Efficacy and Safety of Extended Release Metoprolol Succinate in Hypertensive Children 6 to 16 Years of Age: A Clinical Trial Experience - 12/08/11
, Jonathan M. Sorof, MD, Jennifer Sugg, MS, Michaelene Llewellyn, BSN, RN, MAS, Michael Klibaner, MD, PhD, James W. Hainer, MD, MPH, Ronald J. Portman, MD, Bonita Falkner, MDToprol-XL Pediatric Hypertension Investigators
Reprint requests: Dr Donald L. Batisky, Children’s Hospital, 700 Children’s Drive, Columbus, OH 43205.Résumé |
Objective |
To evaluate the efficacy, tolerability, and blood pressure (BP) lowering effect of extended release metoprolol succinate (ER metoprolol) in children 6 to 16 years of age with established hypertension.
Study design |
Patients were randomized to one of four treatment arms: placebo or ER metoprolol (0.2 mg/kg, 1.0 mg/kg, or 2.0 mg/kg). Data were analyzed on 140 intent-to-treat patients.
Results |
Mean age (±SD) was 12.5 ± 2.8 years and mean baseline BP was 132/78 ± 9/9 mmHg. Following 4 weeks of treatment, mean changes in sitting BP were: placebo = −1.9/−2.1 mmHg; ER metoprolol 0.2 mg/kg = −5.2/−3.1 mmHg; 1.0 mg/kg = −7.7/−4.9 mmHg; 2.0 mg/kg = −6.3/−7.5 mmHg. Compared with placebo, ER metoprolol significantly reduced systolic blood pressure (SBP) at the 1.0 and 2.0 mg/kg dose (P = .027 and P = .049, respectively), reduced diastolic blood pressure (DBP) at the 2.0 mg/kg dose (P = .017), and showed a statistically significant dose response relationship for the placebo-corrected change in DBP from baseline. There were no serious adverse events or adverse events requiring study drug discontinuation among patients receiving active therapy.
Conclusion |
These data indicate that ER metoprolol is an effective and well-tolerated treatment for hypertension in children.
Le texte complet de cet article est disponible en PDF.Abbreviations : ANOVA, BMI, BP, CI, DBP, ER, SBP, SiDBP, SiSBP
Plan
| AstraZeneca LP provided support for this study. Toprol-XL and Seloken ZOK are registered trademarks of the AstraZeneca group of ompanies. Clinicaltrials.gov Identifiers: NCT00255502 and NCT00255528. |
Vol 150 - N° 2
P. 134 - février 2007 Retour au numéro
Article précédent
- Pediatric Workforce: A Look at Pediatric Infectious Diseases Data from the American Board of Pediatrics
- Linda A. Althouse, James A. Stockman
- Diagnosis and Localization of Focal Congenital Hyperinsulinism by 18F-Fluorodopa PET Scan
- Olga T. Hardy, Miguel Hernandez-Pampaloni, Janet R. Saffer, Mariko Suchi, Eduardo Ruchelli, Hongming Zhuang, Arupa Ganguly, Richard Freifelder, N. Scott Adzick, Abass Alavi, Charles A. Stanley
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?