title: INDACO project: COPD and link between comorbidities, lung function and inhalation therapy.
abstract: BACKGROUND
  Chronic Obstructive Pulmonary Disease (COPD) is characterized by respiratory and extrarespiratory components referring both to systemic complications of COPD, like skeletal muscle myopathy, weight loss and others, and frequently associated comorbidities, interesting various organs and systems (cardiovascular diseases, malignancies, osteoporosis, diabetes, etc.). These comorbidities may increase the rate of hospitalization of COPD patients and have a huge effect on the outcomes of the respiratory disease. Inhalation therapy of COPD with bronchodilators and steroid is primary driven by airflow obstruction, symptoms like dyspnoea, and acute exacerbations. INDACO project has been developed in 2013 to assess the prevalence and type of comorbidities in COPD patients referred to the outpatient wards of some hospitals in Central and South Italy and a preliminary report has recently been published. In the present study, after widening that database, we evaluate the prevalence of comorbidities and the relationships between comorbidities and sex, age, symptoms, lung function and inhalation therapy in COPD patients.
  
  
  METHODS
  In each enrolled patient, anthropometric and anamnestic data, smoking habits, respiratory function, GOLD (Global initiative for Chronic Obstructive Lung Disease) severity stage, Body Mass Index (BMI), number of acute COPD exacerbations in previous years, presence and type of comorbidities, and the Charlson Comorbidity Index (CCI) were recorded.
  
  
  RESULTS
  We collected data of 569 patients (395 males and 174 females, mean age 73 ± 8.5 yrs). The prevalence of patients with comorbidities was 81.2%. Overall number of comorbidities was not related to airflow obstruction and age, but to acute exacerbation of COPD, dyspnoea measured with MRC scale, and male gender. A subgroup analysis revealed that ischaemic heart disease was predominant in males, whereas mood disorders in females. The use of a more complex (multi-drug) inhalation therapy was related with bronchial obstruction measured by FEV1/FVC (p for trend = 0.003) and number of comorbidities (p for trend = 0.001). In multivariate analysis, only airflow obstruction and number of comorbidities were determinant of complexity of therapy, but not MRC and acute exacerbation of COPD. However, the statistical model reached an extreme low degree of significance (r^2 = 0.07).
  
  
  CONCLUSIONS
  Our study showed a high prevalence of comorbidities in COPD, with some differences related to gender. Number of comorbidities and airflow obstruction represent the determinant of inhalation therapy prescription. Dyspnoea and acute exacerbation of COPD, unlikely suggested by guidelines, are not significant drivers of therapy in the real life setting of our study.
authors.affiliation: Pulmonary Departments, San Filippo Neri General Hospital, Rome, Italy ; UOC Pneumologia, A.C.O. San Filippo Neri, Via Martinotti, 20, 00135 Rome, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Fumagalli
authors.affiliation: San Giovanni-Addolorata General Hospital, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fabiani
authors.affiliation: San Giovanni-Addolorata General Hospital, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Forte
authors.affiliation: San Giovanni Battista Hospital, Rome, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Napolitano
authors.affiliation: Pulmonary Rehabilitation Unit, Salvatore Maugeri Foundation, Telese Terme, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Balzano
authors.affiliation: Department of Public Health and Infectious Diseases, "La Sapienza" University of Rome, Rome, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Bonini
authors.affiliation: Department of Pneumology, Villa Margherita, Rehabilitation Institute of Benevento, Benevento, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Simone
authors.affiliation: Pulmonary Rehabilitation Unit, Salvatore Maugeri Foundation, Telese Terme, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Fuschillo
authors.affiliation: San Giovanni Battista Hospital, Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Pentassuglia
authors.affiliation: Pneumology Rehabilitation, Villa delle Querce Hospital, Nemi, Rome, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Pasqua
authors.affiliation: Pulmonary Department, San Pietro Hospital, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Alimonti
authors.affiliation: San Giovanni-Addolorata General Hospital, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Carlone
authors.affiliation: Quisisana Clinical Center, Rome, Italy.
authors.forename: Claudio M
authors.initials: CM
authors.lastname: Sanguinetti
keywords: BMI; COPD; COPD exacerbation; Charlson Index; Comorbidities; FEV1; Inhaled therapy; Smoking