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7. Association American D. Updates to the Standards of Medical Care in Diabetes-2018. Diabetes Care 2018; 41(9): 2045-2047.
8. 中華民國糖尿病學會. 糖尿病臨床照護指引: 2018.
9. WHO. In: Guidelines on second-and third-line medicines and type of insulin for the control of blood glucose levels in non-pregnant adults with diabetes mellitus.
Geneva; 2018.
10. CADTH.ca. Canadian Agency for Drugs and Technologies in Health,.
https://www.cadth.ca/. Published 2018. Accessed on November 2, 2018.
11. Pharmaceutical Benefits Advisory Committee. Public Summary Document – November 2017 PBAC Meeting. 4.03 DAPAGLIFLOZIN tablet 10 mg (as propanediol monohydrate),Foxiga®; DAPAGLIFLOZIN WITH METFORMIN tablet containing 10 mg dapagliflozin with 1000 mg metformin XR, tablet containing 10 mg dapagliflozin with 500 mg metformin XR, tablet containing 5 mg dapagliflozin with 1000 mg metformin XR, Xigduo® XR;
DAPAGLIFLOZIN WITH SAXAGLIPTIN fixed dose combination tablet 10 mg/ 5 mg Qtern®, AstraZeneca Pty Ltd. Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2017-11/files /dapagliflozin-dapa-with-metformin-and-dapa-with-saxa-psd-november-2017.pdf.
Published 2017. Accessed on November 2, 2018.
12. Pharmaceutical Benefits Advisory Committee. Public Summary Document – July 2017 PBAC Meeting 5.13 DAPAGLIFLOZIN/SAXAGLIPTIN, Fixed dose combination tablet 10 mg/5 mg, Qtern®, AstraZeneca. Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2017-07/files /dapagliflozin-saxagliptin-psd-july-2017.pdf. Published 2017. Accessed on November 2, 2018.
13. Pharmaceutical Benefits Advisory Committee. Public Summary Document – July 2013 PBAC Meeting Dapagliflozin, tablet, 10 mg, Forxiga® - July 2013.
Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2013-07/dap agliflozin-psd-07-2013.pdf. Published 2013. Accessed on November 5, 2018.
14. Pharmaceutical Benefits Advisory Committee. Public Summary Document – November 2014 PBAC Meeting 7.4 DAPAGLIFLOZIN Tablet; 10 mg; Forxiga®; AstraZeneca Australia Pty Ltd. Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2014-11/files /dapagliflozin-psd-11-2014.pdf. Published 2014. Accessed on November 5, 2018.
15. Pharmaceutical Benefits Advisory Committee. Public Summary Document – March 2015 PBAC Meeting 6.03 DAPAGLIFLOZIN 10 mg tablet, 28, Forxiga®, AstraZeneca Australia Pty Ltd. Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2015-03/File s/dapagliflozin-psd-march-2015.pdf. Published 2015. Accessed on November 5, 2018.
16. Pharmaceutical Benefits Advisory Committee. Public Summary Document – July 2015 PBAC Meeting 6.02 SAXAGLIPTIN 2.5mg and 5mg oral tablets, 28, Onglyza®, AstraZeneca Australia Pty Ltd. Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2015-07/files /saxagliptin-psd-july-2015.pdf. Published 2015. Accessed on November 5, 2018.
17. Pharmaceutical Benefits Advisory Committee. Public Summary Document – July 2017 PBAC Meeting 6.01 DAPAGLIFLOZIN, Tablet 10 mg (as
propanediol monohydrate), Forxiga®, AstraZeneca Pty Ltd. . Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2017-07/files
/dapagliflozin-psd-july-2017.pdf. Published 2017. Accessed on November 2, 2018.
18. Pharmaceutical Benefits Advisory Committee. Public Summary Document – November 2017 PBAC Meeting. 7.03 EMPAGLIFLOZIN with LINAGLIPTIN FDC, 25 mg/5 mg and 10 mg/5 mg Tablets, Glyxambi®, Boehringer Ingelheim Pty Ltd Pharmaceutical Benefits Scheme, Department of Health, Commonwealth of Australia.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2017-11/files /empagliflozin-linagliptin-psd-november-2017.pdf. Published 2017. Accessed on November 6, 2018.
