Safety/tolerability RCT · BMJ 2021
StatinWISE trial
Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials.
The bottom line
In patients with prior statin-associated muscle symptoms, atorvastatin 20 mg did not cause more muscle symptoms than placebo when tested in a blinded n-of-1 design, and most participants intended to resume statin therapy.
No excess harm vs placeboUS status: US-approved
At a glance
- Medicine
- Atorvastatin 20 mg daily
- Compared with
- Placebo
- People
- 200
- Who took part
- 200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms; primary care across 50 sites in the United Kingdom, December 2016 to April 2018
- Design
- Series of randomised, placebo controlled n-of-1 trials, double blinded
- Follow-up
- Six double blinded treatment periods of two months each
- Main question
- Comparison of muscle symptom scores (0-10 visual analogue scale) between statin and placebo periods
Main result
mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40
Other results
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.
Safety
Withdrawals because of intolerable muscle symptoms were 18 participants (9%) during a statin period and 13 (7%) during a placebo period.
In the trial's own words
“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.”
Quoted from the abstract of BMJ 2021, checked word for word against PubMed. PubMed 33627334 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the StatinWISE trial find?
In patients with prior statin-associated muscle symptoms, atorvastatin 20 mg did not cause more muscle symptoms than placebo when tested in a blinded n-of-1 design, and most participants intended to resume statin therapy.
Who was in StatinWISE?
200 people. 200 participants who had recently stopped or were considering stopping treatment with statins because of muscle symptoms; primary care across 50 sites in the United Kingdom, December 2016 to April 2018.
What was StatinWISE's main result?
mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; P=0.40
Related trials
- SAMSON (2021)In patients who had previously stopped statins due to side effects, symptom scores were equally elevated on statin and placebo compared with no treatment, indicating most statin-associated symptoms are a nocebo effect rather than a pharmacological effect of the drug.
- LODESTAR (2023)In patients with coronary artery disease, rosuvastatin and atorvastatin provide similar long-term cardiovascular protection, but rosuvastatin carries a higher risk of new-onset diabetes requiring medication and cataract surgery.
- REPRIEVE (2023)In people with HIV at low-to-moderate cardiovascular risk, daily pitavastatin significantly reduced major adverse cardiovascular events compared with placebo, though with modestly more muscle symptoms and diabetes.
- SPORT (2023)In people with elevated ASCVD risk but no prior ASCVD, low-dose rosuvastatin (5 mg) lowered LDL-C far more than placebo or any of six common dietary supplements, which showed no significant LDL-C benefit over placebo.
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