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LABA/LAMA versus LABA/ICS fixed-dose combinations in the prevention of COPD exacerbations: a modeling analysis of literature aggregate data.

Objectives: This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) and LABA/inhaled corticosteroid (ICS) fixed-dose combinations (FDCs) in preventing moderate or severe chronic obstructive pulmonary disease (COPD)...

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Published in:European Journal of Clinical Pharmacology Vol. 79; no. 10; pp. 1321 - 1333
Main Authors: Gong, Yiwen, Sui, Zichao, Lv, Yinghua, Zheng, Qingshan, Li, Lujin
Format: equations & formulas meta analysis research systematic review tables/charts Journal Article
Published: Springer Nature Oct2023
Online Access:View this record in EBSCOhost
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      dt: Oct2023
      vid: 79
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00228-023-03543-y
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        atl: LABA/LAMA versus LABA/ICS fixed-dose combinations in the prevention of COPD exacerbations: a modeling analysis of literature aggregate data.
      aug:
        au:
          Gong, Yiwen
          Sui, Zichao
          Lv, Yinghua
          Zheng, Qingshan
          Li, Lujin
        affil: Center for Drug Clinical Evaluation Shanghai, University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, China
      sug:
        subj:
          Pulmonary Disease, Chronic Obstructive Drug Therapy
          Adrenergic beta-Agonists Administration and Dosage
          Muscarinic Antagonists Administration and Dosage
          Adrenal Cortex Hormones Administration and Dosage
          Drug Combinations
          Disease Exacerbation Prevention and Control
          Drug Efficacy Evaluation
          Patient Safety Evaluation
          Human
          Male
          Female
          Adverse Health Care Event
          Pneumonia Risk Factors
          Descriptive Statistics
          Forced Expiratory Volume
          Budesonide
          Indacaterol
          Fluticasone
          Salmeterol
          Funding Source
          Systematic Review
          Meta Analysis
          Male
          Female
      ab: Objectives: This study aimed to quantitatively compare the efficacy and safety of long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) and LABA/inhaled corticosteroid (ICS) fixed-dose combinations (FDCs) in preventing moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations. Methods: A literature search was performed using public databases. The time course characteristics of the probability of a moderate or severe exacerbation in stable COPD patients treated with LABA/LAMA and LABA/ICS FDCs were described by the parametric survival function. A random-effects model in a single-arm meta-analysis was used to analyze the incidence of serious adverse events (SAEs) and pneumonia. Results: Twenty studies including 23,955 participants were included. The proportion of participants with a history of COPD exacerbation (%) in the previous year and the postbronchodilator forced expiratory volume in the first second (FEV1) (%predicted) were important factors affecting drug efficacy. After adjusting the above factors to median levels of 100% and 45.5%, respectively, the moderate or severe exacerbation rates at 52 weeks for olodaterol/tiotropium, formoterol/budesonide, indacaterol/glycopyrronium, formoterol/glycopyrronium, vilanterol/fluticasone, salmeterol/fluticasone, and vilanterol/umeclidinium were 38.3%, 41.0%, 42.6%, 47.0%, 47.5%, 47.9%, and 53.0%, respectively. In terms of safety, significant differences were observed among drugs containing different LABA/LAMA FDCs. Conclusions: This study showed that not all LABA/LAMA FDCs were superior to LABA/ICS FDCs in safety and in preventing moderate or severe exacerbations in patients with stable COPD, providing important quantitative information for COPD-related guidelines.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        meta analysis
        research
        systematic review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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