Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience.

Abstract

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.

• Authors: Donald L Batisky, Jonathan M Sorof, Jennifer Sugg, Michaelene Llewellyn, Michael Klibaner, James W Hainer, Ronald J Portman, Bonita Falkner, Toprol-XL Pediatric Hypertension Investigators
• Journal: The Journal of pediatrics (J Pediatr) Vol. 150 Issue 2 Pg. 134-9, 139.e1 (Feb 2007) ISSN: 1097-6833 [Electronic] United States
• PMID: 17236889 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic beta-Antagonists
• Metoprolol

Topics

• Administration, Oral
• Adolescent
• Adrenergic beta-Antagonists (administration & dosage, adverse effects)
• Analysis of Variance
• Blood Pressure Determination
• Child
• Confidence Intervals
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Hypertension (diagnosis, drug therapy)
• Male
• Metoprolol (administration & dosage, adverse effects, analogs & derivatives)
• Probability
• Prospective Studies
• Risk Assessment
• Severity of Illness Index
• Treatment Outcome