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To minimize the systemic effects of orally inhaled corticosteroids, including FLOVENT DISKUS, each patient should be titrated to the lowest dose that effectively controls his/her symptoms. A 52-week, placebo-controlled study to assess the potential growth effects of fluticasone propionate inhalation powder at 50 and 100 mcg twice daily was conducted in the US in 325 prepubescent children (244 males and 81 females) 4 to 11 years of age. The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (n = 76), 6.07 cm/year in the 50-mcg group (n = 98), and 5.66 cm/year in the 100-mcg group (n = 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the study revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). The clinical significance of these growth data is not certain. In children 8.5 years of age, the mean age of children in this study, the range for expected growth velocity is: boys – 3 rd percentile = 3.8 cm/year, 50 th percentile = 5.4 cm/year, and 97 th FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg) 15 percentile = 7.0 cm/year; girls – 3 rd percentile = 4.2 cm/year, 50 th percentile =5.7 cm/year, and 97 th percentile = 7.3 cm/year. Geriatric Use: Text Continues Below
Safety data have been collected on 280 patients (FLOVENT DISKUS n = 83, FLOVENT ® ROTADISK ® n = 197) 65 years of age or older and 33 patients (FLOVENT DISKUS n = 14, FLOVENT ROTADISK n = 19) 75 years of age or older who have been treated with fluticasone propionate inhalation powder in US and non-US clinical trials. There were no differences in adverse reactions compared to those reported by younger patients. In addition, there were no apparent differences in efficacy between patients 65 years of age or older and younger patients. Fifteen patients 65 years of age or older and 1 patient 75 years of age or older were included in the efficacy evaluation of US clinical studies. Page: << Prev | 1 | 2 | 3 | 4 | 5
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