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Statins and muscle-related adverse events: Are subjective adverse events influenced by the nocebo effect?

21 Dec 2017
As part of the 13th Asian-Pacific Congress of Hypertension, Professor Peter Sever discussed the results from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA), suggesting that patient reports of muscle-related adverse events were more common when patients knew they were being treated with a statin. This phenomenon is known as the ‘nocebo effect’, where the suggestion of a link between a treatment and a side effect results in over-reporting.

HK-PFR-578a-3 Sever figure

In the case of statins, a high incidence of muscle pain and weakness had been reported in observational studies of patients who were aware they had been prescribed a statin and where there was no placebo control. In contrast, no significant difference in the incidence of muscle pain and weakness were reported in most double-blind, randomized, placebo-controlled trials.

The 10,180 patients with high cardiovascular (CV) risk enrolled in the ASCOT-LLA study were initially blinded as to whether they were randomized to atorvastatin 10 mg or placebo. In the subsequent non-blinded, non-randomized extension, all patients were offered open-label atorvastatin 10 mg daily.

Professor Sever explained that the high incidence of muscle-related symptoms reported in some studies of statins were not causally related. Rather, they are an example of the nocebo effect.

“During the blinded phase of ASCOT-LLA, the same proportion of patients reported muscle-related pain with the placebo [2.00%] compared with those receiving statins [2.03%]. However, once patients knew they were being administered statins in the non-blinded phase of the study, there was a significant increase in reports of these adverse events compared to the placebo group [1.26% vs 1.00%, respectively].”

Professor Sever commented that “while the reports of muscle-related adverse events may have been psychogenic and based on a patient’s expectations and perceptions, they still have the potential to produce measurable physiological changes.” This highlights the need for physicians to understand the context of, and appropriately interpret, clinical data so that accurate conclusions are made about the clinical effectiveness of treatments, such as statins.

In the clinical setting, the inappropriate interpretation of clinical study results, such as those regarding muscle pain and statin therapy, may ultimately result in patients becoming nonadherent to treatment. This may increase their risk of a major CV event, despite statins offering a potentially life-saving therapy. More broadly, these findings highlight how the nocebo effect, and biases in clinical trial design, have the potential to influence physician decisions and patient outcomes, particularly when treating an asymptomatic condition.

Click here to access the full article: Gupta A, et al. Lancet 2017;389:2473–2481

Click here to view the interview video with one of the authors –
Professor Peter Sever
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Most Read Articles
Tristan Manalac, 09 Sep 2018
Structured and remote patient management interventions are effective in reducing all-cause mortality and the number of days lost due to unplanned hospitalizations in heart failure patients, according to a recent study.
Radha Chitale, 08 Apr 2016
A trial assessing the implantable CardioFit® device designed to stimulate the parasympathetic nervous system in heart failure patients failed to meet its primary endpoints – reducing the rate of hospitalization due to heart failure or death by any cause.
27 Aug 2018
Obese men appear to have better ST-elevation myocardial infarction (STEMI) prognoses than their normal weight counterparts, regardless of metabolic syndrome status, a recent study has shown.
27 Jul 2018
There appears to be no association between intraduodenal administration of the artificial sweetener sucralose in healthy older patients and changes in blood pressure (BP) or superior mesenteric artery (SMA) blood flow, reports a study.