SE/RESP/0010/17; februari 2017
The inhaled therapy Triangle The important components Inhaler Nicola Scichilone; Adv Ther (2015) 32:285 292
Topics in this newsflash Key changes in GOLD 2017 strategy update Data from critical error study in COPD 3
Läkemedelsverkets behandlingsrekommendationer vid KOL - Underhållsbehandling Faktorer av viktig betydelse vid val av underhållsbehandling: Symtom Exacerbationer Lungfunktion Referens: Kroniskt obstruktiv lungsjukdom (KOL) behandlingsrekommendation. Webbpubl. på www.lakemedelsverket.se den 16/10 2015
Läkemedelsverkets behandlingsrekommendationer vid KOL Referens: Kroniskt obstruktiv lungsjukdom (KOL) behandlingsrekommendation. Webbpubl. på www.lakemedelsverket.se den 16/10 2015
Key changes in GOLD 2017 strategy update Global Initiative for Obstructive Lung Disease (GOLD) är ett globalt strategidokument för diagnos, behandling och prevention av kroniskt obstruktiv lungsjukdom (KOL ). Lung function (FEV 1 ) is no longer used for assessing patient s level of risk. Risk assessment now based on exacerbation history only 1 LAMA/LABA is recommended as initial therapy in high risk symptomatic patients (Group D). Furthermore, LAMA/LABA is recommended in patients who is still exacerbating on a LAMA (Group C) or having symptoms on a LAMA or LABA (Group B) 1 LAMA/LABA/ICS (triple therapy) is recommended in patients in Group D still exacerbating on a LAMA/LABA 1 ICS/LABA may be the first choice in patients with a history and/or findings suggestive of asthma-copd overlap 1 GOLD recognises the importance of education and training patients in inhaler technique 1 Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. 6
GOLD 2017: Management of stable COPD in Group A and B GOLD 2016 2 GOLD 2017 1 Recommended 1st choice: SAMA prn or SABA prn Alternative choices: LAMA or LABA or SABA/SAMA Continue, stop or try alternative class of bronchodilator evaluate effect A short- or long-acting bronchodilator A A In Group A, patients should be offered bronchodilator treatment based on its effect on breathlessness. This can be either a short- or a longacting bronchodilator 1 LAMAs and LABAs are preferred over short-acting agents, except for patient with only occasional dyspnoea 1 In Group B, initial therapy should consist of a long-acting bronchodilator 1 For patients with persistent breathlessness on monotherapy, the use of two bronchodilators is recommended 1 For patients with severe breathlessness, initial therapy with two bronchodilators may be considered 1 GOLD 2016 2 GOLD 2017 1 Recommended 1st choice: LAMA or LABA Alternative choices: LAMA/LABA LAMA/LABA B Persistent symptoms A long-acting bronchodilator (LABA or LAMA) B Preferred treatment = Illustration is constructed by GSK based on ref. 1 and 2. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2016. 7
GOLD 2017: Management of stable COPD in Group C GOLD 2016 2 Recommended 1st choice: ICS/LABA or LAMA Initial therapy should consist of a single longacting bronchodilator. In two head-to head comparisons, the tested LAMA was superior to the LABA regarding exacerbation prevention 1 GOLD 2017 1 Alternative choices: LAMA/LABA or LAMA/PDE4i or LABA/PDE4i C Patients with persistent exacerbations may benefit from adding a second long-acting bronchodilator (LAMA/LABA) or using a combination of a long-acting beta2-agonist and an inhaled corticosteroid (LABA/ICS) 1 Further exacerbation(s) LAMA/ LABA ICS/ LABA As ICS increases the risk for developing pneumonia in some patients, LAMA/LABA is the primary choice LAMA C Preferred treatment = Illustration is constructed by GSK based on ref. 1 and 2. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2016. 8
GOLD 2017: Management of stable COPD in Group D GOLD 2016 2 GOLD 2017 1 Recommended 1st choice: ICS/LABA and/or LAMA Alternative choices: ICS/LABA/LAMA or ICS/LABA/PDE4i or LABA/LABA or LAMA/PDE4i Consider roflumilast if FEV 1 <50% predicted and patient has chronic bronchitis Further exacerbation(s) Further exacerbation(s) LAMA Preferred treatment = LAMA/LABA/ICS LAMA/LABA Consider macrolide ICS/ LABA D D Persistent symptoms/further exacerbation(s) Starting therapy with a LAMA/LABA combination is recommended because: 1 In studies with patient-reported outcomes as the primary endpoint, LAMA/LABAs showed superior results compared to the single substances A LAMA/LABA was superior to a ICS/LABA in preventing exacerbations and other patient-reported outcomes In some patients, initial therapy with LABA/ICS may be the first choice. These patients may have a history and/or findings suggestive of asthma-copd overlap. 