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PHARMACOKINETICS

Regadenoson Pharmacokinetics and Tolerability in Subjects With Impaired Renal Function

Toufigh Gordi, PhD, Brent Blackburn, PhD and Hsiao Lieu, MD

From Depomed, Inc, Menlo Park, California (Dr Gordi); CVT, Inc, Palo Alto, California (Dr Blackburn); and Portola Pharmaceuticals, Inc (Dr Lieu).

The authors have investigated the pharmacokinetics and tolerability of regadenoson, a selective A2A adenosine receptor agonist for use in drug-stressed myocardial perfusion imaging in subjects with varying degrees of renal function. Sixteen subjects with different creatinine clearance values (range: 15-132 mL/min) received a single intravenous bolus dose of 400 µg regadenoson. A population pharmacokinetic model was developed to describe the pharmacokinetics of regadenoson in these subjects. Regadenoson elimination half-life was prolonged with decreasing renal function. However, maximum plasma concentrations, number, or severity of adverse events did not differ significantly between the subjects. Heart rate increased in all subjects after regadenoson injection but returned to normal within 150 minutes. There were no blood pressure pattern differences with respect to renal function. Results from this study do not indicate that dose adjustments are necessary when subjects with decreased renal function are administered the clinically relevant dose of 400 µg regadenoson.

Key Words: A2A adenosine receptor agonist • regadenoson • renal impairment • CVT-3146

Address for correspondence: Toufigh Gordi, PhD, Depomed, Inc, 1360 O'Brien Dr, Menlo Park, CA 94025; e-mail: tgordi{at}yahoo.com.






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