Cardiovascular Safety of Long Acting Beta Agonist-Inhaled Corticosteroid Combination Products in Adult Patients with Asthma: A Systematic Review

Iftikhar, Imran H.; Imtiaz, Maria; Brett, Allan S.; Amrol, David J.

doi:10.1007/s00408-013-9525-x

Cited by 15 publications

(12 citation statements)

References 22 publications

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“…Both conventional and IV analyses show that LABA use was not associated with MI risk compared to non‐LABA exposure, which is consistent with results of randomized controlled trials . However, the IV effect estimates are less precise than those of conventional analysis.…”

Section: Discussionsupporting

confidence: 73%

“…Both conventional and IV analyses show that LABA use was not associated with MI risk compared to non-LABA exposure, which is consistent with results of randomized controlled trials. [45][46][47] However, the IV effect estimates are less precise than those of conventional analysis. For the exposure LABA fixed , the IV PPP10 performed better than the other IVs with respect to strength of the association between IV and exposure and balance of confounders between IV categories.…”

Section: Discussionmentioning

confidence: 99%

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Evaluating different physician's prescribing preference based instrumental variables in two primary care databases: a study of inhaled long‐acting beta2‐agonist use and the risk of myocardial infarction

Uddin

Groenwold

Boer³

et al. 2016

Pharmacoepidemiology and Drug

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Purpose Instrumental variable (IV) analysis with physician's prescribing preference (PPP) as IV is increasingly used in pharmacoepidemiology. However, it is unclear whether this IV performs consistently across databases. We aimed to evaluate the validity of different PPPs in a study of inhaled long-acting beta2-agonist (LABA) use and myocardial infarction (MI). Methods Information on adults with asthma and/or COPD and at least one prescription of beta2-agonist, or muscarinic antagonist was extracted from the CPRD (UK) and the Mondriaan (Netherlands) databases. LABA exposure was considered time-fixed or time-varying. We measured PPPs using previous LABA prescriptions of physicians or proportion of LABA prescriptions per practice. Correlation (r) and standardized difference (SDif) were used to assess assumption of IV analysis. Results For time-fixed LABA, the IV based on 10 previous prescriptions outperformed the other IVs regarding strength of the IV (r ≥ 0.15) and balance of confounders between IV categories (SDif < 0.10). None of the IVs we considered appeared to be valid for time-varying LABA. In CPRD (n = 490 499), which included approximately 18 times more subjects than Mondriaan (n = 27 459), IVs appeared more valid. LABA was not associated with MI; hazard ratios ranged from 0.86 to 1.18 for conventional analysis, and from 0.61 to 1.24 for the IV analyses with apparent valid IVs. Conclusions The validity of physician's prescribing preference as IV strongly depends on how this IV is defined and in which database it is applied. Hence, general recommendations cannot be made, other than to generate several plausible IVs, assess their validity, and report the estimate(s) from apparently valid IVs.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Evaluating different physician's prescribing preference based instrumental variables in two primary care databases: a study of inhaled long‐acting beta2‐agonist use and the risk of myocardial infarction

Uddin

Groenwold

Boer³

et al. 2016

Pharmacoepidemiology and Drug

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“…While a systematic review of long-acting β 2 -agonists (LABAs), in combination with inhaled corticosteroids (ICS), concluded that ICS/LABA products may have a good CV safety profile in asthma patients [127], evidence for the CV safety of LABAs in COPD is less definitive. LABAs have been associated with an increased risk of CV events, possibly due to stimulation of sympathetic drive [72,84], which may also increase the risk of arrhythmias and myocardial ischaemia in patients with CVD ( particularly HF).…”

Section: Bronchodilatorsmentioning

confidence: 99%

Cardiovascular disease and COPD: dangerous liaisons?

2018

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Chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD) frequently occur together and their coexistence is associated with worse outcomes than either condition alone. Pathophysiological links between COPD and CVD include lung hyperinflation, systemic inflammation and COPD exacerbations. COPD treatments may produce beneficial cardiovascular (CV) effects, such as long-acting bronchodilators, which are associated with improvements in arterial stiffness, pulmonary vasoconstriction, and cardiac function. However, data are limited regarding whether these translate into benefits in CV outcomes. Some studies have suggested that treatment with long-acting β2-agonists and long-acting muscarinic antagonists leads to an increase in the risk of CV events, particularly at treatment initiation, although the safety profile of these agents with prolonged use appears reassuring. Some CV medications may have a beneficial impact on COPD outcomes, but there have been concerns about β-blocker use leading to bronchospasm in COPD, which may result in patients not receiving guideline-recommended treatment. However, there are few data suggesting harm with these agents and patients should not be denied β-blockers if required. Clearer recommendations are necessary regarding the identification and management of comorbid CVD in patients with COPD in order to facilitate early intervention and appropriate treatment.

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“…LABAs, like LAMAs, are recommended as first-line maintenance bronchodilator therapy in patients without history of exacerbation but with significant symptoms (GOLD group B) [1]. In general, LABAs have an acceptable safety profile, although there is still a debate on their cardiovascular safety [22, 23]. Key LABAs used for the treatment of COPD include formoterol, indacaterol, and olodaterol (Fig.…”

Section: Fixed-dose Combinations Of Long-acting Bronchodilators For Copdmentioning

confidence: 99%

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives

2019

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Maintenance bronchodilator therapy with long-acting β-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) is the cornerstone treatment for patients with stable chronic obstructive pulmonary disease (COPD). Fixed-dose combinations (FDCs) of LABA/LAMA are recommended for the majority of symptomatic COPD patients by global guidelines; regional guidelines such as the Japanese and Korean guidelines also provide similar recommendations for the use of LABA/LAMA FDCs. This review comprehensively describes the latest clinical evidence from key studies on the efficacy and safety of four approved LABA/LAMA fixed-dose combinations: indacaterol/glycopyrronium, vilanterol/umeclidinium, formoterol/aclidinium, and olodaterol/tiotropium. Additionally, in this review we describe the rationale behind the use of LABA/LAMA FDC therapy, key findings from the preclinical and clinical trial evaluation of respective LABA and LAMA monocomponents, and the efficacy and safety of LABA/LAMA FDCs. Special emphasis is placed on the clinical evidence for the monocomponents and LABA/LAMA FDCs from the Asian population. This detailed overview of the efficacy and safety of LABA/LAMA FDCs in global and Asian COPD patients is envisaged to provide a better understanding of the benefits of these therapies and to inform healthcare providers and patients on their appropriate use.Funding: Novartis Pharma K.K.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-0893-3) contains supplementary material, which is available to authorized users.

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Cardiovascular Safety of Long Acting Beta Agonist-Inhaled Corticosteroid Combination Products in Adult Patients with Asthma: A Systematic Review

Cited by 15 publications

References 22 publications

Evaluating different physician's prescribing preference based instrumental variables in two primary care databases: a study of inhaled long‐acting beta2‐agonist use and the risk of myocardial infarction

Evaluating different physician's prescribing preference based instrumental variables in two primary care databases: a study of inhaled long‐acting beta2‐agonist use and the risk of myocardial infarction

Cardiovascular disease and COPD: dangerous liaisons?

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives

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