Key result
IV levosimendan relieves ADHF symptoms but increases hypotension and arrhythmias with no survival benefit.
RCT
p-value: p=0.29
Levosimendan may relieve symptoms in ADHF but increases hypotension and arrhythmias; challenges routine inotrope use pending definitive safety data.
intensification of adjunctive therapy in the placebo group.Improvements in patient self-assessment and declines in Btype natriuretic peptide levels with levosimendan persisted for 5 days and were associated with reduced length of hospital stay (p ¼ 0.009).However, levosimendan was associated with more frequent hypotension and cardiac arrhythmias during the infusion period and a numerically higher risk of death (p ¼ 0.29).An excess risk of deaths in the levosimendan group was apparent as early as 5 days; was nominally significant at 14 days, and was largely seen in subgroups at highest risk of death before entry into the study (eg patients with systolic blood pressure <100 mmHg).After 90 days, the relative risk of death (levosimendan/placebo) was 1.9 in patients with a pretreatment systolic blood pressure <100 mmHg but was 1.1 in patients with a systolic blood pressure >100 mmHg.Conclusions: In patients with ADHF, intravenous levosimendan provided rapid and durable symptomatic relief.However, levosimendan was associated with an increased risk of adverse cardiovascular events.
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Manish Bansal (2013) conducted an RCT in Acute decompensated heart failure (ADHF). Levosimendan vs. Placebo was evaluated on Death (p=0.29). Intravenous levosimendan provided rapid symptomatic relief in patients with ADHF but was associated with more frequent hypotension, arrhythmias, and a numerically higher risk of death (p=0.29).
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