StatinWISE - 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

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http://eprints.org/relation/isVersionOf https://datacompass.lshtm.ac.uk/id/document/7103 http://eprints.org/relation/isVolatileVersionOf https://datacompass.lshtm.ac.uk/id/document/7103 http://eprints.org/relation/isIndexCodesVersionOf https://datacompass.lshtm.ac.uk/id/document/7103 Generate index codes conversion from Text to indexcodes archive 182 disk0/00/00/13/14 2019-08-07 13:59:26 2026-02-12 11:04:52 2019-08-07 13:59:26 collection show Perkins Alexander 0000-0002-9817-2390 TRUE 39fa0570b7f1e51e9aa64479308e9485 PrincipalInvestigator Smeeth Liam TRUE b77507afb7742dd51f5b8bd6bc2dc017 CoInvestigator Shakur-Still Haleema TRUE 7b8641668ecd9f3c2694b35bd4235670 London School of Hygiene & Tropical Medicine, London, United Kingdom StatinWISE - 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 admin_epidPopHealth EPPH 2019-08-07 published London School of Hygiene & Tropical Medicine 10.17037/DATA.00001314 Project London School of Hygiene & Tropical Medicine Clinical Trials Unit http://purl.org/dc/terms/hasPart /id/eprint/1695 Perkins Alexander alexander.perkins@lshtm.ac.uk TRUE Statins are the most commonly prescribed treatment in the UK. Recently updated NICE guidelines have lowered the threshold for statin use to include all patients with a 10% or greater 10-year risk of cardiovascular disease. Previous randomised trials have established the prevalence of serious adverse effects of statins such as rhabdomyolysis, however, many patients discontinue statins due to less severe symptoms, such as muscle pain or fatigue. Randomised trials have shown no differences between those taking statin and placebo in terms of the prevalence of these side effects (approximately 9%), but currently there is no pathway of care for clinicians to empirically and objectively evaluate whether symptoms reported by a statin-user are caused by the statin itself or the so-called ‘nocebo’ effect (symptoms reflecting patient expectation of side effects). Given the effectiveness of statins in preventing cardiovascular disease, accurate data on the cause of symptoms experienced during statin use are needed to reliably inform patient and clinician about continuation of use. The proposed StatinWISE trial will provide definitive answers to this important uncertainty about statin therapy. 41 RJ.AW-CDT public London, United Kingdom National Institute for Health Research (NIHR) Project en Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials https://researchonline.lshtm.ac.uk/id/eprint/4672036 National Institute for Health Research (NIHR) National Institute for Health Research (NIHR) http://dx.doi.org/10.13039/501100000272 2019-08-07