Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Schabert V

PROVIDER: S-EPMC8058794 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:To compare the rate of moderate to severe exacerbations between triple therapy and dual therapy or monotherapy in patients with chronic obstructive pulmonary disease (COPD). DESIGN:Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES:PubMed, Embase, Cochrane databases, and clinical trial registries searched from inception to April 2018. ELIGIBILITY CRITERIA:Randomised controlled trials comparing triple therapy with dual therapy or monotherapy in patients with COPD were eligible. Efficacy and safety outcomes of interest were also available. DATA EXTRACTION AND SYNTHESIS:Data were collected independently. Meta-analyses were conducted to calculate rate ratios, hazard ratios, risk ratios, and mean differences with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methodology (grading of recommendations assessment, development, and evaluation). RESULTS:21 trials (19 publications) were included. Triple therapy consisted of a long acting muscarinic antagonist (LAMA), long acting ? agonist (LABA), and inhaled corticosteroid (ICS). Triple therapy was associated with a significantly reduced rate of moderate or severe exacerbations compared with LAMA monotherapy (rate ratio 0.71, 95% confidence interval 0.60 to 0.85), LAMA and LABA (0.78, 0.70 to 0.88), and ICS and LABA (0.77, 0.66 to 0.91). Trough forced expiratory volume in 1 second (FEV1) and quality of life were favourable with triple therapy. The overall safety profile of triple therapy is reassuring, but pneumonia was significantly higher with triple therapy than with dual therapy of LAMA and LABA (relative risk 1.53, 95% confidence interval 1.25 to 1.87). CONCLUSIONS:Use of triple therapy resulted in a lower rate of moderate or severe exacerbations of COPD, better lung function, and better health related quality of life than dual therapy or monotherapy in patients with advanced COPD. STUDY REGISTRATION:Prospero CRD42018077033.

Project description:BACKGROUND:Guidelines recommend that treatment with a long-acting β2 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 .