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Clinical use of tobramycin inhalation solution (TOBI®) shows sustained improvement in FEV1 in cystic fibrosis.


ABSTRACT: Tobramycin inhalation solution (TIS; TOBI®) has improved forced expiratory volume in 1?sec (FEV1 ) in cystic fibrosis (CF) trials. Using data from the Epidemiologic Study of CF (ESCF), we assessed the change in level and trend of FEV1 % predicted (pred) over a 2-year period associated with initiation of TIS during routine clinical practice.Patients age 8-38 years and in ESCF for ?2 years before treatment with TIS as a chronic therapy were selected if they remained on therapy for 2 years, defined as being on TIS for at least 3 months per year (C-TIS group). Comparator intervals age 8-38 years used TIS <10% of the time. For each interval, we estimated the level and trend (rate of decline) in FEV1 % pred before and after the index using a piecewise linear mixed-effects model adjusted for potential confounders.During the 2-year pre-index period the C-TIS group (n?=?2,534) had a more rapid decline in FEV1 (-2.49% vs. -1.39% pred/year) and a lower FEV1 at index (62.6% vs. 74.7% pred) than the comparator group (N?=?17,656 intervals). After starting chronic TIS, the FEV1 trend line over the 2-year post-index period was higher, but the comparator group's FEV1 was essentially unchanged (difference 2.22, P?

SUBMITTER: Konstan MW 

PROVIDER: S-EPMC4038134 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Clinical use of tobramycin inhalation solution (TOBI®) shows sustained improvement in FEV1 in cystic fibrosis.

Konstan Michael W MW   Wagener Jeffrey S JS   Pasta David J DJ   Millar Stefanie J SJ   Morgan Wayne J WJ  

Pediatric pulmonology 20130909 6


<h4>Objectives</h4>Tobramycin inhalation solution (TIS; TOBI®) has improved forced expiratory volume in 1 sec (FEV1 ) in cystic fibrosis (CF) trials. Using data from the Epidemiologic Study of CF (ESCF), we assessed the change in level and trend of FEV1 % predicted (pred) over a 2-year period associated with initiation of TIS during routine clinical practice.<h4>Methods</h4>Patients age 8-38 years and in ESCF for ≥2 years before treatment with TIS as a chronic therapy were selected if they remai  ...[more]

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