医薬品リスク管理計画 - 医薬品医療機器総合機構
Contents
1.2. LY2189265 dulaglutide GBDP 6S 63 212 68 GBDY
3. LY2189265 dulaglutide 4 3
4. Butler PC Dry S Elashoff R GLP 1 based therapy for diabetes what you do not know can hurt you Diabetes Care 2010 33 2 453 4S5 Bjerre Knudsen L Madsen LW Andersen S Almholt K de Boer AS Drucker DJ Gotfredsen C Egerod FL Hegelund AC Jacobsen H Jacobsen SD Moses AC Mglck AM Nielsen HS Nowak J Solbers H Th TD Zdravkovic M Moerch U Glucagon hke peptide 1 receptor agonsts actvate rodent thyroid C cells causing calcitonin release and C cell prohferation Endocrinol 2010 151 4 1473 1486 LY2189265 dulaglutide PR
5. 1 2 4 2 Elashoff M Matveyenko AV Gier B Elashoff R Butler PC Pancreattis pancreatc and thyroid cancer with glucagon hke peptide 1 based therapies Gastroenterology 2011 141 1 150 156
6. Sh LY2189265 dulaglutide 4 3 PR LY2189265 dulaglutide
7. 4 3 9 LY2189265 dulaglutide WO 0 GLP 1
8. LY2189265 dulaglutide GBDP 42 238 GBDY 41 140
9. 2 LY2189265 dulaglutide 1 2 52 R
10. 2 4 75 1000 Urushihara et al 2012 3 25 3000 3 30 TL m 360 65 MACE 3000 5
11. Urushihara H Taketsuna M Liu Y Oda E Nakamura M Nishiuma S Maeda R Increased risk of acute pancreatitis in patients with type 2 diabetes an observational study using a Japanese hospital database PLoS One 2012 7 12 e53224 don 10 1371 journal pone 0053224 Epub 2012 Dec 27 LY2189265 dulaglutde 3 ul LY2189265 dulaglutide 4 6 LY2189263
12. I 6 2 MACE Major Adverse Cardiovascular Events 1 HbAlc 2 Diabetes Treatment Satisfaction Questionnaire DTSQ 5 2 3 3150 3000 36 MACE
13. Ot 1 2 3 4 1 8 pe4 EE LY2189265 dulaglutide
14. 1 E 1 LY2189265 dulaglutide L T GBCZ 2 GLP 1 C GLP 1 Butler et al 2010 Bjerre Knudsen et al 2010
15. 1 GBDQ 1 5 1 GBDY TL TI GBCZ 1 6 0 7 64 34 0 9 1 4 O
16. EC LY2189265 dulaglutide GBDP 32 2 1 GBDY 1 7 GBDG 4 86 GLP 1
17. LY2189265 dulaglutide m 26 12 5 7 0 7 0 3 6 PT TL GBCZ GBDP 0 7 1 1 49 1
18. GBDP eGFR mL min 1 73m 30 60 60 90 90 48 189 43 GBDY eGFR mL min1 73m 30 60 ER 24 128 29 UA A DN SE 0 CT
19. 2 f LY2189265 dulaglutide
20. 5 2 3130 6 Last Patient Visit 1 Last Patient ul Visit 1 Si a LY2189265 dulaglutide 5 3
21. 65 63 136 45 4 1 6 75 75 e
22. 6
23. GBDD 2 4 GBDC GBDB IL 0 75 mg GBDP 52 2 9 SU BG GBDY 26 0 SU GBDQ 33 6 GBDQ 9 9 PR SU 35 3 MM 0 a
24. 2 LY2189265 dulaglutide B C C GLP 1 C C NU
25. dulaglutde 5 1 8 EE 3130 6 Last Patient Visit 1 Last 1 Patient Visit 1 Fl
26. 0 73mg LY2189263 dulaglutde 2015 7 3 27 8 10 7 1 87 2499 8 22700AMX00701000 2014 9 18 s 0 75 mg e 1 0 75 mg
27. GLP 1 1 8 re arranged during transfection RET 0 75 mg C C C
28. C C 3 C 2 35 10 C C
29. 1 5 LY2189265 dulaglutide f
30. LY2189265 dulaglutide e GLP 1
31. 0 75 mg 1 2 LY2189265 dulaglutide LY2189265 dulaglutide 1 1 1 2 1 GLP 1 SU T 0 75 mg GBDC 11 1 SU GBDB GBDD 36 6 90 1
32. 2 LY2189265 dulaglutide IL IL GBCZ lt 151 9 5 0 1 1 0 1 3 0 7 6
33. 3150 LY2189265 dulaglutide N k
34. GBDP GBDY GBDQ 3 3 13 0 1 4 6 1 4 5 15 3 4 6 14 8 ual 0 H OR 3 8
35. I GBCZ 1 32bpm LI GBDP 3 45bpm GBDY 2 98bpm GBDQ SU 2 77bpm BG 3 05bpm a GI 1 71bpm TZD 1 81bpm 3 70bpm GBCZ PR 200msec 0 75 mg 200msec PR 200msec 0 75 ms 200msec GBDP 4 7 GBDY 5 6 GBDQ 6 4 IL I 0 08 0 24 0 23
36. 2 1 III 40 GBDP 10 0 75 mg S 2 3 GBDY 9 0 75 mg 7 2 GBDQ 21 GBDQ 2 SU GLP 1 Elashoff et al 2011 g
37. GLP 1 GLP 1 GLP 1 2 NN 7
38. 0 66 0 08 0 28 0 31 0 19 I 4 MACE 98 02 0 57 0 30 1 10 MACE
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