Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials
Cholesterol Treatment Trialists' Collaboration
Lancet (London, England) · 193 citas
Etiquetas de revisión
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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
- Cancer Research UK
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Gobierno
- Medical Research Council
- Gobierno
- National Health and Medical Research Council
- Gobierno
- National Institute for Health Research (NIHR)
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- British Heart Foundation (SP/08/010/25939); British Heart Foundation (CH/1996001/9454); Medical Research Council (CH/1996001/9454); British Heart Foundation (FS/14/55/30806); National Institute for Health and Care Research (17/140/02); National Health and Medical Research Council (1150467); British Heart Foundation (SP/14/3/31114); British Heart Foundation (PG/18/16/33570); National Health and Medical Research Council (1037786); Medical Research Council (MC_UU_00017/4); Medical Research Council (MC_UU_00017/3); Medical Research Council (MC_UU_00017/4)
Según 6 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2022-08-29 · Lancet · vol. 400 · número 10355 · págs. 832–845
- Editorial
- Elsevier BV
- Citado
- 264 citas · más que el 100% de estudios similares · 15.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 56 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Pharmacovigilance and Adverse Drug Reactions · Cancer, Lipids, and Metabolism
- Palabras clave
- statins, statin-induced myopathy, myalgia, muscle weakness, adverse drug reactions, statin dose escalation, statin safety, cardiovascular disease prevention
- MeSH
- muscles, humans, hydroxymethylglutaryl-coa reductase inhibitors, middle aged, australia, female, male, atherosclerosis, randomized controlled trials as topic, myalgia
100 autores
- Christina A. Reith
- Colin Baigent
- Lisa S. Blackwell
- Jonathan Emberson
- Enti Spata
- Kelly Davies
- Heather J. Halls
- Lisa Holland
- Kate Wilson
- Jane Armitage
- Charlie Harper
- David Preiss
- Alistair Roddick
- ANTHONY C. KEECH
- Robert John Simes
- Rory Collins
- Elizabeth Helen Barnes
- Jordan Fulcher
- William Guy Herrington
- Adrienne C Kirby
- Borislava Mihaylova
- Rachel L O'Connell
- Pierre Amarenco
- Philip J. Barter
- D. J. Betteridge
- Michael A. Blazing
- Jackie Bosch
- Louise J. Bowman
- Eugene Braunwald M. D
- Christopher Paul Cannon
- Michael B. Clearfield
- Stuart M. Cobbe
- Helen Martina Colhoun
- Björn Dahlöf
- Barry R. Davis
- James A. de Lemos
- John R. Downs
- Paul N. Durrington
- Bengt Fellström
- Ian Ford
- Maria Grazia Franzosi
- John Fuller
- Curt Daniel Furberg
- Robert J. Glynn
- David Gordon
- Antonio M. Gotto
- Richard H. Grimm
- Ajay Kumar Gupta
- C. MORTON HAWKINS
- G. A. Hitman
- Hallvard Holdaas
- Alan G. Jardine
- J. Wouter Jukema
- John J.P. Kastelein
- Sharon Kean
- JOHN K. KJEKSHUS
- Genell L. Knatterud
- Robert H. Knopp
- Wolfgang Köenig
- Michael J. Koren
- Vera Krane
- Martin Landray
- John C. LaRosa
- Roberto Latini
- Eva Lonn
- Donata Lucci
- Jean G. MacFadyen
- P. W. Macfarlane
- Stephen W MacMahon
- Aldo Pietro Maggioni
- Roberto Marchioli
- Ian C. Marschner
- Lemuel A. Moyé
- Sabina A. Murphy
- Andrew Neil
- Enrico Nicolis
- Chris J. Packard
- Sarah Parish
- Terje Rolf Pedersen
- Richard Peto
- Marc Alan Pfeffer
- Neil R Poulter
- Sara Pressel
- Jeffrey L. Probstfield
- Mahboob Rahman
- Paul M. Ridker
- Michele Robertson
- Frank M. Sacks
- Naveed A. Sattar
- Roland Erich Schmieder
- Patrick W.J.C. Serruys
- Peter Sever
- John Shaw
- James Shepherd
- Lara M. Simpson
- Peter Sleight
- Luigi Tavazzi
- Gianni Tognoni
- Andrew Maxwell Tonkin
- Stella Trompet
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Statin therapy is effective for the prevention of atherosclerotic cardiovascular disease and is widely prescribed, but there are persisting concerns that statin therapy might frequently cause muscle pain or weakness. We aimed to address these through an individual participant data meta-analysis of all recorded adverse muscle events in large, long-term, randomised, double-blind trials of statin therapy.
Methods
Randomised trials of statin therapy were eligible if they aimed to recruit at least 1000 participants with a scheduled treatment duration of at least 2 years, and involved a double-blind comparison of statin versus placebo or of a more intensive versus a less intensive statin regimen. We analysed individual participant data from 19 double-blind trials of statin versus placebo (n=123 940) and four double-blind trials of a more intensive versus a less intensive statin regimen (n=30 724). Standard inverse-variance-weighted meta-analyses of the effects on muscle outcomes were conducted according to a prespecified protocol.
Findings
Among 19 placebo-controlled trials (mean age 63 years [SD 8], with 34 533 [27·9%] women, 59 610 [48·1%] participants with previous vascular disease, and 22 925 [18·5%] participants with diabetes), during a weighted average median follow-up of 4·3 years, 16 835 (27·1%) allocated statin versus 16 446 (26·6%) allocated placebo reported muscle pain or weakness (rate ratio [RR] 1·03; 95% CI 1·01-1·06). During year 1, statin therapy produced a 7% relative increase in muscle pain or weakness (1·07; 1·04-1·10), corresponding to an absolute excess rate of 11 (6-16) events per 1000 person-years, which indicates that only one in 15 ([1·07-1·00]/1·07) of these muscle-related reports by participants allocated to statin therapy were actually due to the statin. After year 1, there was no significant excess in first reports of muscle pain or weakness (0·99; 0·96-1·02). For all years combined, more intensive statin regimens (ie, 40-80 mg atorvastatin or 20-40 mg rosuvastatin once per day) yielded a higher RR than less intensive or moderate-intensity regimens (1·08 [1·04-1·13] vs 1·03 [1·00-1·05]) compared with placebo, and a small excess was present (1·05 [0·99-1·12]) for more intensive regimens after year 1. There was no clear evidence that the RR differed for different statins, or in different clinical circumstances. Statin therapy yielded a small, clinically insignificant increase in median creatine kinase values of approximately 0·02 times the upper limit of normal.
Interpretation
Statin therapy caused a small excess of mostly mild muscle pain. Most (>90%) of all reports of muscle symptoms by participants allocated statin therapy were not due to the statin. The small risks of muscle symptoms are much lower than the known cardiovascular benefits. There is a need to review the clinical management of muscle symptoms in patients taking a statin.
Funding
British Heart Foundation, Medical Research Council, Australian National Health and Medical Research Council.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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