SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe
Authors Fležar M, Jahnz-Rózyk K, Enache G, Martynenko T, Kristufek P, Škrinjarić-Cincar S, Kadlecová P, Martinovic G
Received 23 March 2013
Accepted for publication 7 May 2013
Published 9 October 2013 Volume 2013:8 Pages 483—492
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Matjaž Fležar,1 Karina Jahnz-Rózyk,2 Gloria Enache,3 Tatiana Martynenko,4 Peter Kristufek,5 Sanda Škrinjaric-Cincar,6 Pavla Kadlecová,7 Goran Martinovic8
1University Clinic of Respiratory and Allergic Diseases Golnik, Golnik, Slovenia; 2Military Institute of Medicine, Department of Immunology and Allergology, Warsaw, Poland; 3Saint John Clinical Emergency Hospital, Bucharest, Romania; 4Municipal Medical Institution City Hospital, Barnaul, Russian Federation; 5SACCME, Slovak Medical University, Bratislava, Slovakia; 6Clinical Hospital Center, Osijek, Croatia; 7ADDS Sro, Jana Uhra, Brno, Czech Republic; 8Boehringer Ingelheim RCV GmbH and Co KG, Ingelheim, Vienna, Austria
Purpose: The long-acting inhaled anticholinergic agent, tiotropium, is recommended as first-line maintenance therapy for moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) to improve symptoms, exercise tolerance, health status, and to reduce exacerbations. Few studies have evaluated the therapeutic efficacy of tiotropium in patients in routine clinical conditions. The current study was designed to investigate the therapeutic efficacy of tiotropium delivered via the HandiHaler® device on the health status of patients with COPD with Global initiative for chronic Obstructive Lung Disease (GOLD) disease classification 2–4 in six central and eastern European countries in a real-life clinical setting.
Methods: The study was an open-label, prospective, uncontrolled, and single-arm surveillance study with three clinic visits during a 6-month observation period (baseline, and months 3 and 6). Health status was measured using the disease-specific St George's Respiratory Questionnaire (SGRQ). The primary efficacy endpoint was the mean change from baseline in SGRQ total score at the end of the 6-month observational period.
Results: Patients treated with tiotropium 18 µg once daily showed statistically significant and clinically meaningful reduction (improvement) of 21.7 units in the SGRQ total score, regardless of smoking status or cardiac comorbidities at enrollment (P < 0.0001). The analysis also showed that age, treatment compliance, and GOLD disease classification were significant factors that impact the health status of patients with COPD differently.
Conclusion: These results provide further support for the use of the tiotropium HandiHaler® as first-line maintenance treatment of patients with COPD with a clinician-assessed disease.
Keywords: tiotropium, HandiHaler®, chronic obstructive pulmonary disease, health-related quality of life
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