Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial
| العنوان: | Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial |
|---|---|
| المؤلفون: | Eugene Braunwald, Christina Stahre, Boaz Hirshberg, Benjamin M. Scirica, Gil Leibowitz, Mikaela Sjöstrand, Estella Kanevsky, KyungAh Im, Itamar Raz, Ilan Yanuv, Deepak L. Bhatt, Avivit Cahn, Nayyar Iqbal, Aliza Rozenberg, Ofri Mosenzon |
| المصدر: | Diabetes Care. 39:1329-1337 |
| بيانات النشر: | American Diabetes Association, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Population, Adamantane, 030209 endocrinology & metabolism, Type 2 diabetes, Saxagliptin, Hypoglycemia, Placebo, Body Mass Index, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Internal medicine, Diabetes mellitus, Glyburide, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, Renal Insufficiency, 030212 general & internal medicine, education, Aged, Proportional Hazards Models, Glycated Hemoglobin, Advanced and Specialized Nursing, education.field_of_study, business.industry, Insulin, Short-Acting, Hazard ratio, nutritional and metabolic diseases, Dipeptides, Middle Aged, medicine.disease, Surgery, Sulfonylurea Compounds, Diabetes Mellitus, Type 2, chemistry, Multivariate Analysis, Female, Microalbuminuria, business, Follow-Up Studies |
| الوصف: | OBJECTIVE To analyze the impact of adding saxagliptin versus placebo on the risk for hypoglycemia and to identify predictors of any and major hypoglycemia in patients with type 2 diabetes included in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus–Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) study. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes (n = 16,492) were randomized to saxagliptin or placebo and followed for a median of 2.1 years. Associations between any hypoglycemia (symptomatic or glucose measurement RESULTS At least one hypoglycemic event was reported in 16.6% of patients, and 1.9% reported at least one major event. Patients allocated to saxagliptin versus placebo experienced higher rates of any (hazard ratio [HR] 1.16 [95% CI 1.08, 1.25]; P < 0.001) or major (HR 1.26 [1.01, 1.58]; P = 0.038) hypoglycemia. Hypoglycemia rates (any or major) were increased with saxagliptin in patients taking sulfonylureas (SURs) but not in those taking insulin. Rates were increased with saxagliptin in those with baseline HbA1c ≤7.0% and not in those with baseline HbA1c >7.0%. Multivariate analysis of the overall population revealed that independent predictors of any hypoglycemia were as follows: allocation to saxagliptin, long duration of diabetes, increased updated HbA1c, macroalbuminuria, moderate renal failure, SUR use, and insulin use. Predictors of major hypoglycemia were allocation to saxagliptin, advanced age, black race, reduced BMI, long duration of diabetes, declining renal function, microalbuminuria, and use of short-acting insulin. Among SURs, glibenclamide was associated with increased risk of major but not any hypoglycemia. CONCLUSIONS The identification of patients at risk for hypoglycemia can guide physicians to better tailor antidiabetic therapy. |
| تدمد: | 1935-5548 0149-5992 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::02b059958b5488abea0f9cdc22444219Test https://doi.org/10.2337/dc15-2763Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....02b059958b5488abea0f9cdc22444219 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19355548 01495992 |
|---|