Last Updated: 2009-12-02 13:10:58 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Regadenoson, approved last year for use in vasodilator stress myocardial perfusion imaging (MPI), can be given to patients with end-stage renal disease (ESRD) even though it's cleared by the kidney, according to a new study.
Moreover, lead investigator Dr. Wael Aljaroudi told Reuters Health, "Regadenoson has many appealing features such as ease of administration as a bolus, fixed weight-unadjusted dose, fast onset and short duration of action, comparable efficacy to adenosine but with less side effects and better patient tolerability."
Dr. Aljaroudi and colleagues at the University of Alabama at Birmingham studied data on 277 consecutive patients with ESRD and 134 with normal kidney function. In their retrospective analysis, they compared side effects and safety outcomes after gated single photon emission computed tomography MPI. Each patient received an IV bolus of 400 micrograms of regadenoson, with no adjustment for weight or renal function.
As they report online in the November 18th issue of the American Journal of Cardiology, the mean changes in heart rate from baseline to peak stress were similar in the ESRD and control groups (20 beats/min versus 22 beats/min, respectively), as were the average drops in systolic blood pressure (11 mmHg in the ESRD group versus 12 mmHg in controls).
"Remarkably few side effects were reported in either group, certainly much less than what was reported in the pivotal phase III trials," the authors said. At 30 days, no medication-related hospitalizations, serious events, or death had occurred in either group.
As well as being convenient to use, Dr. Aljaroudi said, "unlike adenosine, it can be safely employed in patients with moderate airway disease or asthma."
Whether regadenoson is dialyzable is not yet clear, although it theoretically should be, the authors say, based on unpublished data from the drug's manufacturer. They did not measure the serum concentrations or clearance of the drug in their patients.
However, they write, "The combined effects of a low glomerular filtration rate and inhibition of possible tubular secretion as seen in ESRD would not result in a clinically meaningful increase in regadenoson exposure...because the nonrenal clearance remains constant and greatly exceeds the renal clearance in subjects with severe renal impairment."
"Our results have clearly shown hemodynamic responses and tolerability similar to those seen in patients with normal renal function," Dr. Aljaroudi concluded.
Am J Cardiol 2009.
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