ReviewInternational journal of chronic obstructive pulmonary disease2009
Tiotropium HandiHaler in the treatment of COPD: a safety review.
Review in International journal of chronic obstructive pulmonary disease, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Tiotropium versus ipratropium bromide for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2015Pooled it
- Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2015Pooled it
- Tiotropium versus placebo for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014Pooled it
- Does tiotropium lower exacerbation and hospitalization frequency in COPD patients: results of a meta-analysis.BMC pulmonary medicine · 2010Pooled it
- Bronchodilator Effect of Tiotropium via RespimatInternal medicine (Tokyo, Japan) · 2017Trial
- Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk.International journal of chronic obstructive pulmonary disease · 2016Trial
- Safety and efficacy of tiotropium in patients switching from HandiHaler to Respimat in the TIOSPIR trial.BMJ open · 2015Trial
- Trial
- Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial.Respiratory research · 2011Trial
- Cardiovascular events in patients with COPD after long-acting bronchodilator initiation.ERJ open research · 2026Article
- Adverse drug events associated with tiotropium: a real-world pharmacovigilance study of FDA adverse event reporting system database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025Article
- Risk Assessment of Acute Myocardial Infarction and Stroke Associated with Long-Acting Muscarinic Antagonists, Alone or in Combination, versus Long-Acting beta2-Agonists.International journal of chronic obstructive pulmonary disease · 2022Article
- Article
- Effect of inhaled drugs on anxiety and depression in patients with chronic obstructive pulmonary disease: a prospective observational study.International journal of chronic obstructive pulmonary disease · 2016Observational
- Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis.International journal of chronic obstructive pulmonary disease · 2015Article
- Tiotropium Respimat(®) Soft Mist™ inhaler: a review of its use in chronic obstructive pulmonary disease.Drugs · 2014Review
- Differential pharmacology and clinical utility of emerging combination treatments in the management of COPD--role of umeclidinium/vilanterol.International journal of chronic obstructive pulmonary disease · 2014Review
- Indacaterol-induced severe constipation and abdominal pain: is there a role for colonic β3-adrenoceptors?BMJ case reports · 2013Article
- Risk of acute urinary retention associated with inhaled anticholinergics in patients with chronic obstructive lung disease: systematic review.Therapeutic advances in drug safety · 2013Article
- Safety and tolerability of inhalational anticholinergics in COPD.Drug, healthcare and patient safety · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTiotropium is a long-acting inhaled anticholinergic developed for the treatment of chronic obstructive pulmonary disease (COPD) and has been available since 2002. We sought to update an evaluation of the safety of tiotropium in the HandiHaler formulation as significant clinical trial data have become available over time.
methodsPooled analysis of adverse event reporting from phase III and IV tiotropium HandiHaler clinical trials with the following characteristics was performed: randomized, double-blind, parallel group, placebo-controlled design, tiotropium 18 microg once-daily dosing, COPD indication, duration of at least four weeks. Incidence rates by treatment group, rate differences (tiotropium-placebo), and 95% confidence intervals were determined.
resultsTwenty-six trials were identified involving 17,014 patients. Mean age was 65 years, mean forced expiratory volume in one second was 1.16 L (41% predicted), 76% men. Total exposure to study drug was 11,958 patient-years (tiotropium) and 10,578 patient-years (placebo). Tiotropium was associated with a reduced risk (expressed as rate difference [95% confidence interval] per 100 patients-years at risk) for an adverse event (-17.5 [-22.9, -12.2]), serious adverse event (-1.41 [-2.81, -0.00]) and a fatal event (-0.63 [-1.14, -0.12]). A reduced risk was present for adverse events that were cardiac (-0.79 [-1.48, -0.09]), lower respiratory (-14.2 [-17.0, -11.5]) and for a composite endpoint of major adverse cardiovascular events (-0.45 [-0.85, -0.05]). Typical expected inhaled anticholinergic effects such as dry mouth, constipation, and urinary difficulties were observed in the safety database.
conclusionThe safety data review does not indicate an increased risk for death or cardiovascular morbidity during tiotropium treatment in patients with COPD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.