VENTILATOR WAVEFORMS

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1 2013 Update of KDA Clinical Practice Guidelines on Treatment for Type 2 Diabetes Chul-Hee Kim Division of Endocrinology & Metabolism Soonchunhyang University Bucheon Hospital On behalf of KDA Committee of Clinical Practice Guideline

Background KDA Treatment Guideline for Diabetes (4 th edition) - released in 2011 (based on data published until 2010) Relase of new evidence on risks/benefits of glycemic control Addition of

2 Background KDA Treatment Guideline for Diabetes (4 th edition) - released in 2011 (based on data published until 2010) Relase of new evidence on risks/benefits of glycemic control Addition of clinical trial data on the efficacy and safety of newer drug classes Changes in recommendation by international organizations (such as ADA and EASD) Insufficient randomized controlled trial data in Korean patients -> dependent on clinical evidence from other countries and adapted guidelines from international organizations

3 Update Key Points Phamacological treatment of type 2 diabetes - Oral agents and GLP-1 analogues Change of blood pressure goal in patients with diabetes and hypertension

4 Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Glycemic targets & BG-lowering therapies must be individualized. Diet, exercise, & education: foundation of any T2DM therapy program Unless contraindicated, metformin = optimal 1st-line drug. After metformin, data are limited. Combination therapy with 1-2 other oral / injectable agents is reasonable; minimize side effects. Ultimately, many patients will require insulin therapy alone / in combination with othe r agents to maintain BG control. All treatment decisions should be made in conjunction with the patient (focus on preferences, needs & values.) Comprehensive CV risk reduction - a major focus of therapy.

10 Revision of Guidelines for Drug Treatment of Type 2 Diabetes Revision of drug selection algorithm for glycemic control. Consideration of clinical trial data in Korean patients, cost, and availability of each drug in Korea. Provide a variety of options in combination therapy using agents with different mechanisms of action for individualized therapy. Consideration of KFDA approval, coverage by National Health Insurance on drug combinations - Added those information in the appendix.

11 Oral Hypoglycemic Agents & GLP-1 Analogues Mechanism of action & Usage Wt. gain Hypoglycemia A1C Lowering Cost/ Side effects Tab. Caution Sulfonylurea (Gliclazide, 췌장베타세포에서인슐린분비증가. 있음있음 % 115- 관절통, 관절염, 중증간, 신장애, 이차실패 Glipizide, Glimepiride, 식전복용 276 원 요통, 기관지염 Glibenclamide) Biguanide 간당생성감소. 말초인슐린감수성 없음없음 % 54- 소화기장애 중증간, 신장애, 중증감염, 탈수, (Metformin) 개선. 소량부터시작. 식사와함께복용. 112 원 ( 식욕감퇴 / 오심 / 구 심폐부전시금기. (Cr 남자 1.5, 토 / 설사 ), 젖산증, 여자 1.4mg/dL), 48 시간이내 B12 결핍 중등도이상의수술이나요오드 조영제를사용하는검사시중지. α-glucosidase Inhibitor 상부위장관에서다당류흡수를억제. 없음없음 % 95- 소화장애. 중증간, 신장애, 소화흡수 (Acarbose, Voglibose) 식후고혈당개선. 하루 3 회식전복용 149 원 장애를수반한만성장질환, 중증감염 Thiazolidinedione 근육, 지방의인슐린감수성개선. 간 있음없음 % 648- 체중증가, 혈색소 중증심부전, 간장애, 중증 (Pioglitazone) 당생성감소, 식사관계없이일 1 회복용 940 원 감소, 골절, 부종 신장애, 방광암금기. 심부전 Meglitinide 인슐린분비증가. 식후고혈당개선. 하루 있음있음 % 210- 변비, 상기도 중증간, 신장애, Repaglinide: (Repaglinide, Nateglinide, 3 회식사직전복용 300 원 감염, 부비동염 Gemfibrozil 과병용금기 Mitiglinide) Mitiglinide: 유당불내성금기 DPP4 inhibitor Incretin (GLP-1, GIP) 분해억제. 포도당 없음없음 % 460- 비인두염, 신장애, 장기사용시안전성 (Sitagliptin, Vildagliptin, 의존인슐린분비, 식후글루카곤분비억제, 924 원 상기도감염, 미확보, 췌장염위험 Saxagliptin, Linagliptin, 식후고혈당개선, 식사와관계없이복용 위장장애 (vildagliptin: 유당불내성금기 ) Gemigliptin, Alogliptin*) GLP-1 receptor agonist 포도당의존인슐린분비, 식후 감소없음 % 80,000 위장장애. 장기사용시안전성미확보, 중증 (Exenatide, Liraglutide, 글루카곤분비억제, 식욕감소, 위배출 원 / 펜 간, 심부전, 신장애. 췌장염위험, Exenatide QW*) 억제, 식후고혈당개선. 피하주사 갑상선수질암가족력 / 과거력 ( 일 1~2 회또는주 1 회, 식사와무관 ) 금기, 염증성장질환이나당뇨병성 위마비

