Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials
Ott BR, Daiello LA, Dahabreh IJ, Springate BA, Bixby K, Murali M, Trikalinos TA
Journal of general internal medicine · 182 citas
Cómo se estudió
- Diseño
- Metaanálisis (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Alzheimer's Association
- Gobierno
- Agency for Healthcare Research and Quality
- Gobierno
- AHRQ HHS
- Subvenciones
- Agency for Healthcare Research and Quality (K08HS017735)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2015-01-09 · J Gen Intern Med · vol. 30 · número 3 · págs. 348–358
- Editorial
- Springer Science+Business Media
- Citado
- 239 citas · más que el 99% de estudios similares · 5.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 85 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Dementia and Cognitive Impairment Research · Cancer, Lipids, and Metabolism
- Palabras clave
- statins, cognitive impairment, cognitive function, neuropsychological assessment, adverse drug reactions, Alzheimer's disease, FDA warning, statin safety
- MeSH
- humans, hydroxymethylglutaryl-coa reductase inhibitors, cognition disorders, neuropsychological tests, randomized controlled trials as topic
7 autores
- Brian R. Ott🇺🇸 · autor de correspondenciaBrown University; Rhode Island Hospital
- Lori A. Daiello🇺🇸Brown University; Rhode Island Hospital
- Issa J Dahabreh🇺🇸Brown University
- Beth A. Springate🇺🇸Rhode Island Hospital
- Kimberly Bixby🇺🇸Brown University; Rhode Island Hospital
- Manjari Murali🇺🇸Brown University; Rhode Island Hospital
- Thomas A Trikalinos🇺🇸Brown University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
In 2012, the United States Food and Drug Administration (FDA) issued a warning regarding potential adverse effects of HMG-CoA reductase inhibitors (statins) on cognition, based on the Adverse Events Reporting System and a review of the medical literature. We aimed to synthesize randomized clinical trial (RCTs) evidence on the association between statin therapy and cognitive outcomes.
Methods
We searched MEDLINE, EMBASE, and Cochrane CENTRAL through December 2012, and reviewed published systematic reviews of statin treatment. We sought RCTs that compared statin treatment versus placebo or standard care, and reported at least one cognitive outcome (frequency of adverse cognitive events or measurements using standard neuropsychological cognitive test scores). Studies reporting sufficient information to calculate effect sizes were included in meta-analyses. Standardized and unstandardized mean differences were calculated for continuous outcomes for global cognition and for pre-specified cognitive domains. The main outcome was change in cognition measured by neuropsychological tests; an outcome of secondary interest was the frequency of adverse cognitive events observed during follow-up.
Results
We identified 25 RCTs (all placebo-controlled) reporting cognitive outcomes in 46,836 subjects, of which 23 RCTs reported cognitive test results in 29,012 participants. Adverse cognitive outcomes attributable to statins were rarely reported in trials involving cognitively normal or impaired subjects. Furthermore, meta-analysis of cognitive test data (14 studies; 27,643 participants) failed to show significant adverse effects of statins on all tests of cognition in either cognitively normal subjects (standardized mean difference 0.01, 95% confidence interval, CI, -0.01 to 0.03, p = 0.42) or Alzheimer's disease subjects (standardized mean difference -0.05, 95% CI -0.19 to 0.10, p = 0.38).
Conclusions
Statin therapy was not associated with cognitive impairment in RCTs. These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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