This Article Full Text (PDF) All Versions of this Article: 1076029607303962v1 14/1/75    most recent References Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Otero-Fernández, R. Articles by Fontcuberta, J. Search for Related Content PubMed PubMed Citation Articles by Otero-Fernández, R. Articles by Fontcuberta, J. Social Bookmarking                         What's this?

Evaluation of the Effectiveness and Safety of Bemiparin in a Large Population of Orthopedic Patients in a Normal Clinical Practice

Department of Orthopaedic Surgery & Trauma, Hospital Clínico San Carlos, Madrid, rotero.hcsc{at}salud.madrid.org

Antonio Gómez-Outes, MD

Medical Department, Laboratorios Farmacéuticos Rovi, Madrid

Javier Martínez-González, MD

Medical Department, Laboratorios Farmacéuticos Rovi, Madrid

Eduardo Rocha, MD, PhD

Department of Haematology, Clínica Universitaria de Navarra, Pamplona

Jordi Fontcuberta, MD, PhD

Department of Haematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

The authors conducted a prospective, open, multicenter, observational study to audit the utilization patterns of bemiparin in orthopedic patients in daily clinical practice. They analyzed rates of documented symptomatic venous thromboembolism (VTE) (deep vein thrombosis and pulmonary embolism) confirmed by objective methods, major bleeding, death, thrombocytopenia, and other adverse events. It was also intended to analyze the influence of concomitant factors (bemiparin dose, concomitant medications, age, and obesity) on VTE and bleeding rates. A total of 7959 patients were included and received bemiparin for 28 days (median). Bemiparin 3500 IU/d was used in 84.9% of patients, whereas bemiparin 2500 IU/d was administered to 15.1% of patients. Reason for prophylaxis (number of cases [%]) included cast immobilization of the leg (2052 [25.8%]), knee replacement (1082 [13.6%]), hip replacement (876 [11.0%]), hip fracture surgery (437 [5.5%]), other lower limb surgery (1569 [19.7%]), knee arthroscopy (769 [9.7%]), and spine surgery (231 [2.9%]). A total of 943 patients with insufficient data on reason for prophylaxis and 560 patients with no outcome assessment were excluded from the analysis of clinical outcomes. Among 6456 assessable patients, the authors found a low rate of documented symptomatic VTE (0.91%), major bleeding (0.17%), deaths (0.37%), and mild to moderate thrombocytopenia (0.51%). None of the major bleedings was fatal or occurred in a critical organ. There were 3 deaths in which fatal pulmonary embolism (PE) could not be ruled out. There were no cases of severe type-II thrombocytopenia. VTE rates were not increased in obese patients, and major bleeding rates were not increased in elderly patients or in patients taking nonsteroidal anti-inflammatory drugs. In conclusion, bemiparin prophylaxis, given for 3 to 4 weeks in cast immobilization of the leg and other orthopedic procedures, was associated with low rates of VTE, bleeding, and other adverse events in normal clinical practice.

Key Words: bemiparin • low molecular weight heparin • prophylaxis • orthopedic surgery • venous thromboembolism

This version was published on January 1, 2008

Clinical and Applied Thrombosis/Hemostasis, Vol. 14, No. 1, 75-83 (2008)
DOI: 10.1177/1076029607303962


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?