Formulary drug reviews: Alogliptin

Hospital Pharmacy

Volumn 48, Issue 7, 2013, Pages 580-594

  Cada, Dennis J ^b   Levien, Terri L ^a   Baker, Danial E ^a  

^a WASHINGTON STATE UNIVERSITY   (United States)

^b Washington State University Spokane ^*

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; ALOGLIPTIN; ALOGLIPTIN PLUS METFORMIN; GLIBENCLAMIDE; INSULIN; LINAGLIPTIN; MEGLITINIDE; METFORMIN; PIOGLITAZONE; PLACEBO; SAXAGLIPTIN; SITAGLIPTIN; SULFONYLUREA;

AREA UNDER THE CURVE; COMPARATIVE EFFECTIVENESS; DRUG BIOAVAILABILITY; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; RECOMMENDED DRUG DOSE; REVIEW; RHINOPHARYNGITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; UPPER RESPIRATORY TRACT INFECTION;

EID: 84880238669     PISSN: 00185787     EISSN: 19451253     Source Type: Journal    
DOI: 10.1310/hpj4807-580     Document Type: Review

References (36)

1. Nesina [package insert]. Deerfield, IL: Takeda Pharmaceuticals America Inc; January 2013
2. Covington P, Christopher R, Davenport M, et al. Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes. Clin Ther 2008;30(3):499-512
3. Christopher R, Covington P, Davenport M, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single increasing doses of the dipeptidyl peptidase-4 inhibitor alogliptin in healthy male subjects. Clin Ther 2008;30(3): 513-527
4. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet 2012;51(8):501-514
5. Hirayama M, Matsuno K, Fujita T, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single and multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin in Japanese healthy male subjects [abstract]. American Diabetes Association's 68th Scientific Sessions; June 6-10, 2008; San Francisco, CA. Abstract 521-P. http://professional. diabetes.org/Abstracts-Display.aspx?TYP51&CID569829. Accessed May 30, 2008
6. Moritoh Y, Takeuchi K, Asakawa T, Kataoka O, Odaka H. Chronic administration of alogliptin, a novel, potent, and highly selective dipeptidyl peptidase-4 inhibitor, improves glycemic control and beta-cell function in obese diabetic ob/ob mice. Eur J Pharmacol 2008;588(2-3):325-332
7. Moritoh Y, Takeuchi K, Asakawa T, Kataoka O, Odaka H. The dipeptidyl peptidase-4 inhibitor alogliptin in combination with pioglitazone improves glycemic control, lipid profiles, and increases pancreatic insulin content in ob/ob mice. Eur J Pharmacol 2009;602(2-3):448-454
8. Eliasson B, Mo? ller-Goede D, Eeg-Olofsson K, et al. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia 2012; 55(4):915-925
9. Tradjenta [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; September 2012.
10. Deacon CF. Dipeptidyl peptitase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obes Metab 2011;13(1):7-18
11. Gerich J. DPP-4 inhibitors: what may be the clinical differentiators? Diabetes Res Clin Pract 2010;90(2):131-140
12. Karim A, Fleck P, Hetman L, et al. Single-dose pharmacokinetics of the dipeptidyl peptidase-4 inhibitor alogliptin in subjects with renal impairment [abstract]. American Diabetes Association's 68th Scientific Sessions; June 6-10, 2008; San Francisco, CA. Abstract 538-P. http://professional.diabetes.org/ Abstracts-Display.aspx?TYP51&CID569845. Accessed May 30, 2008
13. Karim A, Fleck P, Dorsey D, Zhang W, Mekki Q, Preston RA. Single-dose pharmacokinetics of alogliptin benzoate (SYR-322), a highly selective dipeptidyl peptidase-4 inhibitor, in subjects with moderate hepatic impairment [abstract]. J Clin Pharmacol 2007;47(9):1207
14. Inzucchi SE, Bergenstal RM, Buse JB, et al American Diabetes Association; European Association for the Study of Diabetes. 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). Diabetes Care 2012; 35(6):1364-1379
15. Fleck P, Christopher R, Covington P, Wilson C, Mekki Q. Efficacy and safety of alogliptin monotherapy over 12 weeks in patients with type 2 diabetes [abstract]. American Diabetes Association's 68th Scientific Sessions; June 6-10, 2008; San Francisco, CA. Abstract 479-P. http://professional.diabetes. org/Abstracts-Display.aspx?TYP51&CID569787. Accessed May 30, 2008
16. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of the dipeptidyl peptidase- 4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008;31(12):2315- 2317
17. Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-nai?ve patients with type 2 diabetes. Diabetes Care 2010;33(11):2406-2408
18. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009; 63(1):46-55
19. Seino Y, Miyata Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012;14(10):927-936
20. DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97(5):1615-1622
21. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study. Diabetes Obes Metab 2011;13(12): 1088-1096
22. Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009;25(10): 2361-2371
23. Kaku K, Itayasu T, Hiroi S, Hirayama M, Seino Y. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo- controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011;13(11):1028-1035
24. Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q; Alogliptin Study 007 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009;11(2):167-176
25. Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab. 2009; 11(12):1145-1152
26. Karim A, Fleck P, Harris S, Schuster J, Zhang W, Mekki Q. Effect of fluconazole, ketoconazole, and gemfibrozil on the pharmacokinetics of alogliptin benzoate (SYR-322) in healthy subjects [abstract]. J Clin Pharmacol 2007;47(9):1207.
27. Karim A, Laurent A, Munsaka M, Wann E, Fleck P, Mekki Q. Coadministration of pioglitazone or glyburide and alogliptin: pharmacokinetic drug interaction assessment in healthy participants. J Clin Pharmacol. 2009;49(10):1210- 1219
28. Covington P, Christopher R, Davenport M, et al. Lack of pharmacokinetic interaction between alogliptin benzoate (SYR-322) and metformin in healthy subjects [abstract]. American Diabetes Association's 67th Scientific Sessions; June 22-26, 2007; Chicago, IL. Abstract 2136-PO. http://professional.diabetes. org/Abstracts-Display.aspx?TYP51&CID5 55607. Accessed January 15, 2008
29. Karim A, Harris S, Fleck P, Moore R, Zhang W, Mekki Q. Assessment of drug interaction between alogliptin benzoate (SYR-322), a highly selective dipeptidyl peptidase-4 inhibitor, and warfarin at steady state [abstract]. J Clin Pharmacol 2007;47(9):1207.
30. Approved risk evaluation and mitigation strategies (REMS). US Food and Drug Administration Web site. http://www.fda. gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationfor PatientsandProviders/ucm111350.htm. Updated December 31, 2012. Accessed January 28, 2013.
31. Merck Sharp & Dohme Corp. NDA 21-995: Januvia (sitagliptin) tablet risk evaluation and mitigation strategy (REMS). Food and Drug Administration website. http://www. accessdata.fda.gov/drugsatfda-docs/label/2010/021995s010s0 11s012s014REMSJanuvia.pdf. Published February 2010. Accessed May 5, 2011.
32. Onglyza [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; December 2011
33. Januvia [package insert]. Whitehouse Station, NJ: Merck & Co Inc; April 2012.
34. Forst T, Uhlig-Laske B, Ring A, Ritzhaupt A, Graefe-Mody U, Dugi KA. The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2011;13(6): 542-550
35. Scheen AJ. Pharmacokinetics of dipeptidylpeptitase-4 inhibitors. Diabetes Obes Metab 2010;12(8):648-658.
36. Dipeptidyl peptidase-4 inhibitors. Facts and Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; 2013. Accessed January 31, 2013.