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Inhaled corticosteroid withdrawal may improve outcomes in elderly patients with COPD exacerbation: a nationwide database study

Taisuke Jo, Hideo Yasunaga, Yasuhiro Yamauchi, Akihisa Mitani, Yoshihisa Hiraishi, Wakae Hasegawa, Yukiyo Sakamoto, Hiroki Matsui, Kiyohide Fushimi, Takahide Nagase
ERJ Open Research 2020 6: 00246-2019; DOI: 10.1183/23120541.00246-2019
Taisuke Jo
1Dept of Health Services Research, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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  • ORCID record for Taisuke Jo
Hideo Yasunaga
3Dept of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
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Yasuhiro Yamauchi
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Akihisa Mitani
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Yoshihisa Hiraishi
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Wakae Hasegawa
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Yukiyo Sakamoto
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Hiroki Matsui
3Dept of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
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Kiyohide Fushimi
4Dept of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan
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Takahide Nagase
2Dept of Respiratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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  • For correspondence: jo-taisuke@umin.ac.jp
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  • FIGURE 1
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    FIGURE 1

    Schematic diagram of study groupings. a) Study schematic showing each period evaluated in the study. Variables defining patient characteristics and comorbidities were obtained from the hospitalisation for COPD exacerbation, outpatient data, and data from prior hospitalisations. The outcomes were re-hospitalisation or death and incidences of prescriptions at 30 days and 1 year after the hospitalisation. The ICS withdrawal group was identified by discontinuation of the prescription during and after the hospitalisation for COPD exacerbation. b) Flow diagram of the study patients. LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid.

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    FIGURE 2

    Cumulative hazard curves for hospitalisation for re-exacerbation or death after hospitalisation for exacerbation in patients with chronic obstructive pulmonary disease (COPD) aged ≥65 years with or without inhaled corticosteroid (ICS) withdrawal. Results for a) 1–2 propensity score-matched population; and b) stabilised inverse probability weighted population.

Tables

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  • Supplementary Materials
  • TABLE 1

    Baseline characteristics of patients with COPD with and without inhaled corticosteroid (ICS) withdrawal, before and after 1–2 propensity score (PS) matching and after stabilised inverse probability weighting (IPTW)

    CharacteristicAll patients1–2 PS matchingStabilised IPTW
    ICS withdrawal (n=971)Control (n=2764)smdICS withdrawal (n=904)Control (n=1808)smdICS withdrawal (n=872)Control (n=2591)smd
    Males84.0%79.0%−12.9%84.0%82.0%−5.6%80.0%81.0%0.7%
    Fiscal year
     20104.1%10.1%−23.6%4.1%3.9%1.1%7.3%8.3%−3.4%
     20119.4%17.0%−22.6%9.4%8.7%2.5%16.8%14.6%6.0%
     201213.8%20.2%−16.9%13.8%12.9%2.8%18.7%17.8%2.4%
     201318.3%18.4%−0.4%18.3%20.7%−6.3%16.3%18.6%−5.9%
     201425.0%19.9%12.4%25.0%25.2%−0.5%21.4%22.2%−1.9%
     201529.4%14.5%36.8%29.4%28.6%1.8%19.4%18.6%2.1%
    Season at admission
     Spring23.7%24.9%−2.8%23.7%24.3%−1.4%23.6%24.0%−1.0%
     Summer24.4%22.2%5.4%24.4%25.1%−1.5%23.3%23.3%0.1%
     Autumn24.4%23.1%3.1%24.4%24.8%−0.8%24.2%24.2%0.1%
     Winter27.4%29.8%−5.3%27.4%25.8%3.6%28.9%28.5%0.8%
    Residential region
     Hokkaido and Tohoku10.1%10.6%−1.8%10.1%10.2%−0.5%8.8%10.8%−6.6%
     Kanto30.6%35.6%−10.6%30.6%29.9%1.7%36.2%34.1%4.5%
     Chubu15.7%15.7%0.0%15.7%14.8%2.5%13.9%15.2%−3.7%
     Kansai16.0%16.0%0.2%16.0%16.1%−0.2%14.6%15.4%2.1%
     Chugoku, Shikoku, Kyushu and Okinawa27.5%22.0%12.8%27.5%29.0%−3.2%26.4%24.5%4.3%
    Hugh–Jones dyspnoea score at admission
     110.8%9.5%4.3%10.8%11.2%−1.2%9.6%9.5%0.2%
     2–333.7%32.2%3.2%33.7%30.9%6.0%32.7%32.7%0.0%
     4–545.7%51.8%−12.3%45.7%48.2%−5.1%50.9%50.3%1.2%
     Missing9.7%6.4%12.2%9.7%9.6%0.4%6.8%7.5%−2.6%
    ADL at admission (Barthel Index score)
     10037.1%37.9%−1.7%37.1%35.0%4.3%35.4%37.4%−4.1%
     0–9049.0%46.4%5.2%49.0%50.8%−3.7%48.4%47.6%1.5%
     Missing13.9%15.7%−5.0%13.9%14.2%−0.6%16.2%15.0%3.4%
    ADL at discharge (Barthel Index score)
     10055.4%62.4%−14.3%55.4%53.4%4.1%57.8%59.8%−4.0%
     0–9036.0%29.8%13.2%36.0%36.7%−1.6%34.7%31.9%6.1%
     Missing8.6%7.8%3.1%8.6%9.9%−4.4%7.4%8.3%−3.2%
    Smoking index
     200–5999.0%9.8%−2.8%9.0%7.5%5.2%8.9%9.3%−1.2%
     ≥60049.4%48.3%2.3%49.4%49.8%−0.7%48.3%49.3%−2.1%
     Missing41.6%41.9%−0.7%41.6%42.7%−2.2%42.8%41.4%2.9%
    Age years77.8±7.076.9±6.613.977.8±7.078.1±6.9−4.277.5±7.177.2±6.70.4
    Body mass index kg·m−220.5±3.921.3±4.0−19.920.5±3.920.3±3.73.420.8±4.121.0±4.0−4.1
    Frequency of hospitalisation before hospitalisation for COPD exacerbation0.84±1.30.59±1.218.50.84±1.30.98±2.1−8.10.83±1.20.77±1.64.4
    Observation period before hospitalisation for COPD exacerbation days1055.4±574.0847.0±571.335.91058.2±576.71055.4±610.10.5912.7±567.4913.9±587.4−0.2

