Clinical characteristics, use and switch of drugs for obstructive airway diseases among patients with COPD experiencing an exacerbation: a retrospective analysis of Italian administrative healthcare data

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease
• Additional medical condition(s):
  Exacerbations of chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  From the ReS database, including Italian inhabitants and beneficiaries of the SSN, patients aged ≥ 45 years, variously distributed throughout northern, central and southern Italy, and with at least 6 years of look-back period (i.e., analysed until 2013) were identified. ; The study population was categorized according to the first treatment strategy for COPD dispensed in the accrual periods into the following cohorts: patients treated with TT (SI or MI), DT (SI or MI), other treatment strategy with drugs for obstructive airway diseases.
• Age groups:
  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  Patients aged ≥ 45 years with COPD were identified in 2019 and in 2020. ; A look-back (until 2014) was required. Different groups by dispensed treatment strategy for COPD were analysed in 1 year before index to assess exacerbations and in 1 year before exacerbation to assess eventual therapy switch
• Main study objective:
  This descriptive retrospective observational cohort study of Italian administrative healthcare data aimed to identify patients with COPD and describe them in terms of treatment approach in 2019 and 2020, and how treatment strategies changed following an acute exacerbation, in the light of the GOLD guidelines of the time and soon after the marketing and reimbursement in Italy of the SI-TT.
• Setting:
  Italian inhabitants and beneficiaries of the SSN which is a universal coverage health system. Two overall observation periods: 2014-2020 and 2014-2021. Patients with asthma during the accrual periods were excluded. Inhospital/local outpatient settings.
• Summary results:
  From ~ 4.7 million beneficiaries of the Italian National Health Service in 2019 and 2020, respectively, 105,828; and 103,729 (43 and 41 × 1,000 inhabitants aged ≥ 45 years) were identified as having COPD. Of 2019/2020 patients: 3.4%/5.2% received SI-TT, 20.7%/17.5% MI-TT, 35.9%/38.1% DT, 33.0%/33.1% other treatments, and 7.0%/6.0% were untreated. ; Males were prevalent and median age was > 73 years for all groups. Of 2019/2020 cohorts, heart failure and coronary artery disease affected 24/20%, 18/17%, and 11%/16% patients with SI-TT, MI-TT, DT, and other treatments, respectively. A previous moderate/severe exacerbation (2019/2020 patients) occurred to 60.5%/56.6%, 39.9%/37.4%, 30.8%/29.2% and 31.9%/29.7% patients treated with SI-TT, MI-TT, DT, and other treatments, respectively. Of 2019/2020 patients experiencing moderate/severe exacerbation: 6.0%/7.0% receiving DT, 5.1%/7.0% receiving other treatments and 4.5%/10.0% untreated, switched to SI-TT; 23.7%/16.9% receiving DT, 21.4%/17.7% receiving other treatments and 15.4%/12.0% untreated, switched to MI-TT.