SESSION TITLE: Hot Topics in Pediatic Pulmonology
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: Tobramycin Inhalation Powder (TIP; 112 mg BID) has been shown to improve lung function vs. placebo (EVOLVE) and significantly reduce administration time vs. Tobramycin inhalation solution (TIS; 300 mg BID; EAGER) in patients (pts) with cystic fibrosis (CF) & Pseudomonas aeruginosa (Pa) infection. We report the rate of hospitalizations due to respiratory events from 2-placebo controlled trials (EVOLVE and EDIT) & one comparative trial vs. TIS (EAGER).
METHODS: Two trials were randomized double-blind (28 days-on; 28 days-off) multicenter studies in CF pts (age 6-21) with Pa infection & FEV1 25%-80% predicted receiving TIP (EVOLVE, n=46; EDIT, n=32) or placebo (EVOLVE, n=49; EDIT, n=30). EAGER was a 3-cycle open-label trial of TIP vs. TIS in CF pts ≥6 years & FEV1 25% -75% predicted; randomized 3:2 to TIP (n=308) or TIS (n=209). Hospitalization for respiratory-related events was a secondary or exploratory end point in the 3 studies.
RESULTS: All pts in EVOLVE & EDIT and 30% of EAGER pts were < 22 years. In both placebo-controlled trials, no pts in the TIP arm were hospitalized due to respiratory events during cycle-1, whereas 6 (12.2%) & 1 (3.3%) placebo pts were hospitalized, with mean length of stay of 12.3 and 10 days (d) in EVOLVE & EDIT respectively. In EAGER, hospitalization rates over 3-cycles were similar for TIP & TIS (24.4% vs. 22.0%, treatment difference: 2.3% [-5.2%, 9.6%] p=0.54), with mean duration of 10d & 13d.
CONCLUSIONS: TIP significantly reduced hospitalization rates due to respiratory events compared with placebo. Hospitalization rates were higher in EAGER in both TIP & TIS arms than in EVOLVE & EDIT (possibly due to observation time: 1-cycle for EVOLVE & EDIT vs. 3-cycle for EAGER and likely due to higher % of adults in EAGER); however rates were similar between TIP & TIS.
CLINICAL IMPLICATIONS: In CF patients, TIS and TIP provide similar reductions in rate of hospitalizations due to respiratory events.
DISCLOSURE: Stanley Fiel: Grant monies (from industry related sources): Novartis,CFF, MPEX,Gilead, Vertex, Consultant fee, speaker bureau, advisory committee, etc.: Consultant at Novartis, Bayer, Pfizer, Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: speakers bureau- Pfizer, Genetech, Novartis, Gilead, GSK, Dey Samya Nasr: Consultant fee, speaker bureau, advisory committee, etc.: Consultant Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Speaker bureau-Gilead, Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Advisory Committee-Gilead, Genentech, Grant monies (from industry related sources): Researcher-Vertex, Gilead, Mpex, Hologic, , Grant monies (from sources other than industry): Researcher-CFF Robert Wan: Employee: Novartis Pharmaceuticals Corporation Gerhild Angyalosi: Employee: Novartis Pharma AG Florian Brockhaus: Employee: Novartis Pharma AG Robert Maykut: Employee: Novartis Pharma AG Anthony Yadao: Employee: Novartis Pharmaceuticals Corporation
Tobramycin Inhalation Powder (TOBI® Podhaler)was approved by US FDA on 22 March 2013.