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JARDIANCE (empagliflozin), oral antidiabetic

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.


Actual benefit




Improvement in actual benefit

V (absence)


Therapeutic use



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