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

Michael W. Konstan, Jeffrey S. Wagener, David J. Pasta, Stefanie J. Millar, Wayne J Morgan

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives 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.

Original languageEnglish (US)
Pages (from-to)529-536
Number of pages8
JournalPediatric Pulmonology
Volume49
Issue number6
DOIs
StatePublished - 2014

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Tobramycin
Forced Expiratory Volume
Cystic Fibrosis
Inhalation
Epidemiologic Studies
Therapeutics
Patient Care

Keywords

  • cystic fibrosis
  • epidemiology
  • pulmonary function
  • tobramycin inhalation solution

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Clinical use of tobramycin inhalation solution (TOBI®) shows sustained improvement in FEV1 in cystic fibrosis. / Konstan, Michael W.; Wagener, Jeffrey S.; Pasta, David J.; Millar, Stefanie J.; Morgan, Wayne J.

In: Pediatric Pulmonology, Vol. 49, No. 6, 2014, p. 529-536.

Research output: Contribution to journalArticle

Konstan, Michael W. ; Wagener, Jeffrey S. ; Pasta, David J. ; Millar, Stefanie J. ; Morgan, Wayne J. / Clinical use of tobramycin inhalation solution (TOBI®) shows sustained improvement in FEV1 in cystic fibrosis. In: Pediatric Pulmonology. 2014 ; Vol. 49, No. 6. pp. 529-536.
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abstract = "Objectives Tobramycin inhalation solution (TIS; TOBI{\circledR}) 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.",
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AU - Konstan, Michael W.

AU - Wagener, Jeffrey S.

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AU - Millar, Stefanie J.

AU - Morgan, Wayne J

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N2 - Objectives 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.

AB - Objectives 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.

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KW - epidemiology

KW - pulmonary function

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