Statin therapy: When to think twice

The researchers found no significant difference between the rosuvastatin and placebo groups in the primary outcome of death from cardiovascular causes, nonfatal MI, or nonfatal stroke (11.4% in the rosuvastatin group vs 12.3% among those on placebo; 95% confidence interval, 0.83-1.02; P=.12). No difference was found in patients with a history of MI (13.9% placebo event rate vs 12.7% rosuvastatin arm; P=not significant [NS]). Neither death from worsening HF nor sudden death was reduced.²⁶

There were fewer hospitalizations among those taking rosuvastatin, however (NNT=17 per year). And there was a trend towards a benefit among those with more advanced HF (NYHA III/IV), with primary outcome rates of 12.7% for those in the rosuvastatin group vs 14.2% in the placebo group. (P=NS). Rosuvastatin was safe for HF patients, as most types of adverse events were more common in the placebo group. Assessments of muscle toxicity were similar in both groups.

The GISSI-HF study, another RCT of rosuvastatin vs placebo in HF patients, also showed a lack of benefit from statin treatment.²⁷ Researchers enrolled more than 4500 patients with NYHA Class II to IV HF, from both ischemic and nonischemic causes.26 Similar to the findings in the CORONA trial, LDL-C was substantially reduced by rosuvastatin 10 mg/d (-32% vs no change for those in the placebo group), but this did not translate into clinically relevant endpoints. After 3.9 years of therapy, the primary endpoints of time to death and time to death or hospitalization for cardiovascular causes were not significantly reduced, nor were any of the secondary endpoints.²⁶

"We think it is important that primary care as well as specialty organizations be included in guideline development so that special interests do not interfere with good science." --Jeff Cain, MD, Board chair, AAFPThe similar lack of benefit in these 2 trials is striking in view of the benefit of statins in patients with coronary heart disease but without HF. Given these findings, focusing on optimizing therapies known to reduce mortality in patients with HF rather than adding a statin in an attempt to alter the atherosclerotic process appears to be a better approach. Thus, the recently published cholesterol guideline does not advocate the initiation or continuation of statin therapy in patients with NYHA Class II-IV HF.