Empagliflozin (trade name: Jardiance) has been approved in Germany since May 2014 for adults with type 2 diabetes when diet and exercise alone do not provide adequate control of blood sugar levels.
It is a treatment option for people who do not tolerate the standard treatment metformin. Empagliflozin may also be used in addition to other blood sugar lowering drugs (including insulin) if they do not provide adequate control of blood sugar levels.
Diabetes is a metabolic disease that affects many parts of the body. In type 2 diabetes, the pancreas still produces enough insulin at first, but the body’s cells gradually lose the ability to absorb and use the insulin. If blood sugar levels cannot be lowered enough by changes in diet and exercise habits, blood-sugar-lowering drugs are used.
The treatment aims to avoid strong fluctuations in blood sugar levels and prevent problems caused by high and low blood sugar in people with diabetes. A further goal of this treatment is to prevent long-term complications that may arise if blood sugar levels are too high.
Empagliflozin inhibits the reabsorption of glucose (sugar) by the kidneys, so more sugar leaves the body in the urine.
Empagliflozin is taken once a day in tablet form (10 mg).
If this dose is well tolerated and there is no kidney failure, the dose can be increased up to 25 mg per day if blood sugar levels need to be lowered more. If empagliflozin is combined with other blood-sugar-lowering drugs or insulin, their doses may have to be adjusted to prevent hypoglycemia.
Type 2 diabetes can be treated with a number of different blood-sugar-lowering medicines, including metformin, sulfonylurea and insulin. These are either used alone as monotherapy or in combination with each other.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether empagliflozin has an added benefit for people with type 2 diabetes compared to standard treatments.
However, the manufacturer did not provide any suitable data with which to do the assessment. This was also true for the study kown as 'EMPA-REG Outcome.'
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of empagliflozin (Jardiance).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Empagliflozin – Benefit assessment according to §35a Social Code Book V. Dossier assessment A14-26. Cologne: IQWiG. November 17, 2014.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Empagliflozin – Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-12. Cologne: IQWiG. May 30, 2016.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Empagliflozin - Addendum to Commission A16-12. Commission A16-46. Cologne: IQWiG. July 29, 2016.
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