Microsoft PowerPoint - Symbicort-SMART

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1 Proceeding to the Future of Asthma Therapy Terry Wu 吳中隆 AstraZeneca Taiwan

2 氣喘定義 1. 氣喘乃是一種呼吸道持續性的慢性發炎反應, 且支氣管對於各種刺激, 會產生過度反應 ( 遺傳體質加上外來過敏原 ) 2. 反覆發作的氣流阻滯會自行緩解或經適當治療而恢復 ( 可逆性的肺功能障礙 ) 3. 依嚴重程度, 可出現 : 呼吸困難哮嗚音胸悶和咳嗽, 尤其是在夜間或清晨, 症狀更明顯有些人會出現多痰

Current golden standard treatment manages the two components of asthma separately * Inflammation Bronchoconstriction Maintenance Inhaler Daily

3 Current golden standard treatment manages the two components of asthma separately * Inflammation Bronchoconstriction Maintenance Inhaler Daily use Prevention `Rescue Inhaler Rapid symptom relief Does not address underlying inflammation * Canadian Asthma Consensus Report., CMAJ; 1999 P.3

4 Evolving Treatment Options Large use of short-acting ß 2 -agonists ICS treatment introduced 1972 Fear of short-acting ß 2 -agonists Adding LAßA to ICS therapy Kips et al, AJRCCM 2000 Pauwels et al, NEJM 1997 Single Greening et al, Lancet 1992 inhaler therapy (Symbicort ) Bronchospasm Inflammation Remodelling P.4

5 Patients over-rely on SABAs vs. ICS; irrespective of asthma severity Rabe KF at al, Eur Respir J 2000; 16: P.5

6 Despite ICS or ICS/LABA maintenance, 74% of patients used rescue therapy each day SABA Use (puffs/day in last week) Number of inhalations None Base: all patients (n=2,406) % of patients Partridge MR at al, BMC Pulmonary Medicine 2006; 6:13 P.6

7 Patients adjust their SABAs early and ICS too late at the time of worsening symptoms ICS & LABA 5 Mean no. of puffs per day of SABA ICS no LABA Seretide 5 Symbicort Mean no. of puffs per day of ICS 4 3 Early adjustment 4 * 3 No early adjustment When well Signs/ warnings 4-fold increase at worst At worst Recovery 1 0 When well Signs/ warnings 2-fold increase at worst At worst Recovery Partridge MR at al, BMC Pulmonary Medicine 2006; 6:13 P.7

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10 Your suggestion is??? P.10

11 Symbicort SMART Symbicort Maintenance And Reliever Therapy Symbicort 維持和緩解雙效療法 Inflammation and Bronchoconstriction It provides rapid symptom relief and improved control Patients do not require a separate SABA P.11

12 What is SMART? P.12

13 SMART strategy is unique to Symbicort SMART features Budesonide + Formoterol Anti-inflammatory agent Long-acting bronchodilator Fast onset within 3-5 hours Onset as rapid as salbutamol (1-3 minutes) Demonstrated dose response Demonstrated dose response 6 µg to 48 µg/day Greater efficacy in combination with formoterol vs. higher doses of budesonide alone Only Symbicort can be prescribed in this manner P.13 Nov 13th, 2007

Symbicort SMART has better efficacy over fixed-dose combination at lower dose Total daily medication use (maintenance and relief) Fixed Symbicort + prn SABA Fixed Symbicort + prn Symbicort (Symbicort

14 Symbicort SMART has better efficacy over fixed-dose combination at lower dose Total daily medication use (maintenance and relief) Fixed Symbicort + prn SABA Fixed Symbicort + prn Symbicort (Symbicort SMART) If a combination inhaler containing formoterol and budesonide is selected, it may be used for both rescue and maintenance. This approach has been shown to result in reductions in exacerbations and improvements in asthma control in adults and adolescents at relatively low doses of treatment (Evidence A) page60 P.14

15 The underlying inflammation is treated with every inhalation even when used as needed P.15

16 Symbicort SMART reduces asthma exacerbation rates more effectively than fixed combination Exacerbations (events/100 patients/year) * Extrapolated to one year from six month result % * ** * P<0.001 vs. Seretide + SABA ** P<0.01 vs. 2x Symbicort + SABA 0 Seretide 50/250 µg bid + SABA A six month double-blind study including 3,335 patients Symbicort 320/9 µg bid + SABA Symbicort SMART 160/4.5 µg bid + as needed COMPASS: Kuna P et al, Int J Clin Prac. 2007; 61: P.16

17 Symbicort SMART improves daily symptom control * Change in am PEF from run-in p< Total symptom score Awakenings 20 p= % p< p< Maintenance Symbicort + as needed: A one year double-blind study including 3,394 patients -60 Bricanyl Oxis Symbicort p<0.05 p<0.01 * SMILE: Rabe KF et al, Lancet. 2006; 368: P.17

18 Symbicort SMART reduces the use of daily reliever Inhalations use/patient/24 hours % * * P< Seretide + SABA Symbicort SMART Maintenance dose of Seretide titrated on clinicians judgment to be either 2x50/100 µg; 2x50/250 µg or 2x50/500 µg Maintenance dose of Symbicort 160/4.5 µg; 1 or 2 puffs bid based on clinicians judgment One year randomized real life study including 2,143 patients COSMOS: Vogelmeier C et al, Eur Respir J. 2005; 26: P.18

