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JUPITER: Rosuvastatin reduced risk for venous thromboembolism
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Apparently healthy adults assigned to daily rosuvastatin therapy experienced a 43% risk reduction in the occurrence of venous thromboembolism, according to a substudy analysis of the JUPITER trial.
“VTE is a serious event that occurred about as often as MI and stroke in the JUPITER study,” said Robert J. Glynn, PhD, ScD, biostatistician at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School. He presented the findings during a late-breaking clinical trials session at the American College of Cardiology’s 58th Annual Scientific Sessions.
JUPITER researchers recruited 17,802 men and women with LDL <130 mg/dL and high-sensitivity CRP >2 mg/L. Researchers randomly assigned participants to placebo or rosuvastatin 20 mg per day (Crestor; AstraZeneca).
Thirty-four participants assigned to rosuvastatin had symptomatic VTE after a median follow-up of 1.9 years compared with 60 assigned to placebo (HR=0.57; 95% CI, 0.37-0.86).
The effect of rosuvastatin on both unprovoked (0.10 vs. 0.17) and provoked VTE (0.08 vs. 0.16) was comparable. The researchers also reported reductions in deep vein thrombosis (0.09 vs. 0.20) and pulmonary embolism (0.09 vs. 0.12) with the statin.
Rosuvastatin was associated with a “clear clinical benefit in the absence of any bleeding hazard,” Glynn said.
These data may potentially broaden the perspective on treatment targets for statin therapy because “widening the treatment target to include prevention of VTE and death in addition to arterial thrombosis increases the estimated benefit of statin use,” Glynn said. Consideration of these wider treatment targets improved the number needed to treat at five years from 25 with the primary end point (MI, stroke, unstable angina/revascularization/CV death) to 18.
Evidence demonstrates that VTE is not secondary to CV events and reductions were independent of the previously described CV benefits of rosuvastatin, Glynn said. More than 90% (88 of 94 events) occurred in participants before having a CV event.
These results were also published in The New England Journal of Medicine today. – by Katie Kalvaitis
This study will certainly change our concept of lipid-lowering. I look forward to a metaanalysis of other studies of lipid-lowering and VTE. I was impressed with the number needed to treat – 18 – and impressed with the apparent separation of the curves early in the unprovoked VTE group.
– Harvey D. White, DSc
Director, Coronary Care and Cardiovascular Research,
Green Lane Hospital, Auckland, New Zealand
This was a superb analysis. I was intrigued by the fact that there was a large and impressive reduction in VTE events but no increase in bleeding. It’s intriguing because it argues that there is some mechanism at play, [the researchers mentioned] anticoagulant or tissue-related, but it seems to me it must be something else if it is affecting thrombotic events and not affecting bleeding at all.
– Deepak L. Bhatt, MD
Chief of Cardiology, VA Boston Healthcare System
Director, Integrated Interventional Cardiovascular Program
Brigham and Women’s Hospital and the VA Boston Healthcare System
For more information:
- Glynn RJ. A randomized trial of rosuvastatin in the prevention of venous thromboembolism: the JUPTER trial. #401. Presented at: American College of Cardiology 58th Annual Scientific Sessions; March 29-31, 2009; Orlando, Fla.
- N Engl J Med. 2009;doi:10.1056/NEJMoa0900241.