JARDIANCE (empagliflozin), oral antidiabetic
DIABETOLOGY - Update
Opinions on drugs - Posted on Jan 12 2017
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
No clinical benefit demonstrated in the management of patients with type 2 diabetes, insufficiently controlled:
- in combination with metformin
- in combination with metformin and a sulfonylurea or with metformin and insulin.
- JARDIANCE has a Marketing Authorisation in the treatment of type 2 diabetes mellitus in monotherapy and in combination with other blood glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
- The results of a study on a large population of patients at high cardiovascular risk indicate that empagliflozin does not induce an increase in cardiovascular events compared with placebo.
- These results do not make it possible to conclude with a sufficient level of evidence that empagliflozin reduces cardiovascular events and/or total mortality in patients with type 2 diabetes and high cardiovascular risk.
Improvement in actual benefit
Évaluation des médicaments
HAS opinions and decisions