Alogliptin: A review of its use in patients with type 2 diabetes mellitus

Drugs

Volumn 75, Issue 7, 2015, Pages 777-796

  Keating, Gillian M ^a  

^a NONE   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; ANTIDIABETIC AGENT; PIPERIDINE DERIVATIVE; URACIL;

ANALOGS AND DERIVATIVES; ANIMAL; DIABETES MELLITUS, TYPE 2; DRUG COMBINATION; HUMAN; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANIMALS; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIC AGENTS; PIPERIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; URACIL;

EID: 84937763343     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0385-y     Document Type: Article

References (85)

1. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010;87(1):4-14.
2. Deacon CF, Holst JJ. Dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes: comparison, efficacy and safety. Expert Opin Pharmacother. 2013;14(15):2047-58.
3. Capuano A, Sportiello L, Maiorino MI, et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy: focus on alogliptin. Drug Des Dev Ther. 2013;7:989-1001.
4. Takeda Pharmaceuticals America Inc. Nesina (alogliptin) tablets: US prescribing information. 2013. http://www.takeda.us/products/default.aspx. Accessed 3 Mar 2015.
5. European Medicines Agency. Vipidia (alogliptin): EU summary of product characteristics. 2014. http://www.ema.europa.eu/. Accessed 3 Mar 2015.
6. Takeda Pharmaceuticals America Inc. Kazano (alogliptin and metformin HCl) tablets for oral administration: US prescribing information. 2013. http://www.takeda.us/products/default.aspx. Accessed 3 Mar 2015.
7. European Medicines Agency. Vipdomet (alogliptin/metformin): EU summary of product characteristics. 2015. http://www.ema.europa.eu/. Accessed 3 Mar 2015.
8. Takeda Pharmaceuticals America Inc. Oseni (alogliptin and pioglitazone) tablets: US prescribing information. 2013. http://www.takeda.us/products/default.aspx. Accessed 3 Mar 2015.
9. European Medicines Agency. Incresync (alogliptin/pioglitazone): EU summary of product characteristics. 2015. http://www.ema.europa.eu/. Accessed 3 Mar 2015.
10. Feng J, Zhang Z, Wallace MB, et al. Discovery of alogliptin: a potent, selective, bioavailable, and efficacious inhibitor of dipeptidyl peptidase IV. J Med Chem. 2007;50(10):2297-300.
11. Christopher RJ, Davenport JM, Gwaltney S, et al. Pharmacokinetic and pharmacodynamic profiles of SYR-322, a novel inhibitor of dipeptidyl peptidase-IV, in rats, dogs, and monkeys [abstract no. 452-P]. In: 66th Annual Scientific Sessions of the American Diabetes Association. 2006.
12. Seino Y, Fujita T, Hiroi S, et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin. 2011;27(9):1781-92.
13. 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.
14. Hirayama M, Matsuno K, Fujita H, et al. Pharmacokinetics, pharmacodynamics, and tolerability of single and multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin in Japanese healthy male subjects [abstract no. 521-P]. In: 68th Scientific Sessions of the American Diabetes Association. 2008.
15. 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):513-27.
16. Van Raalte DH, van Genugten RE, Eliasson B, et al. The effect of alogliptin and pioglitazone combination therapy on various aspects of beta-cell function in patients with recent-onset type 2 diabetes. Eur J Endocrinol. 2014;170(4):565-74.
17. Seino Y, Hiroi S, Hirayama M, et al. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012;3(6):517-25.
18. Seino Y, Miyata Y, Hiroi S, et al. 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):927-36.
19. Pratley RE, Fleck P, Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naive patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014;16(7):613-21.
20. Nauck MA, Ellis GC, Fleck PR, et al. 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.
21. Kaku K, Itayasu T, Hiroi S, et al. 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):1028-35.
22. Seino Y, Fujita T, Hiroi S, et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011;27(Suppl 3):21-9.
23. Kutoh E, Ukai Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug naive type 2 diabetes: a randomized, control trial. Endocrine. 2012;41(3):435-41.
24. Eliasson B, Möller-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):915-25.
25. null mice treated with alogliptin. Diabetes Metab Syndr Obes. 2013;6:493-9.
26. Zhang X, Wang Z, Huang Y, et al. Effects of chronic administration of alogliptin on the development of diabetes and β-cell function in high fat diet/streptozotocin diabetic mice. Diabetes Obes Metab. 2011;13(4):337-47.
27. Fleck P, Christopher R, Covington P. Efficacy and safety of alogliptin monotherapy over 12 weeks in patients with type 2 diabetes [abstract no. 479-P]. Diabetes. 2008;57(Suppl 1):143.
28. Pratley RE, Reusch JE-B, Fleck PR, et al. 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):2361-71.
