Regeneron's anti-cholesterol drug Praluent reduces death risk in trial

Sanofi and Regeneron presented Odyssey outcomes data for Praluent at ACC 2018 on Saturday

"With almost 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", added Elias Zerhouni, president, Global R&D, Sanofi. The findings are welcome news for the drug's manufacturers, as the high list price has proven unpalatable to insurance companies. Approximately 90% of patients were on a high-intensity statin.

Last year, researchers reported similar results for a different PCSK9 inhibitor called Repatha (evolocumab), made by Amgen Pharmaceuticals, which also cut the risk of heart attack, stroke, and hospitalization for blocked arteries by 15 percent.

The study tested the injected biotech drug versus placebo in almost 19,000 patients who had a recent heart attack or severe chest pain episode and were already on maximum doses of cholesterol-lowering statins, such as Pfizer's Lipitor.

Praluent's impact on the actual number of deaths from coronary heart disease was modest, however, failing to reach statistical significance (p=0.38).

Results were presented at the American College of Cardiology's 67th Annual Scientific Session in Orlando.

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Efforts will be focused on patients who are most vulnerable for future cardiovascular events, such as those who have suffered a previous coronary event and are unable to reduce their cholesterol below a healthy level despite maximally-tolerated statin therapy.

"The results were not trivial", said Fuster, from Mount Sinai Hospital in NY.

Patients were randomized equally to be treated either by Praluent injection or a placebo, with the treatment period lasting an average of 2.8 years.

Some cardiologists believe much longer studies are needed to discover the true value of these drugs. Patients with baseline low-density lipoprotein-cholesterol (LDL-C) at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR, 0.76; CI, 0.65-0.87).

With an LDL target range of 25-50, rather than taking it as low as possible, three-quarters of patients ended up on a lower dose of Praluent and some were taken off the drug if their LDL remained at 15 or lower. There was no difference in neurocognitive events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6% Praluent; 10.1% placebo).

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