Utilisation and safety of bemiparin, a low-molecular-weight heparin, in medical patients : a prospective, uncontrolled cohort study

Abstract

Introduction: Venous thromboembolism (VTE) is the cause of approximately 10-12% of all deaths occurring in hospitalised patients. In a previous study, bemiparin suppressed markers of hypercoagulability in acutely ill medical patients with heart failure.

Objective: To estimate the rate of symptomatic VTE, bleeding events, thrombocytopenia and death in acutely ill medical patients treated with low and high prophylactic doses of bemiparin in standard clinical practice.

Methods and patients: This was a prospective, open, multicentre, non-randomised cohort study. Acutely ill patients hospitalised in medical departments were included and treated with bemiparin 2500 IU/day or 3500 IU/day, depending on the degree of VTE risk (moderate or high) as assessed by the investigator. The main efficacy and safety endpoints were: symptomatic confirmed VTE (deep vein thrombosis and pulmonary embolism), major bleeding, thrombocytopenia and death. The observation period was 41 days. A total of 297 medical patients hospitalised for several reasons (lung disease: 87 [29.3%], heart disease: 80 [26.9%], neurological disease 25 [8.4%], gastrointestinal disease: 18 [6.1%], rheumatic disorder: 14 [4.7%], haematological disease: 11 [3.7%], renal disease: 8 [2.7%], other: 54 [18.2%]) were included from 13 centres in Spain. The median age of the patients included was 78 years (range 31-100). Overall, 208 patients received bemiparin 2500 IU/day and 89 patients received bemiparin 3500 IU/day.

Results: There was one case of symptomatic VTE in 297 patients (0.3%). Four patients (1.3%) experienced a major bleeding event. There were two cases (0.7%) of mild-moderate type I heparin-induced thrombocytopenia (HIT) during the treatment period that did not require treatment discontinuation. There were no cases of severe type II HIT. A total of 22 (7.4%) patients died during the treatment period as a result of factors unrelated to VTE.

Conclusions: Bemiparin appears to be effective and safe in the prevention of VTE in acutely ill medical patients.