Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial".
J Nucl Cardiol
; 19(3): 448-57, 2012 Jun.
Article
em En
| MEDLINE
| ID: mdl-22395779
ABSTRACT
BACKGROUND:
It is unknown whether the standardized intravenous aminophylline administration following regadenoson-stress can prevent the gastrointestinal and other adverse effects associated with regadenoson.METHODS:
In a randomized, double-blinded, placebo-controlled clinical trial we compared the frequency and severity of regadenoson adverse effects in those who received 75 mg of intravenous aminophylline versus a matching placebo administered 2 minutes after regadenoson or 90 seconds post-radioisotope injection.RESULTS:
248 patients [44.8% women, mean age 62.2 (± 13.3) years] were randomized to receive aminophylline (124) or placebo (124). In the aminophylline arm, there was 50% reduction in the incidence of the primary endpoint of diarrhea and abdominal discomfort [11 (8.9%) vs 22 (17.7%), P = .04] and 70% reduction in the incidence of diarrhea [4 (3.2%) vs 13 (10.5%), P = .02]. Additionally, aminophylline use was associated with 34% reduction in the secondary endpoint of any regadenoson adverse effects [55 (44.4%) vs 83 (66.9%), P < .001] and 71% reduction in headache [9 (7.3%) vs 31 (25%), P < .001]. The stress protocol was better tolerated in the aminophylline group (P = .007). The quantitative summed difference score was similar in both study groups (P = .92). There were no excess adverse events in the aminophylline arm.CONCLUSIONS:
This trial supports the routine administration of IV-aminophylline to reduce the frequency and severity of adverse effects associated with regadenoson-stress.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Purinas
/
Pirazóis
/
Dor Abdominal
/
Tomografia Computadorizada de Emissão de Fóton Único
/
Diarreia
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Imagem de Perfusão do Miocárdio
/
Aminofilina
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Guideline
Limite:
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article