Risks associated with statin therapy: a systematic overview of randomized clinical trials
Kashani A, Phillips CO, Foody JM, Wang Y, Mangalmurti S, Ko DT, Krumholz HM
Circulation · 341 citas
Cómo se estudió
- Diseño
- Metaanálisis (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Heart and Stroke Foundation of Canada
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (3 R01 HL 080228-01S1); National Heart, Lung, and Blood Institute (R01 HL080228); National Heart, Lung, and Blood Institute (R01 HL)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2006-12-12 · Circulation · vol. 114 · número 25 · págs. 2788–2797
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 475 citas · más que el 100% de estudios similares · 22.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 75 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cancer, Lipids, and Metabolism · Acute Myocardial Infarction Research
- Palabras clave
- statins, adverse drug reactions, rhabdomyolysis, myalgia, creatine kinase elevation, transaminase elevation, drug discontinuation, hyperlipidemia, statin safety, randomized controlled trials
- MeSH
- humans, muscular diseases, pain, placebos, hydroxymethylglutaryl-coa reductase inhibitors, risk assessment, reproducibility of results, dose-response relationship, drug, patient selection, united states food and drug administration, documentation, adult, united states, randomized controlled trials as topic
7 autores
- Amir Kashani🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- Christopher O. Phillips🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- JoAnne Micale Foody🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- Yongfei Wang🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- Sandeep S. Mangalmurti🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- Dennis T. Ko🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
- Harlan M. Krumholz🇺🇸🇨🇦Cleveland Clinic; Sunnybrook Health Science Centre; Yale University; VA Connecticut Healthcare System; United States Navy
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Although statins reduce the risk of cardiovascular events, concerns about adverse effects may deter physicians from prescribing these agents. We performed a systematic overview of randomized statin trials to quantify the risks of musculoskeletal, renal, and hepatic complications associated with therapy.
Methods and results
Major statin trials were identified by electronic search of the MEDLINE database from 1966 to December 2005. We included English language reports of adults with documented hyperlipidemia; double-blind, random allocation of > or = 100 patients to statin monotherapy versus placebo; and reports of myalgia, creatine kinase elevations, rhabdomyolysis, transaminase elevations, and discontinuation due to adverse events. Among 74,102 subjects enrolled in 35 trials (follow-up range, 1 to 65 months), statin therapy (excluding cerivastatin) did not result in significant absolute increases in risks of myalgias (risk difference/1000 patients [RD], 2.7; 95% CI, -3.2 to 8.7), creatine kinase elevations (RD, 0.2; 95% CI, -0.6 to 0.9), rhabdomyolysis (RD, 0.4; 95% CI, -0.1 to 0.9), or discontinuation due to any adverse event (RD, -0.5; 95% CI, -4.3 to 3.3). The absolute risk of transaminase elevations was significantly higher with statin therapy (RD, 4.2; 95% CI, 1.5 to 6.9).
Conclusions
On the basis of data available from published clinical trials, statin therapy is associated with a small excess risk of transaminase elevations, but not of myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal of therapy compared with placebo. Further study is necessary to determine whether the results from these published clinical trials are similar to what occurs in routine practice, particularly among patients who are older, have more severe comorbid conditions, or receive higher statin doses than most patients in these clinical trials.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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