(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%; 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% in the semuloparin and placebo groups, respectively (HR, 1.40; 95% confidence interval [CI], 0.89 to 2.21) with major bleeding occurring in 1.2% of patients receiving semuloparin and 1.1% receiving placebo (HR, 1.05; 95% CI, 0.55 to 1.99). All other adverse events had similar incidences in the two study groups.

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“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.

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