Dataset Information

The Efficacy and Safety of Short-Term Tolvaptan Usage in Patients with Acute Decompensated Heart Failure.

ABSTRACT:

Background

Patients admitted with acute decompensated heart failure (ADHF) have a poor prognosis and poor quality of life due to dyspnea and edema. Tolvaptan, a vasopressin V2 receptor antagonist, is an effective water diuretic. This study aimed to evaluate the efficacy and safety of a short course of tolvaptan to treat volume overload in patients with ADHF.

Methods

We conducted a phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a short course of tolvaptan (15 mg/day for 4 days) in hospitalized ADHF patients with volume overload despite the use of conventional diuretics. The primary end-point was the change in body weight after 4 days of treatment. The secondary end-points were the change in intake/output balance, change in serum sodium/potassium concentrations, physician/patient assessed signs and symptoms of heart failure after 4 days of treatment, and all-cause mortality in 1 month.

Results

A total of 110 patients were screened, and 91 were randomized to receive 15 mg/day of tolvaptan for 4 days (n = 46) or matching placebo (n = 45). Compared to the placebo-treated patients, tolvaptan significantly reduced body weight (-1.36 ± 2.13 kg in the tolvaptan group vs. -0.59 ± 1.27 kg in the placebo group, p = 0.0394). The tolvaptan group also had a negative intake/urine volume balance compared to the placebo group (-509.3 ± 2788.2 ml vs. 975.5 ± 1903.1 ml, p = 0.0059). The safety profile of tolvaptan was acceptable.

Conclusions

Tolvaptan significantly reduced volume overload in hospitalized ADHF patients with volume overload despite the use of conventional diuretics.

SUBMITTER: Lin YH

PROVIDER: S-EPMC9692217 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

The Efficacy and Safety of Short-Term Tolvaptan Usage in Patients with Acute Decompensated Heart Failure.

Lin Yen-Hung YH Tsai Cheng-Hsuan CH Chiang Chern-En CE Kuo Jen-Yuan JY Yin Wei-Hsian WH Wen Ming-Shien MS Lo Ping-Han PH Liu Ping-Yen PY Lin Tsung-Hsien TH Chen Zhih-Cherng ZC Shyu Kou-Gi KG Hung Ming-Jui MJ Hwang Juey-Jen JJ Tseng Chuen-Den CD

Acta Cardiologica Sinica 20221101 6

<h4>Background</h4>Patients admitted with acute decompensated heart failure (ADHF) have a poor prognosis and poor quality of life due to dyspnea and edema. Tolvaptan, a vasopressin V2 receptor antagonist, is an effective water diuretic. This study aimed to evaluate the efficacy and safety of a short course of tolvaptan to treat volume overload in patients with ADHF.<h4>Methods</h4>We conducted a phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy a ...[more]

