August 2017 post
8/3/2017 10:35:01 AM
LION-Heart and LAICA clinical trials: differences and similarities
Advanced heart failure (AdHF) is associated with high morbidity and mortality and imposes considerable burdens on the health systems of developed countries. The LION-HEART (www.clinicaltrials.gov NCT01536132) and LAICA (NCT00988806) trials are part of a suite of clinical studies of intermittent levosimendan therapy in this setting.
The LION-HEART trial evaluated the safety and efficacy of repetitive 6-h doses of levosimendan (0.2 micrograms/kg/min) every 2 weeks, as compared to placebo. The primary endpoint is the change in NT-proBNP levels between baseline 12 weeks later in a population of 69 adult patients with left ventricular ejection fraction <35%a and diagnostic criteria of advanced chronic heart failure.
The LAICA study assessed the effects of intermittent levosimendan 0.1 micrograms/kg/min every 30 days for a year) on combined overall mortality rate and hospital admission rate for acute cardiac decompensation or HF worsening in 213 adults with AdHF of any etiology, including at least one admission for acute decompensation within 6 months prior to randomization. Sub-studies were planned to examine effects on renal function and the cost-effectiveness of levosimendan.
Both these Phase 4 trials, conducted in Spain, are double-blind and placebo-controlled. LION-HEART has a smaller patient population but is powered for its primary focuses on NT-proBNP levels, which are indicative of heart failure status. The larger LAICA trial emphasizes widely-accepted and established clinical and health-related quality of life outcomes. The results were presented in Seville (ESC-HF 2015) and Florence (ESC-HF 2016), respectively, and provide insights into the usefulness, effectiveness and safety of intermittent levosimendan as an addition to the pharmacological repertoire for advanced heart failure.