Helmholtz Gemeinschaft

Search
Browse
Statistics
Feeds

Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 x 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol

[img] PDF - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
785kB

Item Type:Article
Title:Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 x 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol
Creators Name:Gulati, G. and Heck, S.L. and Ree, A.H. and Hoffmann, P. and Schulz-Menger, J. and Fagerland, M.W. and Gravdehaug, B. and von Knobelsdorff-Brenkenhoff, F. and Bratland, Å. and Storås, T.H. and Hagve, T.A. and Røsjø, H. and Steine, K. and Geisler, J. and Omland, T.
Abstract:Aims: Contemporary adjuvant treatment for early breast cancer is associated with improved survival but at the cost of increased risk of cardiotoxicity and cardiac dysfunction. We tested the hypothesis that concomitant therapy with the angiotensin receptor blocker candesartan or the {beta}-blocker metoprolol will alleviate the decline in left ventricular ejection fraction (LVEF) associated with adjuvant, anthracycline-containing regimens with or without trastuzumab and radiation. Methods and results: In a 2 x 2 factorial, randomized, placebo-controlled, double-blind trial, we assigned 130 adult women with early breast cancer and no serious co-morbidity to the angiotensin receptor blocker candesartan cilexetil, the {beta}-blocker metoprolol succinate, or matching placebos in parallel with adjuvant anticancer therapy. The primary outcome measure was change in LVEF by cardiac magnetic resonance imaging. A priori, a change of 5 percentage points was considered clinically important. There was no interaction between candesartan and metoprolol treatments (P = 0.530). The overall decline in LVEF was 2.6 (95% CI 1.5, 3.8) percentage points in the placebo group and 0.8 (95% CI −0.4, 1.9) in the candesartan group in the intention-to-treat analysis (P-value for between-group difference: 0.026). No effect of metoprolol on the overall decline in LVEF was observed. Conclusion: In patients treated for early breast cancer with adjuvant anthracycline-containing regimens with or without trastuzumab and radiation, concomitant treatment with candesartan provides protection against early decline in global left ventricular function.
Keywords:Angiotensin Antagonist, {beta}-Blocker, Breast Cancer, Cardiomyopathy, Imaging, Biomarkers
Source:European Heart Journal
ISSN:0195-668X
Publisher:Oxford University Press (U.K.)
Volume:37
Number:21
Page Range:1671-1680
Date:June 2016
Official Publication:https://doi.org/10.1093/eurheartj/ehw022
PubMed:View item in PubMed

Repository Staff Only: item control page

Downloads

Downloads per month over past year

Open Access
MDC Library