PMID: 36440253

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Project description:IntroductionThere is a dearth of comprehensive studies on the association between serum electrolyte and adverse short-term prognosis of Chinese patients with acute decompensated heart failure (ADHF).Patients and methodsA total of 5166 patients with ADHF were divided into four serum electrolyte-related study populations (potassium (n = 5145), sodium (n = 5135), chloride (n = 4966), serum total calcium (STC) (n = 4143)) under corresponding exclusions. Different logistic regression models were utilized to gauge the association between these electrolytes or the number of electrolyte abnormalities and the risk of a composite of all-cause mortality or 30-day heart failure (HF) readmission.ResultsIn multivariable adjusted analysis, patients with potassium below 3.5 mmol/L (odds ratios (ORs) 1.45; 95% confidence interval (CI):1.07-1.95), 4.01-4.50 mmol/L (OR: 1.29, CI: 1.02-1.62), 4.51-5.00 mmol/L (OR: 1.43, CI: 1.08-1.90) and above 5.00 mmol/L (OR: 1.74, CI: 1.21-2.51) had an increased risk of outcome when compared with potassium at 3.50-4.00 mmol/L. Sodium levels were inversely related to the risk of a composite outcome (<130 mmol/L: OR: 2.73 (95% CI, 1.81-4.12); 130-134 mmol/L: OR, 1.97 (CI, 1.45-2.68); 135-140 mmol/L: OR, 1.45 (CI, 1.17-1.81); p for trend < 0.001) in comparison with sodium at 141-145 mmol/L. Chloride < 95 mmol/L corresponded to a higher risk of a composite outcome with an OR of 1.65 (95% CI, 1.16-2.37) in contrast to chloride levels at 101-105 mmol/L. In addition, the adjusted ORs (95% CI) for a composite outcome comparing the STC < 2.00 and 2.00-2.24 vs. 2.25-2.58 mmol/L were 0.98 (0.69-1.43) and 1.13 (0.89-1.44), respectively. Besides that, the number of electrolyte abnormalities was positively related to the risk of a composite outcome (N = 1, OR 1.40, 95% CI: 1.13-1.73; N = 2, OR 2.51, 95% CI: 1.85-3.42; N = 3, OR 2.47, 95% CI: 1.45-4.19; p for trend < 0.001) in comparison with N = 0.ConclusionsA deviation of potassium levels from 3.50 to 4.00 mmol/L, lower sodium levels and hypochloremia were associated with poorer short-term prognosis of ADHF. Furthermore, the number of electrolyte abnormalities positively correlated with adverse short-term prognosis of patients with ADHF. Key MessagesADHF patients with baseline serum potassium at first half part of normal range (3.50-4.00 mmol/L) may herald the lowest risk of recent cardiovascular events.Serum sodium and chloride levels exhibit discrepancies in terms of risk of short-term adverse events of ADHF patients.The number of electrolyte abnormalities is a significant predictor of poor short-term prognosis in patients with ADHF.Clinical trial registration urlhttp://www.chictr.org.cn/showproj.aspx?proj=23139. Unique identifier: ChiCTR-POC-17014020.

Project description:BackgroundThe prognostic values of the left ventricular ejection fraction (LVEF) and end-diastolic dimension (LVEDD) have primarily been shown among patients with chronic heart failure (HF), with little representation of patients with acute HF (AHF). Therefore, we investigated the value of these echocardiographic parameters in predicting clinical outcomes among patients in the Korean Heart Failure (KorHF) Registry.MethodsThe KorHF Registry consists of 3,200 patients who were hospitalized with AHF from 2005 to 2009. The Kaplan-Meier method was used to estimate survival and readmission, and differences were assessed using the log-rank test. Predictors of survival were identified using univariate and multivariate Cox proportional hazards regression analyses.ResultsEchocardiograms from 2,910 of the 3,200 patients (90.9%) were evaluated. The median LVEF and LVEDD (37% and 56 mm, respectively) were used as cut-offs for the binary transformation of each parameter. The cumulative death-free survival rates for all patients did not significantly differ based on LVEF or LVEDD quartiles; however, an LVEF greater than the median was associated with a better prognosis in ischemic HF patients (log-rank test; p = 0.039). Among ischemic HF patients, LVEF (dichotomized) was a significant predictor of death in a Cox model after adjusting for a history of HF, age, systolic blood pressure (SBP), serum sodium, sex, diabetes mellitus (DM), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), acute myocardial infarction (AMI), atrial fibrillation (Af) and anemia (hazard ratio (HR) 1.475, 95% confidence interval (CI) 1.099-1.979, p = 0.010). The cumulative readmission-free survival rates significantly differed among ischemic HF patients only when based on LVEDD quartiles (log-rank test; p = 0.001). In multivariate Cox proportional hazards regression analyses, LVEDD (dichotomized) remained a significant variable only among patients with ischemic HF after adjusting for sex, age, AMI, DM, COPD, serum sodium, SBP, blood urea nitrogen (BUN) and anemia (HR 1.401, 95% CI 1.067-1.841, p = 0.015).ConclusionsAmong ischemic AHF patients in the KorHF Registry, LVEF is associated with mortality, whereas LVEDD is only associated with readmission in a binary transformed form.

Dataset Information

The Efficacy and Safety of Short-Term Tolvaptan Usage in Patients with Acute Decompensated Heart Failure.

Background

Methods

Results

Conclusions

Publications

The Efficacy and Safety of Short-Term Tolvaptan Usage in Patients with Acute Decompensated Heart Failure.

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