Abstract:
We aimed to survey the status of tolvaptan administration in routine clinical practice since the approval of a novel indication for treating syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in Japan. Data from a population of 3,152 patients aged ≥18 years and diagnosed with SIADH between July 1, 2020 and June 30, 2021 were extracted from a Japanese database. Tolvaptan was administered to 586 patients while 2,566 patients were followed up without tolvaptan. In the tolvaptan-treated group, the standard initial doses were 3.75 mg and 7.5 mg in 290 (49.5%) and 250 (42.7%) patients, respectively. The dose was increased in 112 (38.6%) and 71 (28.4%) and decreased in 8 (2.8%) and 46 (18.4%) of patients with 3.75 and 7.5 mg initial doses, respectively. Of the total 586 SIADH patients treated with tolvaptan, serum sodium concentrations were analyzed in 60 patients. In both treatment groups of 3.75 and 7.5 mg initial doses, the serum sodium concentration was elevated from the second day of treatment and reached 135 mEq/L on the fourth day, which was maintained for 2 weeks. Rapid correction of hyponatremia (>10 mEq/L increase in serum sodium concentration over 1 day or >18 mEq/L increase over 2 days) occurred in 26.7% patients with a 7.5 mg initial dose (4 of 15 patients) but not in the patients with a 3.75 mg initial dose (n = 16), suggesting that an initial dose of 3.75 mg of tolvaptan may be a better choice for the safe and proper correction of hyponatremia.
摘要:
我们旨在调查自日本批准用于治疗抗利尿激素分泌不当综合征(SIADH)的新适应症以来,托伐普坦在常规临床实践中的使用状况。从日本数据库中提取了2020年7月1日至2021年6月30日期间诊断为SIADH的3,152名年龄≥18岁的患者的数据。对586例患者给予托伐普坦,对2,566例患者进行了随访。在托伐普坦治疗组中,290例(49.5%)和250例(42.7%)患者的标准初始剂量分别为3.75mg和7.5mg,分别。在初始剂量为3.75和7.5mg的患者中,剂量增加了112(38.6%)和71(28.4%),减少了8(2.8%)和46(18.4%)。分别。在使用托伐普坦治疗的586例SIADH患者中,分析了60例患者的血清钠浓度。在3.75和7.5mg初始剂量的两个治疗组中,血清钠浓度从治疗的第二天开始升高,第四天达到135mEq/L,维持2周。低钠血症的快速校正(血清钠浓度在1天内增加>10mEq/L或在2天内增加>18mEq/L)发生在27.7%的患者(15例患者中的4例),但未发生在患者中。提示3.75mg托伐普坦的初始剂量可能是安全和正确纠正低钠血症的更好选择。