4 Voorlopig advies Farmacotherapeutisch Kompas 4.1 Oud advies
4.2 Nieuw advies
Bij COPD zijn de belangrijkste stappen bij de behandeling: stoppen met roken en voldoende bewegen. Start in eerste instantie (bij een lichte ziektelast) met een kortwerkende luchtwegverwijder: ipratropium of een β2-sympathicomimeticum. Bij aanhoudende klachten en/of exacerbaties is onderhoudsbehandeling met een langwerkende luchtwegverwijder (parasympathicolyticum, β2-
sympathicomimeticum) aangewezen. Bij de keuze van een inhalator spelen patiëntgebonden factoren zoals coördinatie en inspiratiekracht, een belangrijke rol voor het behalen van een optimaal effect. Bij aanhoudende exacerbaties komt als eerste keus een onderhoudsbehandeling met twee langwerkende
luchtwegverwijders in aanmerking, een combinatie van een langwerkend β2- sympathicomimeticum en een langwerkend parasympathicolyticum (LABA/LAMA). Bij aanhoudende frequente ernstige exacerbaties is de volgende behandeloptie het toevoegen van (een proefbehandeling met) inhalatiecorticosteroïden aan de
langwerkende luchtwegverwijders (triple therapie of drievoudige inhalatietherapie). Toevoeging van roflumilast aan triple therapie kan worden overwogen bij patiënten met ernstig en zeer ernstig COPD geassocieerd met chronische bronchitis die
ondanks optimale triple therapie frequente exacerbaties hebben (≥ 2 matig tot ernstige exacerbaties of ≥ 1 ziekenhuisopname in het voorafgaande jaar).
Behandeling moet plaatsvinden onder leiding van een arts met ervaring in de behandeling met roflumilast.
5 Literatuur
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8. SmPC Daxas®
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chronische obstructieve longziekte (COPD). Zorginstituut Nederland, 2010.
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DEFINITIEF | Farmacotherapeutisch rapport roflumilast (Daxas®) als aanvullende onderhoudsbehandeling bij ernstig COPD met frequente exacerbaties ondanks optimale triple therapie | 11 juli 2018
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publicatie Martinez, 2015 REACT17 Dubbelblind, gerandomiseerd, placebogecontroleerd (A2) [ITT] Follow-up 12 mnd 1.945 Ernstig COPD, ≥40 jaar, (ex)roker ≥20 pakjaren, chronische bronchitis, ≥2 exacerbaties in het voorgaande jaar huidige medicatie: minimaal 1 jaar ICS/LABA±LAMA Roflumilast + LABA+ICS±LAMA Placebo + LABA+ICS±LAMA Primair: % matige-tot-ernstige COPD- exacerbaties per patiënt per jaar Secundair:
Postbronchodilatoire FEV1,
verandering ten opzichte van randomisatie
% ernstige COPD-exacerbaties per patiënt per jaar
Aantal COPD-exacerbaties behandeld met antibiotica
Martinez, 2016 RESPOND18 Dubbelblind, gerandomiseerd, placebogecontroleerd (A2) [ITT] 2.354 Ernstig/zeer ernstig COPD, ≥40 jaar, chronische bronchitis, ≥2 exacerbaties en/of ziekenhuisopname in Roflumilast + LABA+ICS±LAMA Placebo + Primair: % matige-tot-ernstige COPD- exacerbaties per patiënt per jaar Secundair:
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Int J Chron Obstruct Pulmon Dis. 2016 Aug 17;11:1921-8. doi: 10.2147/COPD.S109661. eCollection 2016. PMID: 27574416 3. Efficacy and Safety of Roflumilast in Korean Patients with COPD. Lee JS, Hong YK et al.
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pagina 44 van 44
Bijlage 3: Overzicht gebruikte richtlijnen en standaarden
Organisatie, ref
Datum Titel
EMA / CBG 2018 Samenvatting van de productkenmerken roflumilast. EMEA/H/C/001179 -X/0035.8
EMA / CBG 2010 European Public Assessment Report (EPAR) roflumilast. EMA/464905/2010. 22 April 2010.19
EMA /CBG 2018 European Public Assessment Report (EPAR) roflumilast - Extension. EMA/154975/2018. 22 February 2018.11
NHG 2015 NHG-standaard COPD, derde herziening. Nederlands Huisartsen Genootschap. Utrecht, 2015.1
NVALT 2010 NVALT-CBO-richtlijn diagnostiek en behandeling van COPD. Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose.6
GOLD 2018 Global Initiative for the Diagnosis, Management, and Prevention of COPD. Global Strategy for the Diagnosis, Management and Prevention
of Chronic Obstructive Pulmonary Disease 2018 Report . Available from: http://goldcopd.org.5
ERS-ATS 2017 Guideline Management of COPD exacerbations.16
NICE 2017 Roflumilast for treating chronic obstructive pulmonary disease. Technology appraisal guidance [TA461] Published date: 26 July 2017.
https://www.nice.org.uk/guidance/ta461.24
SMC 2017 Resubmission. Roflumilast, 500 microgram, film-coated tablet (Daxas®) SMC No 635/10.
https://www.scottishmedicines.org.uk/files/advice/roflumilast_Daxas_Resubmission_FINAL_August_2017_for_website.pdf.31
NICE 2010 Chronic obstructive pulmonary disease in over 16’s: diagnosis and management. Clinical Guideline [CG101]. Published date: June 2010.