SYmbicort given as needed in mild asthma (SYGMA study): a retrospective subanalysis of the Russian population

Abstract

Introduction

While mild asthma is generally better controlled than more severe disease, patients with mild asthma may experience severe exacerbations. Definite differences between countries in terms of asthma severity and control were described previously. Since SYGMA was a global study, this sub-analysis was conducted in geographic region to investigate potential regional specificities.

Methods

The SYGMA2 trial is double-blind multicenter study involving patients ≥12 years of age with mild asthma (n = 4176), eligible for regular treatment with inhaled corticosteroid (ICS). We conducted an open-label descriptive subanalysis of the baseline characteristics of the Russian population (n = 579) comparing to rest of participants of SYGMA2 trial from other 24 countries. The subanalysis is solely descriptive and will be used for hypothesis generation.

Results

The Russian population of patients with mild asthma hardly differs from the population in other countries in terms of baseline demographic and anthropometric characteristics, smoking status, and duration of asthma. At the study entry few patients from Russia received maintenance therapy with ICS and had symptom control, but the majority was uncontrolled on short-acting bronchodilators, thus the uncontrolled/controlled ratio was 52%/48% vs 45%/55% in other countries. More patients with mild asthma in the Russian group had faced at least one severe exacerbation in the previous year (30.1% vs 20.7%).

Conclusions

The subanalysis revealed a delayed prescription of controller (ICS) therapy and overuse of short-acting bronchodilators in the Russian population with mild asthma. These factors can lead to insufficient symptom control and higher risk of severe exacerbation in the Russian population with mild asthma.

Keywords:

• Epidemiology
• morbidity and mortality
• therapy
• treatment
• pharmacotherapy
• mild asthma

Acknowledgements

We thank Dr Nikolay Voznesenskiy, PhD for assistance in the development of the manuscript (data processing, preparation of the tables and the figures, literature search and text translation into English), this support was sponsored by LLC AstraZeneca. We also acknowledge the contribution of all SYGMA2 investigators and LLC AstraZeneca for providing the access to the SYGMA2 database.

Contributors

The study design was conceived by ZRA and ASB. Data analysis was done by SNA and VVA. ZRA drafted the initial manuscript, and all authors reviewed and approved it and subsequent drafts including the final manuscript.

Funding

LLC AstraZeneca.

Role of the funding source

The Sponsor was not involved in the subanalysis design, data analysis and interpretation, or writing of the report. The authors had full access to all the data during the subanalysis, and ZRA had final responsibility for the decision to submit the paper for publication. The views expressed are those of the authors and not necessarily reflect opinions of their institutions or the Sponsor. Being a principal investigator and national study coordinator in SYGMA1 and SYGMA2 studies ZRA has received investigator and national coordinator fees. ZRA also received speaker/consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Teva; and research grants from AstraZeneca, GlaxoSmithKline and Novartis, outside the submitted work. SNA reports personal fees, grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Novartis, outside the submitted work. ASB reports personal fees from AstraZeneca, GlaxoSmithKline, Novartis and Sanofi outside the submitted work. VVA reports speaker/consultancy fees from Astellas, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Teva, and research grants from AstraZeneca, outside the submitted work.

Notes

1 Australia, Brazil, Bulgaria, Chile, Colombia, Czech Republic, France, Germany, Hungary, Mexico, New Zealand, Peru, Philippines, Poland, Republic of Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Thailand, Ukraine, Vietnam