Cholesterol drug significantly reduced patients' risk of death in trial

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Alirocumab injection (Praluent, Regeneron Pharmaceuticals/Sanofi) reduced the risk of major cardiac events by 15% among patients who had suffered heart attacks and other coronary events in the ODYSSEY OUTCOMES trial.

Patients with higher baseline LDL-C levels (at or above 100 mg/dL) experienced a more pronounced effect from the drug, which reduced the risk of MACE by 24 percent, and cut the risk of death from any cause by 29 percent.

Praluent is part of a relatively new class of drugs called PCSK9 inhibitors which can dramatically lower cholesterol, and may work even better than statins, the traditional first line of treatment.

The trial succeeded on its primary goal - reducing the combined risk of heart attack, stroke, heart disease-related death and chest pain requiring hospitalization - by 15 percent. At the American College of Cardiology meeting, where the data was presented, 62% of the doctors surveyed stated they would change their prescribing habits because of the data. For those in the alirocumab treatment arm, approximately 75% of patient time was on the 75 mg dose.

"In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk". The discount deal would apply only to patients with dangerously high levels of cholesterol who are at especially high risk for heart attack or stroke. The findings are welcome news for the drug's manufacturers, as the high list price has proven unpalatable to insurance companies.

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"Sanofi and Regeneron have launched a new initiative that will expand access to their drug Praluent in the USA". In the long-term trail patients on high-dose statin therapy had been randomised 1:1 for Pradulent combination and statin monotherapy and were treated for an average (median) of 2.8 years. The organization recommended a price range of $4,500 to $8,000 for those high-risk patients likely to gain the most benefit from Praluent therapy.

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.

Praluent functions by preventing the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the LDL receptor.

However, the drug had been approved in the U.S. as an adjunct to diet and maximally-tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who need further lowering of LDL-C.

Sources: Regeneron (study results); March 10, 2018; Regeneron (pricing offer); March 10, 2018; ICER, March 10, 2018.