کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5719202 | 1607418 | 2017 | 11 صفحه PDF | دانلود رایگان |
ObjectivesTo investigate the safety, tolerability, and pharmacokinetics of liraglutide in adolescents with obesity.Study designThis was a randomized, double-blind, placebo-controlled trial. Twenty-one subjects, aged 12-17 years and Tanner stage 2-5, with obesity (body mass index [BMI] corresponding to both a BMI â¥95th percentile for age and sex and to a BMI of â¥30âkg/m2 for adults; additionally, BMI was â¤45âkg/m2) were randomized (2:1) to receive 5 weeks of treatment with liraglutide (0.6âmg with weekly dose increase to a maximum of 3.0âmg for the last week) (nâ=â14) or placebo (nâ=â7). The primary endpoint was number of treatment-emergent adverse events (TEAEs). Secondary endpoints included safety measures, and pharmacokinetic and pharmacodynamic endpoints.ResultsAll participants receiving liraglutide, and 4 receiving placebo (57.1%), had at least 1 TEAE. The most common TEAEs were gastrointestinal disorders. No severe TEAEs, TEAE-related withdrawals, or deaths occurred. Twelve hypoglycemic episodes occurred in 8 participants receiving liraglutide and 2 in 1 participant receiving placebo. No severe hypoglycemic episodes were reported. Liraglutide exposure in terms of trough concentration increased with dose, although dose proportionality was confounded by unexpectedly low trough concentration values at the 2.4âmg dose. Exposure in terms of model-derived area under the plasma concentration time curve from 0 to 24 hours after dose in steady state was similar to that in adults with obesity.ConclusionsLiraglutide had a similar safety and tolerability profile compared with adults when administered to adolescents with obesity, with no unexpected safety/tolerability issues. Results suggest that the dosing regimen approved for weight management in adults may be appropriate for use in adolescents.Trial registrationClinicalTrials.gov: NCT01789086.
Journal: The Journal of Pediatrics - Volume 181, February 2017, Pages 146-153.e3