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techkenyot.com April 22, 2018


Cholesterol drug significantly reduced patients' risk of death in trial

13 March 2018, 10:30 | Silvia Roy

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

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

The findings are welcome news for the drug's manufacturers, as the high list price has proven unpalatable to insurance companies.

Patients receiving Praluent also experienced a statistically valid reduction in the overall risk of death (hazard ratio = 0.85) versus control. "We are prepared to improve access and affordability, eliminating burdensome barriers for high-risk patients in need". That price would be tied to an independent review of Praluent's value based on the new risk reduction data from the multi-year study called Odyssey Outcomes. The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization. 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. The study, reported at the conference of the American College of Cardiology, involved 18,000 high-risk patients who had uncontrolled cholesterol despite taking a maximum amount of statins.

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

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The findings described Saturday at the American College of Cardiology conference in Orlando, Florida, were based on an worldwide trial of almost 19,000 people randomly assigned to either alirocumab or a placebo.

"Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event".

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

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"It may take years and years to really reap all the benefits that one can achieve", study co-chairman Dr. Gregory Schwartz said.

Regeneron president and chief scientific officer George Yancopoulos said: "This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline".

The trial was created to maintain patients' LDL-C levels between 25-50 mg/dL, using two different doses of alirocumab (75 mg and 150 mg).

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