BACKGROUND: There are limited data on the effect of body mass index (BMI) on the actions of fixed-dose regadenoson. The purpose of this study was to determine the effect of BMI on the efficacy, side effects, and plasma concentration of regadenoson for Myocardial Perfusion Imaging (MPI). METHODS AND RESULTS: The study included 2,015 subjects from the ADVANCE MPI trials. Initial adenosine MPI was followed by randomization to regadenoson (400-μg bolus injection) or adenosine (6-minute infusion) MPI. Subjects were classified according to BMI into six categories from underweight (<20 kg/m(2)) to extremely obese (≥40 kg/m(2)). PK modeling was used to predict the effect of BMI on plasma regadenoson concentration (PRC). Adenosine-regadenoson agreement rates for the presence and extent of reversibility were similar across BMI categories (P > .05). The incidence of side effects was also similar across BMIs (P ≥ .06). Subjects were less likely to feel very or extremely uncomfortable after regadenoson vs adenosine in all groups with BMI ≥ 25 kg/m(2), but this trend was not statistically significant in subjects with BMI 20-24 kg/m(2) (P > .05). PRC was inversely related to BMI with 19% higher PRC in the underweight and 36% lower PRC in the extremely obese compared with a normal weight subject. CONCLUSIONS:BMI does not alter the efficacy of regadenoson MPI despite lower PRC in high BMI subjects, or its side effect profile despite higher PRC in low BMI subjects. Regadenoson is better tolerated than adenosine but this benefit seems to lose statistical significance in subjects with BMI < 25 kg/m(2).
RCT Entities:
BACKGROUND: There are limited data on the effect of body mass index (BMI) on the actions of fixed-dose regadenoson. The purpose of this study was to determine the effect of BMI on the efficacy, side effects, and plasma concentration of regadenoson for Myocardial Perfusion Imaging (MPI). METHODS AND RESULTS: The study included 2,015 subjects from the ADVANCE MPI trials. Initial adenosineMPI was followed by randomization to regadenoson (400-μg bolus injection) or adenosine (6-minute infusion) MPI. Subjects were classified according to BMI into six categories from underweight (<20 kg/m(2)) to extremely obese (≥40 kg/m(2)). PK modeling was used to predict the effect of BMI on plasma regadenoson concentration (PRC). Adenosine-regadenoson agreement rates for the presence and extent of reversibility were similar across BMI categories (P > .05). The incidence of side effects was also similar across BMIs (P ≥ .06). Subjects were less likely to feel very or extremely uncomfortable after regadenoson vs adenosine in all groups with BMI ≥ 25 kg/m(2), but this trend was not statistically significant in subjects with BMI 20-24 kg/m(2) (P > .05). PRC was inversely related to BMI with 19% higher PRC in the underweight and 36% lower PRC in the extremely obese compared with a normal weight subject. CONCLUSIONS: BMI does not alter the efficacy of regadenosonMPI despite lower PRC in high BMI subjects, or its side effect profile despite higher PRC in low BMI subjects. Regadenoson is better tolerated than adenosine but this benefit seems to lose statistical significance in subjects with BMI < 25 kg/m(2).
Authors: Z Gao; Z Li; S P Baker; R D Lasley; S Meyer; E Elzein; V Palle; J A Zablocki; B Blackburn; L Belardinelli Journal: J Pharmacol Exp Ther Date: 2001-07 Impact factor: 4.030
Authors: Francis J Klocke; Michael G Baird; Beverly H Lorell; Timothy M Bateman; Joseph V Messer; Daniel S Berman; Patrick T O'Gara; Blase A Carabello; Richard O Russell; Manuel D Cerqueira; Martin G St John Sutton; Anthony N DeMaria; James E Udelson; J Ward Kennedy; Mario S Verani; Kim Allan Williams; Elliott M Antman; Sidney C Smith; Joseph S Alpert; Gabriel Gregoratos; Jeffrey L Anderson; Loren F Hiratzka; David P Faxon; Sharon Ann Hunt; Valentin Fuster; Alice K Jacobs; Raymond J Gibbons; Richard O Russell Journal: J Am Coll Cardiol Date: 2003-10-01 Impact factor: 24.094
Authors: Ami E Iskandrian; Timothy M Bateman; Luiz Belardinelli; Brent Blackburn; Manuel D Cerqueira; Robert C Hendel; Hsiao Lieu; John J Mahmarian; Ann Olmsted; S Richard Underwood; João Vitola; Whedy Wang Journal: J Nucl Cardiol Date: 2007 Sep-Oct Impact factor: 5.952
Authors: John J Mahmarian; Manuel D Cerqueira; Ami E Iskandrian; Timothy M Bateman; Gregory S Thomas; Robert C Hendel; Lemuel A Moye; Ann W Olmsted Journal: JACC Cardiovasc Imaging Date: 2009-08
Authors: Gregory S Thomas; Randall C Thompson; Michael I Miyamoto; Tze K Ip; Deborah L Rice; Douglas Milikien; Hsiao D Lieu; Vandana S Mathur Journal: J Nucl Cardiol Date: 2009-01-20 Impact factor: 5.952
Authors: Carlos Salgado-Garcia; Amelia Jimenez-Heffernan; Juana Lopez-Martin; Manuela Molina-Mora; Tarik Aroui; Elena Sanchez de Mora; Carlos Ramos-Font; Francisco Rivera de Los Santos; Carlos Ruiz-Frutos Journal: Eur J Nucl Med Mol Imaging Date: 2017-05-25 Impact factor: 9.236
Authors: Edward V R DiBella; Jacob U Fluckiger; Liyong Chen; Tae Ho Kim; Nathan A Pack; Brian Matthews; Ganesh Adluru; Tiffany Priester; Suman Kuppahally; Ronny Jiji; Chris McGann; Sheldon E Litwin Journal: Int J Cardiovasc Imaging Date: 2011-10-04 Impact factor: 2.357
Authors: Kim-Lien Nguyen; W Patricia Bandettini; Sujata Shanbhag; Steve W Leung; Joel R Wilson; Andrew E Arai Journal: Eur Heart J Cardiovasc Imaging Date: 2014-01-21 Impact factor: 6.875
Authors: M Brinkert; E Reyes; S Walker; K Latus; A Maenhout; R Mizumoto; C Nkomo; K Standbridge; K Wechalekar; S R Underwood Journal: Eur J Nucl Med Mol Imaging Date: 2013-11-22 Impact factor: 9.236