Sanofi and Regeneron Pharmaceuticals Inc. have announced that the Odyssey Outcomes trial has met its primary endpoint, showing that Praluent (Alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack.
A more pronounced effect was observed in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally tolerated statins, who are at a high risk of suffering a future event. In this group, Praluent reduced the risk of major adverse heart events by 24 percent and was associated with a 29 percent lower risk of death.
Results from the trial were presented during a late-breaker session at the American College of Cardiology’s 67th Annual Scientific Session (ACC.18) in Orlando, Florida.
“This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline,” said George D. Yancopoulos, president and chief scientific officer, Regeneron. “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 because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk.”
“Not all patients with heart disease are the same. 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,” said Elias Zerhouni, president, global R&D, Sanofi. “With nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrates that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients.”
A more pronounced effect was observed in patients with baseline LDL-C levels at or above 100 mg/dL despite maximally tolerated statins, who are at a high risk of suffering a future event. In this group, Praluent reduced the risk of major adverse heart events by 24 percent and was associated with a 29 percent lower risk of death.
Results from the trial were presented during a late-breaker session at the American College of Cardiology’s 67th Annual Scientific Session (ACC.18) in Orlando, Florida.
“This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline,” said George D. Yancopoulos, president and chief scientific officer, Regeneron. “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 because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk.”
“Not all patients with heart disease are the same. 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,” said Elias Zerhouni, president, global R&D, Sanofi. “With nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrates that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients.”
