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
Après délibération, le collège de la Haute Autorité de santé, en sa séance du 20 avril 2016 a consta...