NEW YORK (Reuters Health) – Rosuvastatin halves the rate of primary cardiovascular events in patients who have a high global cardiovascular risk profile, according to a post hoc analysis of data from the JUPITER trial.
The current study was conducted at the request of European regulators, explain Dr. Wolfgang Koenig at the University of Ulm Medical Center, Germany, and Dr. Paul M. Ridke at Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts.
The JUPITER trial, they note in the European Heart Journal published online October 22, “was designed to investigate whether rosuvastatin decreased first major cardiovascular events among patients with levels of low-density lipoprotein cholesterol (LDL-C) <3.4 mmol/L (130 mg/dL), but who were at increased cardiovascular risk due to elevated levels of hs C-reactive protein.”
On the basis of the results, the US Food and Drug Administration approved rosuvastatin for primary prevention of cardiovascular events in individuals with elevated hs CRP and at least one additional risk factor. European health authorities, however, approved the statin for patients at high risk, based on a subset of JUPITER participants who had an estimated 10-year Framingham risk score >20% or an estimated Systematic COronary Risk Evaluation (SCORE) risk of >5%.
The data for that decision, which have not been published before, “are likely to be of utility for European practitioners,” the authors point out.
The post hoc analysis included about 1500 subjects considered high risk based on the Framingham score, approximately 9000 classified as high risk using an extrapolated SCORE model, and roughly 6300 using a SCORE model capped at 65 years.
During a median follow-up of 1.8 years, the hazard ratio for the composite of MI, stroke or cardiovascular death was 0.50 with rosuvastatin versus placebo in the Framingham high-risk group, 0.57 in the extrapolated SCORE group, and 0.47 in the capped SCORE group.
By comparison, in the entire JUPITER cohort, the HR for the same end point was 0.53, and was similar for participants with risk scores above or below those analyzed in the post hoc study.
“Thus,” Drs. Koenig and Ridke conclude, “the JUPITER trial data also indicate that many individuals with elevated hs C-reactive protein who fall outside ‘high-risk’ subgroups defined by either Framingham or SCORE have both substantive absolute risk and large relative risk reductions when treated with rosuvastatin.”
Reference:
Rosuvastatin for primary prevention in patients with European systematic coronary risk evaluation risk ≥5% or Framingham risk >20%: post hoc analyses of the JUPITER trial requested by European health authorities
Eur Heart J 2010.