    Data are presented as mean±sd unless otherwise stated. smd: standardised mean difference; ADL: activities of daily living.

    • TABLE 2

      Comorbidities during hospitalisation and treatments for COPD with and without inhaled corticosteroid (ICS) withdrawal, before and after 1–2 propensity score (PS) matching and after stabilised inverse probability weighting (IPTW)

      All patients1–2 PS matchingStabilised IPTW
      ICS withdrawal (n=971) ×100Control (n=2764) ×100smdICS withdrawal (n=904) ×100Control (n=1808) ×100smdICS withdrawal (n=872) ×100Control (n=2591) ×100smd
      Comorbidity
       Lung cancer0.14%0.08%16.8%0.14%0.14%−0.2%0.12%0.11%3.9%
       Other malignancy0.10%0.07%12.5%0.10%0.11%−2.2%0.08%0.08%−1.1%
       Diabetes/abnormal glucose tolerance0.21%0.22%−2.4%0.21%0.22%−3.5%0.27%0.22%11.5%
       Bone fracture/osteoporosis0.06%0.07%−2.1%0.06%0.07%−4.0%0.05%0.07%−4.7%
       Interstitial pneumonia0.11%0.05%24.5%0.11%0.11%−0.9%0.07%0.07%2.6%
       Bronchial asthma0.37%0.66%−61.0%0.37%0.39%−4.6%0.58%0.58%−0.2%
       Bronchiectasis0.24%0.22%4.2%0.24%0.21%7.2%0.22%0.22%−0.6%
       Pneumothorax0.04%0.03%3.1%0.04%0.04%−2.6%0.04%0.03%1.6%
       Pulmonary thromboembolism0.00%0.01%3.8%0.00%0.00%4.7%0.01%0.01%−0.2%
       Mycobacterium infection0.02%0.01%10.9%0.02%0.02%2.6%0.01%0.01%−0.5%
       Mycotic infection0.02%0.02%0.6%0.02%0.03%−6.5%0.02%0.02%−1.7%
       Cor pulmonale0.02%0.02%2.2%0.02%0.02%−0.8%0.02%0.02%0.7%
       Congestive heart failure0.21%0.22%−0.8%0.21%0.20%2.9%0.22%0.22%0.2%
       Ischaemic heart disease0.14%0.14%1.8%0.14%0.14%−0.3%0.17%0.14%9.6%
       Tachycardia0.11%0.10%3.8%0.11%0.11%1.1%0.11%0.10%0.5%
       Autoimmune disease0.04%0.03%7.5%0.04%0.05%5.0%0.03%0.03%1.2%
       Stroke0.03%0.02%5.0%0.03%0.03%−0.3%0.02%0.03%−1.5%
       Liver dysfunction0.03%0.02%5.3%0.03%0.05%−9.2%0.03%0.03%0.7%
       Renal failure0.04%0.03%5.2%0.04%0.05%−2.4%0.03%0.03%−1.6%
       GORD0.19%0.22%−6.9%0.19%0.22%−5.9%0.23%0.23%0.4%
       Constipation or ileus0.17%0.15%4.6%0.17%0.16%1.9%0.20%0.16%11.2%
       Prostate hypertrophy0.11%0.10%3.7%0.11%0.10%4.5%0.10%0.10%−1.1%
      Treatment, categorical data
      Before hospitalisation
       Home ventilatory support0.02%0.02%−0.3%0.02%0.02%0.8%0.03%0.02%5.9%
       Home oxygen therapy0.25%0.29%−9.3%0.25%0.24%0.8%0.29%0.28%2.5%
       Both LAMAs and LABAs0.24%0.20%8.3%0.24%0.24%−1.3%0.24%0.22%4.8%
       LAMAs only0.58%0.67%−17.4%0.58%0.59%−0.6%0.64%0.65%−1.6%
       LABAs only0.46%0.36%20.7%0.46%0.47%−2.3%0.42%0.40%5.4%
