Trial reportBMJ (Clinical research ed.)2021
Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials.
Trial report in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02781064. Cited by 65 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Series of Randomised Controlled N-of 1 Trials in Patients Who Have Discontinued or Are Considering Discontinuing Statin Use Due to Muscle-related Symptoms to Assess if Atorvastatin Treatment Causes More Muscle Symptoms Than Placebo
Open the trial in the graphWho cites it
65 citing papers in PubMed, 5 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Safety outcomes of statin vs non-statin lipid-lowering interventions in patients with prior statin-associated muscle symptoms: A systematic review and meta-analysis.PloS one · 2025 · on this mapPooled it
- Intolerance upon statin rechallenge: A systematic review and meta-analysis of randomized controlled trials.PloS one · 2023Pooled it
- Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials.Lancet (London, England) · 2022 · on this mapPooled it
- Comparative effectiveness of statins on non-high density lipoprotein cholesterol in people with diabetes and at risk of cardiovascular disease: systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2022Pooled it
- Associations between statins and adverse events in primary prevention of cardiovascular disease: systematic review with pairwise, network, and dose-response meta-analyses.BMJ (Clinical research ed.) · 2021 · on this mapPooled it
- Mevalonate in blood and muscle: Response to atorvastatin treatment and the relationship to statin intolerance in patients with coronary heart disease.Clinical and translational science · 2024Trial
- Clinical and psychological factors in coronary heart disease patients with statin associated muscle side-effects.BMC cardiovascular disorders · 2021Trial
- Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment.Journal of the American College of Cardiology · 2021Trial
- The effect of statins on muscle symptoms in primary care: the StatinWISE series of 200 N-of-1 RCTs.Health technology assessment (Winchester, England) · 2021Trial
- Statin Therapy and Cardiovascular Prevention: Contemporary Evidence, Challenges, and Future Directions-A Narrative Review.International journal of environmental research and public health · 2026Review
- Article
- Statin-Associated Muscle Symptoms and Myotoxicity: A Clinically Oriented Narrative Review with a Practical Prevention, Evaluation, and Management Algorithm.Medicina (Kaunas, Lithuania) · 2026Review
- Statins, LDL-C and Beyond: A Contemporary Review of Atherosclerotic Cardiovascular Risk Assessment and Management.Journal of lipid and atherosclerosis · 2026Review
- Drug-Induced Raynaud's Phenomenon and Underlying Mechanism: A Disproportionality Analysis From the World Health Organization Pharmacovigilance Database.Arthritis & rheumatology (Hoboken, N.J.) · 2026Article
- Statin therapy and stroke risk in patients with hypercholesterolaemia: a population-based longitudinal study using electronic health records in South London.BMC medicine · 2026Article
- Randomized Personalized Trial for Stress Management Compared to Standard of Care.Journal of personalized medicine · 2026Article
- Diagnosis and Management of Statin-Associated Muscle Symptoms.Korean circulation journal · 2025Review
- Drug-induced Myopathy: Wolf at the Door?JCEM case reports · 2025Article
- Demystifying the nuances of the lipid patient: a guide for primary care providers.American journal of preventive cardiology · 2025Review
- Therapeutic potential of atorvastatin in ischemic stroke: an investigation into its anti-inflammatory effect by targeting the gut-brain axis.Journal of translational medicine · 2025Article
5 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
21 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo establish the effect of statins on muscle symptoms in people who had previously reported muscle symptoms when taking statins.
designSeries of randomised, placebo controlled n-of-1 trials.
settingPrimary care across 50 sites in the United Kingdom, December 2016 to April 2018.
participants200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms.
interventionsParticipants were randomised to a sequence of six double blinded treatment periods (two months each) of atorvastatin 20 mg daily or placebo.
main outcome measuresAt the end of each treatment period, participants rated their muscle symptoms on a visual analogue scale (0-10). The primary analysis compared symptom scores in the statin and placebo periods.
results151 participants provided symptoms scores for at least one statin period and one placebo period and were included in the primary analysis. Overall, no difference in muscle symptom scores was found between the statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40)). Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period. Two thirds of those completing the trial reported restarting long term treatment with statins.
conclusionsNo overall effect of atorvastatin 20 mg on muscle symptoms compared with placebo was found in participants who had previously reported severe muscle symptoms when taking statins. Most people completing the trial intended to restart treatment with statins. N-of-1 trials can assess drug effects at the group level and guide individual treatment.
trial registrationISRCTN30952488, EUDRACT 2016-000141-31, NCT02781064.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.