Alogliptin (Nesina) for type 2 diabetes mellitus
in combination with a sulfonylurea when diet and exercise plus a sulfonylurea alone do not provide adequate glycemic control. Upon review of the draft CDR clinical and pharmacoeconomic reports, the manufacturer asked that the requested listing criteria be modified to reflect the two indications unde...
Corporate Author: | |
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Format: | eBook |
Language: | English |
Published: |
Ottawa (ON)
Canadian Agency for Drugs and Technologies in Health
2015, 2015 Aug
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Series: | Common drug review
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Online Access: | |
Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
Summary: | in combination with a sulfonylurea when diet and exercise plus a sulfonylurea alone do not provide adequate glycemic control. Upon review of the draft CDR clinical and pharmacoeconomic reports, the manufacturer asked that the requested listing criteria be modified to reflect the two indications under review. Of note, the Canadian Drug Expert Committee recommendations for the existing DPP-4 inhibitors have recommended listing for patients with inadequate glycemic control on metformin and a sulfonylurea who are unable to use insulin. However, alogliptin is not approved for use in combination with metformin and a 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, which 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 type 2 diabetes. There are currently 11 classes of antihyperglycemic drugs approved for use in Canada for type 2 diabetes: metformin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 analogues, sodium-glucose cotransporter-2 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. Upon submission, the manufacturer requested listing of alogliptin in a manner similar to other DPP-4 inhibitors in Canada. Based on consideration of listing criteria across Canada for existing DPP-4 inhibitors, and in consultation with the manufacturer, the following two of the six approved indications for alogliptin were reviewed by the CADTH Common Drug Review (CDR): 1. in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycemic control2. |
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Physical Description: | 1 online resource illustrations |