Pfizer completes enrolment for bococizumab cardiovascular outcomes trial

Pfizer has completed enrolment for a new clinical trial assessing the cardiovascular outcomes associated with its investigational agent bococizumab.

The SPIRE-2 trial is part of the wider SPIRE phase III global clinical development programme and will assess the efficacy and safety of bococizumab compared to placebo in reducing the risk of major cardiovascular events among approximately 10,600 patients at high risk for cardiovascular disease.

This includes those without a prior history of cardiovascular events and patients who are on highly-effective statins or with documented statin intolerance.

Bococizumab is a PCSK9 inhibitor therapy and will be assessed among approximately 32,000 patients with high cholesterol over the course of the SPIRE programme. The SPIRE-2 study is expected to be completed in the second half of 2017.

Dr James Rusnak, therapeutic area clinical head for cardiovascular and metabolic disease at Pfizer's global product development business, 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."