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

2007; Elsevier BV; Volume: 150; Issue: 2 Linguagem: Inglês

10.1016/j.jpeds.2006.09.034

1097-6833

Donald L. Batisky, Jonathan M. Sorof, Jennifer Sugg, Michaelene P. Llewellyn, Michael Klibaner, James W. Hainer, Ronald J. Portman, Bonita Falkner,

Renal function and acid-base balance

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. 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. 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. 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. These data indicate that ER metoprolol is an effective and well-tolerated treatment for hypertension in children.