, Volume 20, Issue 2, pp 205-213
Date: 13 Dec 2012

The safety and tolerability of regadenoson in patients with end-stage renal disease: The first prospective evaluation

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Abstract

Background

There has not been any prospective evaluation of the safety and tolerability of regadenoson (REG)-stress in patients with end-stage renal disease (ESRD).

Methods

From the pooled database of two identically designed randomized, double-blinded, placebo-controlled clinical trials, ASSUAGE and ASSUAGE-CKD (IV-aminophylline vs placebo following REG-stress), we extracted the placebo-treated subjects to form 2 study groups: ESRD (dialysis or GFR < 15 mL/minute/1.73 m2) and control (GFR ≥ 30). The incidence of REG adverse effects and the hemodynamic and ECG responses to REG-stress were compared.

Results

We identified 146 ESRD subjects and 97 controls. There was no significant difference in the incidence of the composite of any REG adverse effect [ESRD 108 (74%) vs control 73 (75%), P = .82]. ESRD patients seem to have excess incidences of diarrhea [42 (29%) vs 14 (14%), P = .009] and fewer events of dizziness [28 (19%) vs 43 (44%), P < .001]. There were no serious adverse events in either group. There was no significant difference in the incidence of ST-segment deviation, tachyarrhythmias, atrioventricular block, or hypotension.

Conclusion

This is the first prospective study to confirm the safety and tolerability of REG in patients with ESRD.

Rami Doukky and Maria Octavia Rangel contributed equally to the manuscript and should be treated as co-first authors.
See related editorial, doi: 10.1007/s12350-012-9658-y