Mirabegron相較solifenacin在乾燥症併膀胱過動症的患者有更好的耐受性

曾浩翔¹、吳柏樟^2,3,4,5、  楊凱介²、張詩欣²、藍忠亮²、黃柏豪²、黃春明²、黃志平¹ 、陳得源²、鄒頡龍¹

¹中國醫藥大學附設醫院 泌尿部,²風濕免疫中心; ³國立中興大學 轉譯醫學博士學位學程, ⁴榮興轉譯醫學研究中心; ⁵中國醫藥大學醫學院

Mirabegron is More Tolerable than Solifenacin in Sjogren’s Syndrome Patients with Overactive Bladder Symptoms

Chen Hao Xiang¹, Po-Chang Wu^2,3,4,5, Kai-Jieh Yeo², Shih-Hsin Chang², Joung-Liang Lan², Po-Hao Huang², Chung-Ming Huang², Chi-Ping Huang¹, Der-Yuan Chen², Eric Chieh-Lung Chou¹

¹Department of Urology, ² Rheumatology and Immunology Center, China Medical University Hospital, Taichung 408, Taiwan;

³Ph.D. Program in Translational Medicine, ⁴Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung 402, Taiwan;

⁵College of Medicine, China Medical University, Taichung 408, Taiwan

Purpose:

Both Sjogren’s syndrome and overactive bladder(OAB) are more prevalent in female. Previous studies have shown that patients with Sjogren's syndrome have a higher risk of developing OAB. However, the optimal management for these patients is unknown. Therefore, the purpose of this study is to evaluate the efficacy and safety profile of mirabegron, a beta-3 agonist compared to the anti-muscarinic agent in treating overactive bladder symptoms of patients with Sjogren’s syndrome.

Materials and Methods:

This is a prospective, randomized controlled trial. 55 Sjogren’s syndrome patients with Overactive Bladder Symptom Score (OABSS)≥4 were enrolled in this study. The included patients were randomized into two groups: beta-3 agonist and anti-muscarinic agent group. The primary outcome is the change in OABSS and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI). The secondary outcomes include the change in IPSS, bladder capacity, postvoid residual volume, voiding velocity, Patient Perception of Bladder Condition (PPBC). Secondary analysis of individual components of OABSS, IPSS, seropositive, and negative Sjogren syndrome was done. The statistical analysis was done using IBM SPSS v25.

Results: The median age was 64(34-85) years old. There were 55 patients enrolled in the study, with 28 randomized to the mirabegron arm and 27 to the solifenacin arm. All of the included patients were female. The change of OABSS in the mirabegron arm and solifenacin arm is comparable. The total OABSS of the mirabegron arm at the first visit, 1week, 1month, and 3 months is 6.8, 4.5, 4.6, 4 while the OABSS of the solifenacin arm is 7.5, 5.4, 4.4, 2.4. The change of ESSPRI is -5.1 in the mirabegron arm and 1.2 in the solifenacin arm. Four patients(15%) of the solifenacin arm chose to crossover to the mirabegron arm because of intolerance of the side effect, mainly dry mouth and constipation. There was no patient in the mirabegron arm who chose to crossover to solifenacin.

Conclusion:  Mirabegron and solifenacin are both effective in managing the OAB symptoms of Sjogren’s syndrome. Solifenacin has a higher rate of intolerance compared to mirabegron, suggesting that mirabegron might be a more suitable choice for Sjogren's syndrome patients with OAB symptoms.