Key result
Levosimendan was generally well tolerated in early studies, with headache being the most common adverse event (40% with oral dosing and 10% with intravenous dosing in healthy volunteers).
Why the study?
What is the safety and tolerability profile of levosimendan in healthy volunteers and heart failure patients?
Population
Approximately 200 subjects, including healthy volunteers and heart failure patients, from several phase I…
Design
Review
Follow-up
up to 24 hours for i.v. infusion
Authors
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Early tolerability data support cautious exploration in heart failure; leaves open confirmation in larger randomized trials.
What is the safety and tolerability profile of levosimendan in healthy volunteers and heart failure patients?
Early phase I and II data suggest levosimendan is generally well-tolerated, particularly in heart failure patients, with no significant proarrhythmic effects observed during short-term use.
Lehtonen et al. (1995) conducted a review in Heart failure and healthy volunteers (n=200). Levosimendan was evaluated on Adverse drug events (ADEs), safety laboratory values, and ambulatory ECG findings. Levosimendan was generally well tolerated in early studies, with headache being the most common adverse event (40% with oral dosing and 10% with intravenous dosing in healthy volunteers).
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