Early
Statin Therapy After Coronary Event Does Not Appear to Improve Outcome
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.
FACT
Even
in the absence of diabetes, even modest elevations in HbA1c, increase
the risk of cardiovascular disease. Those in the highest quartile of A1c levels had almost three
times the risk compared to those in the lowest group. Hoorn Study (Framingham Study of the Netherlands ADA#258)
Kristina
Sandstedt,
MS,
Clinical
Exercise
Physiologist,
Diabetes
Educator
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