WCTD2016 Abstract Topics Cardiovascular Outcome Studies (12 abstracts)
1Clinical Trials, Clinical Trial Network, USA; 2College of Medicine, Windsor University College of Medicine, USA.
Background: SGLT2-I is a promising new class of diabetes pharmacotherapy, it targets blood glucose lowering in both postprandial and fasting states. It offers minimal risk of hypoglycemic events and demonstrates modest effects on blood pressure and weight.
Objective: Meta-analysis review of SGLT2-I outcome, safety and efficacy RCT.
Methods: Medline, EMBASE & CENTRAL were searched until August 2015, double blind RCT in T2DM with at least 12 weeks treatment duration evaluated.
Study | IND | Duration (Weeks) | Baseline A1c | Change in A1c (%±S.D.) |
Stenlof et al. | Canagliflozin 300 mg | 26 | 8% | −1.03 |
Canagliflozin 100 mg | 26 | 8% | −0.77 | |
Placebo | 26 | 8% | +0.14 | |
Haring et al. | Empagliflozin 10 mg + Metformin | 24 | 7.90% | −0.7±0.05 |
Empagliflozin 25 mg + Metformin | 24 | 7.90% | −0.77±0.05 | |
Ferrannini et al. | Empagliflozin 5 mg + Metformin | 12 | 7.90% | −0.4 |
Empagliflozin 10 mg + Metformin | 12 | 7.90% | −0.5 | |
Empagliflozin 25 mg + Metformin | 12 | 7.90% | −0.6 | |
Placebo + Metformin | 12 | 7.90% | +0.1 | |
*Note: P<0.001 vs Placebo |
Potential AE | Genitourinary Infections, Bone Fractures, Diabetic Ketoacidosis, Long term safety not established |
Cardiovascular Outcomes | Reduction in CV death in patients with known ASCVD; Unclear benefit in primary prevention |
Hypoglycaemic Event Risk | Low |
Weight Loss (kg) | 1.53.0 |
SBP Reduction (mmHg) | 35 |