Nishikawa Ryusuke, Kato Takao, Morimoto Takeshi, Yaku Hidenori, Inuzuka Yasutaka, Tamaki Yodo, Yamamoto Erika, Ozasa Neiko, Tada Tomohisa, Sakamoto Hiroki, Seko Yuta, Shiba Masayuki, Yoshikawa Yusuke, Yamashita Yugo, Kitai Takeshi, Taniguchi Ryoji, Iguchi Moritake, Nagao Kazuya, Kawai Takafumi, Komasa Akihiro, Kawase Yuichi, Morinaga Takashi, Toyofuku Mamoru, Furukawa Yutaka, Ando Kenji, Kadota Kazushige, Sato Yukihito, Kuwahara Koichiro, Kimura Takeshi
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan.
Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
ESC Heart Fail. 2023 Oct;10(5):3141-3151. doi: 10.1002/ehf2.14494. Epub 2023 Aug 29.
The use of tolvaptan is increasing in clinical practice in Japan. However, the characteristics of patients who used tolvaptan and the timing of its use in patients with acute heart failure (AHF) are not fully elucidated.
Among consecutive 4056 patients in the Kyoto Congestive Heart Failure registry, we analysed 3802 patients after excluding patients on dialysis, prior or unknown tolvaptan use at admission, and unknown timing of tolvaptan use, and we divided them into two groups: tolvaptan use (N = 773) and no tolvaptan use (N = 3029). The prevalence of tolvaptan use varied widely from 48.7% to 0% across the participating centres. Factors independently associated with tolvaptan use were diabetes, poor medical adherence, oedema, pleural effusion, hyponatraemia, estimated glomerular filtration rate < 30 mL/min/1.73 m , moderate/severe tricuspid regurgitation, dobutamine infusion within 24 h, and additional inotropes infusion beyond 24 h after admission. The mortality rate at 90 days after admission was significantly higher in the tolvaptan use group than in the no tolvaptan use group (14.3% vs. 8.6%, P = 0.049). However, after adjustment, the excess mortality risk of tolvaptan use relative to no tolvaptan use was no longer significant (hazard ratio = 1.53, 95% confidence interval = 0.77-3.02, P = 0.22). Patients with tolvaptan use had a longer hospital stay [median (interquartile range): 22 (15-34) days vs. 15 (11-21) days, P < 0.0001] and a higher prevalence of worsening renal failure (47.0% vs. 31.8%, P < 0.0001) and worsening heart failure (24.8% vs. 14.4%, P < 0.0001) than those without.
AHF patients with tolvaptan use had more congestive status with poorer in-hospital outcomes and higher short-term mortality than those without tolvaptan use.
https://clinicaltrials.gov/ct2/show/NCT02334891 (NCT02334891) and https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017241 (UMIN000015238).
在日本的临床实践中，托伐普坦的使用正在增加。然而，使用托伐普坦的患者特征以及其在急性心力衰竭（AHF）患者中的使用时机尚未完全阐明。
在京都充血性心力衰竭登记处连续纳入的4056例患者中，我们排除了透析患者、入院时曾使用或未知是否使用托伐普坦以及托伐普坦使用时间未知的患者，分析了3802例患者，并将他们分为两组：使用托伐普坦组（N = 773）和未使用托伐普坦组（N = 3029）。各参与中心托伐普坦的使用率差异很大，从48.7%到0%不等。与托伐普坦使用独立相关的因素包括糖尿病、药物依从性差、水肿、胸腔积液、低钠血症、估计肾小球滤过率<30 mL/min/1.73 m²、中度/重度三尖瓣反流、24小时内使用多巴酚丁胺以及入院后24小时后额外使用正性肌力药物。入院后90天的死亡率在使用托伐普坦组显著高于未使用托伐普坦组（14.3%对8.6%，P = 0.049）。然而，经过调整后，使用托伐普坦相对于未使用托伐普坦的额外死亡风险不再显著（风险比 = 1.53，95%置信区间 = 0.77 - 3.02，P = 0.22）。使用托伐普坦的患者住院时间更长[中位数（四分位间距）：22（15 - 34）天对15（11 - 21）天，P < 0.0001]，肾衰竭恶化（47.0%对31.8%，P < 0.0001）和心力衰竭恶化（24.8%对14.4%，P < 0.0001）的发生率也高于未使用托伐普坦的患者。
与未使用托伐普坦的AHF患者相比，使用托伐普坦的患者充血状态更严重，住院结局更差，短期死亡率更高。
