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• W2072990160 abstract "COPD is increasingly recognized as a complex systemic disorder with a whole range of comorbidities, especially cardiovascular, contributing significantly to COPD morbidity and mortality.1Fabbri LM Luppi F Beghé B Rabe KF Complex chronic comorbidities of COPD.Eur Respir J. 2008; 31: 204-212Crossref PubMed Scopus (497) Google Scholar Among the most frequently prescribed inhaled medications for this disorder are anticholinergic agents, such as short-acting ipratropium bromide, available for 20 years, and the long-acting drug tiotropium bromide, introduced in 2002, which has been shown to improve airflow, hyperinflation, exercise tolerance, exacerbations of COPD, and health-related quality of life with once-daily dosing2Disse B Speck GA Rominger KL Witek Jr, TJ Hammer R Tiotropium (Spiriva): mechanistical considerations and clinical profile in obstructive lung disease.Life Sci. 1999; 64: 457-464Crossref PubMed Scopus (256) Google Scholar, 3Casaburi R Mahler DA Jones PW et al.A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease.Eur Respir J. 2002; 19: 217-224Crossref PubMed Scopus (852) Google Scholar, 4Brusasco V Hodder R Miravitlles M Korducki L Towse L Kesten S Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.Thorax. 2003; 58: 399-404Crossref PubMed Scopus (463) Google Scholar, 5O'Donnell DE Flüge T Gerken F et al.Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD.Eur Respir J. 2004; 23: 832-840Crossref PubMed Scopus (786) Google Scholar, 6Maltais F Hamilton A Marciniuk D et al.Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD.Chest. 2005; 128: 1168-1178Abstract Full Text Full Text PDF PubMed Scopus (297) Google Scholar, 7Niewoehner DE Rice K Cote C et al.Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator.Ann Intern Med. 2005; 143: 319-326Crossref Google Scholar, 8Tashkin DP Celli B Senn S et al.UPLIFT Study investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease.N Engl J Med. 2008; 359: 1543-1554Crossref PubMed Scopus (1909) Google Scholar in patients with COPD. Since these drugs are poorly absorbed by the gastrointestinal tract and the lungs, systemic adverse effects such as tachycardia are considered unlikely,9Barnes PJ The role of anticholinergics in chronic obstructive pulmonary disease.Am J Med. 2004; 117: 24S-32SPubMed Google Scholar and prescription habits might have been biased toward administering this class of drugs to patients with a higher perceived cardiovascular risk. However, for many years a link between anticholinergic drugs and an increased risk of mortality, especially from cardiovascular disease, has been reported10Anthonisen NR Connett JE Enright PL Manfreda J Lung Health Study Research Group Hospitalizations and mortality in the Lung Health Study.Am J Respir Crit Care Med. 2002; 166: 333-339Crossref PubMed Scopus (455) Google Scholar, 11Guite HF Dundas R Burney PG Risk factors for death from asthma, chronic obstructive pulmonary disease, and cardiovascular disease after a hospital admission for asthma.Thorax. 1999; 54: 301-307Crossref PubMed Scopus (57) Google Scholar, 12Lee TA Pickard AS Au DH Bartle B Weiss KB Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease.Ann Intern Med. 2008; 149: 380-390Crossref PubMed Scopus (169) Google Scholar, 13Macie C Wooldrage K Manfreda J Anthonisen N Cardiovascular morbidity and the use of inhaled bronchodilators.Int J Chron Obstruct Pulmon Dis. 2008; 3: 163-169PubMed Google Scholar, 14Singh S Loke YK Furberg CD Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis.JAMA. 2008; 300: 1439-1450Crossref PubMed Scopus (453) Google Scholar and debated. Although there seems no reasonable explanation based on the pharmacology that short-acting anticholinergics would affect the cardiovascular system differently than long-acting drugs, a pattern seems to evolve favoring tiotropium over ipratropium also in terms of safety. Three recent publications again highlighted potential concerns in relation to short-acting anticholinergic ipratropium bromide and cardiovascular safety in patients with COPD. The metaanalysis by Singh et al14Singh S Loke YK Furberg CD Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis.JAMA. 2008; 300: 1439-1450Crossref PubMed Scopus (453) Google Scholar seemed to indicate an increased risk for myocardial infarctions with a risk ratio (RR) of 1.53, (1.05–2.23) and cardiovascular death RR 1.80, (1.17–2.77) in patients randomized to inhaled anticholinergics. Similarly, two observational studies found an increased risk between anticholinergic use and cardiovascular events13Macie C Wooldrage K Manfreda J Anthonisen N Cardiovascular morbidity and the use of inhaled