New results from the SPIRE program studying the effect of Pfizer's PCSK9 inhibitor bococizumab on LDL cholesterol levels and clinical outcomes in high-risk patients already taking statin therapy were presented at the American College of Cardiology (ACC) meeting and simultaneously published in the NEJM, reported ScienceDaily.
Researchers say bococizumab had short-term benefits on lowering cholesterol levels and significantly reduced the risk of cardiovascular events by 21 percent compared to placebo among those who had baseline LDL cholesterol levels of greater than 100 mg/dL. However, the cholesterol lowering effect tended to diminish over time in some patients and bococizumab did not reduce cardiovascular event rates among those with LDL levels lower than 100 mg/dL.
Researcher Paul Ridker said "the new data show a meaningful reduction in cardiovascular events in the highest-risk patients who had the highest LDL cholesterol levels, despite already taking high-intensity statin therapy."
The SPIRE program included six trials involving 4449 patients, who previously had a heart attack or stroke or had extremely high baseline cholesterol levels and were on statin therapy. Patients were randomised to receive either bococizumab or placebo to determine the effects on LDL levels. Two other trials randomized 27 438 patients to either bococizumab or placebo and were designed to evaluate the impact of the drug on cardiovascular outcomes.
Last November, the entire SPIRE clinical trials program was stopped when Pfizer discontinued the development of the drug when initial results from the LDL cholesterol lowering trials indicated that some participants had developed an immunologic response to the drug.
Further analysis indicated that bococizumab effectively reduced LDL cholesterol levels by an average of 56 percent after 14 weeks, but the immunologic reaction attenuated the reduction in LDL cholesterol in approximately 15 percent of those who received the drug. Data also show that there was a wide variation in the magnitude of cholesterol reduction that patients achieved with bococizumab, even among patients who did not develop the immunologic response.
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