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Statin tolerability: In defence of placebo-controlled trials

BACKGROUND: Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant. METHODS: Examination of differe...

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Autores principales: Tobert, Jonathan A, Newman, Connie B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847124/
https://www.ncbi.nlm.nih.gov/pubmed/26318980
http://dx.doi.org/10.1177/2047487315602861
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author Tobert, Jonathan A
Newman, Connie B
author_facet Tobert, Jonathan A
Newman, Connie B
author_sort Tobert, Jonathan A
collection PubMed
description BACKGROUND: Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant. METHODS: Examination of differences between statin and placebo in withdrawal rates due to adverse events – a good measure of tolerability – in statin cardiovascular outcome trials in patients with advanced disease and complex medical histories, who may be more vulnerable to adverse effects. The arguments commonly used to dismiss safety and tolerability data in statin clinical trials are examined. RESULTS: Rates of withdrawal due to adverse events in trials in patients with advanced disease and complex medical histories are consistently similar in the statin and placebo groups. We find no support for arguments that statin cardiovascular outcome trials do not translate to clinical practice. CONCLUSIONS: Given the absence of any signal of intolerance in clinical trials, it appears that statin intolerance in the clinic is commonly due to the nocebo effect causing patients to attribute background symptoms to the statin. Consistent with this, over 90% of patients who have stopped treatment because of an adverse event can tolerate a statin if re-challenged. Consequently, new agents, including monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, will be useful when added to statin therapy but should rarely be used as a statin substitute.
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spelling pubmed-48471242016-05-12 Statin tolerability: In defence of placebo-controlled trials Tobert, Jonathan A Newman, Connie B Eur J Prev Cardiol Prevention BACKGROUND: Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant. METHODS: Examination of differences between statin and placebo in withdrawal rates due to adverse events – a good measure of tolerability – in statin cardiovascular outcome trials in patients with advanced disease and complex medical histories, who may be more vulnerable to adverse effects. The arguments commonly used to dismiss safety and tolerability data in statin clinical trials are examined. RESULTS: Rates of withdrawal due to adverse events in trials in patients with advanced disease and complex medical histories are consistently similar in the statin and placebo groups. We find no support for arguments that statin cardiovascular outcome trials do not translate to clinical practice. CONCLUSIONS: Given the absence of any signal of intolerance in clinical trials, it appears that statin intolerance in the clinic is commonly due to the nocebo effect causing patients to attribute background symptoms to the statin. Consistent with this, over 90% of patients who have stopped treatment because of an adverse event can tolerate a statin if re-challenged. Consequently, new agents, including monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, will be useful when added to statin therapy but should rarely be used as a statin substitute. SAGE Publications 2015-08-28 2016-05 /pmc/articles/PMC4847124/ /pubmed/26318980 http://dx.doi.org/10.1177/2047487315602861 Text en © The European Society of Cardiology 2015 http://creativecommons.org/licenses/by-nc/3.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page(https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Prevention
Tobert, Jonathan A
Newman, Connie B
Statin tolerability: In defence of placebo-controlled trials
title Statin tolerability: In defence of placebo-controlled trials
title_full Statin tolerability: In defence of placebo-controlled trials
title_fullStr Statin tolerability: In defence of placebo-controlled trials
title_full_unstemmed Statin tolerability: In defence of placebo-controlled trials
title_short Statin tolerability: In defence of placebo-controlled trials
title_sort statin tolerability: in defence of placebo-controlled trials
topic Prevention
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847124/
https://www.ncbi.nlm.nih.gov/pubmed/26318980
http://dx.doi.org/10.1177/2047487315602861
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