Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study
| Autor: | Penny R. Fleck, Craig A. Wilson, Julio Rosenstock |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty Endocrinology Diabetes and Metabolism Dipeptidyl peptidase-4 inhibitor Pharmacology Weight Gain Lower risk Dizziness Double blind Endocrinology Double-Blind Method Piperidines Internal medicine Internal Medicine Humans Hypoglycemic Agents Medicine Prospective Studies Uracil Triglycerides Aged Aged 80 and over Glycated Hemoglobin Dipeptidyl-Peptidase IV Inhibitors business.industry Headache Type 2 Diabetes Mellitus Hypoglycemia Metformin Confidence interval Treatment Outcome Diabetes Mellitus Type 2 Hyperglycemia Female medicine.symptom business Weight gain Glipizide Alogliptin medicine.drug |
| Zdroj: | Diabetes, Obesity and Metabolism. 15:906-914 |
| ISSN: | 1462-8902 |
| Popis: | Aim To prospectively evaluate the efficacy and safety of alogliptin versus glipizide in elderly patients with type 2 diabetes mellitus (T2DM) over 1 year of treatment. Methods This was a randomized, double-blind, active-controlled study of elderly T2DM patients (aged 65–90 years) with mild hyperglycaemia on diet/exercise therapy alone [glycosylated haemoglobin (HbA1c) 6.5–9.0%] or plus oral antidiabetic monotherapy (HbA1c 6.5–8.0%). Patients were randomized to once-daily alogliptin 25 mg or glipizide 5 mg titrated to 10 mg, if needed. Hypoglycaemic episodes were systematically captured under predefined criteria. Results In the primary analysis, HbA1c mean changes from a baseline of 7.5% were −0.14% with alogliptin (n = 222) and −0.09% with glipizide (n = 219) at the end of the study, demonstrating non-inferiority of alogliptin to glipizide [least squares (LS) mean difference = −0.05%; one-sided 97.5% confidence interval (CI): −∞, 0.13%]. More clinically relevant HbA1c reductions occurred among patients who completed the study: −0.42 and −0.33% with alogliptin and glipizide, with non-inferiority again confirmed (LS mean difference = −0.09%; one-sided 97.5% CI: −∞, 0.07%). Overall, alogliptin was safe and well tolerated, with notably fewer hypoglycaemic episodes than glipizide [5.4% (31 episodes) vs. 26.0% (232 episodes), respectively]; three patients experienced severe hypoglycaemia, all with glipizide. Alogliptin also resulted in favourable weight changes versus glipizide (−0.62 vs. 0.60 kg at week 52; p |
| Databáze: | OpenAIRE |
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