Heart 1998;79:593-598 ( June )
Quality of life in chronic heart failure: cilazapril and captopril versus placebo
a Epidemiology Research
Unit, Division of Geriatric Medicine, Hammersmith Hospital, Imperial
College of Medicine, London, UK, b London
School of Hygiene and Tropical Medicine, London, UK, c Department of Clinical Research, F Hoffmann La-Roche,
Basel, Switzerland, d Institute für Medizische Statistik und
Epidemiologie der Technischen, Universität München, Germany, e Gesellschaft für angewandte Mathematik und
Informatik (GMI), Munich, Germany
Correspondence to: Professor C J Bulpitt, Division of Geriatric Medicine, Royal Postgraduate Medical School, Du Cane Road, London W12 0NN, UK.
Accepted for publication 28 January 1998
Objective
To measure quality of life (QOL) in
patients with mild to moderate heart failure treated with angiotensin
converting enzyme (ACE) inhibitors cilazapril or captopril.
DesignRandomised, double blind, placebo
controlled, parallel groups trial.
Subjects367 patients with New York Heart
Association (NYHA) heart failure class II (62%), III (36%) or IV
(1%).
MethodsPatients were randomised to receive
cilazapril 1 mg daily (n = 191) or captopril 25 mg three times daily
(n = 90) for 24 weeks, or placebo for 12 weeks followed by cilazapril
1 mg daily for a further 12 weeks (n = 86). If patients had not
responded after four weeks cilazapril was increased to 2.5 mg daily
and captopril to 50 mg three times daily. QOL was assessed at
baseline, 12, and 24 weeks using the sickness impact profile (SIP), the
profile of mood states (POMS), the Mahler index of dyspnoea-fatigue,
and a health status index (HSI).
ResultsThe physical dimension of the SIP averaged
7 units at baseline and improved after 12 weeks by 2.24 units in the
cilazapril group, 2.38 units in the captopril group, and 1.51 units in
the placebo group. The difference between drug and placebo was
therefore 0.73 units (95% CI 
0.86 to 2.32) for cilazapril, and 0.87 units (95% CI 0.96 to 2.70) for captopril, with small
non-significant effect sizes (a statistical method for estimating the
importance of a treatment related change) of 0.12 and 0.14. Similar
results were observed for the total POMS and HSI scores. Although QOL improved more on the ACE inhibitors than on placebo, the effect sizes
were not significant (
0.26).
ConclusionsImprovements in QOL in mild to
moderate heart failure were small when treated with cilazapril or
captopril compared with placebo.
© 1998 by Heart
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