Alogliptin plus metformin (Kazano) for type 2 diabetes mellitus

There are currently 11 classes of anti-hyperglycemic drugs approved for use in Canada for T2DM: metformin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones (TZDs), dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose cotran...

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Corporate Author: Canadian Agency for Drugs and Technologies in Health
Format: eBook
Language:English
Published: Ottawa (ON) Canadian Agency for Drugs and Technologies in Health 2015, 2015 Aug
Series:Common drug review
Subjects:
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Summary:There are currently 11 classes of anti-hyperglycemic drugs approved for use in Canada for T2DM: metformin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones (TZDs), dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose cotransporter-2 (SGLT2) inhibitors, basal insulins, bolus insulins, and biphasic insulins. Alogliptin is the fourth DPP-4 inhibitor to be introduced in Canada after sitagliptin, saxagliptin, and linagliptin. DPP-4 inhibitor/metformin fixed-dose combinations (FDCs) are marketed for all four DPP-4 inhibitors. Upon submission, the manufacturer requested listing of alogliptin/metformin (ALO/MET) FDC in a similar manner as other DPP-4 inhibitor/MET FDCs in Canada.
Based on consideration of listing criteria across Canada for existing DPP-4 inhibitor/MET FDCs, and in consultation with the manufacturer, the following approved indication for ALO/MET FDC was reviewed by the CADTH Common Drug Review (CDR): 1. As an adjunct to diet and exercise in patients inadequately controlled on metformin or in patients already being treated with the combination of alogliptin and metformin. Upon review of the draft CDR clinical and pharmacoeconomic reports, the manufacturer asked that the requested listing criteria be modified to reflect the indication under review. Of note, Canadian Expert Drug Advisory Committee/Canadian Drug Expert Committee (CEDAC/CDEC) recommendations for the existing DPP-4 inhibitors have recommended listing for patients who are unable to use insulin. Recommendations for the corresponding DPP-4 inhibitor/MET FDCs align with the recommendations for the single drugs. However, ALO/MET FDC is not approved for use in combination with sulfonylurea
Diabetes is a chronic, metabolic disease with significant health impacts on individuals and societies. The prevalence of diabetes in Canada was 6.8% (2.4 million Canadians) in 2009 and is expected to rise to 3.7 million people by 2019. Ninety per cent of people with diabetes have type 2 diabetes mellitus (T2DM). T2DM is characterized by increased hepatic glucose output, reduced insulin secretion, and insulin resistance. People with diabetes are at risk of microvascular complications such as diabetic nephropathy and retinopathy, macrovascular complications such as cardiovascular disease, and premature mortality. Improved glycemic control reduces the risk of microvascular complications, and possibly of macrovascular complications. Current guideline recommendations specify a target for glycated hemoglobin (A1C) of 7% or less for most patients with T2DM.
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