Abstract
BackgroundRegadenoson is a selective A2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. However, the safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed. Method and ResultsHealthy males and females were randomized to receive intravenous regadenoson [100 μg (3 doses), 200 μg (3 doses), or 400 μg (2 doses)], or placebo (2 or 3 doses; 0.9% sodium chloride); all doses 10 minutes apart. The primary endpoint was vital sign measurements (blood pressure and heart rate). Secondary endpoints included 12-lead electrocardiogram measurements, clinical laboratory evaluations (hematology, chemistry, and urinalysis), and adverse events. Thirty-six subjects were randomized and completed the study. Plasma concentrations of regadenoson increased in a dose-related manner and with successive doses. No consistent effect was observed for systolic blood pressure, although diastolic blood pressure was slightly lower than placebo for all regadenoson groups. Transient, dose-dependent increases in heart rate were observed in all regadenoson groups. There were no serious adverse events; 27 adverse events occurred in 14 regadenoson-treated subjects vs two events in two placebo-treated subjects. ConclusionRepeated doses of regadenoson appeared to be safe and well tolerated in healthy subjects.
Highlights
Patients who are unable to perform adequate exercise stress for myocardial perfusion imaging (MPI) are generally administered a pharmacologic stress agent such as adenosine, dipyridamole, or regadenoson.[1]
No consistent effect was observed for systolic blood pressure, diastolic blood pressure was slightly lower than placebo for all regadenoson groups
400-lg regadenoson groups discontinued treatment after the first planned dose. These subjects presented quantifiable plasma concentrations up to 4 and 8 hours, respectively, but because they did not receive the subsequent planned doses, plasma concentrations measured more than 9 minutes after the initial dose were excluded from the summary statistics, and data from both subjects were excluded from the pharmacodynamics analysis set
Summary
Patients who are unable to perform adequate exercise stress for myocardial perfusion imaging (MPI) are generally administered a pharmacologic stress agent such as adenosine, dipyridamole, or regadenoson.[1]. Regadenoson is a selective A2A adenosine receptor agonist indicated for radionuclide MPI in patients unable to undergo adequate exercise stress.[2] In phase 3 clinical studies, single doses of regadenoson were found to be efficacious as adenosine.[3,4] The safety and tolerability of regadenoson have been confirmed in various special populations of patients, including those with kidney, liver and airway diseases.[5,6,7,8,9]. The safety and tolerability of repeat consecutive doses of regadenoson, as well as the associated plasma concentrations, have not been systematically assessed. Regadenoson is a selective A2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. The safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed
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