Abstract
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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Acknowledgments
Our deep appreciation goes to the incredible team of the stress testing laboratories at Rush University Medical Center; without their dedication this trial would not be possible.
Funding
A Rush-County collaborative research grant (non-profit).
Conflict of interest
Rami Doukky: received research support from Astellas Pharma, none of which was used to fund this investigation. No conflicts of interest to be reported by other authors.
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Rami Doukky and Maria Octavia Rangel contributed equally to the manuscript and should be treated as co-first authors.
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Doukky, R., Rangel, M.O., Dick, R. et al. 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. Int J Cardiovasc Imaging 29, 1029–1037 (2013). https://doi.org/10.1007/s10554-012-0166-6
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DOI: https://doi.org/10.1007/s10554-012-0166-6