Efficacy and Safety of Extended Release Metoprolol Succinate in Hypertensive Children 6 to 16 Years of Age: A Clinical Trial Experience
Received 2 June 2006; received in revised form 24 July 2006; accepted 18 September 2006.
Refers to article:
Is There a Role for β-Adrenergic Blockers in Treating Hypertension in Children?
Russell W. Chesney, Deborah P. Jones
The Journal of Pediatrics
February 2007 (Vol. 150, Issue 2, Pages 121-122) Full Text |
Full-Text PDF (59 KB)
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.
Department of Pediatrics, Section of Nephrology, Columbus Children’s Hospital, The Ohio State University College of Medicine, Columbus, Ohio; Cardiovascular Clinical Research, AstraZeneca LP, Wilmington, DE; the Department of Pediatric Nephrology, University of Texas-Houston Medical School, Houston, TX; and Medicine and Pediatrics, Thomas Jefferson University Medical School, Philadelphia, PA.
Reprint requests: Dr Donald L. Batisky, Children’s Hospital, 700 Children’s Drive, Columbus, OH 43205.
AstraZeneca LP provided support for this study.
Toprol-XL and Seloken ZOK are registered trademarks of the AstraZeneca group of ompanies.
ABSTRACT