Obstructive Lung Diseases: COPD |

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

Nanshan Zhong; ChunXue Bai; Achim Mueller; Norbert Metzdorf; Antonio Anzueto
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First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China

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

Chest. 2016;149(4_S):A345. doi:10.1016/j.chest.2016.02.360
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SESSION TYPE: Original Investigation Slide

PRESENTED ON: Sunday, April 17, 2016 at 09:45 AM - 11:15 AM

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 whether the demographic characteristics of patients in China only vs RoW account for these differences.

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

RESULTS: A total of 1007 and 14,779 patients were randomized and treated within China and RoW, respectively. Patients in China were proportionally more male, had lower BMI, and more severe disease (GOLD stage) than those in RoW. Risk of death was lower in patients in China vs RoW (4.9 vs 7.5% deaths; HR [95% confidence interval (CI)]: 0.74 [0.55, 0.98]), as was the risk of exacerbation (41.9 vs 49.7% patients with exacerbations; HR [95% CI]: 0.83 [0.76, 0.92]; P=0.0003). In comparison, 8.0% of patients in Asia died and 42.9% had an exacerbation. However, the risk of severe exacerbations (hospitalization) was significantly higher in China (20.4 vs 13.9%; HR [95% CI]: 1.66 [1.44, 1.92]; P<0.0001) versus RoW, as it was in Asia (19.4%). Overall mortality was lower in China (RR [95% CI]: 0.72 [0.54, 0.96]), including for cardiovascular causes. Deaths due to respiratory, thoracic and mediastinal disorders were similar for both regions (RR [95% CI]: 1.07 [0.67, 1.70]) (with the majority of respiratory deaths due to COPD exacerbations); however, deaths due to lung neoplasms were more numerous in China (RR [95% CI]: 2.26 (1.24, 4.13). Patients in China and RoW had similar risk of major adverse cardiovascular event (MACE) of 2.8 vs 3.8% (HR [95% CI]: 0.79 [0.54, 1.15]) and of fatal MACE 0.9 vs 2.0% (HR [95% CI]: 0.52 [0.27, 1.00]).

CONCLUSIONS: Consistent with the Asia findings, patients in China with COPD receiving tiotropium treatment had greater disease severity compared with RoW; they reported fewer exacerbations and had a reduced risk of death.

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

DISCLOSURE: Nanshan Zhong: Employee: Chinese Government Achim Mueller: Employee: Boehringer Ingelheim Pharma GmbH & Co. KG 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: ChunXue Bai

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