Assessment of the EMPA-REG Outcome study
Empagliflozin (trade name: Jardiance) has been approved since May 2014 for adults with type 2 diabetes when diet and exercise alone do not provide adequate control of blood sugar levels.
In 2015, a study involving over 7,000 men and women with diabetes gained international attention. The study was called EMPA-REG Outcome, and its results were published in a scientifc journal. According to the results, empagliflozin decreases the risk of dying of cardiovascular disease.
But according to an assessment by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany), no conclusions can be drawn from the study regarding the treatment of diabetes in Germany. The Institute examined the study and its results in detail. IQWiG's main criticism is the fact that the majority of participants did not receive an appropriate standard treatment, although this was originally planned according to the study protocol.
Who participated in EMPA-REG Outcome?
The participants were people with diabetes who either had not had any treatment for at least three months at the beginning of the study, or who were unable to control their blood sugar enough despite treatment. In addition to diabetes, they already had a cardiovascular disease, such as a past heart attack or stroke.
At the beginning of the study, the participants were 63 years old on average. They were mainly of Asian, European, as well as North, South and Central American origin.
Which treatments were compared?
All participants were to receive individualized diabetes treatment to regulate their blood sugar. Type 2 diabetes can be treated with a number of different blood-sugar-lowering medicines, the main ones being metformin, sulfonylurea and insulin. These are either used alone as monotherapy or in combination with each other.
The participants were randomly assigned to one of three groups:
- 2,347 men and women also received 10 mg of empagliflozin per day.
- 2,344 also received 25 mg of empagliflozin per day.
- 2,337 also received a placebo.
What did they find?
The analysis of the study data showed that its requirement to provide individualized treatment had not been met. As a result, blood sugar levels did not improve over the course of the study in the group that was given the placebo. This means that these participants did not receive the treatment that was originally meant to be the standard treatment.
So the study found an advantage for high-risk patients who did not receive the usual standard treatment. This is not typical of the health care situation in Germany, though, so the results of the study are of little relevance for patients in Germany. This was also obvious from the results of the study: The effects of empagliflozin treatment were much less pronounced in patients from Germany or other European countries than in participants from other parts of the world, such as Latin America or Asia.
In conclusion, according to the analyses done by the researchers at IQWiG, it cannot be assumed that the published results of the EMPA-REG Outcome study can be applied to patients receiving treatment for type 2 diabetes in Germany.
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.
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med 2015; 373 (22): 2117-28.
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