19 Symbicort SMART reduces numbers of hospitalizations and ER treatments Hospitalizations/ER treatment (events/100 patients/year) * Extrapolated to one year from six month result % 10 10* * P<0.01 vs. Seretide + SABA 0 Seretide 50/250 µg bid + SABA A six month double-blind study including 3,335 patients Symbicort 320/9 µg bid + SABA Symbicort SMART 160/4.5 µg bid + as needed COMPASS: Kuna P et al, Int J Clin Prac. 2007; 61: P.19

20 Symbicort SMART reduces drug load of oral corticosteroids days with use of oral streoids % Seretide 50/250 µg bid + SABA A six month double-blind study including 3,335 patients Symbicort 320/9 µg bid + SABA Symbicort SMART 160/4.5 µg bid + as needed COMPASS: Kuna P et al, Int J Clin Prac. 2007; 61: P.20

Formoterol provides not only rapid symptom relief but also anti-inflammatory benefits 30 Mean FEV 1 (% change from baseline) Formoterol 9 µg Formoterol 4.

21 Formoterol provides not only rapid symptom relief but also anti-inflammatory benefits 30 Mean FEV 1 (% change from baseline) Formoterol 9 µg Formoterol 4.5 µg Salbutamol 200 µg Salbutamol 450 µg Placebo Neutrophil count (x10 3 /mm 3 ) P< P<0.01 P<0.5 rapid symptom relief Formoterol Placebo Budesonide Baseline 4 weeks Baseline 4 weeks Baseline 4 weeks Time after drug administration (minutes) FEV 1 at 3 minutes after inhalation: p<0.001 for all active treatments compared with placebo Seberova E et al, Respiratory Medicine 2000; 94(6): Maneechotesuwan et al, CHEST 2005; 128(4): P.21

22 Budesonide has anti-inflammatory effect much faster than we thought it d be rapid symptom relief Single dose of budesonide (2,400 µg) within 6 hours FEV 1 (L) 4 Budesonide 800 µg Placebo 60 Eosinophils Treatment at the start of the late response * p< * Time (hours) * * * * Sputum eosinophils (%) Placebo Budesonide p<0.05 Paggiaro PL et al, Am J Crit Care Med 1994;149: Gibson P et al: Am J Respir Crit Care Med 2001; 163: P.22

23 Balanag V.M et al, Pulm Pharm Thera 2006; 19(2): prn Symbicort P.23

24 Symbicort is as effective and well tolerated as salbutamol in treating acute asthma prn Symbicort Balanag VM et al, Pulm Pharm Thera 2006; 19(2): P.24

25 Timing is more important than overall dosage Number of days using oral steroids over 6 months Foresi A et al, CHEST 2000; 117(2): p< Budesonide 800 µg bid + placebo qd Budesonide 100µg bid +budesonide 200µg qd Budesonide 100 µg bid + placebo qd It is the timing of the increase in ICS dose, resulting from as-needed use of budesonide/formoterol to treat symptoms, rather than the total inhaled dose of ICS that improves efficacy. O Byrne PM et al, J Allergy Clin Immuno 2007; 119: Prof. O Byrne is the member of GINA scientific committee P.25

26 Symbicort Maintenance And Reliever Therapy Symbicort 維持和緩解雙效療法 Symbicort SMART license has been received on Sep 26 th, 2007 Symbicort Turbuhaler 160/4.5μg/dose (Budesonide/formoterol) 衛署藥輸字第號.. B. 以吸必擴作為氣喘症之維持和緩解療法成人和青少年 (12 歲及以上 ): 一般維持劑量是每天 1 次, 每次吸入 2 劑 ; 或每天 2 次, 每次吸入 1 劑有些病人可能需要使用每天 2 次, 每次吸入 2 劑的維持劑量病患應視症狀需求而增加吸入劑量, 但單次使用不得吸入超過 6 劑每日可在短時間內使用最高可至共 12 劑之總劑量一般原則為緩解症狀而增加吸入劑數的病人, 如果在 2 週內, 氣喘控制情況仍未見改善, 應考慮重新評估氣喘的治療成人和青少年每日通常不需要吸入 8 劑以上特殊情況下, 成人和青少年每日可在短時間內最高吸入 12 劑 P.26

27 Symbicort SMART means more effective treatment, yet simpler Current treatment plan Symbicort SMART P.27

28 P.28

29 How to use Turbuhaler 1. 旋轉並移去瓶蓋 2. 一手拿直瓶身, 另一手推底盤, 先向右再向左轉到底, 聽到卡嚓一聲, 即填藥完成 3. 先請吐氣, 含住吸嘴後深深快速地吸飽一口氣, 閉氣 5 秒後, 輕輕且慢慢的吐氣, 即完成一次吸入動作勿對著藥瓶吐氣 4. 將瓶蓋旋轉歸位不要忘了漱口 P.29

30 Turbuhaler checking dose P.30

31 One or many? or Which treatment would you choose? P.31 Nov 13th, 2007

32 謝謝聆聽 P.32 Nov 13th, 2007

ment group was more effective than that of the control group OR = % CI = Conclusion The clinical efficacy of Chinese medic

ment group was more effective than that of the control group OR = % CI = Conclusion The clinical efficacy of Chinese medic 33 243 HAART Meta * 1 1 1 1 1 2 3 3 3 1. 530001 2. 538000 3. 530011 highly active anti-retroviral therapy HAART Pubmed HAART randomized controlled trials RCT Jadad RevMan5. 3 Meta 5 RCT 761 Meta HAART