자누비아 100 - 한국MSD

1 396 1/12 100 50 25 100 : 1 ( mg) , : ( ) ------------------------------------- mg ( ---------------------------------------- ------------- 100 mg) 50 : 1 ( mg) , : ( ) ------------------------------------- mg ( ---------------------------------------- -------------- 50 mg) 25 : 1 ( mg) , : ( ) ------------------------------------- mg ( ---------------------------------------- -------------- 25 mg) 100 : 277 50 : 112 25 : 221 2.

2 1.. 2.. 396 2/12 3.. 4. , , , . 1 1 100 mg 1 100 mg .. ( , 5. ).. 1. ( [eGFR] 60 mL/ m2 < 90 mL/ m2) . 2. ( [eGFR] 45 mL/ m2 < 60 mL/ m2) . 3. ( [eGFR] 30 mL/ m2 < 45 mL/ m2) 1 1 50 mg . 4. ( [eGFR] 15 mL/ m2 < 30 mL/ m2) (ESRD) ( [eGFR] < 15 mL/ m2) 1 1 25 mg.

3 1. 1) , , - .. 3 , . 396 3/12 , (2. 4. , 2) ). 2) / (4. ).. 2. 1) 1 2) (1. ) 3. 1) : . [eGFR] < 45 mL/ m2 (ESRD) ( , ).

4 4. 1) , . ( , , ) .. ( 3).. 18 24 2 100 mg 200 mg, . 5 , 396 4/12 , , ( ), ( ) 100 mg . 100 mg 18 5% 1.

5 3 . 1. ( , , ( )) : 5% (%) (18 24 ) 100 mg (443 ) (363 ) 23 ( ) 12 ( ) (24 ) 100 mg + (175 ) + (178 ) 11 ( ) 6 ( ) 9 ( ) 7 ( ) (18 ) 100 mg + + (181 ) + + (97 ) 10 ( ) 5 ( ) 11 ( ) 4 ( ) ( ) (24 ) 100 mg + ( ) (222 ) + ( ) (219 ) 14 ( ) 10 ( ) 13 ( ) 5 ( ) ITT(Intent-to treat) 24 5%.

6 24 ( ) 5% ( 3 ). 24 ( ) 5% ( ; ). 54 396 5/12 5% : ( , ), ( , ), ( , ) ( , ) . 2 , , : ( 100 mg , ), ( 100 mg , ), ( 100 mg , ) 24 (factorial trial) 5% 2.

7 2. : 5% , , (%) (176 ) 100 mg1 1 (179 ) 500 1000 mg1 2 (364 ) 50 mg 1 2 + 500 1000 mg 1 2 (372 ) 9 ( )8 ( ) 19 ( ) 23 ( ) 5 ( )2 ( ) 14 ( ) 22 ( ) ITT(Intent to treat) , ECG(QTc ) . 100 mg/ (N=5429) ( )(N=4817) 10,246 19 , 100 - (patient-years) ( 4708 - 4 , 3942 - 4 ). TECOS , 100 - (patient-years) (23/7,332 , 25 ), 100 - (patient-years) (12/7,339 , 17 ).

8 (1. , 2) , TECOS ) 396 6/12 TECOS (TECOS: Trial Evaluating Cardiovascular Outcomes with Sigagliptin) ITT(Intent-to-treat) 100 mg ( eGFR 30 < 50 mL/ m2 50 mg) 7,332 7,339 . (HbA1c) (CV) . (9. ). , . (160 , 100 - (patient-years) ), (143 , 100 - (patient-years) ) . / , (138/5,021 ), (125/4,931 ) , / , (22/2,311 ), (18/2,408 ).

9 , . (9 ) . (74%) 70 mg/dL . ( 3 ). 3. ( ) ( ) : (24 ) 100 mg + ( ) (222 ) + ( )(219 ) (%) 27 ( ) 4 ( ) ( / - ) (%) 0 ( ) 0 ( ) (24 ) 100 mg + ( ) (322 ) + ( ) (319 ) (%) 50 ( ) 25 ( ) ( / - ) 396 7/12 (%) 2 ( ) 1 ( ) (24 ) 100 mg + ( ) (329 ) + ( ) (329 ) (%) 83 ( ) 121 ( ) ( / - ) (%) 10 ( ) 13 ( )

10 ; ITT(Intent to treat) ( ) . 2 , , 100 mg ( 100 mg , ). 18 , . 54 . 24 (factorial trial) , , , . 100 mg.