PCV41: SOCIOECONOMIC RELEVANCE OF TREATMENT OF CHRONIC HEART FAILURE STAGE NYHA II WITH CRATAEGUS EXTRACT WS 1442—ONE-YEAR-RESULTS OF A PROSPECTIVE PHARMACOECONOMIC STUDY

Abstract

OBJECTIVES: To evaluate the pharmacoeconomic properties of crataegus treatment compared to any other treatment option of CHF at stage NYHA II, a prospective 3-year observational study has been conducted since summer 1999. A cost-utility-analysis will be performed to investigate, if crataegus treatment avoids rapid deterioration with higher costs and lower HRQL. The results of the first year are presented. METHODS: Open, non-randomized observational cohort study. The first cohort (Crataegus-Cohort, CC) comprises patients receiving crataegus extract therapy of CHF. In the second cohort (Standard-Cohort, SC) patients without crataegus but any other treatment were observed. In 217 study centres 952 patients were included (CC: 588; SC: 364). For measuring HRQL the EuroQoL-5D was used. The perspective of the German statutory health insurance funds and the matched-pairs technique were applied. RESULTS: No significant differences in physical condition and demographic variables were detected between the matched groups. HRQL (143 pairs) shows significant improvement in both cohorts. The mean EuroQoL-VAS value for the CC is 55.50 before and 67.13 after half-a-year (SC: 58.06 before and 66.78 after). Improvement of HRQL in the CC is significantly higher (p = 0.023). After one year, an improvement of clinical symptoms were diagnosed in both cohorts (79 pairs) but slightly higher in the CC with no significance. Mean direct costs for CC patients amounted to DM 1,373 in the first year whereas SC patients amounted to DM 1,551 with no significant difference (p = 0.998, 98 pairs). Cost driving factors were drug acquisition and physicians fees. CONCLUSIONS: Even if the first analysis of the three-year-study indicates comparable direct costs in both cohorts and suggests improved HRQL in the CC further investigation in the second and third period is mandatory.