       SABAs or SAMAs0.43%0.56%−27.2%0.43%0.44%−2.0%0.54%0.51%5.5%
       Theophylline0.32%0.47%−31.2%0.32%0.33%−0.5%0.45%0.43%4.6%
       Expectorants0.75%0.76%−1.9%0.75%0.74%1.5%0.71%0.75%−9.2%
       Antibiotic prescriptions per 30 days0.23%0.31%−11.9%0.23%0.20%5.0%0.26%0.28%−2.8%
       Macrolides per 30 days0.11%0.19%−19.4%0.11%0.09%8.6%0.14%0.16%−5.2%
       TMP/SMX combination per 30 days0.03%0.02%4.5%0.03%0.02%4.2%0.02%0.02%−2.0%
       Anti-MRSA drugs per 30 days0.00%0.00%5.5%0.00%0.00%2.4%0.00%0.00%1.5%
       Antifungal agent per 30 days0.00%0.00%−0.9%0.00%0.00%−2.8%0.00%0.00%−0.6%
       Medication for influenza per 30 days0.00%0.00%−3.6%0.00%0.00%−2.5%0.00%0.00%−0.0%
       Oral corticosteroids per 30 days0.10%0.18%−15.8%0.10%0.09%3.1%0.15%0.16%−1.6%
       i.v. corticosteroids per 30 days0.06%0.13%−14.3%0.06%0.07%−3.7%0.10%0.11%−2.3%
      At and during hospitalisation
       Ambulance transport0.22%0.23%−1.7%0.22%0.21%4.4%0.21%0.23%−4.2%
       ICU admission0.01%0.02%−6.1%0.01%0.02%−4.6%0.02%0.03%−1.4%
       Corticosteroids0.37%0.58%−41.8%0.37%0.38%−1.8%0.50%0.52%−3.8%
       Aminoglycosides0.01%0.01%−2.6%0.01%0.01%−3.4%0.01%0.01%−2.4%
       Carbapenems0.13%0.13%0.9%0.13%0.14%−2.6%0.14%0.13%2.3%
       Anti-MRSA drugs0.02%0.01%6.8%0.02%0.03%−2.1%0.03%0.02%8.2%
       Macrolides0.24%0.33%−22.1%0.24%0.23%2.4%0.29%0.30%−2.2%
       Fluoroquinolones0.29%0.31%−3.3%0.29%0.28%2.3%0.30%0.30%−0.8%
       Mechanical ventilation0.06%0.06%−0.6%0.06%0.07%−4.3%0.08%0.07%5.9%
       Haemodialysis0.01%0.01%4.6%0.01%0.01%3.0%0.01%0.01%−1.2%
       Nasal tube feeding0.02%0.01%7.2%0.02%0.01%1.3%0.02%0.01%7.2%
       Surgery under general anaesthesia0.00%0.00%−1.6%0.00%0.00%6.3%0.00%0.00%−2.8%
       Prescription of LABAs/LAMAs0.05%0.01%25.7%0.05%0.05%0.0%0.02%0.02%−0.9%
       Prescription of LAMAs0.24%0.60%−77.3%0.24%0.25%−1.0%0.25%0.22%7.7%
       Prescription of LABAs0.26%0.19%16.9%0.26%0.27%−2.6%0.49%0.50%−1.1%
       Discharge to home0.92%0.97%−22.8%0.92%0.91%4.0%0.95%0.95%0.8%
      Treatment, numerical dataMean±sdMean±sdMean±sdMean±sdMean±sdMean±sd
      Length of stay days19.3±20.019.3±15.91.719.4±20.319.9±14.2−2.920.0±21.419.4±15.33.7

      smd: standardised mean difference; GORD: gastro-oesophageal reflux disease; LAMA: long-acting muscarinic antagonist; LABA: long-acting β2-agonist; SABA: short-acting β2-agonist; SAMA: short-acting muscarinic antagonist; TMP/SMX: trimethoprim/sulfamethoxazole; MSRA: methicillin-resistant Staphylococcus aureus; ICU: intensive care unit.

