Document Detail

Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials.
MedLine Citation:
PMID:  23042705     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The active-treatment comparative safety information for all inhaled medications in patients with chronic obstructive pulmonary disease (COPD) is limited. We aimed to compare the risk of overall and cardiovascular death for inhaled medications in patients with COPD.
METHODS: Through systematic database searching, we identified randomised controlled trials of tiotropium Soft Mist Inhaler, tiotropium HandiHaler, long-acting β2 agonists (LABAs), inhaled corticosteroids (ICS), and LABA-ICS combination with at least a 6-month treatment duration. Direct comparison and mixed treatment comparison (MTC) meta-analyses were conducted to estimate the pooled ORs of death for each comparison.
RESULTS: 42 trials with 52 516 subjects were included. The MTC meta-analysis with the fixed effect model indicated tiotropium Soft Mist Inhaler was associated with an universally increased risk of overall death compared with placebo (OR 1.51; 95% CI 1.06 to 2.19), tiotropium HandiHaler (OR 1.65; 95% CI 1.13 to 2.43), LABA (OR 1.63; 95% CI 1.10 to 2.44) and LABA-ICS (OR 1.90; 95% CI 1.28 to 2.86). The risk was more evident for cardiovascular death, in patients with severe COPD, and at a higher daily dose. LABA-ICS was associated with the lowest risk of death among all treatments. No excess risk was noted for tiotropium HandiHaler or LABA. The results were similar for MTC and direct comparison meta-analyses, with less precision in the random effects model.
CONCLUSION: Our study provided a comparative safety spectrum for each category of inhaled medications. Tiotropium Soft Mist Inhaler had a higher risk of mortality and should be used with caution.
Yaa-Hui Dong; Hsien-Ho Lin; Wen-Yi Shau; Yun-Chun Wu; Chia-Hsuin Chang; Mei-Shu Lai
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Publication Detail:
Type:  Comparative Study; Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review     Date:  2012-10-06
Journal Detail:
Title:  Thorax     Volume:  68     ISSN:  1468-3296     ISO Abbreviation:  Thorax     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2012-12-11     Completed Date:  2013-02-08     Revised Date:  2013-08-12    
Medline Journal Info:
Nlm Unique ID:  0417353     Medline TA:  Thorax     Country:  England    
Other Details:
Languages:  eng     Pagination:  48-56     Citation Subset:  IM    
Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
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MeSH Terms
Administration, Inhalation
Adrenal Cortex Hormones / administration & dosage*,  adverse effects
Albuterol / administration & dosage*,  adverse effects
Bronchodilator Agents / administration & dosage*,  adverse effects
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Pulmonary Disease, Chronic Obstructive / diagnosis,  drug therapy*,  mortality
Randomized Controlled Trials as Topic
Respiratory Function Tests
Risk Assessment
Scopolamine Derivatives / administration & dosage*,  adverse effects
Severity of Illness Index
Survival Rate
Treatment Outcome
Reg. No./Substance:
0/Adrenal Cortex Hormones; 0/Bronchodilator Agents; 0/Drug Combinations; 0/Scopolamine Derivatives; 0EB439235F/tiotropium; 18559-94-9/Albuterol
Comment In:
Ann Intern Med. 2013 Jun 18;158(12):JC2   [PMID:  23778926 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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