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.

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].

RCT Entities:   Population Interventions Outcomes