Long-term safety of desmopressin orally disintegrating tablets in men with nocturia due to nocturnal polyuria: Interim results of a specified drug use–results survey in Japan

IF 1.5 4区医学 Q3 UROLOGY & NEPHROLOGY LUTS: Lower Urinary Tract Symptoms Pub Date : 2024-04-15 DOI:10.1111/luts.12513

Yoshimasa Ogawa, Shujiro Murata, Kiyotoshi Kuramoto, Atsushi Nakano

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Abstract

Objectives

This interim report presents the 12-week results of a post-marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets 25 and 50 μg in Japanese men with nocturia due to nocturnal polyuria.

Methods

Of the planned study population of 1000 Japanese men receiving desmopressin for the first time for nocturia due to nocturnal polyuria, 971 cases were enrolled. In this interim analysis, 9 cases, including 6 registry violations and 3 cases of unconfirmed desmopressin dosing, were excluded from the 354 case report forms collected and fixed by the end of December 2021, and data up to 12 weeks after administration in 345 cases were defined as the safety analysis set.

Results

The mean age was 74.5 ± 9.9 years and 88.7% of the survey participants were aged ≥65 years. Desmopressin was started at a dose of 25 μg in 153 cases (44.3%). There were 102 adverse drug reactions (ADRs) reported in 71 cases, including 6 serious ADRs in 3 cases (0.9%). The most common ADR was hyponatremia occurring in 29 cases (8.4%). Eight of the hyponatremic cases were asymptomatic. Symptoms were resolved or slightly improved within 4 weeks of onset in 13 of 29 cases of hyponatremia. In addition, hyponatremia occurred in 11 of 217 cases (5.1%), with a serum sodium level before the administration of desmopressin of ≥140 mmol/L, and in 13 of 87 cases (14.9%), with a level of 135–139 mmol/L, and was not measured in 5 hyponatremia cases. Patient characteristics that showed significant differences in the occurrence of hyponatremia included body weight, body mass index, renal function, and pretreatment serum sodium level. Regular monitoring of serum sodium is necessary for early detection of hyponatremia.

Conclusions

Hyponatremia was the most common ADR when desmopressin orally disintegrating tablets were used to treat nocturia due to nocturnal polyuria over a 12-week period.

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去氨加压素口腔崩解片对夜间多尿症男性患者的长期安全性：日本特定药物使用效果调查的中期结果

目的本中期报告介绍了一项上市后监测的 12 周结果，该监测评估了去氨加压素口腔崩解片 25 μg 和 50 μg 在因夜间多尿引起夜尿的日本男性患者中的安全性。方法在计划的 1000 名首次接受去氨加压素治疗夜间多尿引起的夜尿症的日本男性研究人群中，有 971 个病例入选。在本次中期分析中，从收集到的354份病例报告表中剔除了9个病例，其中包括6个违反注册规定的病例和3个未确认去氨加压素剂量的病例，并在2021年12月底之前进行了固定，345个病例用药后12周内的数据被定义为安全性分析集。结果平均年龄为（74.5±9.9）岁，88.7%的调查参与者年龄≥65岁。153例（44.3%）患者的去氨加压素起始剂量为25微克。71例患者中报告了102例药物不良反应（ADR），其中3例（0.9%）发生了6例严重药物不良反应。最常见的药物不良反应是低钠血症，有 29 例（8.4%）。其中 8 例低钠血症患者无症状。29 例低钠血症中有 13 例在发病后 4 周内症状缓解或略有改善。此外，217 例低钠血症病例中有 11 例（5.1%）在使用去氨加压素前血清钠水平≥140 毫摩尔/升，87 例低钠血症病例中有 13 例（14.9%）血清钠水平为 135-139 毫摩尔/升，5 例低钠血症病例未测量血清钠水平。体重、体重指数、肾功能和治疗前血清钠水平等患者特征在低钠血症发生率上存在显著差异。定期监测血清钠对早期发现低钠血症很有必要。结论低钠血症是去氨加压素口腔崩解片在 12 周内用于治疗夜间多尿引起的夜尿症时最常见的不良反应。

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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.