Clinical use of tobramycin inhalation solution (TOBI®) shows sustained improvement in FEV1 in cystic fibrosis. Issue 6 (9th September 2013)

• Record Type: Journal Article
• Authors: Konstan, Michael W.; Wagener, Jeffrey S.; Pasta, David J.; Millar, Stefanie J.; Morgan, Wayne J.
• Is Part Of: Pediatric pulmonology. Volume 49:Issue 6(2014:Jun.)
• Page Start: 529
• Page End: 536
• Publication Date: 2013-09-09
• Subjects: Pediatric respiratory diseases -- Periodicals; Pediatrics -- Periodicals; 618.922
• DOI: 10.1002/ppul.22874
• Languages: English
• ISSNs: 8755-6863

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Summary</title> <sec id="ppul22874-sec-0001" sec-type="section"> <title>Objectives</title> <p>Tobramycin inhalation solution (TIS; TOBI®) has improved forced expiratory volume in 1 sec (FEV<sub>1</sub>) in cystic fibrosis (CF) trials. Using data from the Epidemiologic Study of CF (ESCF), we assessed the change in level and trend of FEV<sub>1</sub> % predicted (pred) over a 2‐year period associated with initiation of TIS during routine clinical practice.</p> </sec> <sec id="ppul22874-sec-0002" sec-type="section"> <title>Methods</title> <p>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 FEV<sub>1</sub> % pred before and after the index using a piecewise linear mixed‐effects model adjusted for potential confounders.</p> </sec> <sec id="ppul22874-sec-0003" sec-type="section"> <title>Results</title> <p>During the 2‐year pre‐index period the C‐TIS group (n = 2, 534) had a more rapid decline in FEV<sub>1</sub> (−2.49% vs. −1.39% pred/year) and a lower FEV<sub>1</sub> at index (62.6% vs. 74.7% pred) than the comparator group (N = 17, 656 intervals). After starting chronic TIS, the FEV<sub>1</sub> trend line over the 2‐year post‐index period was higher, but the comparator group's FEV<sub>1</sub> was essentially unchanged (difference 2.22, <italic>P </italic>< 0.001). Change in slope was not different between groups (0.06, <italic>P </italic>= 0.82).</p> </sec> <sec id="ppul22874-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Initiating chronic TIS therapy in the routine clinical care of patients with CF was associated with improvement in FEV<sub>1</sub> % pred but no change in rate of decline, which means that this benefit was sustained over the 2 years studied. <bold>Pediatr Pulmonol. 2014; 49:529–536.</bold> © 2013 Wiley Periodicals, Inc.</p> </sec> </abstract>