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DDG maintains support for EndoBarrier despite ENDO Trial

Interim analysis of trial data demonstrates statistically significant benefit of EndoBarrier Therapy in reducing blood sugar levels

The German Diabetes Society (DDG) has published their scientific statement regarding the termination of the US pivotal study (ENDO Trial). The statement balances background for the termination of the FDA study and the preliminary results with the experiences and data observed in Germany. Based on a review of ENDO Trial study data, a significant (p=0.008) reduction in HbA1c by 1.11% (8.8 baseline HbA1c) was observed in the intervention group after 12 months. The HbA1c reduction recorded in the German national register is 1.72% (baseline: 8.6%).  The DDG’s affirmative statement maintains support for hospitals and physicians to offer EndoBarrier Therapy as a beneficial treatment option to obese patients who have uncontrolled type 2 diabetes.   

The ENDO Trial was terminated in July 2015 due to a number of liver abscesses reported in the study, which occurred in seven out of 217 patients (3.2%) in the intervention group and in 0 out of 108 patients in the sham Group (control group: Endoscopy without EndoBarrier implantation). For all affected patients, the liver abscesses were cured using standard treatments (antibiotics and, if necessary, drainage) without consequences. All the studies currently running outside of the US are continuing. The rate of liver abscesses is significantly higher in the Endo Trial than the rate observed around the world with a global rate of liver abscesses of around 0.73% (3,000 patients) and 0.46% (651 patients) in Germany.

The national EndoBarrier register currently includes three cases of liver abscesses. In 202 documented cases, this corresponds to an event rate of 1.48%. The background to the increased complication rate observed in the US is not known. However, it is possible that the high dose of proton pump inhibitors envisaged in the study protocol contributed to this. The effects of a reduction in the dosage of proton pump inhibitors over the course of the EndoBarrier implantation period are not being investigated at this time.

In addition, all patients treated in the US suffered from type 2 Diabetes mellitus and liver abscesses occur more frequently in persons suffering from diabetes than in the normal population. It is not currently known whether the prophylactic cyclical administration of antibiotics on two days per month would have a protective effect on the development of liver abscesses after EndoBarrier implantation.

On the basis of an initial review of the EndoTrial study data, a significant, and at 1.11% also greater, reduction in HbA1c can be seen in the intervention group after 12 months (absolute value: intervention group -1.25%; sham group -0.15%). The initial value was 8.8% (duration of diabetes 7.6 years), the BMI was 38.4. The HbA1c reduction recorded in the national register is 1.72%according to the latest analysis (initial value: 8.6%). 

Since the effects on diabetes mellitus and body weight were already significant nine to ten months after implantation according to the investigation results in Germany, in the future it will be necessary to consider whether the EndoBarrier could routinely be explanted after just ten months. A procedure of this type could prevent infectious complications, particularly liver abscesses, as the international registers show that liver abscesses occurred in particular in the later phase of the implantation period (months ten to twelve). 

The DDG statement can be downloaded using following links:

Original (German) version click here 

Certified translation (English) here


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