29. 1C without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab. 2009;11(12):1145-52.
30. Pratley RE, Kipnes MS, Fleck PR, et al. 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):167-76.
31. Noda Y, Miyoshi T, Oe H, et al. Alogliptin ameliorates postprandial lipemia and postprandial endothelial dysfunction in non-diabetic subjects: a preliminary report. Cardiovasc Diabetol. 2013;12:8.
32. Kato S, Kirigaya H, Gyotoku D, et al. DPP-4 inhibition by alogliptin improves the coronary flow reserve evaluated by phase contrast cine magnetic resonance imaging in type 2 diabetic patients with coronary artery disease [abstract no. 16542]. In: 86th Annual Scientific Sessions of the American Heart Association. 2013.
33. Yamauchi Y, Tunekawa S, Seino Y, et al. The effect of DPP-4 inhibitor, alogliptin, on bone metabolism in patients with type 2 diabetes mellitus [abstract no. 1071-P]. In: 73rd Annual Scientific Sessions of the American Diabetes Association. 2013.
34. Karim A, Harris S, Fleck P, et al. Assessment of drug interaction between alogliptin benzoate (SYR-322), a highly selective dipeptidyl peptidase-4 inhibitor, and warfarin at steady state [abstract no. 106]. J Clin Pharmacol. 2007;47(9):1207.
35. Karim A, Covington P, Christopher R, et al. Pharmacokinetics of alogliptin when administered with food, metformin, or cimetidine: a two-phase, crossover study in healthy subjects. Int J Clin Pharmacol Ther. 2010;48(1):46-58.
36. European Medicines Agency. Vipidia (alogliptin): EU public assessment report. 2013. http://www.ema.europa.eu/. Accessed 3 Mar 2015.
37. Karim A, Fleck P, Hetman L, et al. Single-dose pharmacokinetics of the dipeptidyl peptidase-4 inhibitor alogliptin in subjects with renal impairment [abstract no. 538-P]. In: 68th Annual Scientific Sessions of the American Diabetes Association. 2008.
38. Karim A, Fleck P, Dorsey D, et al. Single-dose pharmacokinetics of alogliptin benzoate (SYR-322), a highly selective dipeptidyl peptidase-4 inhibitor, in subjects with moderate hepatic impairment [abstract no. 107]. J Clin Pharmacol. 2007;47(9):1207.
39. Karim A, Fleck P, Harrell RE, et al. Effects of age, race, and gender on the pharmacokinetics and pharmacodynamics of alogliptin, a novel and highly selective dipeptidyl peptidase-4 inhibitor in healthy subjects [abstract no. PI-14]. Clin Pharmacol Ther. 2008;83(Suppl 1):S13.
40. Karim A, Fleck P, Harris S, et al. Effect of fluconazole, ketoconazole, and gemfibrozil on the pharmacokinetics of alogliptin benzoate (SYR-322) in healthy subjects [abstract no. 105]. J Clin Pharmacol. 2007;47(9):1207.
41. Karim A, Laurent A, Munsaka M, et al. Coadministration of pioglitazone or glyburide and alogliptin: pharmacokinetic drug interaction assessment in healthy participants. J Clin Pharmacol. 2009;49(10):1210-9.
42. Karim A, Fleck P, Harris S, et al. Lack of pharmacokinetic interaction between multiple doses of the dipeptidyl peptidase-4 inhibitor alogliptin and digoxin in healthy subjects [abstract no. PI-13]. Clin Pharmacol Ther. 2008;83(Suppl 1):S12-3.
43. Karim A, Fleck P, Harris S, et al. Assessment of drug interaction between alogliptin, a highly selective dipeptidyl peptidase-4 inhibitor, and atorvastatin in healthy subjects [abstract no. PI-17]. Clin Pharmacol Ther. 2008;83(Suppl 1):S14.
44. Karim A, Chiselko P, Fleck P, et al. Lack of effect of cyclosporine on the single-dose pharmacokinetics of alogliptin, a novel dipeptidyl peptidase-4 inhibitor, in healthy subjects [abstract no. PI-15]. Clin Pharmacol Ther. 2008;83(Suppl 1):S13.
45. ® 1/35) in healthy adult female subjects [abstract no. PI-16]. Clin Pharmacol Ther. 2008;83(Suppl 1):S14.
46. DeFronzo RA, Fleck PR, Wilson CA, et al. 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):2315-7.
47. Ji Q, Han P, Li C, et al. Efficacy and safety of alogliptin in subjects with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 study in mainland China, Taiwan and Hong Kong [abstract no. 915]. In: 49th Annual Meeting of the European Association for the Study of Diabetes. 2013.
48. Rosenstock J, Inzucchi SE, Seufert J, et al. Initial combination therapy with alogliptin and pioglitazone in drug-naive patients with type 2 diabetes. Diabetes Care. 2010;33(11):2406-8.
49. Bosi E, Ellis GC, Wilson CA, et al. 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):1088-96.
50. DeFronzo RA, Burant CF, Fleck P, et al. 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):1615-22.
51. Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab. 2013;15(10):906-14.
52. Del Prato S, Camisasca R, Wilson C, et al. Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes Obes Metab. 2014;16(12):1239-46.
53. Kaku K, Mori M, Kanoo T, et al. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014;15(15):2121-30.
