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 1,046 patients who withdrew ICS were matched 1:4 by time on TT to 4,184 patients who continued with TT. Up to 76.1% of the total population had 0 or 1 exacerbation he 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subgroup of patients with more frequent courses of oral corticosteroids and high blood eosinophil counts should not be withdrawn from ICS.
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 1,046 patients who withdrew ICS were matched 1:4 by time on TT to 4,184 patients who continued with TT. Up to 76.1% of the total population had 0 or 1 exacerbation he 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.
Original language | English |
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Article number | 25 |
Number of pages | 14 |
Journal | Respiratory Research |
Volume | 22 |
DOIs | |
Publication status | Published - 21 Jan 2021 |
Bibliographical note
FUNDINGThe study was funded by a grant from Boehringer Ingelheim.
ACKNOWLEDGMENTS
The study was designed and conducted by the Respiratory Effectiveness Group (REG; www.regresearchnetwork.org; Ely, UK) and data was delivered by Optimum Patient Care (OPC; www.optimumpatientcare.org) with support from Derek Skinner.
Keywords
- COPD
- Inhaled corticosteroids
- Withdrawal
- real life
- effectiveness
- Humans
- Middle Aged
- Administration, Inhalation
- Male
- Treatment Outcome
- United Kingdom/epidemiology
- Safety-Based Drug Withdrawals/trends
- Pulmonary Disease, Chronic Obstructive/diagnosis
- Aged, 80 and over
- Female
- Adrenal Cortex Hormones/administration & dosage
- Aged
- Bronchodilator Agents/administration & dosage
- Real life
- Effectiveness