title: Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial".
abstract: BACKGROUND
  It is unknown whether the standardized intravenous aminophylline administration following regadenoson-stress can prevent the gastrointestinal and other adverse effects associated with regadenoson.
  
  
  METHODS
  In a randomized, double-blinded, placebo-controlled clinical trial we compared the frequency and severity of regadenoson adverse effects in those who received 75 mg of intravenous aminophylline versus a matching placebo administered 2 minutes after regadenoson or 90 seconds post-radioisotope injection.
  
  
  RESULTS
  248 patients [44.8% women, mean age 62.2 (± 13.3) years] were randomized to receive aminophylline (124) or placebo (124). In the aminophylline arm, there was 50% reduction in the incidence of the primary endpoint of diarrhea and abdominal discomfort [11 (8.9%) vs 22 (17.7%), P = .04] and 70% reduction in the incidence of diarrhea [4 (3.2%) vs 13 (10.5%), P = .02]. Additionally, aminophylline use was associated with 34% reduction in the secondary endpoint of any regadenoson adverse effects [55 (44.4%) vs 83 (66.9%), P < .001] and 71% reduction in headache [9 (7.3%) vs 31 (25%), P < .001]. The stress protocol was better tolerated in the aminophylline group (P = .007). The quantitative summed difference score was similar in both study groups (P = .92). There were no excess adverse events in the aminophylline arm.
  
  
  CONCLUSIONS
  This trial supports the routine administration of IV-aminophylline to reduce the frequency and severity of adverse effects associated with regadenoson-stress.
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: Raysa
authors.initials: R
authors.lastname: Morales Demori
authors.forename: Sidharth
authors.initials: S
authors.lastname: Jain
authors.forename: Roy
authors.initials: R
authors.lastname: Kiriakos
authors.forename: Victor
authors.initials: V
authors.lastname: Mwansa
authors.forename: James E
authors.initials: JE
authors.lastname: Calvin
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced* / Q000175:diagnosis / Q000517:prevention & control*; D058917:Adenosine A2 Receptor Antagonists / Q000627:therapeutic use; D000628:Aminophylline / Q000008:administration & dosage*; D002316:Cardiotonic Agents / Q000008:administration & dosage; D003967:Diarrhea / Q000139:chemically induced* / Q000175:diagnosis; D004311:Double-Blind Method; D004347:Drug Interactions; D005080:Exercise Test / Q000009:adverse effects; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000009:adverse effects*; D015990:Placebo Effect; D011292:Premedication; D011687:Purines / Q000009:adverse effects*; D011720:Pyrazoles / Q000009:adverse effects*; D015899:Tomography, Emission-Computed, Single-Photon / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D058917:Adenosine A2 Receptor Antagonists; D002316:Cardiotonic Agents; D011687:Purines; D011720:Pyrazoles; D000628:Aminophylline; C430916:regadenoson