ABSTRACT
ABSTRACT Objective: This analysis compared the efficacy and safety of the sodium-glucose cotransporter-2 (SGLT2) inhibitor, dapagliflozin, and the dipeptidyl peptidase-4 (DPP4) inhibitor, saxagliptin, both added on to metformin. Materials and methods: This was a post-hoc analysis from a double-blind, randomized, 24-week clinical trial (NCT01606007) of patients with type 2 diabetes (T2D) inadequately controlled with metformin. We compared the dapagliflozin 10 mg (n = 179) and saxagliptin 5 mg (n = 176) treatment arms. Results: Dapagliflozin showed significantly greater mean reductions versus saxagliptin in HbA1c (difference versus saxagliptin [95% CI]: −0.32% [-0.54, −0.10]; p < 0.005), fasting plasma glucose (-0.98 [-1.42, −0.54] mmol/L; p < 0.0001), body weight (-2.39 [-3.08, −1.71] kg; p < 0.0001) and systolic blood pressure (SBP) (-3.89 [-6.15, −1.63] mmHg; p < 0.001). More dapagliflozintreated than saxagliptin-treated patients achieved the composite endpoint of HbA1c reduction ≥ 0.5%, weight loss ≥ 2 kg, SBP reduction ≥ 2 mmHg and no major/minor hypoglycemia (24% versus 7%). No major events of hypoglycemia were reported. More patients on dapagliflozin (6%) versus saxagliptin (0.6%) experienced genital infections. Conclusion: Dapagliflozin demonstrated greater glycemic efficacy than saxagliptin with additional benefits on weight and SBP, and the safety profile was consistent with previous studies.
Subject(s)
Humans , Male , Female , Middle Aged , Benzhydryl Compounds/therapeutic use , Adamantane/analogs & derivatives , Diabetes Mellitus, Type 2/drug therapy , Dipeptides/therapeutic use , Dipeptidyl-Peptidase IV Inhibitors/therapeutic use , Glucosides/therapeutic use , Benzhydryl Compounds/adverse effects , Blood Glucose/drug effects , Blood Pressure/drug effects , Body Weight/drug effects , Adamantane/adverse effects , Adamantane/therapeutic use , Double-Blind Method , Diabetes Mellitus, Type 2/blood , Dipeptides/adverse effects , Sodium-Glucose Transporter 2/therapeutic use , Dipeptidyl-Peptidase IV Inhibitors/adverse effects , Hypoglycemic Agents/therapeutic use , Metformin/therapeutic useABSTRACT
The Acarbose Cardiovascular Evaluation ( ACE ) trial assessed whether acarbose could reduce the incidence of cardiovascular event ( CVE) s in Chinese patients suffering from impaired glucose tolerance ( IGT) and coronary heart disease. ACE differs from a previous study on IGT people, the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus ( STOP-NIDDM) trial in terms of sample size, number of CVE, mean age, acarbose dose, and population. ACE supported STOP-NIDDM's results by showing that acarbose prevents the progression of prediabetes to diabetes in IGT people, and extended the effect to people with coronary heart disease. However it did not reduce CVE incidence, probably due to the low dose used (50 mg tid). Overall, ACE is well-designed and high-powered enough to confirm that acarbose can prevent progression of prediabetes to diabetes, but is not able to reduce CVE incidence. However, in light of the fast growing prediabetic Chinese population, usage of acarbose is warranted to avert an explosion of diabetes.