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Statin side-effects linked to nocebo effect

Wednesday May 3rd, 2017

Common side-effects linked to statins may be caused by a nocebo effect, according to a major new study reported today.

Researchers say that patients are more likely to report problems of muscle pain and weakness when they know they are taking the drugs.

The findings come from a study which sought to analyse the impact of patients knowing for certain that they were taking the drug.

To do this researchers conducted a second study after completing a randomised control study of statins. In the second study all patients received statins if they wanted to continue the therapy - and knew they were receiving the drug.

The research, reported in The Lancet, found that when patients knew they were receiving the drug, they were 41% more likely to report muscle-related symptoms than during the period when they might have been on a placebo.

About 10,000 patients took part in the research, led by Professor Peter Sever, of Imperial College, London, UK. The patients came from the UK, Ireland and Scandinavia and took part in a blinded, randomised trial from 1998 to 2002.

The second part of the study took place over the next two years before allegations about statin side-effects had become common-place.

The researchers studied 26 possible side-effects, including erectile dysfunction, sleep disturbance and cognitive impairment. The study found statins linked to reduced rates of erectile dysfunction and of sleep disturbance - but a small increase in renal and urinary side-effects.

Professor Sever said: "Just as the placebo effect can be very strong, so too can the nocebo effect.

"Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm. What our study shows is that it's precisely the expectation of harm that is likely causing the increase in muscle pain and weakness, rather than the drugs themselves causing them."

He added: "We know that statins can prevent a significant number of heart attacks and strokes. We know there is a small increase in the risk of diabetes, and at high doses there is a very small increase in myopathy, but overall the benefits greatly outweigh the harms.

"Widespread claims of high rates of statin intolerance still prevent too many people from taking an affordable, safe and potentially life-saving medication."

Writing in the journal, Dr Juan Pedro-Botet, of Hospital del Mar, and Dr Juan Rubiés-Prat, of Universitat Autònoma de Barcelona, Barcelona, Spain, say: "The strengths of Gupta and colleagues' study lie in the fact that these were the same patients, no run-in period existed to exclude patients intolerant to therapy and few patients had previously taken any statins."

Dr Ajay Gupta et al. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase Lancet 3 May 2017; doi:10.1016/S0140-6736(17)31075-9 [abstract]

Tags: Heart Health | Pharmaceuticals | UK News

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