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1 2 형당뇨병환자에서 vildagliptin-metformin 병합과 glimepiride-metformin 병합치료의비교 충북대학병원내분비내과 오태근

2 DPP-4 억제제 혈중 GLP-1 분해효소인 DPP-4 를억제시킴으로써활성 GLP-1 의혈중농도를증가시켜혈당강하를유도하는경구용혈당강하제 최근폭발적으로사용이증가 혈당강하효과가좋고부작용이적다

3 Current DPP-4 Inhibitors Sitagliptin : FDA approval(2006), marketed by Merck & Co. Vildagliptin : EU approval(2008), marketed in the EU by Norvatis Saxagliptin : FDA approval(2009), marketed by BMS & AstraZeneca Linagliptin : FDA approval(2011), marketed by Lilly & Boehringer Ingelheim Alogliptin : FDA under review, developed by Takeda Dutogliptin : being developed by Phenomix Co. Gemigliptin : being developed by LG Life Sciences

4 Hypoglycemia

5 Definitions of Hypoglycaemia Definition - There is no consensus definition of hypoglycaemia in diabetes, and a variety of criteria have been used. - Each group has defined a different level for this threshold, ranging from < 3.9 down to < 3.0 mmol/l. Severity Severe hypoglycemia Moderate hypoglycemia Mild hypoglycemia an episode in which the mental state of a patient is so disturbed that they are unable to self-treat. self-treated episodes involving significant disruption to lifestyle all other episodes, recognized by the patient and selftreated. Diabet Med. 2008, 25,:245-54

6 Risk factors for Hypoglycaemia the most common cause of hypoglycemia in T2DM Therapeutic factors Behavioural factors Physiological factors Insulin Insulin secretagogues (e.g. SU, glinide ) Missed or irregular meals, alcohol, exercise and incorrect use of glucose-lowering medication(dose, timing) Older age, duration of diabetes, presence of comorbidities, renal impairment, loss of residual insulin secretion, defective counterregulation, loss of awareness of hypoglycaemia Diabet Med. 2008, 25,:245-54

THE CONSEQUENCES OF HYPOGLYCAEMIA Death 2,3 Coma 3 Hospitalisation costs 4 Cardiovascular complications 3

consciousness 3 Increased risk of car accident 6 Increased risk of seizures 3 1 Whitmer RA, et al. JAMA.

2010; 26: 1333 1342; 4 Jönsson L, et al. Value Health. 2006; 9: 193 198; 5 Foley JE, Jordan J.

7 THE CONSEQUENCES OF HYPOGLYCAEMIA Death 2,3 Coma 3 Hospitalisation costs 4 Cardiovascular complications 3 Increased risk of dementia 1 Hypoglycaemia Weight gain by defensive eating 5 Reduced quality of life 7 Loss of consciousness 3 Increased risk of car accident 6 Increased risk of seizures 3 1 Whitmer RA, et al. JAMA. 2009; 301: ; 2 Bonds DE, et al. Br Med J. 2010; 340: b4909; 3 Barnett AH. Curr Med Res Opin. 2010; 26: ; 4 Jönsson L, et al. Value Health. 2006; 9: ; 5 Foley JE, Jordan J. Vasc Health Risk Manag. 2010; 6: ; 6 Begg IS, et al. Can J Diabetes. 2003; 27: ; 7 McE wan P, et al. Diabetes Obes Metab. 2010; 12:

8 Hypoglycemia and Risk of incident Dementia No. of Hypoglycemic Episodes No. of Dementia cases 1 or more or more 43 HR (95% CI) 1.44 ( ) 1.26 ( ) 1.80 ( ) 1.94 ( ) Severe hypoglycemia are associated with risk of dementia in older patients with T2DM. JAMA. 2009;301:

9 Hazard ratios for all-cause mortality by HbA1c deciles Cohort 1 Cohort 2 HbA1c decile 4(red circle) was reference. Low and high mean HbA1c values were associated with increased all-cause mortality and cardiac events. Lancet. 2010;375:

