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Obstructive Lung Diseases: COPD Pharmacotherapy |

Tiotropium Safety and Performance in Respimat (TIOSPIR) Study: Analysis of Demographic Characteristics and Clinical Outcomes in Patients Enrolled in Asia Countries (Excluding China) Versus Rest of the World FREE TO VIEW

Marie Isidro; Aziah Mahayiddin; Watchara Boonsawat; Achim Mueller; Norbert Metzdorf; Antonio Anzueto
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West Visayas State University Medical Center, Jaro Iloilo City, Philippines


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(4_S):A393. doi:10.1016/j.chest.2016.02.408
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SESSION TITLE: COPD Pharmacotherapy

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Saturday, April 16, 2016 at 11:45 AM - 12:45 PM

PURPOSE: A subanalysis of TIOtropium Safety and Performance In Respimat (TIOSPIR) found different exacerbation profiles in patients with COPD enrolled in Asia vs the rest of the World (RoW). We aimed to determine if this was reflected in those enrolled in Asia excluding China (Asia exC) vs RoW.

METHODS: TIOSPIR, a large-scale (n=17,135), 2-3 year, randomized, double-blind, parallel-group, event-driven trial, compared the safety and efficacy of tiotropium Respimat 5 and 2.5 µg with HandiHaler 18 µg in patients with COPD. This post hoc analysis compared patients in Asia exC (n=1349) vs RoW (n=14,779) using proportional hazards ratio (HR) or rate ratios (RR). Total Asia population (n=2356) data were included as reference. Treatment arms were pooled.

RESULTS: Patients in Asia exC were proportionally more male, had a lower BMI, more severe disease (GOLD stage) and less cardiac history than those in RoW. Risk of death was higher for patients in Asia exC vs RoW (10.3 vs 7.5% deaths; HR [95% confidence interval (CI)]: 1.44 [1.2, 1.7]). Although patients in Asia exC had a lower risk of exacerbation (43.6 vs 49.7% patients with exacerbations; HR [95% CI]: 0.84 [0.77, 0.91]; P<0.0001), their risk of severe exacerbations (hospitalization) was higher (18.8 vs 13.9%; HR [95% CI]: 1.44 [1.26, 1.64]; P<0.0001) than that of patients in RoW. Comparatively, in overall Asia, 8.0% of patients died, 42.9% had an exacerbation and 19.4% had severe exacerbations. Overall mortality was higher for patients in Asia exC (RR [95% CI]: 1.43 [1.20, 1.71]), mainly due to greater rate of deaths from respiratory, thoracic and mediastinal disorders (RR [95% CI]: 2.33 [1.76, 3.08]) (mostly COPD exacerbations). The risk of major adverse cardiovascular event (MACE) was 3.9 vs 3.8% (HR [95% CI]: 1.06 [0.80, 1.41]) and fatal MACE was 2.6 vs 2.0% (HR [95% CI]: 1.40 [0.99, 1.99]). MACE was 3.4% and fatal MACE 1.9% in patients enrolled in overall Asia.

CONCLUSIONS: Patients with COPD on tiotropium treatment in Asia exC had a greater mortality risk vs those in the RoW and in overall Asia. Patients in Asia exC were also more likely to experience severe exacerbations than in RoW, although the risk of any exacerbation was lower, similar to the overall Asia population findings.

CLINICAL IMPLICATIONS: Geographical differences in demographic characteristics observed in patient recruitment may impact the likelihood of particular outcomes in trials of COPD treatment.

DISCLOSURE: Aziah Mahayiddin: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Grant monies (from industry related sources): GlaxoSmithKline, Grant monies (from industry related sources): AstraZeneca Watchara Boonsawat: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Novartis, Grant monies (from industry related sources): GlaxoSmithKline, Grant monies (from industry related sources): AstraZeneca Achim Mueller: Employee: achim.mueller@boehringer-ingelheim.com Norbert Metzdorf: Employee: Boehringer Ingelheim Pharma GmbH & Co KG Antonio Anzueto: Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Forest Laboratories, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Grant monies (from industry related sources): GlaxoSmithKline The following authors have nothing to disclose: Marie Isidro

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