JOURNAL ARTICLE
MULTICENTER STUDY

Thromboprophylaxis with the low-molecular-weight heparin bemiparin sodium in elderly medical patients in usual clinical practice: the ANCIANOS study

Leocadio Rodríguez-Mañas, Ricardo Gómez-Huelgas, Fernando Veiga-Fernández, Gema Monteagudo Ruiz, Javier Martínez González
Clinical Drug Investigation 2010, 30 (5): 337-45
20384389

BACKGROUND: Venous thromboembolism (VTE) is a preventable common disease in geriatric medical patients, causing substantial morbidity and mortality.

OBJECTIVE: To assess the effectiveness and safety of bemiparin sodium thromboprophylaxis in non-surgical elderly medical patients (aged > or =65 years) bedridden for at least 4 days due to acute medical illness. This was a prospective, observational, multicentre cohort study carried out in patients treated in the setting of geriatric centres (GCs) or hospital-at-home units (HHUs). The study included 507 non-surgical elderly patients recruited from 49 Spanish centres who were administered subcutaneous bemiparin sodium (Hibor) 2500 IU/day or 3500 IU/day, depending on the degree of VTE risk - moderate or high, respectively. Rates of VTE, major and minor bleeding events, thrombocytopenia and deaths that occurred during the 3-month study period were extracted.

RESULTS: Seventy-two percent of the subjects were women, and the mean (SD) age was 82 (8) years. Overall, 70.6% (358 patients) were treated in GCs and 29.4% (149 patients) in HHUs. The main causes of immobilization were: heart failure (30.4%), acute infectious disease (29.8%), acute respiratory insufficiency (19.9%), rheumatological disease (i.e. osteoarthritis, rheumatoid arthritis and osteoporosis) [15.4%] and acute cerebrovascular disease (14.4%). Most of the patients (63%) had a high VTE risk and received the highest dose of prophylactic bemiparin sodium (3500 IU/day) for a mean 33 days. The incidence of VTE was 0.6% (three distal deep vein thromboses confirmed by Doppler ultrasound). No cases of pulmonary embolism were reported. There were two (0.4%) major bleeding events, eight (1.6%) minor bleeding events and seven (1.4%) cases of mild thrombocytopenia; no cases of moderate or severe thrombocytopenia were reported. Twenty-four patients (4.7%) developed mild to moderate injection site complications. Twenty-one patients (4.1%) died, but all from causes not related to study medication.

CONCLUSIONS: Bemiparin sodium thromboprophylaxis for 4-5 weeks was associated with a low incidence of VTE and a low rate of bleeding and other complications in non-surgical elderly patients at risk of VTE, treated either in GCs or in HHUs, in standard clinical practice.

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