A pilot study in the efficacy and safety of XXXX in a pediatric population.

@entity1 @entity1674 @entity8445 @entity492 @entity209 @entity925 @entity493 @entity65 @entity165
BACKGROUND: @entity8445 reduces plasma @entity1674 and raises high-density lipoprotein @entity165 (HDL-C) in adults and also reduces the incidence of @entity65 in adults. Its efficacy in improving lipid abnormalities has not been evaluated in @entity1 . OBJECTIVE: Our purpose was to investigate whether @entity8445 would lower @entity1674 and raise HDL-C with minimal adverse effects in a pediatric population with @entity209 . METHODS: We conducted a retrospective study of 47 pediatric @entity1 with @entity209 who started @entity8445 treatment, 1200 mg/day because of failure or lack of interest in therapeutic lifestyle changes. Eligibility required @entity1 to be younger than 21 years of age, and have pretreatment and on-treatment fasting lipid profiles. Data recorded included age at start of treatment, blood pressure, body mass index, waist circumference, percent body fat, total plasma @entity165 , HDL, low-density lipoprotein, @entity1674 , @entity493 aminotransferase, and @entity492 aminotransferase. Treatment duration was elapsed time between starting @entity8445 and the last clinic visit. RESULTS: Average age of the study cohort was 14 years and mean duration on medication was 249 days. Those @entity1 who had pretreatment and on-treatment plasma lipid data (33 of 47) were included in an analysis for efficacy. All 47 @entity1 were monitored for safety. Mean @entity1674 decreased by 57%: 426 (standard error of mean = 33.6) to 184 mg/dL (standard error of mean = 19) (P < 0.0001). Mean HDL increased by 20%: 35 to 42 mg/dL (P < 0.001). Body composition changes were insignificant, indicating that the lipid changes can be attributed to @entity8445 . Two of forty-seven @entity1 reported @entity925 from the drug, one of whom was considered to have had a possible adverse effect from the medication as indicated by @entity925 . CONCLUSION: @entity8445 significantly lowers @entity1674 and raises HDL with reasonable safety in a pediatric population with @entity209 .
