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subgroup of patients with more frequent courses of oral corticosteroids and high blood eosinophil counts should not be withdrawn from ICS.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).
- Magnussen, H.
- Lucas, S.
- Lapperre, T.
- Quint, J. K.
- Dandurand, R. J.
- Roche, N.
- Papi, A.
- Price, D.
- Miravitlles, M.
Keywords
- Copd
- Effectiveness
- Inhaled corticosteroids
- Real life
- Withdrawal
- of the study and personal fees from AstraZeneca, Novartis, and ndd Medical
- Technologies, Inc. outside the submitted work. Marc Miravitlles has received speaker
- fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial,
- Sandoz, Zambon, CSL Behring, Grifols and Novartis, consulting fees from AstraZeneca,
- Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL
- Behring, Laboratorios Esteve, Ferrer, Mereo Biopharma, Verona Pharma, TEVA, Spin
- Therapeutics, pH Pharma, Novartis, Sanofi and Grifols and research grants from
- GlaxoSmithKline and Grifols. Sarah Lucas is an employee of the Respiratory
- Effectiveness Group, who received funding from Boehringer Ingelheim for conducting
- this study. Jennifer Quint has received grants from The Health Foundation, MRC, GSK,
- Bayer, BI, British Lung Foundation, IQVIA, Chiesi AZ, Insmed and Asthma UK outside
- the submitted work
- grants and personal fees from GlaxoSmithKline, Boehringer
- Ingelheim, AstraZeneca, Bayer, Insmed. Ronald J. Dandurand has received research
- grants from AstraZeneca Boehringer Ingelheim, GlaxoSmithKline, Novatis, Pfizer and
- Teva Pharma, consulting fees from Boehringer Ingelheim and Grifols, and speaking
- fees from Boehringer Ingelheim and Novartis. Nicolas Roche reports grants and
- personal fees from Boehringer Ingelheim, Novartis, Pfizer and personal fees from
- Teva, GSK, AstraZeneca, Chiesi, Sanofi, Trudell, Zambon. David Price has board
- membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan,
- Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva
- Pharmaceuticals, Thermofisher
- consultancy agreements with Amgen, AstraZeneca,
- Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer,
- Teva Pharmaceuticals, Theravance
- grants and unrestricted funding for
- investigator-initiated studies (conducted through Observational and Pragmatic
- Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi,
- Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals,
- Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance,
- UK National Health Service
- payment for lectures/speaking engagements from
- AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan,
- Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva
- Pharmaceuticals
- payment for the development of educational materials from
- Mundipharma, Novartis
- payment for travel/accommodation/meeting expenses from
- AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher
- funding for patient enrolment or completion of research from Novartis
- stock/stock
- options from AKL Research and Development Ltd which produces phytopharmaceuticals
- owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and
- 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore)
- 5%
- shareholding in Timestamp which develops adherence monitoring technology
- is peer
- reviewer for grant committees of the Efficacy and Mechanism Evaluation programme,
- and Health Technology Assessment
- and was an expert witness for GlaxoSmithKline.
