Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Saxagliptin (Onglyza - Bristol-Myers Squibb/AstraZeneca Canada Inc.) indication: type 2 diabetes mellitus. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Recommendation - Clinical Report. 2014 Authors' conclusions One double-blind, 24-week, RCT demonstrated that the addition of saxagliptin to ongoing treatment with metformin and a sulfonylurea was statistically superior to placebo for reducing A1C in patients who were inadequately controlled on combination therapy with metformin and a sulfonylurea. The effect of saxagliptin on A1C (‒0.66%) was in the range considered clinically significant, and was aligned with effects of other DPP-4 inhibitors in the third-line setting. Saxagliptin was not associated with clinically important changes in body composition compared with placebo. AEs, SAEs, and WDAEs were more commonly reported with placebo than with saxagliptin. The proportion of patients with hypoglycemia was numerically greater in patients treated with saxagliptin compared with those treated with placebo (10% versus 6%), but most events were asymptomatic and there were no events of severe hypoglycemia. Hence, the likelihood of clinically significant hypoglycemia events with saxagliptin appears to be low. There was no evidence regarding the effects of saxagliptin added to metformin and sulfonylurea on the macrovascular and microvascular complications of diabetes, specifically in patients who were unable to use insulin. Indexing Status Subject indexing assigned by CRD MeSH Adamantane; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV Inhibitorss Language Published English Country of organisation Canada English summary An English language summary is available. Address for correspondence Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, Ottawa, Ontario Canada, K1S 5S8 Email: requests@cadth.ca AccessionNumber 32014000843 Date abstract record published 17/07/2014 |