Statin tolerability: In defence of placebo-controlled trials

European Journal of Preventive Cardiology
Jonathan A Tobert, Connie B Newman

Abstract

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. 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. 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. 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 ...Continue Reading

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Citations

Feb 20, 2016·Journal of Clinical Lipidology·Connie B Newman, Jonathan A Tobert
Jun 7, 2016·American Heart Journal·UNKNOWN Cholesterol Treatment Trialists' (CTT) Collaboration
Sep 1, 2016·Journal of Clinical Lipidology·Jonathan A Tobert, Connie B Newman
Oct 30, 2016·Atherosclerosis·Luis Masana, Jeanine Roeters van Lennep
Dec 31, 2016·The British Journal of General Practice : the Journal of the Royal College of General Practitioners·Dharani Yerrakalva, Simon J Griffin
Aug 14, 2018·European Heart Journal. Cardiovascular Pharmacotherapy·Alexander VonbankJuan Tamargo
Aug 10, 2017·Circulation. Cardiovascular Genetics·Moneeza Kalhan SiddiquiUNKNOWN PREDICTION-ADR Consortium
Dec 26, 2018·Arteriosclerosis, Thrombosis, and Vascular Biology·Connie B NewmanUNKNOWN American Heart Association Clinical Lipidology, Lipoprotein, Metabolism and Thrombosis Committee, a Joint Committee of the C
Jan 18, 2019·Circulation Research·Natalie C WardRobert H Eckel
Feb 25, 2020·Expert Review of Clinical Pharmacology·Joseph V PergolizziPeter Magnusson
Apr 25, 2020·Journal of the American College of Cardiology·David PreissChristina Reith

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