J G F Cleland1, A Takala, M Apajasalo, N Zethraeus, G Kobelt. 1. Department of Cardiology, Castle Hill Hospital, Castle Road, Cottingham, University of Hull, Kingston upon Hull HU16 5JQ, UK. j.g.cleland@hull.ac.uk
Abstract
BACKGROUND:Levosimendan, a novel calcium sensitiser, improves cardiac performance and symptoms without increasing oxygen consumption, and decreases the mortality of patients with low-output heart failure. AIMS: To estimate the cost-effectiveness of intravenous treatment with levosimendan compared with dobutamine in patients with severe low-output heart failure. METHODS: This economic evaluation was based on a European clinical trial (LIDO), in which 203 patients with severe heart failure randomly received a 24 h infusion with eitherlevosimendan or dobutamine. Survival and resource utilisation data were collected for 6 months; survival was extrapolated assuming a mean additional lifetime of 3 years based on data from the Cooperative North Scandinavian Enalapril Survival Study trial. Costs were based on study drug usage and hospitalisation in the 6-month follow-up. A sensitivity analysis on dosage of drug and duration of survival was performed. RESULTS: The mean survival over 6 months was 157+/-52 days in the levosimendan group and 139+/-64 days in the dobutamine group (P<0.01). When extrapolated up to 3 years, the gain in life expectancy was estimated at 0.35 years (discounted at 3%). Levosimendan increased the mean cost per patient by 1108, which was entirely due to the cost of the study drug. The incremental cost per life-year saved (LYS) was 3205 at the European level; in the individual countries the cost per LYS ranged between 3091 and 3331. The result was robust in the sensitivity analysis. CONCLUSIONS: Although the patients in the levosimendan group were alive for more days and thus at risk of hospitalisation for longer, there was no increase in hospitalisation or hospitalisation costs with levosimendan treatment. The cost per LYS using levosimendan compares favourably with other cost-effectiveness analyses in cardiology.
RCT Entities:
BACKGROUND:Levosimendan, a novel calcium sensitiser, improves cardiac performance and symptoms without increasing oxygen consumption, and decreases the mortality of patients with low-output heart failure. AIMS: To estimate the cost-effectiveness of intravenous treatment with levosimendan compared with dobutamine in patients with severe low-output heart failure. METHODS: This economic evaluation was based on a European clinical trial (LIDO), in which 203 patients with severe heart failure randomly received a 24 h infusion with either levosimendan or dobutamine. Survival and resource utilisation data were collected for 6 months; survival was extrapolated assuming a mean additional lifetime of 3 years based on data from the Cooperative North Scandinavian Enalapril Survival Study trial. Costs were based on study drug usage and hospitalisation in the 6-month follow-up. A sensitivity analysis on dosage of drug and duration of survival was performed. RESULTS: The mean survival over 6 months was 157+/-52 days in the levosimendan group and 139+/-64 days in the dobutamine group (P<0.01). When extrapolated up to 3 years, the gain in life expectancy was estimated at 0.35 years (discounted at 3%). Levosimendan increased the mean cost per patient by 1108, which was entirely due to the cost of the study drug. The incremental cost per life-year saved (LYS) was 3205 at the European level; in the individual countries the cost per LYS ranged between 3091 and 3331. The result was robust in the sensitivity analysis. CONCLUSIONS: Although the patients in the levosimendan group were alive for more days and thus at risk of hospitalisation for longer, there was no increase in hospitalisation or hospitalisation costs with levosimendan treatment. The cost per LYS using levosimendan compares favourably with other cost-effectiveness analyses in cardiology.
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