12 Fail to reach target Glycemic Control in Type 2 Diabetes Lifestyle modification & Weight control Severe hyperglycemia with metabolic decompensation

13 Classes of Oral Hypoglycemic Agents

14 Fixed Dose Combination Formulas Drug Name Composition Approved Indications Initial Cost Combination Amaryl-M Glimepiride 1/2 mg + Metformin 250/500mg Sulfonylurea 또는 Metformin 단독요법으로혈당조절효과가불충분한경우, Sulfonylurea 와 Metformin 병용요법의대체, 주된식사직전식사와함께투여 인정 원 / 정 Amaryl-Mex Glimepiride + Metformin 2/500m ( 서방정 ) g Glucovance Glibenclamide 2.5/5mg + Metformin 500mg GalvusMet Vildagliptin 50mg + Metformin 5 00mg/850mg/ 1,000mg TrajentaDuo Linagliptin 2.5mg + Metformin 5 00mg/850mg/ 1,000mg Sulfonylurea 또는 Metformin 단독요법으로혈당조절효과가불충분한경우 Sulfonylurea 와 Metformin 병용요법의대체. 최대용량 8/2000mg 인정 290원 / 정 식사와함께투여최대용량 500/5mg 1일 4정 인정 원 / 정 Metformin 단독요법실패, Metformin+Sulfonylurea 2제요 인정 원 / 정 법실패에 Metformin 대체, 인슐린 + Metformin 실패시 Metformin대체. Metformin 단독요법실패, Metformin+Sulfonylurea 2제요 인정 416원 / 정 법실패에 Metformin대체 Dia-M Mitiglinide 10mg + Metformin Metformin 단독요법으로충분한혈당조절을할수없는경우, 인정 279 원 / 정 500mg Mitiglinide 과 Metformin 의병용요법의대체 Kombiglyza Saxagliptin 5mg + Metformin 500 Metformin 단독요법실패, Saxagliptin 과 Metformin 병용요 인정 850 원 / 정 mg/1,000mg 법을대체, 인슐린 + Metformin 실패시 Metformin 대체. Janumet Sitagliptin 50mg + Metformin Metformin 단독요법실패, Metformin+Sulfonylurea 2제요법 500mg/850mg/ 1,000mg 실패에 Metformin 대체, 인슐린 + Metformin 실패시 Metformin 대체 ActosMet PIGTZ 15mg + Metformin 850mg Metformin 또는피오글리타존단독요법실패, 피오글리타존과 Metformin의병용요법의대체 인정 인정안됨 원 / 정 907 원 / 정

15 Combinations covered by National Health Insurance (from )

16 Indications by KFDA approval vs. National Health Insurance coverage Biguani de Sulfonyl urea (SU) TZD Alpha- Glucosida se Inhibitor Drug Metformin (MFOM) Gliclazide, glipizide, glimepiride, glibenclamide Pioglitazone KFDA Approval Mono Dual Combination Triple Combination 국내임상 가능제한없음제한없음제한없음 가능 제한없음 (Meglitinide 계제외 ) 가능 SU, MFOM, Insulin Acarbose 가능경구, Insulin MFOM+SU Voglibose 가능 Megliti nide Repaglinide 가능 SU, MFOM, Glinide, Insulin MFOM, TZD, insulin (3mg) 제한없음 (Meglitinide 계제외 ) MFOM+SU, MFOM+Ins, MFOM+Meg, MFOM+DPP MFOM+SU Insurance Coverage O 제한없음 (Meglitinide 병합불가 ) O α-gi 병합불가 DPP4i, TZD 병합은불가 DPPIV inhibitor (DPPIVi) Nateglinide 가능 O MFOM, a-gi, TZD Mitiglinide 가능 O Sitagliptin Vildagliptin Saxagliptin 가능 가능 가능 MFOM, SU, TZD, insulin SU+MFOM, TZD+MFOM, Insulin+MFOM MFOM+SU, Insu+MFOM Insu+MFOM Gemigliptin 가능 MFOM O O O O SU, DPPI4i 병합불가 HbA1c 7.5% 시 MFOM 과초기병합. 인슐린병합시 1 종본인부담 Meglitinide, α-gi 병합불가 Linagliptin 가능 MFOM, SU, insulin MFOM+SU, Insu+MFOM GLP-1 receptor agonist Exenatide 가능 MFOM, SU, TZD Liraglutide 가능 MFOM, SU MFOM+SU, MFOM+TZD 비급여 O MFOM(±SU) 환자로 BMI 30 또는 Insulin 을투여할수없는환자. 3 제병용 (MFOM+ SU + Exenatide) 시인정 Exenatide QW 불가 MFOM, SU, TZD 미정

