Regeneron and Sanofi announce new Praluent injection analyses presented at AHA scientific sessions 2015
74% of patients reached their LDL cholesterol goals on 75 mg dose; Of the remaining patients whose dose was adjusted to 150 mg, most achieved their goal.
Regeneron Pharmaceuticals and Sanofi have announced a new post-hoc analysis of six Phase III clinical trials showing that approximately three quarters (74%) of patients reached their pre-specified LDL cholesterol targets within 8 weeks of adding Praluent (alirocumab) Injection 75 mg to their standard-of-care, which included statins. In the 26% of patients whose dose was increased to 150 mg, most were able to achieve their pre-specified LDL cholesterol target, with an average additional 14% reduction in LDL cholesterol. The results from this and other analyses, which evaluated Praluent every 2 weeks, were presented at the American Heart Association (AHA) Scientific Sessions in Orlando, FL.
"In this analysis of patients who required further improvement of their LDL cholesterol levels, adding Praluent 75 mg to their standard-of-care allowed the majority of patients to achieve their LDL cholesterol goals. For those who required further LDL cholesterol lowering, increasing Praluent to 150 mg provided additional efficacy," said Harold Bays, from the Louisville Metabolic & Atherosclerosis Research Center, Kentucky, US. "Data such as these provide clinicians practical insight as to how the two Praluent doses may better allow patients to achieve their LDL cholesterol goals."
These results are based on a pooled post-hoc analysis of 1,291 patients with high cardiovascular (CV) risk or an inherited form of high cholesterol (heterozygous familial hypercholesterolemia, or HeFH) which found 74% of patients who added Praluent 75 mg achieved their LDL cholesterol-lowering goals at week 8, and the remaining 26% had their dose adjusted to 150 mg at week 12. In other results:
In a separate pooled post-hoc analysis of 3,499 patients, individuals with diabetes (n=1,051) who initially received Praluent 75 mg or 150 mg every 2 weeks had a mean percent difference in LDL cholesterol of 44% and 58%, respectively, versus placebo at week 24 (p less than 0.0001). In other results:
A third post-hoc analysis of 4,974 patients did not find an increased risk of diabetes-related AEs among those who didn't have diabetes when they entered the trials, regardless of whether they were taking Praluent or were in a control group (placebo or ezetimibe). There was also 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.
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