Metformin does not affect clinically relevant outcomes in patients with idiopathic pulmonary fibrosis / Paolo Spagnolo, Michael Kreuter, Toby M. Maher, Wim Wuyts, Francesco Bonella, Tamera J. Corte, Stefan Kopf, Derek Weycker, Klaus-Uwe Kirchgaessler, Christopher J. Ryerson
BACKGROUND: 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. - OBJECTIVES: This post hoc analysis assessed the effect of metformin on clinically relevant outcomes in patients with IPF. - METHODS: For the primary analysis, patients randomized to placebo (n = 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). - RESULTS: 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%, p = 0.043). Results were similar for the IGT-diabetes population and for the ITT population. Multivariable analyses yielded similar results. - CONCLUSIONS: Metformin has no effect on clinically relevant outcomes in patients with IPF..
Medienart: |
E-Artikel |
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Erscheinungsjahr: |
October 2018 2018 |
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Erschienen: |
October 2018 |
Enthalten in: |
Zur Gesamtaufnahme - volume:96 |
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Enthalten in: |
Respiration - 96(2018), 4, Seite 314-322 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Spagnolo, Paolo [VerfasserIn] |
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Links: |
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Anmerkungen: |
Gesehen am 01.04.2020 |
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Umfang: |
9 |
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doi: |
10.1159/000489668 |
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funding: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
1693710153 |
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245 | 1 | 0 | |a Metformin does not affect clinically relevant outcomes in patients with idiopathic pulmonary fibrosis |c Paolo Spagnolo, Michael Kreuter, Toby M. Maher, Wim Wuyts, Francesco Bonella, Tamera J. Corte, Stefan Kopf, Derek Weycker, Klaus-Uwe Kirchgaessler, Christopher J. Ryerson |
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520 | |a BACKGROUND: 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. - OBJECTIVES: This post hoc analysis assessed the effect of metformin on clinically relevant outcomes in patients with IPF. - METHODS: For the primary analysis, patients randomized to placebo (n = 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). - RESULTS: 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%, p = 0.043). Results were similar for the IGT-diabetes population and for the ITT population. Multivariable analyses yielded similar results. - CONCLUSIONS: Metformin has no effect on clinically relevant outcomes in patients with IPF. | ||
650 | 4 | |a Aged | |
650 | 4 | |a Anti-Inflammatory Agents, Non-Steroidal | |
650 | 4 | |a Diabetes mellitus | |
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