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  • S. Karger AG  (2)
  • Kreuter, Michael  (2)
  • Wuyts, Wim  (2)
  • 1
    In: Respiration, S. Karger AG, Vol. 96, No. 4 ( 2018), p. 314-322
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Diabetes mellitus is a possible risk factor for the development of idiopathic pulmonary fibrosis (IPF), yet the effect of antidiabetic therapy on the course of IPF is unknown. 〈 b 〉 〈 i 〉 Objectives: 〈 /i 〉 〈 /b 〉 This post hoc analysis assessed the effect of metformin on clinically relevant outcomes in patients with IPF. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 For the primary analysis, patients randomized to placebo ( 〈 i 〉 n 〈 /i 〉 = 624) in 3 phase 3, double-blind, controlled trials of pirfenidone (CAPACITY [NCT00287716 and NCT00287729]; ASCEND [NCT01366209] ) were categorized by baseline metformin use. The primary outcome was disease progression (forced vital capacity [FVC] decline ≥10%, 6-min walking distance [6MWD] decline ≥50 m, or death). Other outcomes included mortality, hospitalization, FVC decline (≥10 and ≥5%), and 6MWD decline. Outcomes were also assessed in patients with diabetes and/or hyperglycemia (impaired glucose tolerance [IGT] and diabetes population [IGT-diabetes population] ) and all patients included in the 3 studies (intention-to-treat [ITT] population). 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Overall, 71 (11.4%) patients were metformin users and 553 (88.6%) were nonmetformin users. Baseline data were similar between groups, except for a higher percentage of males (84.5 vs. 73.2%) and a history of diabetes (98.6 vs. 11.6%) in metformin users versus nonmetformin users. The unadjusted 1-year analyses demonstrated no significant differences in disease progression or other outcomes. A higher proportion of metformin users compared with nonmetformin users had a relative FVC decline of ≥5% (63.4 vs. 50.6%, 〈 i 〉 p 〈 /i 〉 = 0.043). Results were similar for the IGT-diabetes population and for the ITT population. Multivariable analyses yielded similar results. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 Metformin has no effect on clinically relevant outcomes in patients with IPF.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2018
    detail.hit.zdb_id: 1464419-8
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  • 2
    In: Respiration, S. Karger AG, Vol. 93, No. 6 ( 2017), p. 415-423
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Gastroesophageal reflux disease is a potential risk factor for idiopathic pulmonary fibrosis (IPF) progression; however, the impact of antacid therapy (AAT) is under debate. 〈 b 〉 〈 i 〉 Objective: 〈 /i 〉 〈 /b 〉 To evaluate the effect of AAT on IPF progression in pirfenidone-treated patients. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 This post hoc analysis included patients with IPF who received pirfenidone in 3 trials (CAPACITY [PIPF-004/PIPF-006] and ASCEND [PIPF-016] ). Pulmonary function, exercise tolerance, survival, hospitalizations, and adverse events (AEs) over 52 weeks were analyzed by baseline AAT use. Disease progression was defined as a decrease in forced vital capacity (FVC) of ≥10%, a decrease in 6-min walking distance of ≥50 m, or death over 1 year. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Of 623 patients, 44% received AAT. No significant differences were found at 52 weeks (AAT versus non-AAT, respectively) in disease progression (24.9 vs. 30.6%; 〈 i 〉 p 〈 /i 〉 = 0.12), all-cause mortality rate (2.9 vs. 4.0%; 〈 i 〉 p 〈 /i 〉 = 0.47), IPF-related mortality rate (1.1 vs. 2.0%; 〈 i 〉 p 〈 /i 〉 = 0.37), all-cause hospitalization rate (16.1 vs. 18.3%; 〈 i 〉 p 〈 /i 〉 = 0.48), or mean change in percent FVC (-2.7 vs. -3.1%; 〈 i 〉 p 〈 /i 〉 = 0.44). A relative, but not absolute, FVC decline of ≥10% favored AAT (15 vs. 22%; 〈 i 〉 p 〈 /i 〉 = 0.03). Severe gastrointestinal AEs (3.7 vs. 0.9%; 〈 i 〉 p 〈 /i 〉 = 0.015) and severe pulmonary infections (3.7 vs. 1.1%; 〈 i 〉 p 〈 /i 〉 = 0.035) were more frequent with AAT. 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 AAT and pirfenidone had outcomes comparable to those of pirfenidone alone in patients with IPF, underscoring the need for prospective trials to elucidate the role of AAT with or without antifibrotic drugs as a treatment for IPF.
    Type of Medium: Online Resource
    ISSN: 0025-7931 , 1423-0356
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2017
    detail.hit.zdb_id: 1464419-8
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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