17 Cautions of Medications in Heart, Kidney, Liver Dysfunction Drug Heart Failure moderate to severe CKD (egfr < 60 ml/min) Advanced CKD (egfr < 30 ml/min) Severe liver dysfunction Metformin 주의 (Severe ventricular dys Cr 남자 1.5 mg/dl, 금지 금지 function 시금지 ) 여자 1.4 mg/dl 금지 TZD (PIGTZ) 금지 사용가능 감량 Active LD, LFT > 2.5배금지 Repaglinide 사용가능 사용가능 사용가능 저혈당주의 Nateglinide 사용가능 사용가능 사용가능 저혈당주의 Mitiglinide 주의 ( 심근경색발생 ) 사용가능 저혈당주의 주의 a-gi 사용가능 사용가능 금지 금지 Glibenclamide 사용가능 감량 비추천 ( 저혈당 ) 저혈당주의 SU 사용가능 사용가능 감량 저혈당주의 Sita 사용가능 50mg 감량 25 mg 감량 가능 Vilda 신중투여 ( 경험없음 ) 사용가능 감량 (50 mg) > 2.5배초과시중지 Saxa 신중투여 ( 경험없음 ) 감량 (2.5 mg) 감량 정상용량 Lina 신중투여 ( 경험없음 ) 정상용량 정상용량 정상용량 Gemiglip 신중투여 ( 경험없음 ) 신중투여 (60% 신장배설 ) 신중투여 ( 경험없음 ) 신중투여 ( 경험없음 ) Exenatide 사용가능 감량 금지 가능 Liraglutide 아직모름 ( 비추천 ) 아직모름 ( 비추천 ) 아직모름 ( 비추천 ) 아직모름 ( 비추천 )

18 Update Key Points Phamacological treatment of type 2 diabetes - Oral agents and GLP-1 analogues Change of blood pressure goal in patients with diabetes and hypertension

19 Until last year

20 But this year

21 The reason for the change is * The proportion of patients with serious side-effect (hypotension, declining renal function) increased from1.3 to 3.3% with aggressive treatment.

22 Patients with Events (%) Patients with Events (%) Primary Outcome Nonfatal MI, Nonfatal Stroke or CVD Death Total Stroke HR = 0.88 HR = % CI ( ) 15 95% CI ( ) NNT for 5 years = Years Post-Randomization Years Post-Randomization

23 Critical review of previous evidence

24 Guidelines from other organizations ESC-EASD Guidelines on Diabetes, Pre-diabetes, and Cardiovascular disease (August, 2013) Target blood pressure in patients with DM <140/85 mmhg AACE guideline 2013: target blood pressure /80 mmhg JDS guideline 2013: target blood pressure < 130/80 mmhg

25 KDA 2013 Guideline Blood pressure goal in patients with diabetes and hypertension <140/80 mmhg

26 KDA Committee of Clinical Practice Guideline Yu-Bae Ahn, Catholic University Jung Min Lee, Catholic University Seung-Hyun Ko, Catholic University Nan Hee Kim, Korea University Dong Jun Kim, Inje University Dong Hee Kim, Sanggye Paik Hospital Sang Yong Kim, Chosun University Sung Rae Kim, Catholic University Soo Kyung Kim, CHA University Chul-Hee Kim, Soonchunhyang University Kang Hee Sim, Samsung Medical Center Mi Hye Woo, Kyung Hee Univ. Hospital Ji Hyun Lee, Daegu Catholic University Hye Jin Lee, Ewha Women s University Eun Gyoung Hong, Hallym University Yu Chul Whang, Kyung Hee University

Pharmacotherapeutics Application of New Pathogenesis on the Drug Treatment of Diabetes Young Seol Kim, M.D. Department of Endocrinology Kyung Hee Univ

Pharmacotherapeutics Application of New Pathogenesis on the Drug Treatment of Diabetes Young Seol Kim, M.D. Department of Endocrinology Kyung Hee Univ Application of New Pathogenesis on the Drug Treatment of Diabetes Young Seol Kim, M.D. Department of Endocrinology Kyung Hee University College of Medicine & Hospital E mail : ycell2@yahoo.co.kr Abstract