Attenuation of the side effect profile of regadenoson: a randomized double-blind
placebo-controlled study with aminophylline in patients undergoing myocardial
perfusion imaging and have severe chronic kidney disease--the ASSUAGE-CKD trial.
Author(s): Doukky R(1), Rangel MO, Dick R, Wassouf M, Alqaid A, Margeta B.
Affiliation(s): Author information:
(1)The Section of Cardiology, Rush University Medical Center, 1653 W. Congress Pkwy,
Chicago, IL 60612, USA. rami_doukky@rush.edu
Publication date & source: 2013, Int J Cardiovasc Imaging. , 29(5):1029-37
A subgroup analysis of the ASSUAGE trial suggested that the standardized
intravenous aminophylline administration following regadenoson-stress leads to
substantial attenuation of regadenoson adverse-effects in patients with severe
chronic kidney disease (CKD). In a randomized, double-blinded, placebo-controlled
clinical trial of patients with stage 4 and 5 CKD, we compared the frequency and
severity of regadenoson adverse-effects in those who received 75 mg of
intravenous aminophylline versus a matching placebo administered 90 s
post-radioisotope injection. Consecutive 300 patients with severe CKD (36% women;
86% end-stage renal disease; age 55 (±13) years) were randomized to receive
aminophylline (n = 150) or placebo (n = 150). In the aminophylline arm, there was
65% reduction in the incidence of the primary endpoint of diarrhea (9 (6.0%) vs.
26 (17.3%), P = 0.002), 51% reduction in the secondary endpoint of any
regadenoson adverse-effect (47 (31.3%) vs. 96 (64%), P < 0.001) and 70% reduction
in headache (16 (10.7%) vs. 54 (36%), P < 0.001). The stress protocol was better
tolerated in the aminophylline group (P = 0.008). The quantitative summed
difference score, as a measure of stress-induced ischemic burden, was similar
between the study groups (P = 0.51). In conclusion, the routine standardized
administration of intravenous aminophylline in patients with severe CKD
substantially reduces the frequency and severity of the adverse-effects
associated with regadenoson-stress without changing the ischemic burden.
[NCT01336140].
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