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.