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Background Controversy persists regarding the extent of shared pathways between arterial and venous thrombosis and whether treatments of known efficacy for one disease process have consistent benefits for the other. Observational studies have yielded variable estimates of the effect of statin therapy on the risk of venous thromboembolism, and evidence from randomized trials is lacking.
Methods We randomly assigned 17,802 apparently healthy men and women with both low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to receive rosuvastatin, 20 mg per day, or placebo. We followed participants for the first occurrence of pulmonary embolism or deep-vein thrombosis and performed analyses of the data on an intention-to-treat basis.
Results During a median follow-up period of 1.9 years (maximum, 5.0), symptomatic venous thromboembolism occurred in 94 participants: 34 in the rosuvastatin group and 60 in the placebo group. The rates of venous thromboembolism were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio with rosuvastatin, 0.57; 95% confidence interval [CI], 0.37 to 0.86; P=0.007); the corresponding rates for unprovoked venous thromboembolism (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization, or surgery) were 0.10 and 0.17 (hazard ratio, 0.61; 95% CI, 0.35 to 1.09; P=0.09) and for provoked venous thromboembolism (i.e., occurring in patients with cancer or during or shortly after trauma, hospitalization, or surgery), 0.08 and 0.16 (hazard ratio, 0.52; 95% CI, 0.28 to 0.96; P=0.03). The rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group (hazard ratio, 0.77; 95% CI, 0.41 to 1.45; P=0.42), whereas the rates of deep-vein thrombosis only were 0.09 and 0.20, respectively (hazard ratio, 0.45; 95% CI, 0.25 to 0.79; P=0.004). Consistent effects were observed in all the subgroups examined. No significant differences were seen between treatment groups in the rates of bleeding episodes.
Conclusions In this trial of apparently healthy persons, rosuvastatin significantly reduced the occurrence of symptomatic venous thromboembolism. (ClinicalTrials.gov number, NCT00239681
[ClinicalTrials.gov]
.)
Source Information
From the Divisions of Preventive Medicine (R.J.G., E.D., J.G.M., P.M.R.) and Cardiovascular Medicine (P.L., P.M.R.), Brigham and Women's Hospital, Harvard Medical School, Boston; Universidade Federal de São Paulo, São Paulo (F.A.H.F.); McGill University Health Center, Montreal (J.G.); Weill Medical College of Cornell University, New York (A.M.G.); Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.); University of Ulm, Ulm, Germany (W.K.); Hospital Cordoba, Cordoba, Argentina (A.J.L.); Herlev Hospital, Copenhagen University Hospital, University of Copenhagen, Herlev, Denmark (B.G.N.); University of Glasgow, Glasgow, Scotland (J.S.); and St. Luke's Episcopal Hospital–Texas Heart Institute, Houston (J.T.W.).
This article (10.1056/NEJMoa0900241) was published at NEJM.org on March 29, 2009.
Address reprint requests to Dr. Glynn at the Division of Preventive Medicine, Brigham and Women's Hospital, 900 Commonwealth Ave., Boston, MA 02215, or at rglynn{at}rics.bwh.harvard.edu.
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