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托伐普坦附加治疗对需要长期充血管理的心力衰竭患者的影响:使用日本医疗索赔数据库的回顾性队列研究。

Impact of tolvaptan add-on treatment on patients with heart failure requiring long-term congestion management: A retrospective cohort study using a medical claim database in Japan.

机构信息

Second Department of Internal Medicine, University of Toyama, Toyama, Japan.

Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.

出版信息

J Cardiol. 2023 Jul;82(1):35-42. doi: 10.1016/j.jjcc.2022.12.006. Epub 2022 Dec 29.

Abstract

BACKGROUND

The impact of tolvaptan on the long-term outcomes of patients with heart failure (HF) remains inconclusive. We evaluated patients requiring long-term congestion management for the time to rehospitalization for HF (HF rehospitalization), the time to in-hospital death and explored the factors that may influence the outcomes.

METHODS

Using data (April 2008 to September 2019) from a medical claims database, patients with HF prescribed tolvaptan (tolvaptan cohort) and those prescribed loop diuretics before tolvaptan was introduced to the hospital (furosemide cohort) were compared. Patients with HF who experienced ≥2 HF hospitalizations and ≥1 tolvaptan or loop diuretic prescription during and after HF hospitalization were included. Data of patients with serum creatinine and estimated glomerular filtration rate were analyzed for time to HF rehospitalization and in-hospital death within 1 year after the second discharge and factors that may influence the outcomes.

RESULTS

Among the 1931 and 631 tolvaptan and furosemide cohort patients, respectively, time to HF rehospitalization was not significantly different (p = 0.0921); time to in-hospital death was significantly longer in the tolvaptan cohort than in the furosemide cohort (p = 0.0005). Age, serum sodium, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers were identified as factors for both outcomes (p < 0.05).

CONCLUSIONS

Tolvaptan did not significantly affect time to HF rehospitalization. However, further worsening of the condition leading to death may be delayed, and time to in-hospital death may be prolonged in patients treated with tolvaptan, indicating its usefulness for long-term congestion management.

摘要

背景

托伐普坦对心力衰竭(HF)患者的长期结局的影响仍不确定。我们评估了需要长期充血管理的患者的再住院时间(HF 再住院)、住院内死亡时间,并探讨了可能影响结局的因素。

方法

使用来自医疗索赔数据库的数据(2008 年 4 月至 2019 年 9 月),比较了 HF 患者服用托伐普坦(托伐普坦组)和托伐普坦引入医院前服用袢利尿剂(呋塞米组)的患者。纳入至少 2 次 HF 住院且在 HF 住院期间和之后至少使用 1 次托伐普坦或袢利尿剂处方的 HF 患者。分析了血清肌酐和估计肾小球滤过率数据,以评估第 2 次出院后 1 年内 HF 再住院和住院内死亡的时间,以及可能影响结局的因素。

结果

在 1931 名和 631 名托伐普坦和呋塞米队列患者中,HF 再住院时间无显著差异(p=0.0921);托伐普坦组的住院内死亡时间明显长于呋塞米组(p=0.0005)。年龄、血清钠、血管紧张素转换酶抑制剂或血管紧张素 II 受体阻滞剂是这两种结局的影响因素(p<0.05)。

结论

托伐普坦并未显著影响 HF 再住院时间。然而,在接受托伐普坦治疗的患者中,病情可能进一步恶化导致死亡的时间可能会延迟,住院内死亡时间可能会延长,这表明其在长期充血管理方面的有效性。

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