19. Søfteland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes
Inadequately Controlled With Linagliptin and Metformin: A 24-Week
Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care 2017; 40(2):
201-209.
20. Mathieu C, Ranetti AE, Li D, et al. Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes. Diabetes Care 2015; 38(11): 2009-2017.
21. Tinahones FJ, Gallwitz B, Nordaby M, et al. Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials. Diabetes Obes Metab 2017; 19(2): 266-274.
22. Matthaei S, Catrinoiu D, Celinski A, et al. Randomized, Double-Blind Trial of Triple Therapy With Saxagliptin Add-on to Dapagliflozin Plus Metformin in Patients With Type 2 Diabetes. Diabetes Care 2015; 38(11): 2018-2024.
23. National Institute for Health and Care Excellence. NICE | The National Institute for Health and Care Excellence. National Institute for Health and Care
Excellence. https://www.nice.org.uk/. Published 2018. Accessed on November 2, 2018.
24. Scottish Medicines Consortium. saxagliptin 5mg / dapagliflozin 10mg film-coated tablets (Qtern®). Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/media/2291/saxagliptin-dapagliflozin_qter n_abbreviated_final_june_2017_for_website.pdf. Published 2017. Accessed on November 2, 2018.
25. Mathieu C, Herrera Marmolejo M, Gonzalez Gonzalez JG, et al. Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes. Diabetes Obes Metab 2016;
18(11): 1134-1137.
26. Matthaei S, Aggarwal N, Garcia-Hernandez P, et al. One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin. Diabetes Obes Metab 2016; 18(11): 1128-1133.
27. Nct. Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin.
Https://clinicaltrials.gov/show/nct03608358 2018.
28. VILSBØ LL T, EKHOLM E, JOHNSSON EK, DRONAMRAJU N, JABBOUR S, LIND M. Dapagliflozin plus Saxagliptin Shows Noninferior A1C Reduction vs. Insulin Glargine in Patients with Type 2 Diabetes Inadequately Controlled by Metformin With or Without Sulfonylurea. Diabetes 2018; 67.
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31. Yu NC, Chen IC. A decade of diabetes care in Taiwan. Diabetes research and clinical practice 2014; 106 Suppl 2: S305-308.
32. Cheng JS, Tsai WC, Lin CL, et al. Trend and factors associated with healthcare use and costs in type 2 diabetes mellitus: a decade experience of a universal health insurance program. Medical care 2015; 53(2): 116-124.
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附錄
附錄一、全民健康保險藥物給付項目及支付標準節錄 第 5 節 激素及影響內分泌機轉藥物
Hormones & drugs affecting hormonal mechanism 2.使用條件：(105/5/1)
(1) 原則上第二型糖尿病治療應優先使用 metformin，或考慮早期開始使用 胰島素。除有過敏、禁忌症、不能耐受或仍無法理想控制血糖的情形 下，可使用其他類口服降血糖藥物。
(2) TZD 製劑、DPP-4抑制劑、SGLT-2抑制劑、以及含該3類成分之複方製 劑，限用於已接受過最大耐受劑量的 metformin 仍無法理想控制血糖 之第二型糖尿病病人，且 SGLT-2抑制劑與 DPP-4抑制劑及其複方製劑 宜二種擇一種使用。
