Author + information
- Edward J. Mills, PhD, MSc⁎ ( and )
- Philip J. Devereaux, MD, PhD
- ↵⁎McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada
In our systematic review (1) we decided a priori to include trials in which <50% of the population had a history of coronary heart disease. The complete PROSPER (Pravastatin in Elderly Individuals at Risk of Vascular Disease) trial fulfills our eligibility criteria (2). Although the PROSPER trial reported the results of their primary composite outcome for the primary prevention group, they did not report the results for the individual components of their composite. Thus, this information does not meet our specified end point criteria, because we excluded composite outcomes, for good reason (3).
We believe that there is a continuum of risk among diabetic patients, and we do not believe that younger, lower-risk patients should be considered at the same risk as those patients enrolled in secondary prevention trials (4). We excluded trials in high-risk diabetic patients, because we accept that their expected event rates are similar to patients with established vascular disease.
When we exclude the trials with predominantly diabetic patients and the PROSPER trial, the results of our meta-analyses are unchanged for both all-cause mortality (relative risk [RR]: 0.93, 95% confidence interval [CI]: 0.87 to 0.99, p = 0.039, I2= 5.6%, p = 0.38) and cardiovascular disease (CVD) mortality (RR: 0.84, 95% CI: 0.72 to 0.98, p = 0.025, I2= 12.3, p = 0.31). Therefore, we stand by our conclusions.
This letter gives us the opportunity to update our analysis in light of the largest primary prevention trial yet, the JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) trial of rosuvastatin for primary cardiovascular prevention (n = 17,802) (5). When we add this trial to our primary analysis, all-cause mortality is RR: 0.92 (95% CI: 0.86 to 0.98, p = 0.006, I2= 14%, p = 0.26) and CVD mortality is RR: 0.85 (95% CI: 0.76 to 0.95, p = 0.004, I2= 30%, p = 0.10).
There is clear evidence for primary and secondary prevention of clinical events across the broad populations involved, including women (6). History has displayed how naïve subgroup concerns can lead to withholding effective treatments from vulnerable populations (7).
- American College of Cardiology Foundation
- Mills E.J.,
- Rachlis B.,
- Wu P.,
- Devereaux P.J.,
- Arora P.,
- Perri D.
- Ferreira-González I.,
- Busse J.W.,
- Heels-Ansdell D.,
- et al.