bronchodilators.Int J Chron Obstruct Pulmon Dis. 2008; 3: 163-169PubMed Google Scholar and cardiovascular-related mortality.12Lee TA Pickard AS Au DH Bartle B Weiss KB Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease.Ann Intern Med. 2008; 149: 380-390Crossref PubMed Scopus (169) Google Scholar The retrospective, nested case-control study by Lee et al12Lee TA Pickard AS Au DH Bartle B Weiss KB Risk for death associated with medications for recently diagnosed chronic obstructive pulmonary disease.Ann Intern Med. 2008; 149: 380-390Crossref PubMed Scopus (169) Google Scholar focused on overall and cause-specific mortality examining the association between several respiratory medications and the risk of death in patients with newly diagnosed COPD. As a critical comment, this study likely contains relevant differences in baseline risk between the treatment groups, and there was no information available on smoking or lung function. The study by Singh et al14Singh S Loke YK Furberg CD Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis.JAMA. 2008; 300: 1439-1450Crossref PubMed Scopus (453) Google Scholar selected randomized controlled trials of any inhaled anticholinergic for treatment of COPD that had at least 30 days of treatment and reported on cardiovascular events. The primary outcome was a composite of cardiovascular death, myocardial infarction, or stroke; the secondary outcome was all-cause mortality. The conclusion was that inhaled anticholinergics significantly increased the risk of the composite cardiovascular end point, myocardial infarction, and cardiovascular death, without a statistically significant increase in the risk of stroke. The study has been criticized for integrating placebo controlled trials with active controlled trials and because the analysis did not take into account differential discontinuation. Interestingly, also in this analysis, most of the evidence was provided by the Lung Health Study, which was conducted using ipratropium. Although the respiratory community has been amply confused in the recent past by post hoc and metaanalyses of treatment (side) effects in COPD, the persistence of these reports since the publication of the Lung Health Study is noteworthy. In contrast and as a reassurance, the recent prospective Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT) study did not find an increase in cardiovascular adverse events in those randomized to tiotropium; the risk for fatal cardiovascular events was reduced (RR=0.8), including patients for whom the specific cause of death was not specified.15Tashkin D Tiotropium in chronic obstructive pulmonary disease.N Engl J Med. 2009; 360: 187Crossref PubMed Scopus (2) Google Scholar Also, a report of a pooled analysis of 19 clinical trials with tiotropium of up to 1 year in duration described data on a variety of selected safety end points.16Kesten S Jara M Wentworth C Lanes S Pooled clinical trial analysis of tiotropium safety.Chest. 2006; 130: 1695-1703Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar Contrary to the report by Singh et al,14Singh S Loke YK Furberg CD Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis.JAMA. 2008; 300: 1439-1450Crossref PubMed Scopus (453) Google Scholar which suggested an increased relative risk for cardiovascular mortality of 1.8, the report from the 19 trials noted a decreased risk for fatal cardiovascular events in patients randomized to the anticholinergic with an RR of 0.57. In this issue of CHEST, this ongoing debate and discrepancy continues. Dr Ogale and colleagues17Ogale SS Lee TA Au DH Boudreau DM Sullivan SD Cardiovascular events associated with ipratropium bromide in COPD.Chest. 2010; 137: 13-19Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar present a cohort study of 82,717 US veterans with a new diagnosis of COPD established between 1999 and 2002 (see page 13). The study essentially examines again the association between inhaled ipratropium bromide and cardiovascular events (CVEs), including the effects of inhaled corticosteroids, in patients with COPD. Subjects were followed until they had their first hospitalization for events such as acute coronary syndrome, heart failure, or cardiac dysrhythmia, or until death. Cumulative anticholinergic exposure was calculated as the number of 30-day equivalents within the past year. The study identified 6,234 cardiovascular events, and compared with subjects not exposed to anticholinergics within the past year, any exposure to anticholinergics within the past 6 months was associated with a significantly increased risk of a cardiac event. Surprisingly, in subjects who received anticholinergics more than 6 months prior, there did not appear to be elevated risk of CVE. The authors conclude that the study results are consistent with previous concerns raised about the cardiovascular safety of ipratropium bromide showing an increased risk of CVEs associated with the use of ipratropium within the past 6 months. The second article by Celli18Celli B Decramer M Leimer I Vogel U Kesten S Tashkin DP Cardiovascular safety of tiotropium in patients with COPD.Chest. 