This patient-level analysis pooled four phase II placebo-controlled trials involving 284 patients: 200 with acute heart failure and 84 with related cardiogenic shock. Istaroxime increased systolic blood pressure versus placebo through 24 hours, with a least-square mean difference in area under the change-from-baseline curve of 121.4 mmHg*h (95% CI 63.9–179.0). Heart rate and pulmonary capillary wedge pressure decreased; dyspnea, quality of life, hospitalization duration, worsening heart failure and death showed numerical improvements, while serious adverse events were reported as similar between groups.
The pooled findings support a haemodynamic signal for istaroxime, but do not establish a patient-centred outcome benefit. Clinical outcome effects require confirmation in a phase III trial.
Study limitation: Only 284 patients were pooled from phase II trials; clinical outcome differences were described numerically without effect estimates or uncertainty.
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