March 12 (UPI) -- Praluent, or alirocumab, a relatively new cholesterol drug, is effective at lowering heart attack and death risk, according to a study sponsored by manufactuers Sanofi and Regeneron Pharmaceuticals.
The results of the study were announced Saturday at an American College of Cardiology conference in Orlando, Fla.
The drug, which is injected every two weeks or every four weeks based on strength, allows the liver to remove more LDL from the blood and lowers the concentration of LDL cholesterol in the blood.
The cost of PCSK9 inhibitors, which also include Amgen's Repatha, is more than $14,000 per year, according to the Institute for Clinical and Economic Review, which has raised concern about their availability to those who need them. Both drugs have been on the market since 2015.
Related
Alirocumab is a fully human monoclonal antibody that works by blocking PCSK9. The study did not raise any major safety concerns for the drug.
"We were really pleased to see the treatment was effective and associated with a reduction in mortality. It is remarkable that such a potent intervention is also so safe," Dr. Philippe Gabriel Steg, chief of cardiology at Bichat Hospital in Paris and co-chairman of the study, said in an ACC press release. "Because the treatment effect was so much more marked in the patients with the highest LDL cholesterol, we believe that these patients are the optimal candidates for therapy."
Researchers enrolled nearly 19,000 patients at more than 1,300 centers in 57 countries to test Praluent. Participants in the trial, called Odyssey Outcomes, had recently had an acute coronary syndrome, which includes heart attack and unstable angina. Patients were tracked for at least two years, including 44 percent who were tracked for three years or more.
These participants, who had high cholesterol despite high-intensity statin therapy, saw their rates of reduced rates of major adverse cardiovascular events, called MACE, reduced by 15 percent compared with a placebo. They had LDL cholesterol at 70 mg/dL or above and non-HDL cholesterol 100 mg/dL or above.
And for patients at the highest risk -- LDL, or "bad" cholesterol, of 100 mg/dL or higher -- had a 24 percent reduction in cardiovascular events, including heart attack and stroke, compared with the placebo.
Alirocumab was linked to a 15 percent reduction in death from any cause among the full patient population and a 29 percent mortality reduction from any cause among those who started the trial with LDL cholesterol above 100 mg/dL.
A first outcomes trial last year, called Fourier, similarly reported that Repatha, a different PCSK9 inhibitor called evolocumab, reduced the risk of death, heart attack, stroke, hospitalization for angina or revascularization procedures. It cleared blocked arteries by 15 percent. But unlike the Odyssey trial, Repatha didn't show a mortality benefit, researchers said.
"Now that we have two trials that consistently show benefits from PCSK9 inhibitors, and given the mortality benefit that we are reporting here for the first time, I think these results may change the equation for these drugs," Steg said. "We're not just talking about preventing nonfatal events such as heart attacks but actually preserving life."
The manufacturers were pleased with the results, suggesting there may be more people who can benefit from them -- including with conversation about the high cost of the drugs.
On Saturday, the independent group said Praluent should cost, based on the new results, between $2,300 to $3,400 per year for people like those in the study. A price of $4,500 to $8,000 per year would be justified for patients with LDL over 100, the group said.
"Not all patients with heart disease are the same," Dr. Elias Zerhouni, president of global research and development for Sanofi said in a company press release. "Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options. With nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients."