1 Higher blood eosinophil counts may also be considered as a parameter to support the use of ICS, although this is still under debate In patients who develop further exacerbations on LAMA/LABA therapy there are two alternative pathways: 1 Escalation to LAMA/LABA/ICS (Triple Therapy). Studies are underway comparing the effects of LAMA/LABA vs. LAMA/LABA/ICS for exacerbation prevention Switch to ICS/LABA. However, there is no evidence that this results in better exacerbation prevention. If ICS/LABA therapy does not positively impact exacerbations/symptoms, a LAMA can be added Illustration is constructed by GSK based on ref. 1 and 2. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2016. 9
GOLD 2017: Role of ICS in stable COPD GOLD 2017 1 Long-term monotherapy with ICS is not recommended (Evidence A) GOLD C patients may benefit from an ICS/LABA As ICS increases the risk for developing pneumonia in some patients, primary choice is LAMA/LABA In some GOLD D patients, ICS/LABA as initial therapy may be the first choice These patients may co-existing asthma or a history and/or findings that are suggestive of asthma-copd overlap syndrome High eosinophil counts may also be considered as a parameter to support the use of ICScontaining therapy For symptomatic patients at risk of exacerbation, the use of LAMA in conjunction with an ICS/LABA (Triple Therapy) is considered an appropriate treatment For patients who did not gain an improvement in efficacy from the addition of ICS or have an elevated risk of adverse effects (including pneumonia), stopping the ICS may be considered However, there is a lack of guidance on how to safely withdraw ICS and/or de-escalate therapy Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. 10
GOLD 2017: Issues related to inhaled delivery There have been significant additions to Chapter 3 relating to inhalational devices On average, more than two thirds of patients make at least one error in using inhalational device Observational studies have identified a significant relationship between poor inhaler use and symptom control One of the determinants of poor inhaler technique is the use of multiple devices GOLD recognises the importance of education and training patients in inhaler technique The inhaled route When a treatment is given by the inhaled route, the importance of education and training in inhaler device technique cannot be over-emphasized. The choice of inhaler device has to be individually tailored and will depend on access, cost, prescriber, and most importantly, patient s ability and preference. It is essential to provide instructions and to demonstrate the proper inhalation technique when prescribing a device, to ensure that inhaler technique is adequate and re-check at each visit that patients continue to use their inhaler correctly. Inhaler technique (and adherence to therapy) should be assessed before concluding that the current therapy is insufficient. Illustration is constructed by GSK based on ref. 1. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. Reference: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. 11
Topics in this newsflash Key changes in GOLD 2017 strategy update Data from critical error study in COPD 12
Inhaler technique & concequences GOLD 2017 update recognises the importance of education and training patients in inhaler technique 1 Critical errors in inhalation technique is associated with increased risk of hospitalization, emergency room visits, use of antibiotics and courses of oral corticosteroids resluts from a Italian cross-sectional, observational study among 1,664 subjects (figure) 2 Characteristic Hospital admission Emergency department visits Antimicrobic courses Corticosteroid courses OR ± SE; P level 1.47 ±0.17; p=0.001 1.62 ±0.20; p=0.0006 1.50 ±0.15; p=0.00004 1.54 ±0.16; p=0.00003 Illustration is constructed by GSK based on ref. 2, table 5. Relationship between risk of at least a critical inhaler error and self-report of some unscheduled health-care resources use in the last year. These are combined asthma and COPD results. References: 1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) 2017. 2017 Global Initiative for Chronic Obstructive Lung Disease, all rights reserved. Use is by express license from the owner. 2. Melani AS et al. Respir Med 2011;105:930-8. 13
