AE symptom intensity similar with atorvastatin and placebo
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AE symptom intensity similar with atorvastatin and placebo The patient-reported symptom intensity of adverse events (AEs) in patients receiving atorvastatin is similar to that when they receive placebo, according to findings of the UK Self Assessment Method for Statin side-effects Or Nocebo (SAMSON) study published in the New England Journal of Medicine. In this double-blind study, 60 patients who had previously discontinued HMG-CoA reductase inhibitors (statins) were given four bottles of atorvastatin 20mg, four bottles of placebo and four empty bottles which were each used for one month in a randomised sequence. They reported the daily symptom severity score (rated from 0 [no symptoms] to 100 [very severe]) via a smartphone application. The 12-month trial duration was completed by 49 patients. In primary end-point analysis, the ratio of the placebo-related symptom intensity to the atorvastatin-related symptom intensity (nocebo ratio) was 2.2 (95% CI –62.3, +66.7). The nocebo ratio was 0.90 when recalculated using pooled patient data. Overall, the symptom severity was significantly higher during statin months (16.3) and placebo months (15.4) than during no-tablet months (8.0; p
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