MedicalResearch.com Interview with:
Evan A. Stein, M.D., Ph.D. FRCP(C), FCAP
Metabolic and Atherosclerosis Research Center
Cincinnati, OH 45225,
MedicalResearch.com: What are the main findings of the study?
Dr. Stein: The study which is the first 52 week randomized double blind trial of a PCSK9 to report results (all others have been 12 weeks) demonstrated that the excellent LDL-C reductions of 55-60% seen at 12 weeks are maintained through 52 weeks, with no fall off in patient compliance, tolerability of efficacy. It also demonstrated that with longer treatment no new or unexpected side effects.
The study also had a unique design in that prior to randomization to the PCSK9 inhibitor (evolocumab) or placebo patients had a run in period during which time they were assigned, based on NCEP-ATP III criteria, to appropriated background therapy which ranged from diet only, to atorvastatin 10 mg a day, to atorvatatin 80 mg a day or
atorvastatin 80 mg a day plus ezetimibe - reflecting how these patients are treated in practice. Only then if their LDL-C was still above 75 mg/dL were they randomized into the treatment part of the study with the new drug. The study showed that irrespective of background therapy the reduction with evolocumab was consistent.