Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study

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• 作者：Joon Chul Kim^a ; Kang Jun Cho^a ; Jeong Gu Lee^b ; Ju Tae Seo^c ; Duk Yoon Kim^g ; Seung-June Oh^d ; Kyu-Sung Lee^e ; Myung-Soo Choo^f ; Jeong Zoo Lee^h ; ^{toohotman@hanmail.net}
• 关键词：urinary bladder ; nocturia ; lower urinary tract symptoms ; adrenergic alpha-antagonists ; deamino arginine vasopressin
• 刊名：The Journal of Urology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：197
• 期：2
• 页码：459-464
• 全文大小：344 K
• 卷排序：197

文摘

We investigated the efficacy and safety of desmopressin add-on therapy for men with persistent nocturia on α-blocker for lower urinary tract symptoms in this placebo controlled study.Materials and MethodsThe study included men 40 to 65 years old with lower urinary tract symptoms and persistent nocturia despite α-blocker therapy for at least 8 weeks. Patients were randomized to once daily placebo or desmopressin 0.2 mg for 8 weeks. The primary end point was to assess changes in the mean number of nocturia episodes from baseline to the final assessment. Other secondary end points and adverse events were evaluated.Results and LimitationA total of 86 patients were randomized to treatment, including placebo in 39 and desmopressin 0.2 mg in 47. Baseline characteristics were similar in the 2 groups. The desmopressin add-on group was significantly superior to placebo in terms of the change from baseline in the mean number of nocturia episodes (−1.13 ± 0.92 vs −0.68 ± 0.79, p = 0.034), the changes in nocturnal urine volume (p <0.001), total I-PSS (International Prostate Symptom Score) (p = 0.041), the nocturnal polyuria index (p = 0.001) and ICIQ-N (International Consultation on Incontinence Questionnaire-Nocturia) (p = 0.001), and the willingness to continue (p = 0.025). The incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group. Most adverse events were mild.ConclusionDesmopressin add-on therapy in men 40 to 65 years old with persistent nocturia on α-blocker monotherapy for lower urinary tract symptoms is effective and well tolerated.