The study is one of two in the SPIRE Phase III program. The SPIRE Phase III program will evaluate approximately 32,000 patients with high cholesterol.
“Pfizer has been a leader in redefining the management of cardiovascular risk for decades, and we are applying our deep understanding of cardiovascular disease to the SPIRE Phase 3 program,” Therapeutic Area Clinical Head for Cardiovascular and Metabolic Disease, Global Product Development Dr. James M. Rusnak said. ”We have designed our cardiovascular outcome trials differently from other PCSK9i outcome trials to include both primary and secondary prevention patients at high risk for a cardiovascular event.”
The study is evaluating Proprotein Convertase Subtillsin Kexin type 9 inhibitor (PCSK9i) in patients with high cholesterol and other high-risk conditions, including chronic kidney disease, diabetes and history of heart problems. The study includes patients that have not had a history of cardiovascular events. The patients in the study receive either brococizumab or a placebo. The patients also receive statins unless statin intolerant. The study is expected to end in mid to late 2017.
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