Article

HMG CoA reductase inhibitors and the risk of venous thrombosis among postmenopausal women.

Department of Epidemiology, Cardiovascular Health Research Unit, University of Washington, Seattle, Washington, USA.
Journal of Thrombosis and Haemostasis (Impact Factor: 5.55). 06/2004; 2(5):700-1. DOI: 10.1111/j.1538-7836.2004.00696.x
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    ABSTRACT: Statins may reduce the risk of first and recurrent venous thromboembolism (VTE). No data are available on their potential benefit in patients treated with the oral anticoagulant rivaroxaban. The EINSTEIN DVT/PE and EINSTEIN Extension studies compared rivaroxaban with standard of care (n=8280) and placebo (n=1188), respectively. The incidences of recurrent VTE and major bleeding per 100 patient-years for exposure (or not) to statins were calculated. A Cox proportional hazards model was constructed, stratified by index event and intended treatment duration, with statin use as a time-dependent variable, for each treatment group (rivaroxaban vs enoxaparin/vitamin K antagonist or placebo) and adjusted for relevant variables. In EINSTEIN DVT/PE, 1509 (18.3%) patients used statins during the at-risk period, and 6731 (81.7%) did not. Overall, 2.6 recurrent VTEs occurred per 100 patient-years with statin use compared with 3.8 per 100 patient-years without statins (adjusted hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.46-1.25). HRs for recurrent VTE were similar for concomitant use of rivaroxaban-statin and enoxaparin/VKA-statin. Major bleeding events occurred in 3.0 per 100 patient-years with statin use compared with 2.3 per 100 patient-years without statins (adjusted HR 0.77; 95% CI 0.46-1.29). Due to adjustments in the Cox regression model, the direction of this HR is in contrast to the crude comparison. In EINSTEIN Extension, no recurrent VTEs occurred with statin use in the rivaroxaban group compared with 1.6 per 100 patient-years without statins. In the placebo group, 12.2 recurrent VTEs occurred per 100 patient-years with statin use compared with 13.2 per 100 patient-years without (adjusted HR 0.81; 95% CI 0.35-1.86). The effect of statins in this secondary analysis of the EINSTEIN VTE treatment program is consistent with other studies that suggest a reduced risk of recurrent VTE, but conclusive evidence of this benefit is lacking. Statins are simple to use, inexpensive, very safe and do not cause bleeding. Therefore, the potential effect on reducing recurrent VTE, which is in the range of that of acetylsalicylic acid, deserves evaluation in a large randomized trial. ClinicalTrials.gov: EINSTEIN PE, NCT00439777; EINSTEIN DVT, NCT00440193; EINSTEIN Extension, NCT00439725.
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    ABSTRACT: Patients who experience venous thromboembolism (VTE) are at important risk for recurrent VTE[1]. When it occurs, recurrent VTE may have serious consequences. Recurrent VTE is fatal in more than 1 in 10 patients if experienced in the first 3 months of therapy and after the initial 3 months of therapy, 1 in 20 episodes of recurrent VTE are fatal[2]. Recurrent VTE leads to significant early morbidity (leg pain, leg swelling, chest pain, shortness of breath), increases the risk of long-term disabling post- thrombotic syndrome[3-5] and chronic thromboembolic pulmonary hypertension[6]This article is protected by copyright. All rights reserved.
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    ABSTRACT: Statins and hormone therapy (HT), often used concurrently in postmenopausal women, have antagonist effects on the risk of venous thromboembolism (VTE). This study aims to determine whether statins attenuate the increased VTE risk associated with HT.
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