Benefit-Risk Assessment of Alogliptin for the Treatment of Type 2 Diabetes Mellitus

Abstract

The dipeptidyl peptidase-4 inhibitor (DPP-4i) alogliptin is an oral, antidiabetic treatment that is approved in many countries to treat patients with type 2 diabetes mellitus (T2DM), including the USA, Europe, and Japan. Alogliptin is efficacious both as monotherapy and as add-on/combination therapy with other commonly prescribed T2DM treatments, such as metformin and pioglitazone. Overall, alogliptin is well-tolerated in patients with T2DM, including older patients, those with renal and/or hepatic impairment, and those at high risk of cardiovascular events. There is a low risk of hypoglycemia, weight gain, acute pancreatitis, and gastrointestinal adverse events with alogliptin treatment, as demonstrated in long-term trials (lasting up to 4.5 years) and in a real-world setting. Additionally, alogliptin has a generally favorable or similar safety profile in comparison to other antidiabetic agents (metformin, thiazolidinediones, sulfonylureas, glucagon-like peptide-1 receptor agonists, sodiumglucose cotransporter 2 inhibitors, α-glucosidase inhibitors, and insulin). However, further evaluation would be required to determine the mechanism and effect of alogliptin on heart failure, bullous pemphigoid, and inflammatory bowel disease. Of note, due to the ethnic diversity in the epidemiology of T2DM, alogliptin has been shown to be more efficacious in Asian patients than in non-Asian patients with T2DM, but with a similar tolerability profile. These data indicate that DPP-4is, including alogliptin, are important treatment options, especially for Asian patients with T2DM, for whom they have potential as a first-line therapy. This benefit-risk assessment aims to place alogliptin within the current armamentarium of T2DM and aid physicians when choosing optimal diabetes treatment for their patients.

Accuracy of Japanese claims data in identifying diabetes‐related complications

“…Insurance claims databases have been increasingly used for studies to identify risk factors for cardiovascular disease and to compare the effectiveness of drugs in treating cardiovascular disease 6‐8 . Recently, studies using claims data have increased in the field of diabetes in Japan 9‐17 . In Japan claims data are recorded electronically using unique master codes 18 .…”

Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010–2019

“…The safety and tolerability of vildagliptin and allogetine were good 24,25 . They have potential as first‐line treatments for patients with T2DM in Asia 26 . There is no increase in cardiovascular risk from the current evidence 27,28 .…”

“…24,25 They have potential as first-line treatments for patients with T2DM in Asia. 26 There is no increase in cardiovascular risk from the current evidence. 27,28 Liraglutide is a representative GLP-1 receptor agonist, and a large number of studies have confirmed its beneficial hypoglycemic effects and good safety profile.…”

Neurochemical Regulators of Food Behavior for Pharmacological Treatment of Obesity: Current Status and Future Prospects

“…However, in the last decade the DPP-4 inhibitors, so called gliptins were developed. Gliptins exert antihyperglycemic effect and are used for treatment of diabetes Type 2 [61]. Another agent used in prevention of Type 2 diabetes is a rare, naturally existing sugar, 3-C epimer of fructose, Dallulose (D-psicose).…”