(HealthDay News) — Semuloparin, a hemisynthetic, ultra-low-molecular-weight heparin, reduces the incidence of thromboembolic events in cancer patients receiving chemotherapy, with no increased risk of a major bleeding event, according to a study published in the Feb. 16 issue of the New England Journal of Medicine.
Giancarlo Agnelli, M.D., of the University of Perugia in Italy, and colleagues conducted a double-blind, multicenter trial in patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy. Patients were randomly assigned to receive either subcutaneous semuloparin (20 mg once daily; 1,608 patients) or placebo (1,604 patients) until there was a change of chemotherapy regimen.
The researchers found that, during a mean treatment duration of 3.5 months, venous thromboembolism occurred in significantly fewer patients receiving semuloparin versus placebo (1.2 versus 3.4 percent; hazard ratio [HR], 0.36; P < 0.001). There was consistent efficacy among subgroups defined by origin and stage of cancer, and by baseline risk of venous thromboembolism. The incidence of clinically relevant bleeding was 2.8 and 2.0 percent in the semuloparin and placebo groups, respectively (HR, 1.40; 95 percent confidence interval [CI], 0.89 to 2.21) with major bleeding occurring in 1.2 percent of patients receiving semuloparin and 1.1 percent receiving placebo (HR, 1.05; 95 percent CI, 0.55 to 1.99). All other adverse events had similar incidences in the two study groups.
“Semuloparin reduces the incidence of thromboembolic events in patients receiving chemotherapy for cancer, with no apparent increase in major bleeding,” the authors write.
The study was funded by Sanofi; several authors disclosed financial relationships with pharmaceutical companies, including Sanofi.