha could be an important drug for some high-risk patients despite its cost. "It would be hard for me to look a patient in the eye, if they've had a couple of heart attacks and is scared to death, and say it's not worth you taking this medication," he said.
Implications for insurance coverage
Kristine Grow, a spokesperson for America's Health Insurance Plans, said insurers would consider the study's findings.
To encourage insurers to cover Repatha, Amgen on Friday said it would refund insurers for Repatha's costs if patients have a heart attack or stroke while taking the drug.
Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, called Amgen's offer "a fig leaf covering a massive price" and predicted that insurers would lose money on the proposal (Kolata/Thomas, New York Times, 3/17; Szabo, Kaiser Health News, 3/17; Bernstein, "To Your Health," Washington Post, 3/17; Krumholz, "Shots," NPR, 3/17).
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