PMID- 20950224 OWN - NLM STAT- MEDLINE DCOM- 20110228 LR - 20171116 IS - 1744-7666 (Electronic) IS - 1465-6566 (Linking) VI - 11 IP - 18 DP - 2010 Dec TI - An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely ill medical patients: CERTAIN. PG - 2953-61 LID - 10.1517/14656566.2010.521498 [doi] AB - OBJECTIVE: Guidelines recommend low-dose unfractionated heparin (UFH) and low-molecular-weight heparin for the prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients. We report the findings of an open-label, active-controlled, multicenter study in acutely ill medical patients comparing certoparin and UFH. RESEARCH DESIGN AND METHODS: Open-label, active-controlled, multicenter study. Patients received certoparin 3000 IU daily or UFH 7500 IU twice daily. MAIN OUTCOME MEASURES: The primary endpoint was a composite of symptomatic or asymptomatic proximal or distal deep vein thrombosis, symptomatic pulmonary embolism, or VTE-related death. RESULTS: 172 patients were randomized to UFH and 163 to certoparin for 8.5 +/- 2.1 days. The incidence of the primary endpoint was 18.0% in patients receiving UFH and 10.7% with certoparin [absolute difference -7.3; 95% confidence interval (CI) -16.9 to 2.3; p = 0.1353]. The incidence during follow-up was 2.6% in the UFH and 2.0% in the certoparin group (absolute difference -0.6; 95%CI -4.0 to 2.8; p = 0.7150). Major bleeding events occurred in three patients with UFH and one patient with certoparin. CONCLUSIONS: In acutely ill medical patients of at least 40 years of age, thromboprophylaxis with certoparin 3000 IU daily is effective and safe in comparison with 7500 IU twice daily UFH. FAU - Schellong, Sebastian M AU - Schellong SM AD - Head of Medical Clinic II, Municipal Hospital of Dresden Friedrichstadt, Dresden, Germany. schellong-se@khdf.de FAU - Haas, Sylvia AU - Haas S FAU - Greinacher, Andreas AU - Greinacher A FAU - Schwanebeck, Uta AU - Schwanebeck U FAU - Sieder, Christian AU - Sieder C FAU - Abletshauser, Claudia AU - Abletshauser C FAU - Bramlage, Peter AU - Bramlage P FAU - Riess, Hanno AU - Riess H LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20101018 PL - England TA - Expert Opin Pharmacother JT - Expert opinion on pharmacotherapy JID - 100897346 RN - 0 (Anticoagulants) RN - 0 (Heparin, Low-Molecular-Weight) RN - 9005-49-6 (Heparin) RN - V72OT3K19I (certoparin) SB - IM MH - Acute Disease MH - Aged MH - Aged, 80 and over MH - Anticoagulants/adverse effects/*therapeutic use MH - Female MH - Follow-Up Studies MH - Hemorrhage/chemically induced/epidemiology MH - Heparin/adverse effects/*therapeutic use MH - Heparin, Low-Molecular-Weight/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Practice Guidelines as Topic MH - Pulmonary Embolism/prevention & control MH - Venous Thromboembolism/*prevention & control MH - Venous Thrombosis/prevention & control EDAT- 2010/10/19 06:00 MHDA- 2011/03/01 06:00 CRDT- 2010/10/19 06:00 PHST- 2010/10/19 06:00 [entrez] PHST- 2010/10/19 06:00 [pubmed] PHST- 2011/03/01 06:00 [medline] AID - 10.1517/14656566.2010.521498 [doi] PST - ppublish SO - Expert Opin Pharmacother. 2010 Dec;11(18):2953-61. doi: 10.1517/14656566.2010.521498. Epub 2010 Oct 18.