Looks like this set off the slide on close to 10M shares traded and over 40% of outstanding shares.
onlinejcf.com
Volume 13, Issue 6, Page S135 (August 2007)
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Compliance with Once Daily Controlled Release vs Twice Daily Immediate Release Carvedilol in Patients with Heart Failure: The CASPER Trial
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James E. Udelson1, Susan J. Pressler2, Jonathan Sackner-Bernstein3, Mary Ann Lukas4, Paul A. Ordronneau4, Joseph Massaro5, Paul Hauptman6
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Article Outline
• Copyright
Background: Once daily (QD) vs twice daily (BID) dosing may increase compliance, thereby increasing effective daily dosage. The CASPER Trial was designed to measure differential compliance, quality of life (QOL) and satisfaction with medication in chronic heart failure (HF) patients taking BID carvedilol immediate release (Carv IR) vs bioequivalent QD Carv controlled release (CR). Methods: HF pts with LV EF < 40% on > 2 mos stable Carv IR BID were randomized to either group A: staying on Carv IR BID double blind, group B: switched to equivalent dose carv CR in AM and placebo in PM, double blind, or Group C: switched to open label equivalent dose carv CR QD. Compliance was measured by medication event monitoring system caps, and QOL by KCCQ and other instruments (including TSQM - satisfaction wth treatment) over 5 months. Sample size assumed 75% BID compliance and 90% QD compliance. Primary endpoint was “taking compliance” (% correct doses/doses prescribed). 405 pts were randomized at 55 US sites (62% HF specialists). Mean age was 65 yrs, mean LVEF 29%, 64% NYHA class II, with > 90% taking ACEi/ARB and 100% on Carv IR BID. Results: see Table. There were also no differences in change in NYHA class. Adverse events were reported in 56% of pts staying on their Carv IR BID and in 58% of pts switched to Carv CR (p = NS). There was no difference in serious adverse events between groups. Conclusions: Switching from Carv IR BID to Carv CR QD in this trial setting was not associated with better drug taking compliance, in part due to higher than anticipated compliance in the BID cohort. Switching from Carv IR to Carv CR was well tolerated, with no adverse events or safety issues associated with switching.
Results
Group A (Carv IR BID) B (Carv CR/Plac) C (Carv CR QD
n = 133 n = 136 n = 136 p
Taking compliance (%) 89 +/- 21 87 +/- 25 88 +/-24 NS
Correct dosing days (%) 86 +/- 20 85 +/- 25 87 +/- 25 NS
KCCQ ? >= 5 (% of pts) 34 23 28 NS
? median BNP (IQR) (pg/ml) - 4 (-337, 418) - 1 (-855, 1556) 0 (-632, 1828) NS
? TSQM score -3 +/- 18 -4 +/- 20 -1 +/- 21 NS
1 Tufts-NEMC, Boston
2 Indiana Univ Nursing, Indianapolis
3 ClinLabs Inc., NY, NY
4 GSK, Phil, PA
5 Boston Univ, Boston, MA
PII: S1071-9164(07)00707-5
doi:10.1016/j.cardfail.2007.06.520
© 2007 Elsevier Inc. All rights reserved. |
