Long-Term Safety of Desmopressin Orally Disintegrating Tablets in Men With Nocturia due to Nocturnal Polyuria: Final Results of a Specified Drug Use-Results Survey in Japan

IF 1.8 4区医学 Q3 UROLOGY & NEPHROLOGY

LUTS: Lower Urinary Tract Symptoms Pub Date : 2026-03-17 DOI:10.1111/luts.70052

Yoshimasa Ogawa, Kiyotoshi Kuramoto, Atsushi Nakano

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Abstract

Objectives

This report presents the final results of a post-marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets (ODT) in Japanese men with nocturia due to nocturnal polyuria (NP).

Methods

In total, 1113 Japanese men who received desmopressin ODT for the first time to treat nocturia due to NP were enrolled in a central registry. Of the 1087 patients for which case report forms were collected, 38 did not meet the safety eligibility criteria of the survey. Consequently, the remaining 1049 patients were included in the analysis. The participants were followed for up to 52 weeks.

Results

The mean age of the total population was 75.0 ± 9.6 years. A total of 351 adverse drug reactions (ADRs) were reported in 259 patients, including 11 serious ADRs in 7 patients (0.7%). The most common ADR was hyponatremia, which occurred in 140 patients (13.3%). Among the 19 patients (13.6%) presenting hyponatremia related symptoms, no reports of confusion, seizures, stupor, or coma was recorded. Multivariate analysis identified age ≥ 75 years, a history of benign prostatic hyperplasia, and a lower serum sodium level before treatment as risk factors for the development of hypernatremia after the treatment with desmopressin ODT.

Conclusions

The survey provides insights into the safety profile of desmopressin ODT in real-clinical practice in Japan. Patients aged ≥ 75 years, those with underlying medical conditions, and those with abnormal clinical laboratory values, such as reduced renal function or a baseline serum sodium level of < 140 mmol/L, should be closely monitored for the development of hyponatremia during desmopressin treatment for nocturia due to NP.

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去氨加压素口腔崩解片治疗夜尿症患者的长期安全性：日本一项特定药物使用结果调查的最终结果。

目的：本报告介绍了去氨加压素口腔崩解片（ODT）在日本男性夜尿症患者（由于夜间多尿症（NP））中安全性的上市后监测的最终结果。方法：总共有1113名首次接受去氨加压素ODT治疗NP所致夜尿症的日本男性被纳入中央登记处。在收集病例报告表格的1087例患者中，38例不符合调查的安全资格标准。因此，剩余的1049例患者被纳入分析。研究人员对参与者进行了长达52周的随访。结果：患者平均年龄75.0±9.6岁。259例患者共报告351例药物不良反应（adr），其中7例（0.7%）发生11例严重adr。最常见的不良反应是低钠血症，发生140例（13.3%）。在19例（13.6%）出现低钠血症相关症状的患者中，没有精神错乱、癫痫发作、麻木或昏迷的记录。多因素分析发现，年龄≥75岁、有良性前列腺增生史、治疗前血清钠水平较低是去氨加压素ODT治疗后发生高钠血症的危险因素。结论：该调查为去氨加压素ODT在日本实际临床实践中的安全性提供了见解。患者年龄≥75岁，有潜在疾病，临床实验室值异常，如肾功能减退或基线血清钠水平为

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来源期刊

LUTS: Lower Urinary Tract Symptoms UROLOGY & NEPHROLOGY-

CiteScore

3.00

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided. LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.