Ryuji Sakakibara1, Hitoshi Hamano2, Hiromitsu Yagi3. 1. Neurology Division, Department of Internal Medicine, Sakura Medical Center, Toho University, Japan. 2. Post-Marketing Medical Research Pharmacovigilance Division, Ono Pharmaceutical Co., Ltd., Japan. 3. Quality Assurance & Reliability Division, Pharmacovigilance Department, Kyorin Pharmaceutical Co., Ltd., Japan.
Abstract
OBJECTIVES: To assess the effect of imidafenacin on cognitive function, including the conversion rate of mild cognitive impairment (MCI) to dementia, in a period of one year. METHODS: Patients newly administered imidafenacin to treat overactive bladder (OAB), including those who had MCI or dementia, were surveyed across Japan (cognitive safety analysis set [CSAS]), on all of whom we performed the Mini-Mental State Examination (MMSE) at baseline, 24- and 48-weeks after treatment. From CSAS, we extracted well described cases of OAB change as well as drug-related adverse events of dry mouth etc. (efficacy analysis set [EAS]). From CSAS, we extracted MCI cases (MCI set [MCIS]) to analyze the conversion rate of MCI to dementia. MCI is defined by exclusion of normal individual and apparent dementia. RESULTS: The cognitive safety analysis set comprised 187 patients who were collected from 51 medical institutions, and no significant decrease was noted in the MMSE scores in the patients during follow-up. EAS comprised 176 patients. In this group, drug-related adverse events such as dry mouth were reported in 15 (8.5%). MCIS comprised 145 patients. In this group, the annual conversion rate of MCI to dementia was 3.6%, and this rate did not exceed those reported in past epidemiological studies (6.8-16.1% per year). CONCLUSIONS: The present findings suggest that imidafenacin can be used safely for cognitively vulnerable patients with OAB.
OBJECTIVES: To assess the effect of imidafenacin on cognitive function, including the conversion rate of mild cognitive impairment (MCI) to dementia, in a period of one year. METHODS:Patients newly administered imidafenacin to treat overactive bladder (OAB), including those who had MCI or dementia, were surveyed across Japan (cognitive safety analysis set [CSAS]), on all of whom we performed the Mini-Mental State Examination (MMSE) at baseline, 24- and 48-weeks after treatment. From CSAS, we extracted well described cases of OAB change as well as drug-related adverse events of dry mouth etc. (efficacy analysis set [EAS]). From CSAS, we extracted MCI cases (MCI set [MCIS]) to analyze the conversion rate of MCI to dementia. MCI is defined by exclusion of normal individual and apparent dementia. RESULTS: The cognitive safety analysis set comprised 187 patients who were collected from 51 medical institutions, and no significant decrease was noted in the MMSE scores in the patients during follow-up. EAS comprised 176 patients. In this group, drug-related adverse events such as dry mouth were reported in 15 (8.5%). MCIS comprised 145 patients. In this group, the annual conversion rate of MCI to dementia was 3.6%, and this rate did not exceed those reported in past epidemiological studies (6.8-16.1% per year). CONCLUSIONS: The present findings suggest that imidafenacin can be used safely for cognitively vulnerable patients with OAB.