The safety and tolerability of regadenoson in patients with end stage renal disease.

摘要

There were no prospective evaluations of the safety and tolerability of regadenoson- stress in end-stage renal disease patients. From the pooled database of two identically designed randomized, double-blinded, placebo-controlled clinical trials, ASSUAGE and ASSUAGE-CKD, the placebo arms were selected to form 2 study-groups: ESRD and Control. Regadenoson adverse-effects incidences, hemodynamic and ECG responses to regadenoson-stress were compared. 146 ESRD subjects and 97 controls were identified. No difference was noted in the composite incidence of any regadenoson adverse-effect [ESRD 108 (74%), Control 73 (75%), P = 0.82]. ESRD patients had higher incidence of diarrhea [42 (29%), 14 (14%), P = 0.009] and fewer events of dizziness [28 (19%), 43 (44%), P < 0.001]. No serious adverse events occurred in either group. No difference was observed in the incidence of ST-segment deviation, tachyarrhythmias, atrioventricular block or hypotension. This was the first prospective study confirming the safety and tolerability of regadenoson in ESRD.