Real-life evaluation of COPD treatment in a Bulgarian population: a 1-year prospective, observational, noninterventional study

Abstract

Introduction: This was the first study designed to prospectively evaluate treatment patterns in chronic obstructive pulmonary disease (COPD) and the degree of adherence with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy recommendations in routine clinical practice in Bulgaria.

Methods: The study was conducted in an outpatient setting and enrolled patients of both genders, aged >40 years, who were diagnosed with COPD (as per GOLD 2013). Evaluations were performed at baseline and at 6- and 12-month visits.

Results: Of the 811 enrolled patients, 719 were assessed and completed the 12-month observation period. Overall, a substantial number of patients experienced moderate airflow limitation (~49% patients, GOLD 2 as per GOLD 2013; mean postbronchodilator forced expiratory volume in 1 second value was ~50% of the predicted value), belonged to GOLD group D (~51% patients), and had COPD assessment test score ≥10 or modified Medical Research Council score ≥2 (~79% patients), and ≤1 exacerbation in the past 1 year (~80% patients). Short-acting β2-agonists (~63% patients), inhaled corticosteroids/long-acting β2-agonist fixed-dose combination (~62% patients), and long-acting muscarinic antagonists (~59% patients) were the most frequently used medications at all visits, regardless of severity. High levels of deviation from GOLD recommendations were observed in GOLD groups A and B patients. The deviation comprised high use of inhaled corticosteroid-containing regimens in ~45% and 63% of patients in GOLD groups A and B, respectively. Only 25 (3%) of the 796 patients reported at least one adverse event.

Conclusion: The routine clinical practice for COPD in Bulgaria deviates from the GOLD recommendations largely in patients at a low risk (GOLD groups A and B), while the deviation was lesser in those at a higher risk (GOLD groups C and D).

Keywords: Bulgaria; COPD; GOLD strategy; observational; prospective; real-life; treatment.

Figure 1

Patient disposition. Abbreviations: FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity.

Figure 2

COPD severity as per GOLD classification based on (A) airflow limitation and (B) GOLD groups (efficacy analysis set). Notes: Data are presented as percentage of patients. A: GOLD group A; B: Gold group B; C: GOLD group C; and D: GOLD group D. Abbreviations: COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease.

Figure 3

Distribution of patients according to (A) CAT scores and (B) mMRC scores (efficacy analysis set). Note: Data are presented as number of patients. Abbreviations: CAT, COPD assessment test; COPD, chronic obstructive pulmonary disease; mMRC, modified Medical Research Council.

Figure 4

Proportion of patients experiencing exacerbations (efficacy analysis set). Note: Data are presented as number of patients. Abbreviation: COPD, chronic obstructive pulmonary disease.