Clinical Pharmacoeconomic Evaluation Of Levosimendan And Milrinone In The Treatment Of Severe Heart Failure

Background:The incidence of chronic diseases such as coronary heart disease,hypertension,hyperlipidemia,diabetes,and obesity are rising year by year with the increasing aging population.Heart failure is the final stage in the development of most chronic cardiovascular diseases and the leading cause of death.Recently,the global prevalence of heart failure has been increasing,and the mortality rate has remained high.The treatment cost of acute and severe heart failure,especially the highly cost of drugs,which brings heavily burden to patients,families and society.Objectives:Based on the re-evaluation of real-world data,using the retrospective medical insurance reimbursement database and electronic case information,combined with the actual clinical efficacy and cost,a cost-effectiveness analysis of levosimendan versus milrinone in the treatment of heart failure was conducted.Comprehensively evaluate its cumulative cost and health effects,carry out the pharmacoeconomic evaluation of levosimendan and milrinone in the treatment of heart failure,provide a theoretical basis for the revision of the medical insurance catalogue and clinical decision-making of rational allocation of medical resources for severe heart failure and explore the strengths and limitations of conducting pharmacoeconomic research based on real-world data.Methods:In this study,patients with severe heart failure admitted to the Department of Cardiovascular Medicine and other departments of Shandong Province Qianfoshan Hospital from December 2016 to September 2019 were selected as the research objects.The NYHA classification of the patient’s cardiac function was Ⅲ-Ⅳ,and the patients were treated with levosimendan or milrinone.The clinical indicators of patients were retrospectively collected from the medical insurance reimbursement database and electronic case information database,and cost-related data for pharmacoeconomic evaluation were obtained.Some of the data that is not available in the real world comes from sources such as literature and expert guides in the field.Patients were divided into normal and mild renal function injury group and moderate and above renal function injury group according to the renal function damage.The baseline indicators of patients taking milrinone and levosimendan were compared in different renal function impairment groups.Two independent samples T test was used for data analysis;chi-square or Fisher’s exact test was used for categorical variables.The decision tree model was selected as the pharmacoeconomics model of this study,with effective rate as the effect index and total hospitalization expenses as the cost index,to carry out cost-effectiveness analysis and sensitivity analysis.Results:No matter in the normal and mild renal impairment group or in the moderate and above renal impairment group,there were only some statistical differences between levosimendan and milrinone in individual baseline indicators.The costeffectiveness analysis of levosimendan and milrinone in the group with moderate and above renal damage was carried out with the markedly effective rate as the effect index.Studies showed that in the time range of 30 days,the effective rate of milrinone and levosimendan were 75%and 71%,respectively,and the total cost was 35,385.35 yuan and 45,635.67 yuan respectively,and milrinone had an absolute advantage;in the normal and mild renal impairment groups,the effect of milrinone(87%)was better than that of levosimendan(79%),and the cost of milrinone(37,286.09 yuan)was higher than that of levosimendan(36,243.92 yuan),the calculated incremental cost-effectiveness ratio is 13027.13,that is,milrinone needs to increase the cost by 130.27 yuan per 1%increase in effective rate compared to levosimendan.Sensitivity analysis results show that the model is robust.Conclusion:Based on real-world evidence,the economics of milrinone and levosimendan in patients with severe heart failure are affected by renal impairment.Milrinone was cost-effective compared with levosimendan in the group with moderate and greater renal impairment.In the normal and mild renal impairment groups,milrinone was more effective than levosimendan,and the cost was higher.