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CASPER
Compliance and quality of life study comparing once-daily controlled-release carvedilol and twice-daily immediate-release carvedilol in patients with heart failure
Author(s)
(a) Hauptman PJ, Pressler SJ, Sackner-Bernstein J, Ordronneau P, Udelson JE
(b) Udelson JE, Pressler SJ, Sackner-Bernstein J, Massaro J, Ordronneau P, Lukas MA, Hauptman PJ
Title(s)
(a) Rationale and design of CASPER: Compliance and Quality of Life Study Comparing Once-Daily Carvedilol CR and Twice-Daily Carvedilol IR in Patients with Heart Failure (b) Adherence with once daily versus twice daily carvedilol in patients with heart failure: the compliance and quality of life study comparing once-daily controlled-release carvedilol CR and twice-daily immediate-release carvedilol IR in patients with heart failure (CASPER) trial
Reference(s)
(a) Am J Cardiol 2006;98 Suppl:60L–6L
(b) J Card Fail 2009;15:385–93
Disease
Heart failure
Purpose
To determine whether a once-daily formulation of carvedilol results in better compliance and increased patient satisfaction relative to a twice-daily formulation
Study design
Randomised, double-blind for comparison of controlled-release vs immediate-release carvedilol, open for comparison of controlled-release carvedilol once daily and usual twice-daily carvedilol, parallel-group
Follow-up
Aim 5 months
Patients
405 patients (133 carvedilol immediate-release, 136 carvedilol controlled-release once daily plus placebo once daily, 136 carvedilol controlled-release once daily), mean age 65 years, with mild to severe heart failure already receiving carvedilol immediate-release 6.25–25 mg bid
Treatment regimen
Carvedilol controlled-release, 20–80 mg/day once daily, or carvedilol immediate-release, 6.25–25 mg bid
Results
The primary endpoint of compliance did not differ between the double-blind carvedilol immediate release bid and the open-label carvedilol controlled-release once daily groups (89.3% vs 88.2%, 95% CI -4.4% to 6.6%; p = ns). There were no statistically significant differences in compliance between any of the three groups, nor differences in quality of life, treatment satisfaction or physiological measures among the three study arms
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