Pfizer has completed enrolment in the global SPIRE-2 cardiovascular outcome trial of its investigational agent bococizumab, in high-risk patients without a history of cardiovascular events.
Bococizumab is a Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i) being studied for its potential to lower LDL-C and improve cardiovascular outcomes in high-risk primary and secondary prevention patients.
SPIRE-2 study expects to evaluate the efficacy and safety of bococizumab compared to placebo by reducing the risk of major cardiovascular events among around 10,600 patients at high risk for cardiovascular disease, including those without a prior history of the events and who are also on highly-effective statins or with documented statin intolerance.
The study is one of two cardiovascular outcome trials that are part of the SPIRE Phase lll global clinical development programme, which will evaluate the investigational proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9i) bococizumab in around 32,000 patients with high cholesterol.
The multicentre, double-blind SPIRE-2 study is expected to be completed by the second half of next year.
The SPIRE-2 study is one of two cardiovascular outcome trials that are part of the SPIRE Phase III global clinical development programme, which will evaluate the investigational PCSK9i bococizumab in approximately 32,000 patients with high cholesterol.
During the SPIRE-2 trial, patients with LDL-C =100 mg/dL or non-HDL-C =130 mg/dL were randomised to receive either bococizumab 150mg or placebo every two weeks, along with highly-effective statins, unless patients had documented statin intolerance.
The main endpoint in SPIRE-2 is timed to the first occurrence of a major cardiovascular event, such as cardiovascular-related death, non-fatal heart attack, non-fatal stroke, and hospitalisation for unstable angina needing urgent revascularisation including heart bypass, angioplasty.
The study is also evaluating other endpoints, including the safety and tolerability of bococizumab.
According to a report by World Health Organisation, cardiovascular disease remains the leading cause of death worldwide.
Various other studies have found that high LDL-C is a known modifiable risk factor for cardiovascular events such as a heart attack and stroke.
However, despite the availability of highly effective lipid-lowering therapies such as statins, many patients remain at high risk for cardiovascular events.
In the US, more than 70% of heart attacks reportedly occur in patients without a previous cardiovascular event.