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Comparative efficacy and safety of the duodenal‐jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study
Author(s) -
Laubner Katharina,
Riedel Nina,
Fink Katharina,
Holl Reinhard W.,
Welp Reinhard,
Kempe HansPeter,
Lautenbach Anne,
Schlensak Matthias,
Stengel Rainer,
Eberl Thomas,
Dederichs Frank,
Schwacha Henning,
Seufert Jochen,
Aberle Jens
Publication year - 2018
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13300
Subject(s) - medicine , type 2 diabetes , diabetes mellitus , type 2 diabetes mellitus , obesity , propensity score matching , gastroenterology , endocrinology
Aims The duodenal‐jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal‐jejunal bypass, and is indicated for the treatment of obesity‐associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. Materials and Methods To determine the efficacy and long‐term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity‐score‐matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. Results Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m 2 ( P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) ( P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (−1.37% vs −0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (−3.02 kg/m 2 vs −0.39 kg/m 2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. Conclusion This study provides the largest, so far, hypothesis‐generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.