Issue 112 Item 14 Early Statin Therapy After Coronary Event Does Not Appear to I

Physicians should use caution in starting a statin early after an acute coronary event in the absence of cholesterol measures or in patients who do not meet current treatment guidelines. >Although previous reports have suggested that starting patients on statins soon after an acute coronary event can improve clinical outcomes, findings from a new report in the June 19th issue of the Journal of the American Medical Association suggest otherwise.

"In contrast to previous reports, we found no association of starting statins early (within 1 to 3 days) after an acute coronary event with better clinical outcomes (death or the composite of death or MI) at 90 days or 1 year," said lead author Dr. L. Kristin Newb.

"In addition, we observed that if LDL cholesterol levels were below current treatment guidelines (<130 mg/dL), starting a statin early after an acute event may be associated with worse outcomes, whereas at higher levels there may be benefit," Dr. Newby, from Duke Clinical Research Institute, Durham, North Carolina, said.

Dr. Newby and colleagues looked at data from the SYMPHONY (Sibrafiban versus Aspirin to Yield Maximum Protection from Ischemic Heart Events Post-acute Coronary Syndromes) and 2nd SYMPHONY trials.

In these trials, 12,365 patients were randomized to statin therapy within 1 to 3 days of an acute coronary event or to no statin therapy. The researchers looked at a combined endpoint of the incidence of death; death or myocardial infarction (MI); or severe recurrent ischemia at 90 days and at 1 year.

At 90 days, there was no apparent benefit from statin therapy compared with no therapy, for death, MI or severe recurrent ischemia, the researchers found.

After propensity and covariate adjustment, there was no benefit found from early statin therapy at 90 days or 1 year compared with no statin therapy, the researchers note. The adjusted hazard ratio for death at 90 days was 1.08, for death or MI 1.08 and for death, MI or severe recurrent ischemia, 1.15. For 1-year mortality the adjusted hazard ratio was 0.99, they add.

Dr. Newby believes that "we need the results of randomized clinical trials of early statin initiation that are adequately powered for the hard endpoints of death and death or MI to satisfactorily address the question of the benefits and risks of early statin initiation and to guide practice."

"Until such evidence is available," Dr. Newby said, "physicians should use caution in starting a statin early after an acute coronary event in the absence of cholesterol measures or in patients who do not meet current treatment guidelines."

"The observations made within the SYMPHONY cohorts are interesting and noteworthy," Drs. Karin B. Michels and Eugene Braunwald from Brigham and Women’s Hospital, Boston, comment in a journal editorial.

"The analyses by Newby et al. indicate the presence of confounding by indication in the observational data and underscore the need for well-conducted large randomized clinical trials on the benefits of early statin initiation," they add. JAMA 2002;287:3087-3095,3130-3132.