ArticleInternational journal of chronic obstructive pulmonary disease2015
Tiotropium HandiHaler(®) and Respimat(®) in COPD: a pooled safety analysis.
Article in International journal of chronic obstructive pulmonary disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.
- A systematic review of comparative studies of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease: does inhaler choice matter?BMC pulmonary medicine · 2016Pooled it
- Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial.Respiratory research · 2020Trial
- Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT® trial.Respiratory research · 2018Trial
- Long-term safety of tiotropium/olodaterol RespimatInternational journal of chronic obstructive pulmonary disease · 2018Trial
- Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk.Heart (British Cardiac Society) · 2017Trial
- Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via DiscairInternational journal of chronic obstructive pulmonary disease · 2016Trial
- Health-related quality of life and its associated factors in patients with chronic obstructive pulmonary disease.PloS one · 2023Article
- Impact of Comorbidities and Commonly Used Drugs on Mortality in COPD - Real-World Data from a Primary Care Setting.International journal of chronic obstructive pulmonary disease · 2020Observational
- No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD.International journal of chronic obstructive pulmonary disease · 2020Article
- Effects of LAMA/LABA Alone and in Combination on Cardiac Safety.International journal of chronic obstructive pulmonary disease · 2020Article
- Management of Chronic Obstructive Pulmonary Disease in Patients with Cardiovascular Diseases.Drugs · 2017Review
- Cardiovascular safety of tiotropium Respimat vs HandiHaler in the routine clinical practice: A population-based cohort study.PloS one · 2017Article
- Tiotropium formulations and safety: a network meta-analysis.Therapeutic advances in drug safety · 2017Article
- Approaches to drug therapy for COPD in Russia: a proposed therapeutic algorithm.International journal of chronic obstructive pulmonary disease · 2017Article
- Tiotropium safety in 'real-world' populations: Response to Schmiedl, et al. in the British Journal of Clinical Pharmacology.British journal of clinical pharmacology · 2016Article
- Pharmacological Management of Elderly Patients with Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome: Room for Speculation?Drugs & aging · 2016Review
- Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial.Respiratory research · 2016Article
- Risk of cardiovascular events after initiation of long-acting bronchodilators in patients with chronic obstructive lung disease: A population-based study.SAGE open medicine · 2016Article
- Long-term safety of tiotropium delivered by RespimatTherapeutics and clinical risk management · 2016Review
- Efficacy of tiotropium-olodaterol fixed-dose combination in COPD.International journal of chronic obstructive pulmonary disease · 2016Review
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTiotropium is prescribed for the treatment of chronic obstructive pulmonary disease (COPD) and delivered via HandiHaler(®) (18 μg once daily) or Respimat(®) Soft Mist™ inhaler (5 μg once daily). The recent TIOtropium Safety and Performance In Respimat(®) (TIOSPIR™) study demonstrated that both exhibit similar safety profiles. This analysis provides an updated comprehensive safety evaluation of tiotropium(®) using data from placebo-controlled HandiHaler(®) and Respimat(®) trials.
methodsPooled analysis of adverse event (AE) data from tiotropium HandiHaler(®) 18 μg and Respimat(®) 5 μg randomized, double-blind, parallel-group, placebo-controlled, clinical trials in patients with COPD (treatment duration ≥4 weeks). Incidence rates, rate ratios (RRs), and 95% confidence intervals (CIs) were determined for HandiHaler(®) and Respimat(®) trials, both together and separately.
resultsIn the 28 HandiHaler(®) and 7 Respimat(®) trials included in this analysis, 11,626 patients were treated with placebo and 12,929 with tiotropium, totaling 14,909 (12,469 with HandiHaler(®); 2,440 with Respimat(®)) patient-years of tiotropium exposure. Mean age was 65 years, and mean prebronchodilator forced expiratory volume in 1 second (FEV1) was 1.16 L (41% predicted). The risk (RR [95% CI]) of AEs (0.90 [0.87, 0.93]) and of serious AEs (SAEs) (0.94 [0.89, 0.99]) was significantly lower in the tiotropium than in the placebo group (HandiHaler(®) and Respimat(®) pooled results), and there was a numerically lower risk of fatal AEs (FAEs) (0.90 [0.79, 1.01]). The risk of cardiac AEs (0.93 [0.85, 1.02]) was numerically lower in the tiotropium group. Incidences of typical anticholinergic AEs, but not SAEs, were higher with tiotropium. Analyzed separately by inhaler, the risks of AE and SAE in the tiotropium groups remained lower than in placebo and similarly for FAEs.
conclusionThis analysis indicates that tiotropium is associated with lower rates of AEs, SAEs, and similar rates of FAEs than placebo when delivered via HandiHaler(®) or Respimat(®) (overall and separately) in patients with COPD.
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