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

AbstractOBJECTIVES:
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.
METHODS:
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.
RESULTS:
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 < 0.001). Change in slope was not different between groups (0.06, P = 0.82).
CONCLUSIONS:
Initiating chronic TIS therapy in the routine clinical care of patients with CF was associated with improvement in FEV1 % pred but no change in rate of decline, which means that this benefit was sustained over the 2 years studied.
AuthorsMichael W Konstan, Jeffrey S Wagener, David J Pasta, Stefanie J Millar, Wayne J Morgan
JournalPediatric pulmonology (Pediatr Pulmonol) Vol. 49 Issue 6 Pg. 529-36 (Jun 2014) ISSN: 1099-0496 [Electronic] United States
PMID24019211 (Publication Type: Journal Article)
Copyright© 2013 Wiley Periodicals, Inc.
Chemical References
  • Anti-Bacterial Agents
  • Tobramycin
Topics
  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents (administration & dosage)
  • Child
  • Cystic Fibrosis (drug therapy, physiopathology)
  • Female
  • Forced Expiratory Volume (physiology)
  • Humans
  • Male
  • Tobramycin (administration & dosage)
  • Treatment Outcome
  • Young Adult

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