Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study

Lane, Daniel C.; Stemkowski, Stephen; Stanford, Richard H.; Tao, Zhuliang

doi:10.18553/jmcp.2018.24.11.1165

Cited by 15 publications

(22 citation statements)

References 16 publications

(18 reference statements)

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“…In a previous study based on a United Kingdom primary setting, 26.8% of the patients who started with LAMA monotherapy progressed to triple therapy within 12 months [28]. Likewise, in a study using the United States health care claims data, more than 50% of patients who used LAMA monotherapy (median 244 days) or the ICS/LABA combination (median 281 days) progressed to triple therapy within 12 months [20]. In a recent study published after LAMA/LABA FDCs became available, patients receiving LAMA/LABA FDC (umeclidinium/vilanterol) were at a lower risk of progression to triple therapy than those receiving LAMA (tiotropium), with a longer mean time to triple therapy (6.5 vs. 5.6 months) [19], but this study lacked data for symptoms and lung function because of the nature of claims data.…”

Section: Discussionmentioning

confidence: 95%

“…However, the duration of LAMA/LABA FDCs cannot be evaluated in randomized controlled studies because randomized medications have to be used until the end of the study unless participants dropped out from the trial. In addition, comparative studies using health care claims data lacked data regarding the reasons for ICS addition due to the nature of claims data [19,20]. Thus, our study reflecting the real-world practice of COPD would be informative to clinicians who will initiate LAMA/LABA FDCs.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the risk of pneumonia is lower in LAMA/LABA FDCs than ICS-containing inhaler regimens [17,18]. Despite these clinical benefits, data investigating the treatment evolution from LAMA/LABA FDCs therapy to ICS-containing therapy are scarce [19,20]. Therefore, the aim of this study was to assess the rate of ICS-containing therapy from LAMA/LABA FDCs and to investigate the factors associated with ICS addition in this new era of double bronchodilator therapy [21].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Stable Clinical Course of Chronic Obstructive Pulmonary Disease Patients in the Era of Double Bronchodilator Therapy: A Single Referral Center Experience

Shin

Kang

Cho

et al. 2020

JCM

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Despite clinical benefits of long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) double bronchodilator therapy, there has been limited evidence for treatment change from LAMA/LABA to inhaled corticosteroid (ICS)-containing therapy. This study aimed to assess the rate of ICS-containing therapy from LAMA/LABA and investigate the factors associated with ICS addition. Between October 2015 and March 2019, consecutive patients prescribed with a LAMA/LABA fixed-dose combinations (FDCs) therapy without ICS were retrospectively identified from a single-referral hospital. The primary outcome was addition of ICS. During LAMA/LABA FDCs therapy (median, 12.4 months), 47 (17.7%) out of 266 patients had ICS addition. Most patients maintained bronchodilators without addition of ICS at 12 (86.5%) or 24 (76.8%) months. Patients with dyspnea (mMRC ≥ 2) at baseline, previous ICS use, and exacerbation in the previous year were at a higher risk of ICS addition. Especially, exacerbation in the previous year and dyspnea were associated with the development of frequent exacerbations during LAMA/LABA FDCs therapy, which might have led to ICS addition. Double bronchodilator therapy could be well-maintained in stable COPD patients. However, patients with exacerbation in the previous year, dyspnea, and previous ICS use should be closely approached and monitored with initiation of LAMA/LABA FDCs therapy without ICS.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Stable Clinical Course of Chronic Obstructive Pulmonary Disease Patients in the Era of Double Bronchodilator Therapy: A Single Referral Center Experience

Shin

Kang

Cho

et al. 2020

JCM

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“…Triple therapy, provided as multiple inhalers, has in pooled analyses been shown to improve lung function, health-related quality of life and exacerbations [3][4][5][6][7]. However, evidence suggests that triple therapy is often over prescribed in clinical practice and used in patients who are not frequent exacerbators [8][9][10]. Recently, two single-inhaler triple therapies have received marketing authorisation from the European Medicines Agency and one other is in late-stage clinical development [11].…”

