NEJM: JUPITER sub-study finds Crestor cuts VTE risk 43%
Rosuvastatin (Crestor from AstraZeneca) significantly reduced the occurrence of symptomatic venous thromboembolism (VTE) in the atria of apparently healthy persons, according to a sub-study of the JUPITER trial published in the April 30 issue of the New England Journal of Medicine.
Robert J. Glynn, ScD, from the division of medicine at Brigham and Women's Hospital, Harvard Medical School in Boston, and colleagues randomly assigned 17,802 apparently healthy men and women with both LDL cholesterol levels of less than 130 mg per deciliter and high-sensitivity C-reactive protein levels of 2 mg per liter or higher to receive rosuvastatin, 20 mg per day, or placebo. They 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.
During a median follow-up period of 1.9 years, the researchers reported that symptomatic VTE occurred in 94 participants: 34 in the rosuvastatin group and 60 in the placebo group. The rates of VTE were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively; the corresponding rates for unprovoked VTE (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization or surgery) were 0.10 and 0.17 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.
They said that the rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group, whereas the rates of deep vein thrombosis only were 0.09 and 0.20, respectively. They observed consistent effects in all the sub-groups examined. No significant differences were seen between treatment groups in the rates of bleeding episodes.
According to the authors, "VTE is common, difficult to diagnose and costly to treat, and it frequently results in venous insufficiency and chronic thromboembolic pulmonary hypertension; preventive strategies that have acceptable costs and side effects are therefore needed. The frequency of VTE among the participants in JUPITER-94 observed cases-was similar to that of fatal or nonfatal stroke (97 cases) and of fatal or nonfatal MI (99 cases)."
Based on their findings, Glynn and colleagues concluded that widening the goal of treatment to include prevention of VTE and death, in addition to arterial thrombosis, increases the estimated benefit of statin use.
The study was supported primarily by AstraZeneca and also by a grant from the National Institute on Aging.
Robert J. Glynn, ScD, from the division of medicine at Brigham and Women's Hospital, Harvard Medical School in Boston, and colleagues randomly assigned 17,802 apparently healthy men and women with both LDL cholesterol levels of less than 130 mg per deciliter and high-sensitivity C-reactive protein levels of 2 mg per liter or higher to receive rosuvastatin, 20 mg per day, or placebo. They 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.
During a median follow-up period of 1.9 years, the researchers reported that symptomatic VTE occurred in 94 participants: 34 in the rosuvastatin group and 60 in the placebo group. The rates of VTE were 0.18 and 0.32 event per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively; the corresponding rates for unprovoked VTE (i.e., occurring in the absence of a known malignant condition, trauma, hospitalization or surgery) were 0.10 and 0.17 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.
They said that the rates of pulmonary embolism were 0.09 in the rosuvastatin group and 0.12 in the placebo group, whereas the rates of deep vein thrombosis only were 0.09 and 0.20, respectively. They observed consistent effects in all the sub-groups examined. No significant differences were seen between treatment groups in the rates of bleeding episodes.
According to the authors, "VTE is common, difficult to diagnose and costly to treat, and it frequently results in venous insufficiency and chronic thromboembolic pulmonary hypertension; preventive strategies that have acceptable costs and side effects are therefore needed. The frequency of VTE among the participants in JUPITER-94 observed cases-was similar to that of fatal or nonfatal stroke (97 cases) and of fatal or nonfatal MI (99 cases)."
Based on their findings, Glynn and colleagues concluded that widening the goal of treatment to include prevention of VTE and death, in addition to arterial thrombosis, increases the estimated benefit of statin use.
The study was supported primarily by AstraZeneca and also by a grant from the National Institute on Aging.