PMID- 12941030 OWN - NLM STAT- MEDLINE DCOM- 20040519 LR - 20230829 IS - 1538-7933 (Print) IS - 1538-7836 (Linking) VI - 1 IP - 9 DP - 2003 Sep TI - Low-molecular-weight heparin for the long-term treatment of symptomatic venous thromboembolism: meta-analysis of the randomized comparisons with oral anticoagulants. PG - 1906-13 AB - BACKGROUND: The management of venous thromboembolism (VTE) requires an initial treatment with unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH), followed by oral anticoagulants (OA) for at least 3 months. OA treatment however, requires laboratory monitoring of anticoagulation, carries a definite risk of bleeding, and may be contraindicated in some patients. As an alternative to vitamin K antagonists, subcutaneous LMWH has been proposed and evaluated in randomized clinical trials, but they are all small studies that lack the power to establish if these two treatment modalities are equivalent in efficacy or safety. OBJECTIVES: The objective of this review was to evaluate the efficacy (VTE recurrence) and safety (bleeds and deaths) of long-term treatment of VTE with LMWH compared with OA. A secondary endpoint was to evaluate the effect of LMWH on cancer mortality. METHODS: Computerized searches of MedLine and EmBase were performed. In addition, randomized clinical trials were located through personal communication with colleagues, and through the manual scanning of meeting proceedings and reference lists of relevant studies. When necessary, the authors of the selected papers were called to obtain additional information. Two reviewers (AI and FG) reviewed and extracted data independently using a standard form. The primary analysis was performed for efficacy and safety endpoints on an intention-to-treat basis for the study period of randomized treatment. A meta-regression analysis was used to investigate the relationship between daily dose and clinical outcome. RESULTS: Seven studies that fulfillled our predefined criteria were identified, for a total of 1379 patients. When all studies were combined, a statistically non-significant reduction in the risk of VTE (OR 0.66; 95% confidence interval [CI] 0.41, 1.07) and in the risk of major bleeding (OR 0.45; 95% CI 0.18, 1.11) in favor of LMWH treatment was found. No difference in total mortality (OR 1.19; 95% CI 0.78, 1.83) or in cancer-related mortality was observed between the LMWH and the OA treatment. CONCLUSIONS: The results of this meta-analysis indicate that a 3-month course of LMWH is as effective and safe as a corresponding period of OA treatment, and may thus be considered as a valuable alternative option for patients in whom OA treatment appears contraindicated or problematic. FAU - Iorio, A AU - Iorio A AD - Sezione de Medicina Interna e Cardiovasculare, Universita di Perugia, Perugia, Italy. iorioa@unigp.it FAU - Guercini, F AU - Guercini F FAU - Pini, M AU - Pini M LA - eng PT - Journal Article PT - Meta-Analysis PL - England TA - J Thromb Haemost JT - Journal of thrombosis and haemostasis : JTH JID - 101170508 RN - 0 (Anticoagulants) RN - 0 (Heparin, Low-Molecular-Weight) SB - IM MH - Anticoagulants/therapeutic use MH - Hemorrhage/chemically induced MH - Heparin, Low-Molecular-Weight/*therapeutic use MH - Humans MH - Neoplasms/complications/drug therapy/mortality MH - Randomized Controlled Trials as Topic/*statistics & numerical data MH - Recurrence MH - Thromboembolism/*drug therapy/epidemiology/mortality MH - Treatment Outcome MH - Venous Thrombosis/*drug therapy/epidemiology/mortality EDAT- 2003/08/28 05:00 MHDA- 2004/05/20 05:00 CRDT- 2003/08/28 05:00 PHST- 2003/08/28 05:00 [pubmed] PHST- 2004/05/20 05:00 [medline] PHST- 2003/08/28 05:00 [entrez] AID - S1538-7836(22)15347-X [pii] AID - 10.1046/j.1538-7836.2003.00364.x [doi] PST - ppublish SO - J Thromb Haemost. 2003 Sep;1(9):1906-13. doi: 10.1046/j.1538-7836.2003.00364.x.