Early changes in dyspnea with 24-h istaroxime infusion among patients with acute heart failure.
We evaluated the effects of a 24-h istaroxime infusion on changes in self-reported dyspnea among patients with acute heart failure (AHF).
Patients hospitalized for AHF with ejection fraction ≤40 were randomized to receive a 24-h infusion of placebo or istaroxime at doses of 0.5 (Ista-0.5) or 1.0 μg/kg/min (Ista-1.0). Self-reported dyspnea was assessed by means of a visual analogue scale (VAS). Dyspnea VAS area under the curve (AUC) and changes in VAS dyspnea from baseline through 24 and 48 h were compared between istaroxime- and placebo-treated patients.
Among 113 AHF patients (n = 39 placebo, n = 39 Ista-0.5, n = 35 Ista-1.0), a statistically significant difference in dyspnea VAS AUC from baseline through 24 h was observed in the pooled istaroxime arm vs. the placebo arm [win odds 1.44, 95% confidence interval (CI) 1.00 to 2.07; P = 0.048], with similar findings for Ista-0.5 vs. placebo (win odds 1.48, 95% CI 1.01 to 2.18; P = 0.047). Win odds consistently favored istaroxime through 48 h, though significance was not maintained. Results were numerically more pronounced among patients with baseline dyspnea VAS < 80, particularly for Ista-0.5 vs. placebo (win odds 1.71, 95% CI 0.76 to 3.83; P = 0.172). Consistent findings were observed changes in dyspnea VAS through 24 h, with a least square mean difference of 2.6 points (95% CI -1.8 to 7.0) between Ista-1.0 and placebo.
Among patients with AHF, 24-h istaroxime infusion was associated with a significantly higher probability of dyspnea improvement compared with placebo through 24 h, with results being numerically more pronounced among patients with worse dyspnea at baseline.
Patients hospitalized for AHF with ejection fraction ≤40 were randomized to receive a 24-h infusion of placebo or istaroxime at doses of 0.5 (Ista-0.5) or 1.0 μg/kg/min (Ista-1.0). Self-reported dyspnea was assessed by means of a visual analogue scale (VAS). Dyspnea VAS area under the curve (AUC) and changes in VAS dyspnea from baseline through 24 and 48 h were compared between istaroxime- and placebo-treated patients.
Among 113 AHF patients (n = 39 placebo, n = 39 Ista-0.5, n = 35 Ista-1.0), a statistically significant difference in dyspnea VAS AUC from baseline through 24 h was observed in the pooled istaroxime arm vs. the placebo arm [win odds 1.44, 95% confidence interval (CI) 1.00 to 2.07; P = 0.048], with similar findings for Ista-0.5 vs. placebo (win odds 1.48, 95% CI 1.01 to 2.18; P = 0.047). Win odds consistently favored istaroxime through 48 h, though significance was not maintained. Results were numerically more pronounced among patients with baseline dyspnea VAS < 80, particularly for Ista-0.5 vs. placebo (win odds 1.71, 95% CI 0.76 to 3.83; P = 0.172). Consistent findings were observed changes in dyspnea VAS through 24 h, with a least square mean difference of 2.6 points (95% CI -1.8 to 7.0) between Ista-1.0 and placebo.
Among patients with AHF, 24-h istaroxime infusion was associated with a significantly higher probability of dyspnea improvement compared with placebo through 24 h, with results being numerically more pronounced among patients with worse dyspnea at baseline.
Authors
Pagnesi Pagnesi, Cotter Cotter, Davison Davison, Carubelli Carubelli, Zhang Zhang, Malfatto Malfatto, La Rovere La Rovere, Lombardi Lombardi, Zhang Zhang, Metra Metra
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