title: A double-blind, placebo-controlled, dose-response study of the effectiveness and safety of lisinopril for children with hypertension.
abstract: BACKGROUND
  Despite widespread use in hypertensive children, the safety and effectiveness of lisinopril had not been previously tested in a controlled study.
  
  
  METHODS
  This study explored the dose-response relationship and safety of lisinopril in 115 hypertensive children, aged 6 to 16 years. Patients were randomized in a double-blind fashion for 2 weeks to one of three doses by body weight at baseline: <50 kg: low (0.625 mg), middle (2.5 mg), high (20 mg), and > or =50 kg: low (1.25 mg), middle (5 mg), high (40 mg). The dose-response for lisinopril was evaluated by analyzing the change in slope in sitting diastolic and systolic blood pressure (BP) by dose after 2 weeks of therapy compared to baseline. Patients then entered a double-blind withdrawal, where patients were either switched to placebo or continued their current lisinopril treatment for up to 2 weeks. Patients completed period II when their BP returned to baseline. Antihypertensive effectiveness, between placebo and lisinopril was determined for all doses. Adverse events were carefully monitored.
  
  
  RESULTS
  There was a dose-response relationship between the lowest and each of the higher doses of lisinopril. Blood pressure in the placebo group increased after withdrawal of lisinopril. The dose-response relationship was consistent across all subgroups (ie, age, Tanner stage, ethnicity, gender).
  
  
  CONCLUSIONS
  Lisinopril, once daily, is an effective and well-tolerated antihypertensive in children aged 6 to 16 years. An initial dose of 0.07 mg/kg, administered once daily, effectively lowered BP within 2 weeks. Blood pressure was reduced in a dose-dependent fashion.
authors.affiliation: Merck and Co., Inc., West Point, Pennsylvania, USA. beth_soffer@merck.com
authors.forename: Beth
authors.initials: B
authors.lastname: Soffer
authors.forename: Zhongxin
authors.initials: Z
authors.lastname: Zhang
authors.forename: Kenneth
authors.initials: K
authors.lastname: Miller
authors.forename: Beth A
authors.initials: BA
authors.lastname: Vogt
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Shahinfar
mesh_terms: D000293:Adolescent; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D017706:Lisinopril / Q000008:administration & dosage*; D008297:Male; D010919:Placebos; D011446:Prospective Studies
chemical_list: D000959:Antihypertensive Agents; D010919:Placebos; D017706:Lisinopril