Safety and Efficacy of Istaroxime in Patients With Acute Heart Failure: A Meta-Analysis of Randomized Controlled Trials.

Abstract

The aim of this study was to assess the efficacy and safety of istaroxime in patients with heart failure.Following the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines, a search was conducted on the EMBASE and Medline databases to identify articles related to the safety and efficacy of istaroxime in patients with heart failure. The search covered the period from inception to May 31st, 2023, without any restrictions on the year of publication.The search strategy utilized relevant terms such as "istaroxime," "heart failure", "efficacy," and other related terms, along with their corresponding Medical Subject Headings (MeSH) terms.The outcomes assessed in this meta-analysis included the change in left ventricular ejection fraction (LVEF), E to A ratio (a marker of left ventricle function), cardiac index in L/min/m2, systolic blood pressure (SBP) in mmHg, left ventricular end-systolic volume (LVESV) in ml, and left ventricular end-diastolic volume (LVDSV) in ml. For safety analysis, gastrointestinal events and cardiovascular events were assessed. A total of three randomized controlled trials (RCTs) were included in this meta-analysis encompassing 211 patients with heart failure. Pooled analysis showed that istaroxime was effective in increasing LVEF (MD: 1.26, 95% CI: 0.91 to 1.62, p-value: 0.001), reducing E to A ratio(MD: -0.39, 95% CI: -0.60 to -0.19, p-value: 0.001), increasing cardiac index(MD: 0.22, 95% CI: 0.18 to 0.25, p-value: 0.001), reducing LVESV (MD: -11.84, 95% CI: -13.91 to -9.78, p-value: 0.001), reducing LVEDV (MD: -12.25, 95% CI: -14.63 to -9.87, p-value: 0.001) and increasing SBP (MD: 8.41, 95% CI: 5.23 to 11.60, p-value: 0.001) compared to the placebo group. However,risk of gastrointestinal events was significantly higher in patients receiving istaroxime compared to the placebo group (RR: 2.64, 95% CI: 1.53 to 4.57, p-value: 0.0005). These findings support the enhancement of heart function with istaroxime administration, aligning with previous clinical and experimental evidence.