title: 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.
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].
authors.affiliation: The Section of Cardiology, Rush University Medical Center, 1653 W. Congress Pkwy, Chicago, IL 60612, USA. rami_doukky@rush.edu
authors.forename: Rami
authors.initials: R
authors.lastname: Doukky
authors.forename: Maria Octavia
authors.initials: MO
authors.lastname: Rangel
authors.forename: Rizcallah
authors.initials: R
authors.lastname: Dick
authors.forename: Marwan
authors.initials: M
authors.lastname: Wassouf
authors.forename: Ammar
authors.initials: A
authors.lastname: Alqaid
authors.forename: Bosko
authors.initials: B
authors.lastname: Margeta
mesh_terms: D058908:Adenosine A2 Receptor Agonists / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000628:Aminophylline / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002641:Chicago; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000150:complications / Q000000981:diagnostic imaging* / Q000503:physiopathology; D055414:Myocardial Perfusion Imaging / Q000379:methods*; D016017:Odds Ratio; D011237:Predictive Value of Tests; D058915:Purinergic P1 Receptor Antagonists / Q000008:administration & dosage*; D011687:Purines / Q000009:adverse effects*; D011720:Pyrazoles / Q000009:adverse effects*; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000175:diagnosis; D012307:Risk Factors; D012720:Severity of Illness Index; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome
chemical_list: D058908:Adenosine A2 Receptor Agonists; D058915:Purinergic P1 Receptor Antagonists; D011687:Purines; D011720:Pyrazoles; D000628:Aminophylline; C430916:regadenoson