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Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study

Eficácia e segurança da risperidona-referência versus risperidona-similar em pacientes idosos com transtornos neuropsiquiátricos: um estudo retrospectivo

Abstract

To compare the efficacy and tolerability of brand-risperidone against similar-risperidone in elderly outpatients. Method: The medical files of 16 elderly outpatients from the IPq-HCFMUSP treated with two formulations of risperidone (brand and similar) between July/1999 and February/2000 were reviewed. Two independent raters, using the Clinical Global Impression scale, evaluated the efficacy of the treatment with risperidone and the frequency of adverse effects. Results: Comparing October/1999 to November/1999, Rater 1 observed a trend (p=0.059) and Rater 2 found a statistically significant difference, in favor of the brand-risperidone group (p=0.014). Comparing October/1999 to February/2000, Rater 1 observed no statistically significant difference (p=0.190), but the Rater 2 found a statistically significant difference in favor of the brand-risperidone group (p=0.029). Comparing November/1999 to February/2000, both raters found no statistically significant differences between both risperidone formulations. Regarding adverse effects, a statistically significant difference (p=0.046) was found in favor of the patients treated with brand-risperidone. Conclusions: The risperidone-reference, compared to similar-risperidone, showed a trend toward greater efficacy and tolerability.

Key words:
risperidone; elderly; treatment; efficacy; side effects

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