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: Karthik Ananthasubramaniam, Robert Weiss, Bruce McNutt, Barbara Klauke, Kathleen Feaheny, Stan Bukofzer
• Journal: Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology (J Nucl Cardiol) Vol. 19 Issue 2 Pg. 319-29 (Apr 2012) ISSN: 1532-6551 [Electronic] United States
• PMID: 22259009 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adenosine A2 Receptor Antagonists
• Purines
• Pyrazoles
• regadenoson

Topics

• Adenosine A2 Receptor Antagonists (adverse effects)
• Adult
• Aged
• Aged, 80 and over
• Comorbidity
• Coronary Artery Disease (diagnostic imaging, epidemiology)
• Double-Blind Method
• Drug Tolerance
• Drug-Related Side Effects and Adverse Reactions (epidemiology)
• Female
• Humans
• Kidney Failure, Chronic (epidemiology)
• Male
• Middle Aged
• Placebo Effect
• Prevalence
• Purines
• Pyrazoles
• Radionuclide Imaging
• Risk Assessment
• Risk Factors
• United States (epidemiology)
• Young Adult