title: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  These data indicate that ER metoprolol is an effective and well-tolerated treatment for hypertension in children.
authors.affiliation: Department of Pediatrics, Section of Nephrology, Columbus Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio 43205, USA. donb@pediatrics.ohio-state.edu
authors.forename: Donald L
authors.initials: DL
authors.lastname: Batisky
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Sorof
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sugg
authors.forename: Michaelene
authors.initials: M
authors.lastname: Llewellyn
authors.forename: Michael
authors.initials: M
authors.lastname: Klibaner
authors.forename: James W
authors.initials: JW
authors.lastname: Hainer
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Portman
authors.forename: Bonita
authors.initials: B
authors.lastname: Falkner
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000704:Analysis of Variance; D001795:Blood Pressure Determination; D002648:Child; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008790:Metoprolol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D008790:Metoprolol