Lung Safety: TS non-inferior to normal treatment

[mnholdem]

pdfs.semanticscholar.org/fa41/680938d9878c73cbbb55440763ac042c5df6.pdf

Excerpt:

Results: Baseline demographics and pulmonary function were similar between diabetes treatment groups. Lung function declined from baseline in all groups. TI was non-inferior to usual care for mean change in FEV1 from baseline to month 24 [mean (s.e.m.) 0.037 (0.0119) l; 95% CI 0.014 to 0.060] using mixed-model repeated-measure with a pre-specified non-inferiority margin of 50 ml/year. After a greater initial decline at month 3 with TI, rate of change (slope) in FEV1, FVC and DLCO (months 3–24) was not statistically different between treatment groups. TI was well tolerated; no serious safety concerns emerged. The most common respiratory event associated with TI was mild, transient cough, occurring within minutes of inhalation.

[Reprint from 2011]

[brotherm1]

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