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Prospective Randomized Flosequinan Longevity Evaluation - PROFILE
Description:
Flosequinan for mortality in chronic heart failure patients.
Hypothesis:
Flosequinan improves survival in chronic heart failure patients on digoxin, diuretics and ACE inhibitors.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 2,304
NYHA Class: All patients class III or IV
Mean Follow Up: 22 months
Patient Populations:
CHF NYHA Class III-IV on digoxin, diuretics and ACE inhibitor
Left ventricular ejection fraction < 35%
Primary Endpoints:
All cause mortality
Secondary Endpoints:
Hospitalizations due to CHF
Drug/Procedures Used:
Flosequinan 75mg or 100 mg/day
Principal Findings:
Increased mortality in flosequinan group compared to placebo with relative risk 1.43; p < 0.05.
Subset analysis revealed greatest mortality risk in patients on 100 mg/d (n = 1865); relative risk 1.51; p < 0.05.
Increased hospitalization for CHF compared to placebo within first 3 months of treatment.
Interpretation:
Flosequinan treatment resulted in excess mortality in patients with moderate to severe heart failure on standard medical therapy. The drug has since been withdrawn by the manufacturer for clinical use.
References:
1. Circulation 1993;88 Suppl I:I-301. (Abstract) Final results
Keywords: Risk, Ventricular Function, Left, Digoxin, Diuretics, Heart Failure, Quinolines, Stroke Volume, Vasodilator Agents
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