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Tiotropium/olodaterol reduces COPD treatment escalation and adverse outcomes vs LABA/ICS

Prof. Jennifer Quint
Imperial College London, UK
28 Oct 2020

Results from a large, noninterventional database study presented at the American Thoracic Society 2020 virtual conference (ATS 2020) have shown that chronic obstructive pulmonary disease (COPD) maintenance therapy with tiotropium/olodaterol (T/O) is associated with a lower risk of escalation to triple therapy or development of adverse outcomes compared with maintenance use of long-acting β2-agonist/inhaled corticosteroid (LABA/ICS) combination therapies. In an interview with MIMS Doctor, lead author Professor Jennifer Quint of Imperial College London, UK, shared insights on the significance of these findings to COPD management in clinical practice.

Maintenance ICS commonly over-prescribed in COPD

T/O, a long-acting muscarinic antagonist (LAMA)/LABA combination, is indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. [Spiolto Respimat Hong Kong Prescribing Information, May 2020]

In patients with high eosinophil counts and a history of more frequent COPD exacerbations, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020 Report states that adding an ICS to regular bronchodilator therapy can confer greater treatment benefit. [https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf] However, ICSs are often overprescribed to COPD patients despite the increased risk of pneumonia associated with their use. [Int J Chron Obstruct Pulmon Dis 2019;14:1267-1280; Cochrane Database Syst Rev 2014;3:CD010115]

“In addition to pneumonia, ICS use is also associated with an increased risk of diabetes and osteoporosis in COPD patients, further increasing the burden of healthcare utilization and costs,” said Quint. [Prim Care Respir Med 2019;29:38]

“The reasons why physicians overprescribe maintenance ICS are multifold,” she suggested. “ICS may be inappropriately prescribed to COPD patients to err on the side of caution, when there is diagnostic uncertainty between asthma and COPD. Furthermore, changes in prescribing behaviour generally lag behind evidence and guideline recommendations.”

Real-world study on COPD maintenance therapy

“Whilst randomized controlled trials [RCTs] are the gold standard for understanding the efficacy of a particular treatment, a large number of COPD patients in the real world do not meet the eligibility criteria for participation in these trials. Hence, an observational study using routinely collected data can add to the evidence base to better understand the effectiveness of a particular therapy in such patients,” Quint explained.

Quint and colleagues therefore conducted a real-world assessment using data derived from healthcare claims and results of laboratory tests from the HealthCore Integrated Research Database. The study individually assessed the risk of escalation to triple therapy (ie, addition of ICS to T/O, or addition of a LAMA to LABA/ICS), COPD exacerbation or pneumonia in COPD patients who initiated treatment with T/O (n=2,600) vs any LABA/ICS combination (n=40,353) between January 2013 and March 2019. The risk of an adverse composite outcome (escalation to triple therapy, COPD exacerbation, or pneumonia) was also evaluated. [Quint JK, et al, ATS 2020, poster A5072]

All patients were 40 years of age and had a diagnosis of COPD (but not asthma) at cohort entry. They were followed until discontinuation or switch of their index treatment, the end of health plan enrollment, or 1 year after the index date.

T/O reduces escalation to triple therapy, exacerbations, pneumonia vs LABA/ICS

Results showed a 77 percent reduction in the risk of escalation to triple therapy among patients treated with T/O vs LABA/ICS (hazard ratio [HR], 0.23; 95 percent confidence interval [CI], 0.19 to 0.27). In addition, significant reductions in COPD exacerbation and pneumonia were also observed with T/O therapy. (Figure 1) [Quint JK, et al, ATS 2020, poster A5072]

HK-BIN-114_01

Patients receiving T/O were also less likely to experience an adverse composite outcome vs those on LABA/ICS (HR, 0.46; 95 percent CI, 0.42 to 0.51). (Figure 2) [Quint JK, et al, ATS 2020, poster A5072]

HK-BIN-114_02

“Further subgroup analysis showed that the reduction in risk of an adverse outcome was similar irrespective of baseline eosinophil count or exacerbation history,” said Quint. (Figure 2) [Quint JK, et al, ATS 2020, poster A5072]

“Results of this study are encouraging and suggest that T/O is a good alternative to a LABA/ICS combination in this patient population in the clinical setting. They also confirm findings from RCTs that suggest T/O as a good maintenance treatment option for COPD,” pointed out Quint. [Drugs 2019;79:997-1008]

Summary

This real-world study has shown that maintenance therapy with T/O lowers the risk of escalation to triple therapy or adverse outcomes vs maintenance LABA/ICS in patients with COPD, regardless of baseline eosinophil count or exacerbation history.

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