Trial reportBMC clinical pharmacology2009
Effects of simvastatin 40 mg daily on muscle and liver adverse effects in a 5-year randomized placebo-controlled trial in 20,536 high-risk people.
Trial report in BMC clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- The Safety and Tolerability of Statin Therapy in Primary Prevention in Older Adults: A Systematic Review and Meta-analysis.Drugs & aging · 2020 · on this mapPooled it
- Effect of Stains on LDL Reduction and Liver Safety: A Systematic Review and Meta-Analysis.BioMed research international · 2018Pooled it
- Statins for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2013 · on this mapPooled it
- Patients on statins with elevated transaminases: Frequency of follow-up creatine kinase testing and gastroenterology referral.British journal of clinical pharmacology · 2026Article
- Statin-Associated Myopathy: Emphasis on Mechanisms and Targeted Therapy.International journal of molecular sciences · 2021Review
- Intensity of statin therapy and muscle symptoms: a network meta-analysis of 153 000 patients.BMJ open · 2021 · on this mapArticle
- Common Statin Intolerance Variants inFrontiers in genetics · 2021Article
- Biodegradable Simvastatin-Containing Polymeric Prodrugs with Improved Drug Release.ACS biomaterials science & engineering · 2018Article
- Statins for primary prevention in people with a 10% 10-year cardiovascular risk: too much medicine too soon?The British journal of general practice : the journal of the Royal College of General Practitioners · 2017Article
- Statin tolerability: In defence of placebo-controlled trials.European journal of preventive cardiology · 2016Review
- Overcoming Challenges With Statin Therapy.Journal of the American Heart Association · 2016Review
- Hard-Wired Bias: How Even Double-Blind, Randomized Controlled Trials Can Be Skewed From the Start.Mayo Clinic proceedings · 2015Article
- Statin-associated muscle symptoms: impact on statin therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management.European heart journal · 2015Review
- Statin associated hepatic adverse effects: a retrospective review from a regional hospital in sultanate of oman.Oman medical journal · 2014Article
- Non-cardiovascular effects associated with statins.BMJ (Clinical research ed.) · 2014Review
- Synthesis and Characterization of a Poly(ethylene glycol)-Poly(simvastatin) Diblock Copolymer.RSC advances · 2014Article
- A reappraisal of the risks and benefits of treating to target with cholesterol lowering drugs.Drugs · 2013Review
- Assessing appropriateness of lipid management among patients with diabetes mellitus: moving from target to treatment.Circulation. Cardiovascular quality and outcomes · 2013Article
- Treatment of dyslipidemia in chronic kidney disease: Effectiveness and safety of statins.World journal of nephrology · 2012Review
- Drug-related myopathies of which the clinician should be aware.Current rheumatology reports · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundSimvastatin reduces cardiovascular mortality and morbidity but, as with other HMG-CoA reductase inhibitors, can cause significant muscle toxicity and has been associated with elevations of liver transaminases.
methodsMuscle and liver adverse effects of simvastatin 40 mg daily were evaluated in a randomized placebo-controlled trial involving 20,536 UK patients with vascular disease or diabetes (in which a substantial reduction of cardiovascular mortality and morbidity has previously been demonstrated).
resultsThe excess incidence of myopathy in the simvastatin group was < 0.1% over the 5 years of the trial, and there were no significant differences between the treatment groups in the incidence of serious hepatobiliary disease.
conclusionAmong the many different types of high-risk patient studied (including women, older individuals and those with low cholesterol levels), there was a very low incidence (< 0.1%) of myopathy during 5 years treatment with simvastatin 40 mg daily. The risk of hepatitis, if any, was undetectable even in this very large long-term trial. Routine monitoring of liver function tests during treatment with simvastatin 40 mg is not useful.
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What OpenQuestion 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 OpenQuestion graph.