2016
DOI: 10.2147/copd.s118867
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Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

Abstract: Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination the… Show more

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Cited by 20 publications
(26 citation statements)
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“…A number of randomised controlled trials (RCTs) and observational studies provide insight into the effect of COPD treatments on CVD and vice versa, although both study types are subject to limitations. For instance, results from observational studies may be affected by lack of blinding of study treatments and confounding bias [64]. Also, observational studies are often reliant upon patient databases, which may lack accuracy (for instance, the definition of COPD and the presence of comorbidities such as asthma) [64][65][66].…”
Section: Pharmacological Management Of Copd and Cvdmentioning
confidence: 99%
See 1 more Smart Citation
“…A number of randomised controlled trials (RCTs) and observational studies provide insight into the effect of COPD treatments on CVD and vice versa, although both study types are subject to limitations. For instance, results from observational studies may be affected by lack of blinding of study treatments and confounding bias [64]. Also, observational studies are often reliant upon patient databases, which may lack accuracy (for instance, the definition of COPD and the presence of comorbidities such as asthma) [64][65][66].…”
Section: Pharmacological Management Of Copd and Cvdmentioning
confidence: 99%
“…For instance, results from observational studies may be affected by lack of blinding of study treatments and confounding bias [64]. Also, observational studies are often reliant upon patient databases, which may lack accuracy (for instance, the definition of COPD and the presence of comorbidities such as asthma) [64][65][66]. In addition, a number of observational analyses discussed below rely upon prescription data, which may not accurately reflect actual medication intake [65,66].…”
Section: Pharmacological Management Of Copd and Cvdmentioning
confidence: 99%
“…However, it should be noted that the COPD population included in RCTs could be different from the real-world population using bronchodilator therapy. In fact real-world observational investigations are designed to not exclude COPD patients with comorbidities or have limitations with inclusion criteria regarding the severity of disease, upper age limit, or smoking history [39,40]. The results of this meta-analysis showed neither a statistical significance nor a trend toward significance in the increased risk heart failure, with RR effect estimate value at 0.88 (95%CI 0.41 -1.92).…”
Section: Discussionmentioning
confidence: 72%
“…Efforts should be made to interpret and summarise findings originating from different research approaches, i.e. randomised controlled trials and observational studies, to guide decision-making from both clinical and drug-regulatory perspectives [28,29]. COPD patients with concomitant CVD diseases represent a big everyday challenge for clinicians.…”
Section: Discussionmentioning
confidence: 99%