No significant difference versus enoxaparin in prespecified primary efficacy outcome
TUESDAY, May 31, 2016 (HealthDay News) — Betrixaban may be beneficial versus enoxaparin in acutely ill medical patients, according to a study published online May 27 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee, held from May 25 to 28 in Montpellier, France.
Alexander T. Cohen, M.D., from Guy’s and St. Thomas’ Hospitals in London, and colleagues randomized 7,513 patients who were hospitalized for acute medical illnesses to either subcutaneous enoxaparin plus oral betrixaban placebo or subcutaneous enoxaparin placebo plus oral betrixaban. Analyses were performed in three prespecified cohorts: patients with an elevated D-dimer level (cohort 1), patients with an elevated D-dimer level or an age of ≥75 years (cohort 2), and all enrolled patients (overall population cohort).
The researchers found that the primary efficacy outcome (a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism) occurred in 6.9 percent of patients receiving betrixaban and 8.5 percent receiving enoxaparin in cohort 1 (relative risk, 0.81; 95 percent confidence interval [CI], 0.65 to 1.00; P = 0.054). In cohort 2 and the overall population cohort the rates were 5.6 and 7.1 percent (relative risk, 0.80; 95 percent CI, 0.66 to 0.98; P = 0.03) and 5.3 and 7.0 percent (relative risk, 0.76; 95 percent CI, 0.63 to 0.92; P = 0.006), respectively.
“Prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts,” the authors write.
Several authors were employees of Portola Pharmaceuticals, which manufactures betrixaban and funded the study.
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