Withdrawal of inhaled corticosteroids versus continuation of triple therapy in patients with COPD in real life: observational comparative effectiveness study

Abstract

Background Inhaled corticosteroids (ICS) are indicated for prevention of exacerbations in patients with COPD, but they are frequently overprescribed. ICS withdrawal has been recommended by international guidelines in order to prevent side effects in patients in whom ICS are not indicated. Method Observational comparative effectiveness study aimed to evaluate the effect of ICS withdrawal versus continuation of triple therapy (TT) in COPD patients in primary care. Data were obtained from the Optimum Patient Care Research Database (OPCRD) in the UK. Results A total of 1046 patients who withdrew ICS were matched 1:4 by time on TT to 4184 patients who continued with TT. Up to 76.1% of the total population had 0 or 1 exacerbation the previous year. After controlling for confounders, patients who discontinued ICS did not have an increased risk of moderate or severe exacerbations (adjusted HR: 1.04, 95% confidence interval (CI) 0.94–1.15; p = 0.441). However, rates of exacerbations managed in primary care (incidence rate ratio (IRR) 1.33, 95% CI 1.10–1.60; p = 0.003) or in hospital (IRR 1.72, 95% CI 1.03–2.86; p = 0.036) were higher in the cessation group. Unsuccessful ICS withdrawal was significantly and independently associated with more frequent courses of oral corticosteroids the previous year and with a blood eosinophil count ≥ 300 cells/μL. Conclusions In this primary care population of patients with COPD, composed mostly of infrequent exacerbators, discontinuation of ICS from TT was not associated with an increased risk of exacerbation; however, the subgroup of patients with more frequent courses of oral corticosteroids and high blood eosinophil counts should not be withdrawn from ICS. Trial registration European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS30851).

Triple therapy in a single inhaler for chronic obstructive pulmonary disease: clinical studies and case report (real practice)

“…Безусловно, результаты исследований у пациентов с ХОБЛ, участвующих в РКИ, не всегда полностью отражают все характеристики больных, получающих первичную медицинскую помощь по поводу ХОБЛ, поэтому для более полного подтверждения результатов РКИ также важны неинтервенционные обсервационные исследования [15].…”

“…Другое, более крупное наблюдательное сравнительное исследование оценивало эффективность отмены ИГКС по сравнению с продолжением тройной терапии у пациентов с ХОБЛ, получающих первичную медицинскую помощь у врачей общей практики Великобритании [15]. Клинические исходы 1046 пациентов, которым был отменен прием ИГКС, были сопоставлены в соотношении 1 : 4 с исходами 4184 пациентов, которые продолжали применение тройной терапии.…”

CONQUEST: A Quality Improvement Program for Defining and Optimizing Standards of Care for Modifiable High-Risk COPD Patients

“…[38][39][40] A previous QIP in asthma led by OPC has successfully reduced the rate of asthma exacerbation from 24.8% pre-implementation to 15.3% in the year post-implementation, while no improvement was observed among control sites. 40 OPC also has a well-established track record in COPD research in primary care [41][42][43][44] including the establishment of a COPD patient registry. 45,46 A recent evaluation of a COPD QIP led by OPC demonstrated an overall 20% reduction of COPD exacerbations, compared to 10% in control practices, in the year following implementation.…”

Use of single-inhaler triple therapy in the management of obstructive airway disease: Indian medical experts’ review

“…More frequent contacts of severe patients with the healthcare providers may increase the probability of treatment changes, including de-escalation from TT. In a latest real-world study, which included mostly infrequent exacerbators, withdrawal of ICS from TT was not associated with risk of exacerbation [ 77 ]. Current guidelines based on RCTs also propose safe withdrawal of ICS in patients with stable COPD, particularly in non-exacerbators with low blood eosinophil counts [ 78 , 79 ].…”

“…Rapid lung function decline is independently associated with higher mortality. Evidence suggests that of all COPD patients, one-third of them exhibit a rapid decline in lung function [ 77 ]. In a post hoc analysis of the FULFIL study, a clinically meaningful decline in lung function was seen in 25% treated with triple therapy compared with 56% treated with dual therapy.…”