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Statins and Ven..

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Background: New cases of VTE occur in more than 200,000 patients annually and approximately 30% die within 30 days and one fifth suffer sudden death due to pulmonary embolism associated with VTE.1 Venous and arterial thrombosis are age-related events that often occur together and share some risk factors. Risk factors that are shared between the two disorders are obesity (odds ratio 2.33), hypertension (odds ratio 1.51), diabetes (odds ratio 1.42) and triglycerides trended higher and high density lipoprotein lower than in individuals who do not have these disorders.2 

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Why would statins be beneficial in the prevention of VTE? Statins clearly have anti-inflammatory properties and appear to affect thrombosis as well. Statins have multifactorial effects on the coagulation cascade including a decrease in tissue factor expression, a reduction in factor V and VII concentrations, reduction in thrombin and F1.2 levels, decreased fibrinogen cleavage and increases in thrombomodulin and factor Va inactivation.3 It should be noted that not all statins have been observed to cause these changes and there may not be a dose-response relationship. 

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Prior observational studies have yielded conflicting results regarding the reductions in the risk of VTE, however several studies have shown risk reductions as large as 50%.4,5 To this end, the Justification for the Use of Statins in Prevention: Intervention Trial Evaluating Rosuvastatin (JUPITER) determined if rosuvastatin could reduce the first occurrence of pulmonary embolism or deep-venous thrombosis (primary end-point) using an intention-to-treat analysis.JUPITER is a randomized, double-blinded, placebo-controlled trial of rosuvastatin 20 mg per day (N=8901) versus placebo (N=8901) with a median follow-up of 1.9 years. In these apparently healthy men and women (~38%) they also had to have a C-reactive protein (CRP) greater than 2 mg/L (~40% ≥5 mg/L) and low-density lipoprotein <130 mg/dL (~65% ≥100 mg/dL). Approximately 41% had the features of the metabolic syndrome (BMI ≥30 in ~38%). 

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Venous thromboembolism occurred in 34/8901 patients assigned to rosuvastatin or 0.18/100 person-years versus 60/8901 events in placebo patients or 0.32/100 person-years (hazard ratio and 95% confidence interval 0.57 [{0.37-0.86}], p=0.007). Pulmonary embolism occurred in 17/8901 patients assigned to rosuvastatin or 0.09/100 person-years versus 22/8901 events in placebo patients or 0.12/100 person-years (HR 0.77 [{0.41-1.45}], p=0.42). VTE was further broken into provoked versus unprovoked and unprovoked VTE was reduced to a slightly greater extent than provoked VTE. The only significant adverse effects reported in the main outcomes trial were higher A1c levels and more newly reported diabetes with rosuvastatin (3.0% versus 2.4%, p=0.1).7

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In the investigators' analysis, “The estimated number needed to treat for 4 years to prevent either one episode of venous thromboembolism or one primary cardiovascular end point is 26, and the projected number needed to treat 5 years is 21.” In this author’s analysis, using the events reported in the article, for first cardiovascular event, venous thromboembolism, or death, the event rate for rosuvastatin is 3.6% and 5.4% for placebo which yields a number needed to treat of 56 over the median follow-up of 1.9 years. The authors conclude, “In this trial of apparently healthy persons, rosuvastatin significantly reduced the occurrence of symptomatic ...

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