OBJECTIVE: To assess the safety, pharmacokinetics (PKs), and blood pressure (BP)-lowering efficacy of telmisartan in pediatric (6 to <18 years) patients with hypertension. STUDY DESIGN:Patients with diagnosed hypertension were randomized to 4 weeks of treatment with placebo, or with 1 of 2 nominal telmisartan dose levels (1 mg/kg/d or 2 mg/kg/d). The primary end point was change in seated systolic BP (SBP) from baseline to study end. RESULTS: A total of 77 patients were randomized and received at least 1 dose of study medication (placebo, n = 16; low-dose telmisartan, n = 30; high-dose telmisartan, n = 31). Adjusted mean changes (standard errors) in SBP from baseline to study end were -6 (2.4), -14 (1.7), and -9.7 (1.7) mm Hg, respectively, in the placebo, high-dose telmisartan, and low-dose telmisartan groups. CONCLUSIONS:Telmisartan may be an appropriate therapy for treatment of pediatric hypertension, although more extensive studies are required in patients younger than age 12.
RCT Entities:
OBJECTIVE: To assess the safety, pharmacokinetics (PKs), and blood pressure (BP)-lowering efficacy of telmisartan in pediatric (6 to <18 years) patients with hypertension. STUDY DESIGN:Patients with diagnosed hypertension were randomized to 4 weeks of treatment with placebo, or with 1 of 2 nominal telmisartan dose levels (1 mg/kg/d or 2 mg/kg/d). The primary end point was change in seated systolic BP (SBP) from baseline to study end. RESULTS: A total of 77 patients were randomized and received at least 1 dose of study medication (placebo, n = 16; low-dose telmisartan, n = 30; high-dose telmisartan, n = 31). Adjusted mean changes (standard errors) in SBP from baseline to study end were -6 (2.4), -14 (1.7), and -9.7 (1.7) mm Hg, respectively, in the placebo, high-dose telmisartan, and low-dose telmisartan groups. CONCLUSIONS:Telmisartan may be an appropriate therapy for treatment of pediatric hypertension, although more extensive studies are required in patients younger than age 12.
Authors: Perdita Taylor-Zapata; Carissa M Baker-Smith; Gilbert Burckart; Stephen R Daniels; Joseph T Flynn; George Giacoia; Dionna Green; Aaron S Kelly; Mona Khurana; Jennifer S Li; Charlotte Pratt; Elaine M Urbina; Anne Zajicek Journal: Pediatrics Date: 2019-05 Impact factor: 7.124
Authors: Subramanian Krishnan; Muthusamy V Shanmuganathan; Douglas Behenna; Brian M Stoltz; Nemani V Prasadarao Journal: J Infect Dis Date: 2013-09-16 Impact factor: 5.226
Authors: Thomas G Wells; Douglas L Blowey; Janice E Sullivan; Jeffrey Blumer; Joseph R Sherbotie; Saeheum Song; Shashank Rohatagi; Reinilde Heyrman; Daniel E Salazar Journal: Paediatr Drugs Date: 2012-12-01 Impact factor: 3.022