Schulman KA, Buxton MJ, Glick H, Sculpher MJ, Guzman GI, Kong J, Eisenberg JM; International Society of Technology Assessment in Health Care. Meeting.
Annu Meet Int Soc Technol Assess Health Care Int Soc Technol Assess Health Care Meet. 1995; 11: Abstract No. 2.
Georgetown University Medical Center, Washington, DC, USA.
OBJECTIVE. To evaluate the costs of the clinical effects of epoprostenol in patients with severe congestive heart failure. The Flolan International Randomized Survival Trial (FIRST) included secondary endpoints of resource utilization and quality of life. METHODS. Resources were collected for inpatient and outpatient services received by patients throughout the study period. Costs were assigned to these quantities using data from a U.S. hospital. Health related quality of life were derived using the EuroQol instrument which was administered at baseline, 2 weeks, 1 month, and then quarterly. Descriptive statistics of resource quantities were calculated. Multivariable regression was used in the cost analysis to control for continent, baseline clinical characteristics of patients, and baseline employment status. EuroQol scores were analyzed by calculating quality adjusted life years using an area under the curve approach, again based on a multivariable analysis. RESULTS. The study included 469 patients who were followed from randomization until the premature conclusion of the study due to an increase in mortality in the Flolan intervention group. Data were available for 1,932 patient months of follow-up. Flolan was associated with an increase in resource consumption by patients, with an average number of hospital days of 13.80 per patient month compared with 9.02 per patient month in the control over the study period $15,851 vs $9,844 (p<.01). Median baseline EuroQol scores were 50 for Flolan patients, and 46 for control patients (p<0.01). After adjusting for mortality, Flolan had a 10% decrease in QALY score, while European patients reported QALY scores that were 13% lower than N. American patients, however, these findings did not attain statistical significance. CONCLUSION. Prospective economic evaluation was useful in explaining the overall impact of Flolan on study patients. Flolan patients required significantly greater resources while experiencing an increase in mortality and a non-significant decrease in quality of life. These results help to validate the importance of economic evaluation as a secondary endpoint in phase III clinical trials.
Publication Types:
Keywords:
- Biomedical Research
- Clinical Trials, Phase III as Topic
- Epoprostenol
- Heart Failure
- Humans
- Longitudinal Studies
- Prospective Studies
- Quality-Adjusted Life Years
- Treatment Outcome
- United States
- Weights and Measures
- economics
- hsrmtgs
Other ID:
UI: 102215756
From Meeting Abstracts