10 Frequency of hypoglycemia and length of hospital stay In univariate analysis, patients who had at least one episode of hypoglycemia stayed in the hospital 2.8 days longer than patients who did not have any hypoglycemic Episodes. Diabetes Care 32: , 2009

11 Control Hyperglycemia Without Hypoglycemia Control Hyperglycemia Without Hypoglycemia

13 Objective: the efficacy and safety of vildagliptin-metformin treatment compared to those of glimepiride-metformin treatment Target Population: Drug naïve or low dose glimepiride(2-4mg) or low dose metformin ( mg) T2DM; HbA1c 7.5% 12% N* = 102 N=51 - Vilda 50mg bid + Met 500mg bid N=51 Glime 2mg bid + Met 500mg bid 2 weeks 32 weeks

14 Demographics and baseline characteristics of patients Characteristics Vildagliptin+Metformin ( n = 51 ) Glimepiride+Metformin ( n = 51 ) Age (years) ± ± Sex Male 35 (68.6 %) 31 (60.8 %) Female 16 (31.4 %) 20 (39.2 %) BMI (kg/m 2 ) ± ± 4.24 Duration of diabetes (years) 5.89 ± ± 1.74 FPG (mmol/l) 8.78 ± ± 2.14 PP2 (mmol/l) ± ± 2.22 HbA1C (%) 8.01 ± ± 0.86 Insulin (pmol/l) ± ± C-peptide (nmol/l) 1.01 ± ± 0.67 HOMA-β ± ± HOMA-IR 5.11 ± ± 6.51

15 Baseline and post-treatment mean insulin, c-peptide, HOMA-β, HOMA-IR 0 week 12 weeks 24 weeks 32 weeks Insulin (pmol/l) Vildagliptin + Metformin ± ± ± ± 9.54 Glimepiride + Metformin ± ± ± ± C-peptide (nmol/l) Vildagliptin + Metformin 3.03 ± ± ± ± 2.15 Glimepiride + Metformin 2.99 ± ± ± ± 2.99 HOMA-β Vildagliptin + Metformin ± ± ± ± Glimepiride + Metformin ± ± ± ± HOMA-IR Vildagliptin + Metformin 5.11 ± ± ± ± 3.22 Glimepiride + Metformin 5.16 ± ± ± ± 2.21

16 Mean FPG and 2h-PPG reduction 0 Vildagliptin Glimepiride -1 Change from baseline in FPG and 2h PPG (mmol/l) mg/dl mg/dl mg/dl mg/dl FPG 2h PPG -5

17 Decrement of HbA1c on the week 32 end-point 0 Vildagliptin Glimepiride Change from baseline in HbA1c (%) % -1.00%

18 Mean HbA1c changes during 32 weeks Vildagliptin Glimepiride week 12 weeks 24 weeks 32 weeks

19 Mean HbA1c reduction according to the baseline HbA1c category. Vildagliptin Glimepiride 0 HbA1c < 8 % 8 HbA1c < 9 % HbA1c 9 %

20 Body weight change (kg) vildagliptin glimepiride

21 Safety summary Vildagliptin ( n = 51 ) Glimepiride ( n = 51 ) One or more AE 5 10 SAEs 0 1 Discontinuations due to AE 3 1 Hypoglycemia (patient number) 1 10 Overall gastrointestinal AE 4 0 Selected gastrointestinal AE Abdominal pain 0 0 Nausea 1 0 Vomiting 2 0 Diarrhea 1 0 AE : adverse event SAE : serious adverse event, which means to need medical assistance The patients who discontinued medication due to AE were not contained in final analysis.

22 결론 Vildaglitin-metformin 병합요법은 glimepiride-metformin 병합요법에비교해혈당강하작용은비슷하면서상대적으로저혈당의부작용은적은안전한약제조합이다.

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00약제부봄호c03逞풚 경희대학교 동서신의학병원 약품 정보지 2 0 0 7. S P R I N G. V O L. 0 1 신약 소개 02 Journal Review 03 Special Subject 04 복약 지도 06 의약품 안전성 정보 07 약제부 알림 07 약제부 업무 소개 08 E A S T - W E S T N E O M E D I C A L C E N T E R 본 약품