BACKGROUND:
Statin
agents play a major role in secondary prevention after acute cerebral
ischemia (ACI) events but are not indicated in all patients with
ischemic stroke and transient ischemic attack. National guidelines
recommend statins for patients with ACI of large or small vessel
atherosclerotic origin and without these stroke mechanisms but
coexisting coronary artery disease or primary prevention indications.
The potential adverse effect burden of statin overuse in the remaining
ACI patients have not been well delineated.
METHODS:
Per
Preferred Reporting Items of Systematic Reviews and Meta-Analyses
guidelines, we performed systematic meta-analyses of: (1) statin
randomized clinical trials to determine absolute risk increases for 6
major adverse events; (2) large clinical series to determine the
proportion of ACI events due to large or small vessel atherosclerotic
disease; and (3) the proportion of remaining patients with coronary
artery disease/primary prevention statin indications.
RESULTS:
For
adverse effects, data were available from 63 randomized clinical trials
enrolling 155 107 patients. Statin therapy was associated with an
increased risk of the occurrence of 6 conditions: diabetes, myalgia or
muscle weakness, myopathy, liver disease, renal insufficiency, and eye
disease. Across 55 large series enrolling 53 501 patients, the rate of
ACI due to large and small artery atherosclerosis was 45.0% (large
artery atherosclerosis 21.6%, small vessel disease 23.4%), the rate of
remaining patients with coronary artery disease/primary prevention
statin indications was 31.8%, and the rate of patients without statin
indications was 23.2%. Data synthesis indicated that, in the United
States, were all patients with ACI without statin indications treated
with statins, a total of 5601 patients would develop needless adverse
events each year, most commonly diabetes, myopathy, and eye disease.
CONCLUSIONS:
More
than one-fifth of patients with ACI do not have an indication for
statins, and statin overuse in these patients could annually lead to
over 5600 adverse events each year in the United States, including
diabetes, myopathy, and eye disease. These findings emphasize the
importance of adhering to guideline indications for the start of statin
therapy in ACI.