54. Nakamura Y, Inagaki M, Shimizu T, et al. Long-term effects of alogliptin benzoate in hemodialysis patients with diabetes: a 2-year study. Nephron Clin Pract. 2013;123(1-2):46-51.
55. Fujii Y, Abe M, Higuchi T, et al. The dipeptidyl peptidase-4 inhibitor alogliptin improves glycemic control in type 2 diabetic patients undergoing hemodialysis. Expert Opin Pharmacother. 2013;14(3):259-67.
56. White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369(14):1327-35.
57. Zannad F, Cannon CP, Cushman WC, et al. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015. doi: 10.1016/S0140-6736(14)62225-X.
58. Data on file, Takeda, 2014.
59. Inzucchi SE, Bergenstal RM, Buse JB, et al. 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):1364-79.
60. Standards of medical care in diabetes: 2013. Diabetes Care. 2013;36 Suppl 1:S11-66.
61. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19(2):327-36.
62. Charbonnel B, Schweizer A, Dejager S. Combination therapy with DPP-4 inhibitors and insulin in patients with type 2 diabetes mellitus: what is the evidence? Hosp Pract (Minneap). 2013;41(2):93-107.
63. Berhan A, Berhan Y. Efficacy of alogliptin in type 2 diabetes treatment: a meta-analysis of randomized double-blind controlled studies. BMC Endocrine Disord. 2013;13:9.
64. Bourdel-Marchasson I, Schweizer A, Dejager S. Incretin therapies in the management of elderly patients with type 2 diabetes mellitus. Hosp Pract. 2011;39(1):7-21.
65. Pratley RE. Alogliptin: a new, highly selective dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2009;10(3):503-12.
66. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-26.
67. McMurray JJV, Ponikowski P, Bolli GB, et al. The Vildagliptin in Ventricular Dysfunction Diabetes trial (VIVIDD) [late-breaking abstract]. In: Heart Failure 2013. 2013.
68. Green JB, Bethel MA, Paul SK, et al. Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. Am Heart J. 2013;166(6):983-9.
69. Rosenstock J, Marx N, Kahn SE, et al. Cardiovascular outcome trials in type 2 diabetes and the sulphonylurea controversy: rationale for the active-comparator CAROLINA trial. Diabetes Vasc Dis Res. 2013;10(4):289-301.
70. Katakami N, Mita T, Yoshii H, et al. Rationale, design, and baseline characteristics of a trial for the prevention of diabetic atherosclerosis using a DPP-4 inhibitor: the Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). J Atheroscler Thromb. 2013;20(12):893-902.
71. Singh S, Chang H-Y, Richards TM, et al. Glucagonlike peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus: a population-based matched case-control study. JAMA Intern Med. 2013;173(7):534-9.
72. Faillie J-L, Babai S, Crépin S, et al. Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database. Acta Diabetol. 2014;51(3):491-7.
73. Scheen A. Gliptins (dipeptidyl peptidase-4 inhibitors) and risk of acute pancreatitis. Expert Opin Drug Saf. 2013;12(4):545-57.
74. Butler AE, Campbell-Thompson M, Gurlo T, et al. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013;62(7):2595-604.
75. Yang L, He Z, Tang X, et al. Type 2 diabetes mellitus and the risk of acute pancreatitis: a meta-analysis. Eur J Gastroenterol Hepatol. 2013;25(2):225-31.
76. Brodovicz KG, Kou TD, Alexander CM, et al. Impact of diabetes duration and chronic pancreatitis on the association between type 2 diabetes and pancreatic cancer risk. Diabetes Obes Metab. 2012;14(12):1123-8.
77. Monami M, Dicembrini I, Martelli D, et al. Safety of dipeptidyl peptidase-4 inhibitors: a meta-analysis of randomized clinical trials. Curr Med Res Opin. 2011;27(Suppl 3):57-64.
78. Gokhale M, Sturmer T, Gray C, et al. Dipeptidyl peptidase 4 inhibitors and comparative pancreatic cancer risk [abstract no. 111-LB]. In: 73rd Scientific Sessions of the American Diabetes Association. 2013.
79. Richard KR, Shelburne JS, Kirk JK. Tolerability of dipeptidyl peptidase-4 inhibitors: a review. Clin Ther. 2011;33(11):1609-29.
80. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014;16(1):48-56.
81. Faillie JL, Azoulay L, Patenaude V, et al. Incretin based drugs and risk of acute pancreatitis in patients with type 2 diabetes: cohort study. BMJ. 2014;348:g2780.
82. Egan AG, Blind E, Dunder K, et al. Pancreatic safety of incretin-based drugs: FDA and EMA assessment. N Engl J Med. 2014;370(9):794-7.
83. Monami M, Dicembrini I, Antenore A, et al. Dipeptidyl peptidase-4 inhibitors and bone fractures: a meta-analysis of randomized clinical trials. Diabetes Care. 2011;34(11):2474-6.
84. Marino AB, Cole SW. Alogliptin: safety, efficacy, and clinical implications. J Pharm Pract. 2015;28(1):99-106.
85. Bron M, Ferrufino CP, Samyshkin Y, et al. Evaluation of the pharmacy budget impact of alogliptin plus pioglitazone fixed dose combination in the treatment of type-2 diabetes mellitus [abstract no. PDB25]. Value Health. 2013;16(3):A160.