      • TABLE 3

        Hazard ratios (HRs) and 95% confidence intervals of re-hospitalisation for COPD exacerbation or death after 1–2 propensity score (PS) matching and stabilised inverse probability weighting (IPTW) in the inhaled corticosteroid (ICS) withdrawal group versus the control group

        Re-hospitalisation or death
        Study populationICS withdrawalControlHR (95% CI)p-value
        1–2 PS matchingAll90418080.65 (0.52–0.80)<0.001
        Comorbid asthma3306840.67 (0.50–0.91)0.010
        Without asthma57411240.68 (0.51–0.90)0.008
        Stabilised IPTWAll83526210.71 (0.56–0.90)0.005
        Comorbid asthma48115130.82 (0.57–1.18)0.294
        Without asthma35311080.58 (0.45–0.75)<0.001
      • TABLE 4

        Incident rate ratios (IRRs) and 95% confidence intervals of post-discharge frequency of outpatient antimicrobial and corticosteroid prescriptions after 1–2 propensity score (PS) matching and stabilised inverse probability weighting (IPTW) in the inhaled corticosteroid (ICS) withdrawal group versus the control group

        Observation periodPrescriptionIRR (95% CI)p-value
        1–2 PS matching30 daysAntimicrobials0.94 (0.73–1.23)0.668
        Corticosteroids0.97 (0.72–1.31)0.856
        1 yearAntimicrobials0.78 (0.63–0.98)0.029
        Corticosteroids0.78 (0.60–1.02)0.067
        Stabilised IPTW30 daysAntimicrobials0.90 (0.63–1.31)0.598
        Corticosteroids1.06 (0.76–1.47)0.733
        1 yearAntimicrobials0.65 (0.51–0.83)0.001
        Corticosteroids0.76 (0.56–1.02)0.065

      Supplementary Materials

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        Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

        Supplementary tables 00246-2019.supptables

        FIGURE S1 Cumulative hazard curves for hospitalization for re-exacerbation or death after hospitalization for exacerbation in patients with chronic obstructive pulmonary disease (COPD) aged ≥65 years with or without ICS withdrawal. Results for (A) 1-to-2 propensity score-matched population; and (B) stabilized inverse probability of treatment weighted population. ICS, inhaled corticosteroids 00246-2019.figureS1

        FIGURE S2 Cumulative hazard curves for hospitalization for re-exacerbation or death after hospitalization for exacerbation in patients with chronic obstructive pulmonary disease (COPD) aged ≥40 years with or without ICS withdrawal. Results for the 1-to-2 propensity score-matched population are shown. (A) All patients. (B) Patients aged ≥70 years. (C) Patients aged <70 years. ICS: inhaled corticosteroids 00246-2019.figureS2

        FIGURE S3 Cumulative hazard curves for hospitalization for re-exacerbation or death after hospitalization for exacerbation in patients with chronic obstructive pulmonary disease (COPD) aged ≥40 years with or without ICS withdrawal. Results for the stabilized inverse probability of treatment weighted population are shown. (A) All patients. (B) Patients aged ≥70 years. (C) Patients aged <70 years. ICS: inhaled corticosteroids 00246-2019.figureS3

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      Inhaled corticosteroid withdrawal may improve outcomes in elderly patients with COPD exacerbation: a nationwide database study
      Taisuke Jo, Hideo Yasunaga, Yasuhiro Yamauchi, Akihisa Mitani, Yoshihisa Hiraishi, Wakae Hasegawa, Yukiyo Sakamoto, Hiroki Matsui, Kiyohide Fushimi, Takahide Nagase
      ERJ Open Research Jan 2020, 6 (1) 00246-2019; DOI: 10.1183/23120541.00246-2019

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      Inhaled corticosteroid withdrawal may improve outcomes in elderly patients with COPD exacerbation: a nationwide database study
      Taisuke Jo, Hideo Yasunaga, Yasuhiro Yamauchi, Akihisa Mitani, Yoshihisa Hiraishi, Wakae Hasegawa, Yukiyo Sakamoto, Hiroki Matsui, Kiyohide Fushimi, Takahide Nagase
      ERJ Open Research Jan 2020, 6 (1) 00246-2019; DOI: 10.1183/23120541.00246-2019
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