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Flolan International Randomized Survival Trial (phase III [develop economic data]) - FIRST
Description:
Cost and efficacy of epoprostenol in end-stage CHF.
Hypothesis:
Flolan may have a beneficial effect on clinical outcomes and cost for patients with severe CHF.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 471
NYHA Class: class III and IV
Mean Follow Up: ~2 years
Mean Patient Age: not given
Mean Ejection Fraction: not given
Patient Populations:
End-stage CHF
Exclusions:
Not given
Primary Endpoints:
Mortality
Secondary Endpoints:
Clinical events, congestive heart failure symptoms, distance walked in 6 minutes, and quality-of-life measures.
Drug/Procedures Used:
epoprostenol (Flolan)
Principal Findings:
The median dose of epoprostenol was 4.0 ng/kg/min, resulting in a significant increase in cardiac index (1.81 to 2.61 L/min/m2), a decrease in pulmonary capillary wedge pressure (24.5 to 20.0 mm Hg), and a decrease in systemic vascular resistance (20.76 to 12.33 units).
Interpretation:
The trial was terminated early because of a strong trend toward decreased survival in the patients treated with epoprostenol. Chronic intravenous epoprostenol therapy is not associated with improvement in distance walked, quality of life, or morbid events and is associated with an increased risk of death.
References:
1. Control Clin Trials 1996;17:304-315. Design of cost analysis
2. Am Heart J 1997;134:44-54. Final results
Keywords: Prostaglandins, Pulmonary Wedge Pressure, Epoprostenol, Quality of Life, Heart Failure, Vascular Resistance
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