Ökonomische Relevanz von Herzinsuffizienz mit erhaltener Ejektionsfraktion und der Einfluss einer Therapie mit Spironolacton. Ergebnisse der prospektiven, randomisierten und placebo- kontrollierten ALDO-DHF-Studie
Economic burden of heart failure with preserved ejection fraction (HFpEF) and the effect of a therapy with spironolactone. Results of the multicentre, prospective, randomized, double-blind, placebo-controlled ALDO-DHF trial.
by Ludwig Dettmann
Date of Examination:2018-06-14
Date of issue:2018-06-14
Advisor:Prof. Dr. Frank Edelmann
Referee:Prof. Dr. Eva Hummers-Pradier
Referee:Prof. Dr. Thomas Meyer
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Name:Dissertation Ludwig Dettmann ediss.pdf
EnglishApproximately half of the patients with congestive heart failure have a preserved ejection fraction (heart failure with preserved ejection fraction, HFpEF). It has become a common condition with increasing importance due to new research results that show an elevated mortality, morbidity and limited quality of life. In contrast to heart failure with reduced ejection fraction (HFrEF) there is very poor data for Germany that describe the consumption of resources and the resulting costs for society. At the same time health economics are often the foundation for decision making in public health. There is a broad agreement that therapy and prevention of diseases not only have to be save and efficient but should also be cost-effective. After all the percentage of health care cost on the gross domestic product is more than 10% and still increasing. Also there are rising costs due to heart failure which is a major burden to the public health system. This paper investigates the consumption of resources, the resulting costs and their composition for the outpatient community of the ALDO-DHF trial. It is also target to analysis whether the aldosterone receptor blockade with spironolactone has an impact on the overall costs and if there causal variables for higher costs. The ALDO-DHF trial, a multicentre, prospective, randomized, double-blind, placebo-controlled trial included 422 ambulatory patients (mean age 67 years; 52% female) with chronic heart failure, preserved left ventricular ejection fraction of 50% or greater and evidence of diastolic dysfunction. Patients were randomly assigned to receive 25 mg of spironolactone once daily (n=213) or matching placebo (n=209) with 12 months of follow-up. The equally ranked co-primary end points were changes in diastolic function (E/e') on echocardiography and maximal exercise capacity (peak VO2) on cardiopulmonary exercise testing, both measured at 12 months. For the economic evaluation we used the bottom-up approach which means that the data was collected on the level of each individual patient. Amount and price of the resources were used for the calculation. Those were medication, contacts with general practitioner and cardiologist and hospitalization due to heart failure. The overall costs per patient where almost 1200 € on average but the median was only about 330 € since three out of four patients caused less than 1000 €. The highest portion of the costs was caused by hospitalization. There was no significant influence of spironolactone on the overall costs. The independent variables for higher costs were male sex, low haemoglobin, a good maximal exercise capacity (peak VO2), a coronary artery disease, hypercholesteraemic and atrial fibrillation. The overall costs are much lower than expected and under match those of patients with HFrEF. Patients from the ALDO-DHF trial were comparatively young with mild symptoms. The inclusion and exclusion criteria were quite strict and ruled out comorbidities such as COPD. There seems to be a huge impact of comorbidities in patients with HFpEF, especially regarding hospitalization. Much higher costs develop in the progression of the disease. Overall the actual costs of HFpEF seem to be much higher in reality. Further studies should use longer periods for follow-up. Early diagnosis and treatment of HFpEF and the consequent therapy of comorbidities are necessary to reduce costs in health care system.
Keywords: Heart failure with preserved ejection fraction; HFpEF; economic burden; cost of illness