Mirabegron 25mg 在老年及多重合併症之膀胱過動症患者的安全性與治療效果–與較年輕患者的比較
李宇坤、郭漢崇
花蓮慈濟醫院 泌尿部
Safety and therapeutic efficacy of mirabegron 25 mg in very old and frail patients with OAB and multiple comorbidities – comparison with younger patients
Yu Khun Lee, Hann-Chorng Kuo
Department of Urology, Hualien Tzu Chi Hospital, Huelien, Taiwan
Purpose: To assess the therapeutic efficacy and safety of mirabegron 25 mg once daily in very old and frail patients with overactive bladder(OAB) and multiple comorbidities compared with younger patients.
Materials and Methods: Patients with OAB at the age range of between twenty to sixty years old and over eighty years old were included in this study. All of the participants were treatment-naive or no treatment more 3 months at the baseline, treated with mirabegron 25 mg once daily. The patients were divided into two groups, younger(20-60 years old) and older(≧ 80 years old). Patients who discontinued mirabegron 25 mg once daily; or changed the dosage of mirabegron; or changed to antimuscarinics during treatment course were excluded. Their underlying comorbidities was recorded. Assessment tools included International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Urgency Severity Score (USS), Patient Perception of Bladder Condition (PPBC), Quality of Life (QoL), uroflowmetry and prostate volume. We compared the difference of the change from baseline to 1st month and 3rd month between two groups. Safety assessments included reporting adverse events(AEs) and post-void residual.
Results: Total 92 patients (younger, N=56; very older, N=40) with OAB treated with mirabegron 25 mg once daily were included. The mean age of younger group was 50.55 ± 10.12 and older group was 85.58 ± 3.76. In overall, the patients in the older group have more underlying comorbidities than younger group (59 vs 30). There was no significant difference of baseline in IPSS, OABSS, USS, QoL and total prostate volume (TPV) between two groups. However, the baseline Qmax, voided volume, post-voided residual (PVR) and PPBC were lower in older group. A statistically significant improvement of PPBC at 1st and 3rd month compared with baseline in younger group. (P<0.05). In older group, the score of QoL and OABSS were significantly decreased at 1st and 3rd month compared with baseline. (P<0.05).The mean changes of most measurements after 3 months of treatment were no significant difference between younger and older patients, except Qmax and voided volume. Younger patients experience more AEs than the elders (26.79% vs 12.5%) during treatment. The common AEs included dry mouth (n=5), abdominal distension (n=3) and dizziness (n=3). Nevertheless, the incidence of AEs when using mirabegron were acceptable low in two groups.
Conclusions: Mirabegron 25 mg once daily is a safe and effective drug to improve OAB symptoms and QoL in old patients with multiple comorbidities. The treatment efficacy were no much difference between younger and older patients.