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
• observational
• prospective
• real-life
• treatment
• GOLD strategy

Supplementary materials

Figure S1 Treatment patterns over 12 months (efficacy analysis set).

Note: Data are presented as percentage of patients.

Abbreviations: FDC, fixed-dose combination; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; PDE-4, phosphodiesterase-4; SABA, short-acting β₂-agonists; SAMA, short-acting muscarinic antagonists.

Figure S2 Long-acting inhaled therapy and agreement of treatment with GOLD guidelines (A and B) at baseline; (C and D) at 6 months; (E and F) at 12 months (efficacy analysis set).

Notes: Data are presented as number of patients (A, C, and E) and percentage of patients (B, D, and F). A: GOLD group A; B: GOLD group B; C: GOLD group C; D: GOLD group D.

Abbreviations: GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist.

Figure S3 Number of patients experiencing hospitalization (efficacy analysis set).

Table S1 List of study centers and contributors

Table S2 Adverse events and serious adverse events, according to system organ class

Acknowledgments

The authors thank Ananya Chikramane, PhD, and Rahul Lad, PhD, of Novartis for providing professional medical writing support, which was funded by Novartis Pharma AG in accordance with Good Publication Practice (GPP3) guidelines. This study was funded by Novartis Pharma AG.

Disclosure

Yavor Ivanov has received honoraria for delivering lectures for Novartis, GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim Chiesi, and Roche, and reports no other conflicts of interest in this work. Ivan Nikolaev is a Novartis employee and reports no other conflicts of interest in this work. Imola Nemeth reports no conflicts of interest in this work.