Safety and tolerability of regadenoson CMR

Abstract

AimsKnowledge of adverse events associated with regadenoson perfusion cardiac magnetic resonance (CMR) and patient tolerability has implications for patient safety and staff training. We sought to assess the safety and tolerability of regadenoson stress CMR.Materials and methodsA group of 728 consecutive patients (median age 58, 44% female) and 25 normal volunteers (median age 21, 24% female) were recruited from August 2009 to March 2012 using a prospective, cross-sectional study design. Subjects were stressed using fixed-dose regadenoson and imaged using a 1.5T MRI scanner. Symptoms and adverse events including death, myocardial infarction (MI), ventricular tachycardia (VT)/ventricular fibrillation (VF), hospitalization, arrhythmias, and haemodynamic stability were assessed.ResultsThere were no occurrences of death, MI, VT/VF, high-grade atrioventricular block, or stress-induced atrial fibrillation. Notable adverse events included one case of bronchospasm and one case of heart failure exacerbation resulting in hospitalization. The most common symptoms in patients were dyspnoea (30%, n = 217), chest discomfort (27%, n = 200), and headache (15%, n = 111). There was minimal change between baseline and peak systolic and diastolic blood pressure in both patients and volunteers (P > 0.05). A blunted heart rate response to regadenoson was noted in patients with body mass index (BMI) ≥30 kg/m2 (P < 0.001), and diabetes (P = 0.001).ConclusionsRegadenoson CMR is well tolerated and can be performed safely with few adverse events.

A Phase 1 study evaluating AMG 337 in Asian patients with advanced solid tumors†

“…This finding was comparable to previous studies that reported a dose-dependent increase in headaches in patients who received AMG 337 (20,21), which was possibly due to the inhibition of adenosine transporters (26,27). Consistent with findings with other inhibitors of the MET pathway (28), low-grade peripheral edema occurred in 27% of patients who received AMG 337; no grade ≥3 peripheral edema was observed in this study.…”

Safety and tolerability of regadenoson for myocardial perfusion imaging – first Danish experience

“…The proportion of AV block with regadenoson has been reported to be very low in other trials. Iskandrian et al (8) did not identify any patients with regadenoson-induced AV block among 471 patients, and Nguyen et al (25) found no cases of AV block in 728 patients. Hendel et al (7) found one patient who developed first-degree AV block among 36 patients.…”

Effects of adenosine and regadenoson on hemodynamics measured using cardiovascular magnetic resonance imaging

“…Dandekar et al demonstrated that this was an effective method to quickly return myocardial blood flow to baseline measurements although the use of aminophylline as a reversal agent is considered off-label and not included in published CMR stress perfusion guidelines [ 9 , 12 ]. Regardless of the vasodilator or protocol used, both vasodilator agents have been shown safe and effective when used with stress CMR [ 13 , 14 ].…”