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Sanofi and Regeneron presented results of a new post-hoc analysis of six Phase 3 clinical trials showing that adding Praluent (alirocumab) Injection 75mg to standard-of-care therapy, including statins, lowered patient’s LDL cholesterol to their pre-specified target within 8 weeks of addition. Findings were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, FL.
These results were based on a pooled post-hoc analysis of six Phase 3 ODYSSEY trials including 1,291 patients with high cardiovascular (CV) risk or heterozygous familial hypercholesterolemia (HeFH), an inherited form of high cholesterol. Praluent 75mg was added to standard-of-care, with dose adjustment at week 12 to 150mg if unable to reach their LDL cholesterol goals, either <70mg/dL or <100 mg/dL, dependent on CV risk, by week 8. All patients in all six trials received background statin therapy.
Results showed that approximately 74% of patients reached their pre-specified LDL cholesterol targets within 8 weeks of adding Praluent to their standard-of-care. The remaining 26% of patients, who had their dose increased to 150mg, achieved their goal, with a mean additional LDL cholesterol reduction of 14% by week 24.
The companies also presented results from a separate pooled post-hoc analysis of five placebo-controlled trials of individuals with diabetes (n=1,051), and without diabetes (n=2,448) with inadequately controlled hypercholesterolemia receiving standard-of-care, including maximally-tolerated statins. Patients who initially received Praluent 75mg or 150mg every two weeks had a mean percent difference in LDL cholesterol of 44% and 58%, respectively, vs. placebo at week 24 (P<0.0001).
In addition, results from a third post-hoc analysis of ten Phase 3 ODYSSEY trials including 4,974 patients with inadequately controlled hypercholesterolemia who had diabetes (n=1,526), pre-diabetes (n=1,969), and no diabetes (n=1,479), were presented. Data showed no evidence that Praluent affected the incidence of new-onset diabetes or pre-diabetes. The ongoing ODYSSEY OUTCOMES trial will provide further data on the impact of Praluent on glycemic measures.
Praluent, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol.
For more information call (800) 633-1610 or visit Sanofi.us or Regeneron.com
