JUPITER: Sub-Analysis in Intermediate-Risk, High-CRP Patients

Intermediate risk is usually defined as a 10-year Framingham risk of 10% to 20%. However there are number of people esp. women who are at increased CV risk if they have a 10-year Framingham risk of 11% to 20% and an elevated hs-CRP.

- Dr. Ridker

Background

Recent primary prevention guidelines issued in Canada endorse the use of statin therapy among individuals at "intermediate risk" who have elevated levels of hs-CRP.
However, trial data directly addressing this recommendation of statin therapy have not previously been published.

Objective

To assess the efficacy of rosuvastatin in individuals' with 10-year Framingham risk of 5%-10% and 10-year Framingham risk of 11%-20% (intermediate risk).

Study Design

Secondary analysis of JUPITER study.
Individuals were randomized to receive rosuvastatin 20 mg once-daily or placebo for 1.8 years (max. 5 years).

Study Participants

N=17,802 (n=6091 for indivcisks of 5%-10% and n=7340 for individuals having 10-year Framingham risks of 11%-20%), LDL-C< 130 mg/dL and hs-CRP ≥2 mg/dL.

Primary Endpoint

Occurrence of first cardiovascular event (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina or death from cardiovascular sources).

Results

In both subgroups (10-year Framingham risk of 5%-10% and 11%-20%) of the study, rosuvastatin therapy gave relative risk reductions similar to the overall relative risk reduction seen with the overall JUPITER trial (see table).

* 5-year NNT = Number needed to treat to prevent 1 primary endpoint over 5 years

The majority of women with elevated hs-CRP who benefited from rosuvastatin therapy were at 10-year Framingham risk of 5%-10% at study entry.

Other primary prevention trials have excluded women because they often do not have 10-year Framingham risk>10%.

- Dr. Ridker

Conclusion

Rosuvastatin therapy significantly reduces major cardiovascular events among men and women with elevated hs-CRP and 10-year Framingham risks of 5% - 10% and 11-20%.

My only concern about Canadian approach of primary prevention is that by not expanding 'intermediate risk' to those at 5% to 10%, women still would be undertreated.

- Dr. Ridker

The Canadian model of primary prevention works very well and is an evidence-based approach to primary prevention, an issue of importance as new US guidelines are being considered.

- Dr. Ridker

Published online in Circulation: Cardiovascular Quality and Outcomes on August 24, 2010