New Aspects for the Medical Treatment of Results of a Double-Blind Randomized Placebo-Controlled Multi-Centre Trial Evaluating the Efficacy and Tolerability of the 5-HT3-Antagonist Tropisetron in Primary Fibromyalgia

Journal/Book: Z Rheumatol 1998; 57 Suppl. 1: 30 (F 16). 1998;

Abstract: 1Novartis Pharma GmbH Klinische Forschung Nürnberg; 2Hochrhein-Institut für Rehabilitationsforschung Bad Säckingen Introduction: We report on a clinial trial being conducted in order to evaluate the efficacy and tolerability of the 5-HT3-receptor antagonist tropisetron in patients suffering from primary fibromyalgia. Design: The study was designed as prospective randomized double-blind placebo controlled trial. A total of 418 fibromyalgia patients (according to ACR criteria) were recruited and randomly assigned to one of four treatment arms: placebo 5 mg 10 mg or 15 mg tropisetron respectively. Study drug was given once daily for a duration of 10 days. Main outcome measure of efficacy was changes in painscore; further evaluations of efficacy comprise changes in visual analogue scale and number of tender-points patients' global assessment and improvements in functional symptoms. Tolerability was assessed according to adverse event experience vital signs laboratory testing and a global assessment provided by each patient. Results: The response rate was significantly (p < 0.05) higher in the group treated with 5 mg tropisetron as compared to placebo. In addition mean painscore was reduced significantly (p < 0.05) for 5 mg and 10 mg tropisetron as compared to placebo. However effects of 15 mg tropisetron were much less pronounced and only placebo-like. Regarding visual analogue scale again a significant (p < 0.05) improvement could be seen for 5 mg tropisetron. Comparing baseline vs. end-of-treatment the number of tenderpoints was reduced significantly (p < 0.01) in the group treated with 5 mg tropisetron. ... le

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