Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study
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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. / Laubner, Katharina; Riedel, Nina; Fink, Katharina; Holl, Reinhard W; Welp, Reinhard; Kempe, Hans-Peter; Lautenbach, Anne; Schlensak, Matthias; Stengel, Rainer; Eberl, Thomas; Dederichs, Frank; Schwacha, Henning; Seufert, Jochen; Aberle, Jens.
In: DIABETES OBES METAB, Vol. 20, No. 8, 08.2018, p. 1868-1877.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study
AU - Laubner, Katharina
AU - Riedel, Nina
AU - Fink, Katharina
AU - Holl, Reinhard W
AU - Welp, Reinhard
AU - Kempe, Hans-Peter
AU - Lautenbach, Anne
AU - Schlensak, Matthias
AU - Stengel, Rainer
AU - Eberl, Thomas
AU - Dederichs, Frank
AU - Schwacha, Henning
AU - Seufert, Jochen
AU - Aberle, Jens
N1 - © 2018 John Wiley & Sons Ltd.
PY - 2018/8
Y1 - 2018/8
N2 - 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/m2 (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/m2 vs -0.39 kg/m2 ; 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.
AB - 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/m2 (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/m2 vs -0.39 kg/m2 ; 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.
KW - Anastomosis, Surgical
KW - Bariatric Surgery
KW - Body Mass Index
KW - Case-Control Studies
KW - Cohort Studies
KW - Diabetes Mellitus, Type 2
KW - Drug Therapy, Combination
KW - Duodenum
KW - Endoscopy, Gastrointestinal
KW - Female
KW - Follow-Up Studies
KW - Germany
KW - Humans
KW - Hyperglycemia
KW - Hypoglycemic Agents
KW - Jejunum
KW - Male
KW - Middle Aged
KW - Obesity, Morbid
KW - Postoperative Complications
KW - Prospective Studies
KW - Registries
KW - Risk Assessment
KW - Weight Loss
KW - Comparative Study
KW - Journal Article
KW - Observational Study
KW - Research Support, Non-U.S. Gov't
U2 - 10.1111/dom.13300
DO - 10.1111/dom.13300
M3 - SCORING: Journal article
C2 - 29569313
VL - 20
SP - 1868
EP - 1877
JO - DIABETES OBES METAB
JF - DIABETES OBES METAB
SN - 1462-8902
IS - 8
ER -