Efficacy and Safety of Extended Release Metoprolol Succinate in Hypertensive Children 6 to 16 Years of Age: A Clinical Trial Experience

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.

Abbreviations: ANOVA, Analysis of variance, BMI, Body mass index, BP, Blood pressure, CI, Confidence intervals, DBP, Diastolic blood pressure, ER, Metoprolol Extended release metoprolol succinate, SBP, Systolic blood pressure, SiDBP, Sitting DBP, SiSBP, Sitting SBP