Evaluation of the undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease

Study type

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

  Cardiac failure

Population studied

• Short description of the study population:
  Patients with chronic obstructive pulmonary disease (COPD) and/or heart failure
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) and cardiac failure patients
• Estimated number of subjects:
  129164

Study design details

• Main study objective:
  To assess the prevalence of comorbid diagnosed COPD and HFTo describe therapies prescribed and diagnostic tests undertaken by clinicians in real-life clinical practice for patients with COPD and/or HF To evaluate the long-term respiratory and cardiovascular outcomes associated with the prescribed therapies for patients with comorbid COPD and HF
• Data analysis plan:
  The proportion of patients with a coexisting diagnosis of COPD and HF of all patients with a diagnosis of COPD and separately of all patients with a diagnosis of HF will be calculated.Diagnostic tests and prescription patterns will be reported as count and percentage and compared using conditional logistic regression within each severity group.Prescribing patterns will be presented graphically as a percentage of patients prescribed each treatment over the one year period for HF and COPD treatments separately.Rates of MACE, COPD exacerbations, HF hospitalizations and cardiovascular events after 1 year of follow-up will be compared using conditional Poisson regression. Deaths after 1 year of follow-up will be compared using conditional logistic regression.Cox regression models will be used to analyze time to first MACE, COPD exacerbation, HF hospitalization, cardiovascular event and death.