Patient enrollment is complete in Pfizer’s global SPIRE-2 clinical trial, which will be evaluating the efficacy of bococizumab in reducing cardiovascular events, according to a Pfizer announcement.
Cardiovascular disease is the leading cause of death worldwide. Particularly in the U.S., the vast majority of heart attacks are reported to occur in patients without a prior history of cardiovascular events. One of the risk causes for events like stroke and heart attack are high levels of low-density lipoprotein cholesterol (LDL-C), and even though highly effective lipid-lowering strategies are available, such as statins, many patients are still at high risk for cardiovascular events.
Pfizer has created the SPIRE (Studies of PCSK9 Inhibition and the Reduction of Vascular Events) program to study its investigational PCSK9i (Proprotein Convertase Subtilisin Kexin type 9 inhibitor) called bococizumab in patients with high cholesterol.
As part of the SPIRE Phase 3 global clinical program, 32,000 patients will be analyzed in six lipid-lowering studies, along with two cardiovascular outcome studies. SPIRE-2 is one of them.
“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,” said James M. Rusnak, M.D., Ph.D., Therapeutic Area clinical head for Cardiovascular and Metabolic Disease and Global Product Development, in a press release.
”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,” he said.
SPIRE-2 will evaluate bococizumab efficacy and safety in reducing the risk of major cardiovascular events compared to placebo. Approximately 10,600 patients at high risk for cardiovascular disease were enrolled in the study, including patients with diabetes, chronic kidney disease, familial hypercholesterolemia, peripheral vascular disease, history of heart attack or stroke, or history of cardiovascular revascularization procedures.
The study’s primary endpoint will be the time of first occurrence of a major cardiovascular event, but other endpoints related to the safety and tolerability of bococizumab will also be evaluated.
A number of factors affect the duration of cardiovascular outcome studies, particularly when the trials are time-to-event, but based on current Pfizer estimates, SPIRE-2 is expected to end in mid-2017.