Abstract：
OBJECTIVE: 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.
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.
摘要：
目的：本中期报告提供了一项为期12周的上市后监测结果，评估了去氨加压素口服崩解片25和50μg在日本男性夜间多尿症患者中的安全性。
方法：在计划的1000名日本男性因夜间多尿症首次接受去氨加压素治疗的研究人群中，纳入971例。在这个中期分析中，9例,包括6起违反登记的事件和3起未经证实的去氨加压素给药的事件,在2021年12月底之前收集和固定的354份病例报告表中排除,345例病例给药后12周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％）以25μg的剂量开始去氨加压素。71例报告药物不良反应（ADR）102例，其中严重不良反应6例3例(0.9%)。最常见的不良反应为低钠血症29例(8.4%)。低钠血症病例中有8例无症状。29例低钠血症中有13例在发病4周内症状缓解或略有改善。此外,217例中有11例(5.1%)发生低钠血症,给予去氨加压素前的血清钠水平≥140mmol/L，87例中有13例(14.9%)，水平为135-139mmol/L，在5例低钠血症中没有测量。显示低钠血症发生显着差异的患者特征包括体重，身体质量指数,肾功能,和预处理血清钠水平。定期监测血清钠对于早期发现低钠血症是必要的。
结论：使用去氨加压素口腔崩解片治疗12周夜间多尿症时，低钠血症是最常见的不良反应。
方法：在计划的1000名日本男性因夜间多尿症首次接受去氨加压素治疗的研究人群中，纳入971例。在这个中期分析中，9例,包括6起违反登记的事件和3起未经证实的去氨加压素给药的事件,在2021年12月底之前收集和固定的354份病例报告表中排除,345例病例给药后12周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％）以25μg的剂量开始去氨加压素。71例报告药物不良反应（ADR）102例，其中严重不良反应6例3例(0.9%)。最常见的不良反应为低钠血症29例(8.4%)。低钠血症病例中有8例无症状。29例低钠血症中有13例在发病4周内症状缓解或略有改善。此外,217例中有11例(5.1%)发生低钠血症,给予去氨加压素前的血清钠水平≥140mmol/L，87例中有13例(14.9%)，水平为135-139mmol/L，在5例低钠血症中没有测量。显示低钠血症发生显着差异的患者特征包括体重，身体质量指数,肾功能,和预处理血清钠水平。定期监测血清钠对于早期发现低钠血症是必要的。
结论：使用去氨加压素口腔崩解片治疗12周夜间多尿症时，低钠血症是最常见的不良反应。
