Real-world outcomes of tadalafil plus mirabegron combination therapy in men with lower urinary tract symptoms and overactive bladder symptoms: a retrospective cohort study.
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引用次数: 0
Abstract
Background: Men with mixed lower urinary tract symptoms (LUTS) often have storage symptoms that drive bother and quality-of-life impairment. Evidence on tadalafil plus mirabegron in routine clinical practice is limited.
Objective: To determine whether tadalafil plus mirabegron was associated with clinically meaningful within-person improvement in IPSS and OABSS in men with mixed LUTS and overactive bladder (OAB) symptoms.
Methods: A single-centre retrospective cohort study of 50 men treated with tadalafil 5 mg plus mirabegron 50 mg. The primary endpoints were within-person change in International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS). Secondary endpoints included bladder diary variables, maximum urinary flow rate (Qmax), post-void residual (PVR) volume, International Index of Erectile Function-5 (IIEF-5), and NIH-Chronic Prostatitis Symptom Index (NIH-CPSI).
Results: Symptoms improved after combination therapy, but the OABSS response was less consistent than the IPSS response. Mean IPSS decreased by 4.18 points (95% CI -4.86 to -3.54; r_rb = -1.00; two-sided P < 0.001) and mean OABSS decreased by 1.86 points (95% CI -2.22 to -1.50; r_rb = -1.00; two-sided P < 0.001). Clinically meaningful IPSS improvement occurred in 38 of 50 men, or 76.0% (95% CI 62.6% to 85.7%); clinically meaningful OABSS improvement occurred in 17 of 50, or 34.0% (95% CI 22.4% to 47.8%). Dual response was seen in 15 of 50 men, or 30.0% (95% CI 19.1% to 43.8%). IIEF-5 increased by 2.92 points (95% CI 2.14 to 3.70; r_rb = 0.86; two-sided P < 0.001). Adverse events were recorded in 3 of 50 men, or 6.0% (95% CI 2.1% to 16.2%), and no patient developed acute urinary retention.
Conclusions: In men with mixed LUTS and prominent storage symptoms, tadalafil plus mirabegron was associated with improvement in overall symptom burden, bladder diary measures, and erectile-function scores without an obvious retention signal. The clinical benefit was clearer for IPSS than for OABSS, so early reassessment is important to identify men who do not improve.
背景:患有混合性下尿路症状(LUTS)的男性通常有储尿症状,导致困扰和生活质量受损。在常规临床实践中,他达拉非联合米拉贝龙的证据是有限的。目的:确定他达拉非加米拉比龙是否与伴有混合LUTS和膀胱过动症(OAB)的男性IPSS和OABSS的有临床意义的人内改善相关。方法:对50名男性患者进行单中心回顾性队列研究,他达拉非5mg加米拉比龙50mg。主要终点是国际前列腺症状评分(IPSS)和膀胱过度活跃症状评分(OABSS)的人内变化。次要终点包括膀胱日记变量、最大尿流率(Qmax)、空后残留(PVR)体积、国际勃起功能指数-5 (IIEF-5)和美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)。结果:联合治疗后症状有所改善,但OABSS反应不如IPSS反应一致。平均IPSS下降4.18点(95% CI -4.86 ~ -3.54; r_rb = -1.00;双侧P P P P P结论:在混合LUTS和突出储存症状的男性中,他达拉非加米拉比龙与总体症状负担、膀胱日记测量和勃起功能评分的改善相关,但没有明显的保留信号。IPSS的临床获益比OABSS更明显,因此早期重新评估对于识别没有改善的男性很重要。
期刊介绍:
The Aging Male , the official journal of the International Society for the Study of the Aging Male, is a multidisciplinary publication covering all aspects of male health throughout the aging process. The Journal is a well-recognized and respected resource for anyone interested in keeping up to date with developments in this field. It is published quarterly in one volume per year.
The Journal publishes original peer-reviewed research papers as well as review papers and other appropriate educational material that provide researchers with an integrated perspective on this new, emerging specialty. Areas of interest include, but are not limited to:
Diagnosis and treatment of late-onset hypogonadism
Metabolic syndrome and related conditions
Treatment of erectile dysfunction and related disorders
Prostate cancer and benign prostate hyperplasia.