Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis
Macedo AF, Taylor FC, Casas JP, Adler A, Prieto-Merino D, Ebrahim S
BMC medicine · 124 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Metaanálisis (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- British Heart Foundation
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- British Heart Foundation (PG/09/022/26739)
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2014-03-22 · BMC Med · vol. 12 · número 1 · pág. 51
- Editorial
- BioMed Central
- Citado
- 184 citas · más que el 98% de estudios similares · 5.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 148 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cancer, Lipids, and Metabolism · Pharmacovigilance and Adverse Drug Reactions
- Palabras clave
- statins, adverse drug reactions, unintended consequences, dementia, cognitive impairment, venous thromboembolism, fracture, pneumonia, myopathy, liver enzymes, diabetes mellitus, depression, observational studies, general population, drug safety, heterogeneous effects, quality of evidence, randomized trial comparison, cardiovascular disease prevention
- MeSH
- humans, dementia, diabetes mellitus, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, population surveillance, randomized controlled trials as topic, observational studies as topic
6 autores
- Ana Filipa Macedo🇬🇧 · autor de correspondenciaLondon School of Hygiene & Tropical Medicine
- Fiona C. Taylor🇬🇧London School of Hygiene & Tropical Medicine
- Juan Pablo Casas🇬🇧London School of Hygiene & Tropical Medicine; University College London
- Alma J Adler🇬🇧London School of Hygiene & Tropical Medicine
- David Prieto‐Merino🇬🇧London School of Hygiene & Tropical Medicine
- Shah B J Ebrahim🇬🇧London School of Hygiene & Tropical Medicine
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Efficacy of statins has been extensively studied, with much less information reported on their unintended effects. Evidence from randomized controlled trials (RCTs) on unintended effects is often insufficient to support hypotheses generated from observational studies. We aimed to systematically assess unintended effects of statins from observational studies in general populations with comparison of the findings where possible with those derived from randomized trials.
Methods
Medline (1998 to January 2012, week 3) and Embase (1998 to 2012, week 6) were searched using the standard BMJ Cohort studies filter. The search was supplemented with reference lists of all identified studies and contact with experts in the field. We included prospective studies with a sample size larger than 1,000 participants, case control (of any size) and routine health service linkage studies of over at least one year duration. Studies in subgroups of patients or follow-up of patient case series were excluded, as well as hospital-based cohort studies.
Results
Ninety studies were identified, reporting on 48 different unintended effects. Statins were associated with lower risks of dementia and cognitive impairment, venous thrombo-embolism, fractures and pneumonia, but these findings were attenuated in analyses restricted to higher quality studies (respectively: OR 0.74 (95% CI 0.62 to 0.87); OR 0.92 (95% CI 0.81 to 1.03); OR 0.97 (95% CI 0.88 to 1.05); OR 0.92 (95% CI 0.83 to 1.02)); and marked heterogeneity of effects across studies remained. Statin use was not related to any increased risk of depression, common eye diseases, renal disorders or arthritis. There was evidence of an increased risk of myopathy, raised liver enzymes and diabetes (respectively: OR 2.63 (95% CI 1.50 to 4.61); OR 1.54 (95% CI 1.47 to 1.62); OR 1.31 (95% CI 0.99 to 1.73)).
Conclusions
Our systematic review and meta-analyses indicate that high quality observational data can provide relevant evidence on unintended effects of statins to add to the evidence from RCTs. The absolute excess risk of the observed harmful unintended effects of statins is very small compared to the beneficial effects of statins on major cardiovascular events.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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