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Thromboprophylaxis with the Low-Molecular-Weight Heparin Bemiparin Sodium in Elderly Medical Patients in Usual Clinical Practice

The ANCIANOS Study

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Abstract

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 ≥65 years) bedridden for at least 4 days due to acute medical illness.

Methods: 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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Acknowledgements

This study was sponsored by Laboratorios Farmaceúticos Rovi S.A. Madrid, Spain. Leocadio Rodríguez-Mañas, Ricardo Gómez-Huelgas and Fernando Veiga-Fernández received research grants from the sponsor to conduct this study. Javier Martínez-González and Gema Monteagudo-Ruíz are employees of Laboratorios Farmaceúticos Rovi S.A. The authors thank Rosaura Maeso-Martín from Laboratorios Farmaceúticos Rovi S.A. for her help with this project.

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Authors and Affiliations

  1. Geriatrics Service and Research Unit, Hospital Universitario de Getafe, Getafe, Spain

    Leocadio Rodríguez-Mañas

  2. Home-Hospitalisation Unit, Hospital Ciudad Jardin, Complejo Hospitalario Carlos Haya, Málaga, Spain

    Ricardo Gómez-Huelgas

  3. Geriatrics Service, Complexo Hospitalario Xeral-Calde, Lugo, Spain

    Fernando Veiga-Fernández

  4. Medical Department, Laboratorios Farmacéuticos Rovi, S.A., Madrid, Spain

    Gema Monteagudo Ruiz & Javier Martínez González

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  1. Leocadio Rodríguez-Mañas
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  2. Ricardo Gómez-Huelgas
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  3. Fernando Veiga-Fernández
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  4. Gema Monteagudo Ruiz
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  5. Javier Martínez González
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Correspondence to Leocadio Rodríguez-Mañas.

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Rodríguez-Mañas, L., Gómez-Huelgas, R., Veiga-Fernández, F. et al. Thromboprophylaxis with the Low-Molecular-Weight Heparin Bemiparin Sodium in Elderly Medical Patients in Usual Clinical Practice. Clin. Drug Investig. 30, 337–345 (2010). https://doi.org/10.2165/11535460-000000000-00000

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