150-mg dose met prespecified threshold for significance for primary and secondary end points
MONDAY, Aug. 28, 2017 (HealthDay News) — Canakinumab at a dose of 150 mg every three months is associated with reduced rate of cardiovascular events among patients with previous myocardial infarction, according to a study published online Aug. 27 in the New England Journal of Medicine. The research was published to coincide with the European Society of Cardiology Congress 2017, held from Aug. 26 to 30 in Barcelona, Spain.
Paul M. Ridker, M.D., from Brigham and Women’s Hospital in Boston, and colleagues conducted a randomized trial of canakinumab (50, 150, and 300 mg) involving 10,061 patients with previous myocardial infarction and high-sensitivity C-reactive protein level of ≥2 mg/L.
The researchers found that the median reduction from baseline in the high-sensitivity C-reactive protein level was 26, 37, and 41 percentage points greater in the groups that received 50, 150, and 300 mg of canakinumab, respectively, compared with the placebo group at 48 months. There was no reduction in lipid levels from baseline with canakinumab. The incidence rate for the primary end point (nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) at a median follow-up of 3.7 years was 4.50, 4.11, 3.86, and 3.90 events per 100 person-years in the placebo group and the 50-, 150-, and 300-mg groups, respectively. The 150-mg dose met the prespecified threshold for significance for the primary end point and secondary end point (hazard ratio versus placebo, 0.83).
“Canakinumab at a dose of 150 mg every three months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering,” the authors write.
Several authors disclosed financial ties to biopharmaceutical companies, including Novartis, which manufactures canakinumab and funded the study.
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