Section: Introductionmentioning

confidence: 99%

Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

Langham¹,

Lewis²,

Pooley³

et al. 2019

Respir Res

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Background: Guidelines recommend that treatment with a long-acting β 2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and inhaled corticosteroids (ICS), i.e. triple therapy, is reserved for a select group of symptomatic patients with chronic obstructive pulmonary disease (COPD) who continue to exacerbate despite treatment with dual therapy (LABA/LAMA). A number of single-inhaler triple therapies are now available and important clinical questions remain over their role in the patient pathway. We compared the efficacy and safety of single-inhaler triple therapy to assess the magnitude of benefit and to identify patients with the best risk-benefit profile for treatment. We also evaluated and compared study designs and population characteristics to assess the strength of the evidence base. Methods: We conducted a systematic search, from inception to December 2018, of randomised controlled trials (RCTs) of single-inhaler triple therapy in patients with COPD. The primary outcome was the annual rate of moderate and severe exacerbations. Results: We identified 523 records, of which 15 reports/abstracts from six RCTs were included. Triple therapy resulted in the reduction of the annual rate of moderate or severe exacerbations in the range of 15-52% compared with LAMA/LABA, 15-35% compared to LABA/ICS and 20% compared to LAMA. The patient-based number needed to treat for the moderate or severe exacerbation outcome ranged between approximately 25-50 (preventing one patient from having an event) and the event-based number needed to treat of around 3-11 (preventing one event). The absolute benefit appeared to be greater in patients with higher eosinophil counts or historical frequency of exacerbations and ex-smokers. In the largest study, there was a significantly higher incidence of pneumonia in the triple therapy arm. There were important differences in study designs and populations impacting the interpretation of the results and indicating there would be significant heterogeneity in cross-trial comparisons. Conclusion: The decision to prescribe triple therapy should consider patient phenotype, magnitude of benefit and increased risk of adverse events. Future research on specific patient phenotype thresholds that can support treatment and funding decisions is now required from well-designed, robust, clinical trials. Trial registration: PROSPERO #CRD42018102125.

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“…Previous studies have demonstrated that clinical management and COPD prescribing patterns deviate significantly from recommended practice. [9][10][11][12] Mannino et al 10 reported that prescribing patterns deviated from GOLD recommendations for about 64% of patients with COPD in the United States. The magnitude of TT use and the pathways thereto are not well understood.…”

mentioning

confidence: 99%

Prescribing pathways to triple therapy in patients with chronic obstructive pulmonary disease in the United States

Schabert¹,

Shah

Holmgren

et al. 2021

Ther Adv Respir Dis

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Background: Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend triple therapy (TT) for chronic obstructive pulmonary disease (COPD) patients based on severity. TT utilization by severity is infrequently studied in real-world settings and may deviate significantly from current clinical recommendations. This study describes prescribing pathways to TT among patients with COPD in the United States. Methods: This study analyzed Geisinger Health System electronic medical records from 1 January 2004 to 30 November 2016. Two retrospective cohorts of COPD patients were included: (1) incident COPD, and (2) incident TT users. COPD treatment patterns, including time to TT, were summarized. Time to TT was estimated using Kaplan–Meier methods. Predictors of the relative hazard for TT among incident COPD patients were estimated using Cox proportional hazards regressions. Results: Incident COPD and TT cohorts included 57,141 and 8173 patients, respectively. TT was used by 9.6% of incident COPD patients. In the year before TT, 34.3% of incident TT patients received treatment combinations recommended before TT according to GOLD recommendations, which mainly included: long-acting muscarinic antagonists (LAMAs), long-acting beta agonists (LABAs) + LAMAs, and inhaled corticosteroids + LABAs. Among incident TT patients, median time from COPD diagnosis to TT exceeded 2 years. The hazard for TT over time was associated with lower forced expiratory volume in 1 s values, more frequent exacerbations, current/previous smoking, and comorbid lung conditions such as pulmonary vascular disease, acute respiratory failure, and lung cancer. About 15–20% of the incident TT patients stepped down to a one- or two-drug regimen. Median time to TT discontinuation or step-down were 2 and 9 months, respectively. Conclusion: The study has revealed discrepancies in the treatment of COPD patients between GOLD guidelines and actual clinical practices in the United States. Pathways to TT differed from recommended therapy regimes. Further studies are needed to understand barriers to the use of guideline-recommended TTs by healthcare providers. The reviews of this paper are available via the supplemental material section.

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Initiation of Triple Therapy with Multiple Inhalers in Chronic Obstructive Pulmonary Disease: An Analysis of Treatment Patterns from a U.S. Retrospective Database Study

Cited by 15 publications

References 16 publications

Stable Clinical Course of Chronic Obstructive Pulmonary Disease Patients in the Era of Double Bronchodilator Therapy: A Single Referral Center Experience

Stable Clinical Course of Chronic Obstructive Pulmonary Disease Patients in the Era of Double Bronchodilator Therapy: A Single Referral Center Experience

Single-inhaler triple therapy in patients with chronic obstructive pulmonary disease: a systematic review

Prescribing pathways to triple therapy in patients with chronic obstructive pulmonary disease in the United States

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