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Flosequinan - ACE Inhibition Trial - FACET
Description:
Flosequinan for exercise capacity and quality of life in heart failure.
Hypothesis:
Flosequinan improves exercise capacity and quality of life in stable patients with heart failure receiving standard therapy with digoxin, diuretic, and ACE inhibitor.
Study Design
Study Design:
Patients Screened: 521
Patients Enrolled: 322
NYHA Class: II=53%, III=44%, IV=3%
Mean Follow Up: 4 months
Mean Patient Age: 58
Female: 29
Mean Ejection Fraction: 23%
Patient Populations:
symptomatic heart failure of at least 12 weeks duration
ejection fraction < 0.35 (by MUGA)
exercise to endpoint of dyspnea/fatigue
ACE inhibitor treatment for at least 12 weeks
diuretic for 12 weeks +/- digoxin
Exclusions:
primary valvular disease
hypertrophic or restrictive cardiomyopathy
recent (< 3 months) myocardial infarction
angina
creatinine > 3.0
total bilirubin > 3.0
other significant co-morbidities
exercise limited by factors not attributable to heart failure
Primary Endpoints:
Change in exercise tolerance
Secondary Endpoints:
Quality of life
Minnesota Living With Heart Failure (LWHF)
Tolerability/safety of treatment
Drug/Procedures Used:
Flosequinan (100mg QD or 75mg BID)
Concomitant Medications:
Diuretics (96%)
Digoxin (89%)
ACE inhibitors (100%)
Principal Findings:
No significant differences between groups at baseline.
There was a significant increase in exercise time (64 seconds at 16 weeks; p < 0.05) in Flosequinan group taking 100 mg QD. Exercise time increased but not statistically significant in 75 mg BID dose Flosequinan group. Exercise time increased by 5 seconds in the placebo group. No differences between active treatment groups were noted.
LWHF scores significantly improved in Flosequinan 100 mg QD group compared to placebo.
Additional clinical assessment revealed a trend toward improvement with Flosequinan but this was not statistically significant.
Due to drug related side-effects (headache, palpitations, tachycardia) the dose of Flosequinan was reduced in 27% of the 100 mg QD group and 33% of the high dose group.
Interpretation:
The findings from this study suggest that Flosequinan at a dose of 100mg QD will improve exercise capacity and quality of life when added to standard therapy in patients with stable heart failure. Subsequent mortality data from PROFILE, however, show increased mortality with 100mg daily of Flosequinan added to digitalis, diuretics, and ACE inhibitors.
References:
1. Circulation 1993;88:492-501. Final results
Keywords: Digoxin, Quality of Life, Diuretics, Heart Failure, Quinolines, Digitalis, Dyspnea, Headache, Vasodilator Agents, Tachycardia
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