2010; 137: 20-30Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar and colleagues in this issue of CHEST (see page 20) presents data from the clinical trial safety database for tiotropium. Trials with a duration of more than 4 weeks, and a randomized, double-blind, parallel-group, or placebo-controlled design were included, and importantly, adverse events were collected throughout each trial using standardized case report forms. Incidence rates were determined for all-cause mortality and selected CVEs, such as cardiovascular (CV) deaths, nonfatal myocardial infarction, nonfatal stroke, and the terms sudden death and (sudden) cardiac death. A total of 19,545 patients, (10,846 on tiotropium and 8,699 on placebo) from 30 trials were included with a cumulative exposure to tiotropium and placebo of 13,146 and 11,095 patient-years, respectively. For all-cause mortality, the incidence rate was 3.44 for tiotropium and 4.10 for placebo per 100 patient-years, and the other incidence rates all favored tiotropium over placebo. The analysis supports earlier conclusions that tiotropium is associated with a reduction in the risk of all-cause mortality, cardiovascular mortality, and cardiovascular events. Where do these two additional studies leave us? The Ogale study18Celli B Decramer M Leimer I Vogel U Kesten S Tashkin DP Cardiovascular safety of tiotropium in patients with COPD.Chest. 2010; 137: 20-30Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar obviously has a number of limitations, including lacking data of patients not dying in the Veterans Affairs setting, the uncertainty of drug dispensing, the lack of some essential clinical data, and the concern about the unknown influence of prescription by severity. Nevertheless, in the chosen setting it adds to the persisting concern about short-acting anticholinergics and CV safety. Quite to the contrary, the tiotropium clinical trial program described by Celli et al18Celli B Decramer M Leimer I Vogel U Kesten S Tashkin DP Cardiovascular safety of tiotropium in patients with COPD.Chest. 2010; 137: 20-30Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar represents a substantial database of 19,545 patients, and the results indicate that tiotropium reduces the risk for cardiovascular events, cardiovascular mortality, and all-cause mortality. It remains important for clinicians and patients to be aware of the potential benefits as well as the risks when making medication decisions for treatment of COPD. Judging from the available evidence so far, the long-acting tiotropium appears to be safe in CV terms, whereas retrospective large cohort analyses frequently conclude that the short-acting ipratropium has a small but consistent effect on CV safety that is unlikely to be explained by pharmacological differences of the drugs and therefore leaves broad room for speculation. In clinical and practical terms, the (more expensive) tiotropium appears to be the drug of choice. Given the vast investment required, it is unlikely that we will ever see the needed prospective trial that further clearly defines the CV risk of short-acting anticholinergics. The apparent differences in safety data between short- and long-acting anticholinergics are not easily explained. At the very least careful monitoring is mandatory. To this end, new efficacy and safety data from clinical trials with anticholinergic drugs, including new formulations used in the Respimat trials, are eagerly awaited. Cardiovascular Events Associated With Ipratropium Bromide in COPDCHESTVol. 137Issue 1PreviewStudies have suggested an increased risk of cardiovascular morbidity and mortality associated with the use of ipratropium bromide. We sought to examine the association between ipratropium bromide use and the risk of cardiovascular events (CVEs). Full-Text PDF Cardiovascular Safety of Tiotropium in Patients With COPDCHESTVol. 137Issue 1PreviewThe clinical trial safety database for tiotropium has been augmented with a 4-year trial in patients with COPD, which provides an opportunity to better evaluate the cardiovascular (CV) profile of tiotropium. Full-Text PDF" @default.
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• W2072990160 title "Anticholinergic Drugs for the Treatment of COPD Are Safe… Are They?" @default.
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