title: A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease.
abstract: BACKGROUND
  The safety and tolerability of regadenoson, a pharmacologic stress agent that is excreted primarily by the kidneys, were examined in subjects with chronic kidney disease (CKD).
  
  
  METHODS
  This multicenter, double-blind, randomized, placebo-controlled study involved men and women, ≥18 years of age, with stage 3 or 4 [estimated glomerular filtration rate (eGFR) 30-59 mL/minute/1.73 m(2) and 15-29 mL/minute/1.73 m(2), respectively] CKD and known or suspected coronary artery disease. Subjects were randomized 2:1 to receive one 10-second intravenous injection of regadenoson 0.4 mg or placebo. The primary outcome measure was the frequency of serious adverse events over 24-h post-dose.
  
  
  RESULTS
  The study included 432 subjects with stage 3 (regadenoson n = 287; placebo n = 145) and 72 with stage 4 (regadenoson n = 47; placebo n = 25) CKD. No serious adverse events or deaths were reported over 24-h post-dose. The overall adverse event incidence was higher with regadenoson than placebo (62.6% vs 21.2%; P < .0001). Of the most common adverse events (≥5%) reported by subjects receiving regadenoson, headache (24.9% vs 7.1%), dyspnea (19.2% vs 0.6%), chest discomfort (14.7% vs 0.6%), nausea (14.7% vs 1.2%), flushing (12.0% vs 1.8%), and dizziness (9.6% vs 0.6%) occurred significantly more often (P < .0001) with regadenoson than placebo. There were no trends for clinically meaningful changes in eGFR from baseline to 24-h post-dose in subjects with stage 3 or 4 CKD.
  
  
  CONCLUSIONS
  Regadenoson was not associated with any serious or unexpected adverse events in subjects with stage 3 or 4 CKD.
authors.affiliation: Department of Internal Medicine, Heart and Vascular Institute, Henry Ford Hospital, Detroit, MI 48202, USA. kananth1@hfhs.org
authors.forename: Karthik
authors.initials: K
authors.lastname: Ananthasubramaniam
authors.forename: Robert
authors.initials: R
authors.lastname: Weiss
authors.forename: Bruce
authors.initials: B
authors.lastname: McNutt
authors.forename: Barbara
authors.initials: B
authors.lastname: Klauke
authors.forename: Kathleen
authors.initials: K
authors.lastname: Feaheny
authors.forename: Stan
authors.initials: S
authors.lastname: Bukofzer
mesh_terms: D058917:Adenosine A2 Receptor Antagonists / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology*; D004311:Double-Blind Method; D004361:Drug Tolerance; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D015995:Prevalence; D011687:Purines; D011720:Pyrazoles; D011877:Radionuclide Imaging; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D058917:Adenosine A2 Receptor Antagonists; D011687:Purines; D011720:Pyrazoles; C430916:regadenoson