(3) 第二型糖尿病病人倘於使用三種口服降血糖藥物治療仍無法理想控制 血糖者，宜考慮給予胰島素治療。
(4) 特約醫療院所應加強衛教第二型糖尿病病人，鼓勵健康生活型態的飲 食和運動，如控制肥胖、限制熱量攝取等措施。
(5) 第二型糖尿病病人使用之口服降血糖藥物成分，以最多四種(含四種) 為限。
備註：本規定生效前已使用超過四種口服降血糖藥物成分之病人，得繼續 使用原藥物至醫師更新其處方內容。
5.1.3.GLP-1受體促效劑(105/8/1、107/4/1)
5.1.3.1 Exenatide(如 Byetta)(100/5/1、105/5/1、107/4/1)
1.限用於已接受過最大耐受劑量的 metformin 及/或 sulfonylurea 類藥物仍無 法理想控制血糖之第二型糖尿病患者。
2.本藥品不得與 insulin、DPP-4抑制劑、SGLT-2抑制劑等藥物併用。
5.1.3.2 Liraglutide (如 Victoza)、dulaglutide(如 Trulicity)、lixisenatide (如 Lyxumia)(101/10/1、105/5/1、105/8/1、107/4/1、107/7/1)
1.限用於已接受過最大耐受劑量的 metformin 及/或 sulfonylurea 類藥物仍無 法理想控制血糖之第二型糖尿病患者。
2.當患者已接受口服降血糖藥物，及/或基礎胰島素治療仍未達理想血糖控 制時，與口服降血糖藥物及/或基礎胰島素併用。
3.本藥品不得與 DPP-4抑制劑、SGLT-2抑制劑併用。
5.1.4.(刪除)(100/8/1、107/10/1) 5.1.5.SGLT-2抑制劑及其複方：
1.Dapagliflozin (如 Forxiga)、empagliflozin (如 Jardiance)、canagliflozin (如
Canaglu) (105/5/1、107/3/1) 每日最多處方1粒。
2.Empagliflozin/metformin 複方(如 Jardiance Duo) (107/3/1) 每日最多處方2粒。
3.Dapagliflozin 及 metformin 複方(如 Xigduo XR)(107/3/1) 每日最多處方1粒。
附錄二、相對療效搜尋策略
PubMed (搜尋日期：2018 年 11 月 7 日)
Search Query Items
found
#1 Search type 2 diabetes 158,523
#2 Search (saxagliptin) AND dapagliflozin 45
#3 Search Qtern 5
#4 Search (((saxagliptin) AND dapagliflozin)) OR Qtern 46
#5 Search (type 2 diabetes) AND ((((saxagliptin) AND dapagliflozin)) OR Qtern) 43 Embase (搜尋日期：2018 年 11 月 6 日)
No. Query Results
#1 'non insulin dependent diabetes mellitus'/exp OR (diabetes AND
type AND (ii OR 2)) 373,395
#2 'dapagliflozin plus saxagliptin'/exp 43
#3 'dapagliflozin'/exp AND 'saxagliptin'/exp OR (dapagliflozin
AND saxagliptin) 391
#4 #2 OR #3 391
#5
#1 AND #4 AND ([cochrane review]/lim OR [systematic review]/lim OR [meta analysis]/lim OR [randomized controlled trial]/lim) AND ([article]/lim OR [article in press]/lim OR [review]/lim)
42
Cochrane Library (搜尋日期：2018 年 11 月 7 日)
ID Search Hits
#1 MeSH descriptor: [Diabetes Mellitus, Type 2] explode all trees 14,615
#2 diabetes type 2 46,388
#3 #1 OR #2 46,389
#4
saxagliptin OR Onglyza OR
"3-hydroxyadamantylglycine-4,5-methanoprolinenitrile hydrate"
OR "BMS 477118" OR "BMS477118" OR "BMS-477118"
350
#5
dapagliflozin OR
"(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol" OR "BMS 512148" OR "BMS-512148" OR "BMS512148"
521
#6 #4 AND #5 67
#7 #3 AND #6 64
附錄三、經濟評估文獻搜尋紀錄
資料庫 查詢日期 關鍵字 篇
數
篩 選 後 篇 數
PubMed 2018.11.08
#1 type 2 diabetes
#2
（DAPAGLIFLOZIN/SAXAGLIPTIN, fixed dose combination） OR Qtern
#3 (((cost-effectiveness analysis) OR cost-utility analysis) OR cost-benefit analysis) OR cost-minimization analysis
#1 AND #2 AND #3
3 0
EMBASE 2018.11.08
#1 type 2 diabetes
#2 Qtern
#1 AND #2
8 0
Cochrane
Library 2018.11.08
#1 type 2 diabetes
#2 Qtern
#1 AND #2
0 0