title: The safety and tolerability of regadenoson in patients with end-stage renal disease: the first prospective evaluation.
abstract: BACKGROUND
  There has not been any prospective evaluation of the safety and tolerability of regadenoson (REG)-stress in patients with end-stage renal disease (ESRD).
  
  
  METHODS
  From the pooled database of two identically designed randomized, double-blinded, placebo-controlled clinical trials, ASSUAGE and ASSUAGE-CKD (IV-aminophylline vs placebo following REG-stress), we extracted the placebo-treated subjects to form 2 study groups: ESRD (dialysis or GFR < 15 mL/minute/1.73 m(2)) and control (GFR ≥ 30). The incidence of REG adverse effects and the hemodynamic and ECG responses to REG-stress were compared.
  
  
  RESULTS
  We identified 146 ESRD subjects and 97 controls. There was no significant difference in the incidence of the composite of any REG adverse effect [ESRD 108 (74%) vs control 73 (75%), P = .82]. ESRD patients seem to have excess incidences of diarrhea [42 (29%) vs 14 (14%), P = .009] and fewer events of dizziness [28 (19%) vs 43 (44%), P < .001]. There were no serious adverse events in either group. There was no significant difference in the incidence of ST-segment deviation, tachyarrhythmias, atrioventricular block, or hypotension.
  
  
  CONCLUSIONS
  This is the first prospective study to confirm the safety and tolerability of REG in patients with ESRD.
authors.affiliation: 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: Marwan
authors.initials: M
authors.lastname: Wassouf
authors.forename: Rizcallah
authors.initials: R
authors.lastname: Dick
authors.forename: Ammar
authors.initials: A
authors.lastname: Alqaid
authors.forename: Raysa
authors.initials: R
authors.lastname: Morales Demori
mesh_terms: D058908:Adenosine A2 Receptor Agonists / Q000009:adverse effects; D015897:Comorbidity; D003967:Diarrhea / Q000175:diagnosis / Q000453:epidemiology*; D004244:Dizziness / Q000175:diagnosis / Q000453:epidemiology*; D064420:Drug-Related Side Effects and Adverse Reactions; D005080:Exercise Test / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D015994:Incidence; D007676:Kidney Failure, Chronic / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000706:statistics & numerical data*; D010865:Pilot Projects; D011446:Prospective Studies; D011687:Purines / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D015899:Tomography, Emission-Computed, Single-Photon / Q000706:statistics & numerical data*; D014481:United States / Q000453:epidemiology; D014665:Vasodilator Agents / Q000009:adverse effects
chemical_list: D058908:Adenosine A2 Receptor Agonists; D011687:Purines; D011720:Pyrazoles; D014665:Vasodilator Agents; C430916:regadenoson