Critical error rates lower with Ellipta Patients making at least one critical error after reading patient information leaflet Percentatage of patients making at least one critical error* 100 80 60 40 20 0 Diskus (n=171) MDI (n=80) Ellipta Turbuhaler (n=100) Comparator p<0,001 p<0,001 p<0,001 p<0,001 p<0,001 Handihaler (n=118) Breezhaler (n=98) Illustration is reproduced from ref. 1. Relationship between risk of at least a critical inhaler error and self-report of some unscheduled health-care resources use in the last year. *A critical error was defined as an error that was likely to result in no, or minimal (i.e., significantly reduced) medication being inhaled. Reference: 1. van der Palen J et al. Prim Care Respir J 2016: (26)16079. doi:10.1038/npjpcrm.2016.79. 14
The majority of participants preferred Ellipta overall Patients rating inhaler very easy or easy to use: Ellipta compared with Diskus (97% vs. 60%), MDI (92% vs. 44%), Turbuhaler (96% vs. 55%), Handihaler (98% vs. 38%) or Breezhaler (94% vs. 55%; all p<0.001). Patient preference: Patients preferred the ELLIPTA inhaler overall compared with the comparator devices (figure). The majority of patients also preferred the ELLIPTA inhaler for most individual criteria (number of steps for correct use, time taken to use, size of the device, dose counter, comfort of mouthpiece and ease of opening; p<0.001). There was no difference for the size of the inhaler. Proportion of participants (%) 100 80 60 40 20 0 p<0.001 Diskus (n=171) Ellipta Comparator No preference p<0.001 MDI (n=80) p<0.001 Turbuhaler (n=100) p<0.001 Handihaler (n=118) p<0.001 Breezhaler (n=98) Illustration is reproduced from ref. 1. Overall device preference reported in each sub study among patients with COPD. Reference: 1. van der Palen J et al. Prim Care Respir J 2016: (26)16079. doi:10.1038/npjpcrm.2016.79. 15
Relvar Relvar Ellipta (flutikasonfuroat/vilanterol), Inhalationspulver, Rx, F, ATC kod: R03AK10 Detta läkemedel är föremål för utökad övervakning. Indikationer Astma: Relvar Ellipta är indicerad för regelbunden behandling av astma hos vuxna och ungdomar från 12 år och äldre, när kombinationsbehandling (långverkande beta 2 -agonist och inhalationssteroid) är lämpligt: patienter som inte uppnår adekvat symtomkontroll med inhalationssteroider och vid behovs medicinering med inhalerade kortverkande beta 2 - agonister. KOL (kroniskt obstruktiv lungsjukdom): Relvar Ellipta är indicerad för symtomatisk behandling av vuxna med KOL med ett FEV 1 <70 % av förväntat normalvärde (efter bronkdilaterare) och med upprepade försämringsepisoder i sjukdomshistorien trots regelbunden behandling med bronkdilaterande läkemedel. Relvar Ellipta är inte rekommenderat till barn och ungdomar, oavsett ålder, för behandling av KOL. Dosering: En inhalation (92 mikrogram flutikasonfuroat + 22 mikrogram vilanterol) en gång dagligen. Vid Astma: Om patienten inte uppnår tillräcklig kontroll med Relvar Ellipta 92/22 mikrogram kan dosen ökas till 184/22 mikrogram, vilket kan ge förbättrad astmakontroll. Den högre dosen 184/22 mikrogram är inte indicerad till patienter med KOL Kontraindikationer och interaktioner: Känd överkänslighet (allergi) mot någon av de aktiva substanserna eller hjälpämnen. Relvar Ellipta ska inte ges samtidigt med andra långverkande beta2-adrenerga agonister eller läkemedel som innehåller långverkande beta 2 -adrenerga agonister. Varningar och försiktighet: Relvar Ellipta ska inte användas för att behandla akuta astmasymtom eller akuta exacerbationer vid KOL. De vanligaste rapporterade biverkningarna har varit huvudvärk och nasofaryngit, därutöver biverkningar som hör till klassen ICS/LABA i allmänhet. En ökning av incidensen av pneumoni, inklusive pneumoni som kräver inläggning på sjukhus, har observerats hos patienter med KOL som får inhalerade kortikosteroider. Läkare bör vara fortsatt vaksamma när det gäller möjlig utveckling av pneumoni hos patienter med KOL eftersom de kliniska tecknen på sådana infektioner överlappar symtomen på KOL-exacerbationer. För fullständig förskrivarinformation och pris, se www.fass.se. Datum för översyn av produktresumén 10/2016. GlaxoSmithKline AB, Box 516, 169 29 Solna. Tel: 08-638 93 00, www.glaxosmithkline.se Om du vill rapportera en biverkning på något av våra läkemedel eller vacciner så kan du kontakta oss på följande sätt: Rapportera en biverkning via webbformulär eller via telefon på 08-638 93 00 (be om att bli kopplad till Biverkningsenheten) 2017 GSK-koncernen. Med ensamrätt. GSK AB, Box 516, SE-169 29 Solna, Sverige. Tel: 08-638 93 00 gsk.com/se 16