Department of Surgery (Urology), University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.
Department of Surgery, University College of Medical Sciences (University of Delhi) & GTB Hospital, Delhi, India.
Int J Clin Pract. 2021 Jul;75(7):e14184. doi: 10.1111/ijcp.14184. Epub 2021 Apr 19.
The efficacy and safety of βeta-3 agonists (Mirabegron 50 mg) have been sparingly assessed in the published English literature. We aim to do an efficacy-safety analysis of Mirabegron-Tamsulosin combination therapy vs tamsulosin-placebo monotherapy in a select subset of medication virgin Benign Prostatic Enlargement (BPE) patients with coexisting predominant non-neurogenic overactive bladder symptoms (OABS).
After prior written informed consent and IEC, 80 patients of uncomplicated BPE with coexisting non-neurogenic OABS and IPSS of >7 without contraindications to drug therapy were computer randomised/allocated to receive either[50 mg Mirabegron plus Tamsulosin 0.4 mg (Intervention arm-I)]or [Tamsulosin 0.4 mg plus capsule lactobacillus (Comparator arm-II)] once daily for 8 weeks. Efficacy was evaluated using the OABS Score (OABSS), mean change in nocturnal frequency (NF), PVR and IPSS, while safety was assessed by recording treatment emergent adverse events (TEAE). Follow-up visits were performed at second, fourth and eighth week.
Patient data in both groups were generally comparable with the exception of NF and IPSS storage sub score (IPSS-ss). Significant improvements were visualised in the eighth week primary endpoint total OABS sub score (OABSS-ss) in the combination group (P < .001).Similar significant improvements were seen with most secondary parameters such as the mean change in NF, IPSS, IPSS-ss, OABS-ss, voided volume, Qmax, and Quality of life index (QOL) (P < .001). No significant increase in PVR was observed in the Mirabegron arm and no patient developed urinary retention. The TEAE were minor, self-limiting and managed symptomatically without drug discontinuity.
Mirabegron can be significantly efficacious and safe in ameliorating non-neurogenic OABS induced by BPE vs placebo by initiating combination therapy from the start as opposed to the usual 'add on therapy' protocol. This combination appeared to be superior in terms of overall safety, minimal side effects, better compliance and tolerability vs Tamsulosin monotherapy in select BPE patients with predominant non-neurogenic OABS.
β3 受体激动剂（米拉贝隆 50mg）的疗效和安全性在已发表的英文文献中鲜有评估。我们旨在对米拉贝隆-坦索罗辛联合治疗与坦索罗辛-安慰剂单药治疗选择的一组药物初治良性前列腺增生（BPE）伴共存主要非神经源性逼尿过度症（OAB）症状的患者进行疗效-安全性分析。
在事先书面知情同意和 IEC 后，80 例无并发症的 BPE 患者伴有共存的非神经源性 OAB 和 IPSS >7 且无药物治疗禁忌证，通过计算机随机分配/分配接受[50mg 米拉贝隆加坦索罗辛 0.4mg（干预组-I）]或 [坦索罗辛 0.4mg 加胶囊乳杆菌（对照组-II）]，每日一次，共 8 周。使用 OAB 评分（OABSS）、夜间频率（NF）、PVR 和 IPSS 的平均变化评估疗效，同时通过记录治疗中出现的不良事件（TEAE）评估安全性。在第 2、4 和 8 周进行随访。
两组患者的数据通常是可比的，除了 NF 和 IPSS 存储子评分（IPSS-ss）。联合组在第 8 周主要终点总 OAB 子评分（OABSS-ss）方面观察到显著改善（P <.001）。大多数次要参数（如 NF、IPSS、IPSS-ss、OABSS-ss、排尿量、Qmax 和生活质量指数（QOL）的平均变化）也观察到类似的显著改善（P <.001）。米拉贝隆组未观察到 PVR 显著增加，也没有患者发生尿潴留。不良事件轻微，为自限性，无需停药即可通过对症治疗管理。
与通常的“附加治疗”方案相比，米拉贝隆通过从一开始就启动联合治疗而不是安慰剂，在改善 BPE 引起的非神经源性 OAB 方面具有显著的疗效和安全性。在伴有主要非神经源性 OAB 的特定 BPE 患者中，与坦索罗辛单药治疗相比，这种联合治疗在总体安全性、最小副作用、更好的依从性和耐受性方面似乎更具优势。
