Odyssey Outcomes Trial Results Are In: Good News

Sanofi and Regeneron Pharmaceuticals, Inc. has announced the primary endpoint of their Odyssey Outcomes trial, which tested the long-term effects of early PCSK9 inhibition in high cardiovascular risk patients who had recently experienced an acute coronary syndrome (ACS) event, such as a heart attack. In this 18 924 patient, long-term trial – which included 505 South African patients, the safety profile of Praluent was consistent with previous trials and no new safety issues were observed.

“Heart disease is the number one killer worldwide. At Sanofi, solutions to help high-risk patients – such as those who have suffered a heart attack – have recently been explored. Cardio Vascular (CV) care has been at the heart of what we do for more than a century. We are committed to delivering innovative solutions to people at high risk for CV events, and to those who need additional treatment options beyond currently available medications,” said Dr. Poobalan Naidoo (Senior Medical Advisor, Sanofi South Africa).

Praluent® (alirocumab) was found also to have significantly reduced the risk of Major Adverse Cardiovascular Events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) events such as a heart attack. Results from the Odyssey Outcome trial were then presented during a late-breaker session at the American College of Cardiology’s 67th Annual Scientific Session in Orlando, Florida and are available here.

Key findings of the Odyssey Outcomes trial:

  • In the primary results, Praluent recued the overall risk of MACE by 15% (HR=0,85, CI=0.78-0.93, p=0.0003).
  • The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization.
  • For the first time, adding a lipid lowering therapy to maximally-tolerated statins was associated with reduced death from any cause – in other words, “all-cause mortality” (HR=0.85; CI:0.73-0.98, nominal p=0.026) – and there were also numerically fewer coronary heart disease (CHD) deaths (HR=0.92; CI: 0.76-1.11, p=0.38).
  • More pronounced effect observed in patients with baseline LDL-C levels. In a pre-specified analysis, the patients with baseline LDL-C levels at or above 100 mg/dL experienced a more pronounced effect from Praluent, reducing their risk of death from any cause by 29% (HR= 0.71, CI: 0.56-0.90). The analyses described above include the results from 730 patients (8%) in the Praluent group who continues to be assessed in the Praluent arm despite stopping active Praluent therapy, as specified in the protocol for patients with persistent LDL-C readings below 15 mg/dL. For those in the Praluent treatment arm, approximately 75% of patient time was on the 75 mg dose.
  • There were no new safety signals in the trial, with injection site reactions experienced more commonly in the Praluent group compared to patients on maximally-tolerated statins alone (3.8% Praluent; 21% placebo). There was no difference in neurocognitive events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6% Praluent; 10.1% placebo). The Odessey Outcomes trial met its primary endpoint demonstrating that high-risk patients who added Praluent® (alirocumab) to maximally-tolerated statins, experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone.

What does this mean for those suffering from heart disease?

“The Odyssey Outcome trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. “Many patients who have survived a recent heart attack or other coronary events are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need to 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, M.D., President, Global R&D, Sanofi. “With nearly 90% 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.”

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