Premium
Effects of liraglutide on gallbladder emptying: A randomized, placebo‐controlled trial in adults with overweight or obesity
Author(s) -
NexøeLarsen Christina C.,
Sørensen Pernille H.,
Hausner Helene,
Agersnap Mikkel,
Baekdal Mille,
Brønden Andreas,
Gustafsson Lea N.,
Sonne David P.,
Vedtofte Louise,
Vilsbøll Tina,
Knop Filip K.
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.13420
Subject(s) - liraglutide , placebo , medicine , overweight , postprandial , nausea , body mass index , gastric emptying , gastroenterology , clinical endpoint , confidence interval , randomized controlled trial , endocrinology , diabetes mellitus , type 2 diabetes , stomach , insulin , alternative medicine , pathology
Aims Treatment with liraglutide 3.0 mg has been associated with gallbladder‐related adverse events. To conduct a single‐centre, double‐blind, 12‐week trial comparing the effect of 0.6 mg liraglutide and steady‐state liraglutide 3.0 mg with placebo on gallbladder emptying in adults with body mass index (BMI) ≥27 kg/m 2 and without diabetes. Methods Participants were randomized 1:1 to once‐daily subcutaneous liraglutide ( n = 26) or placebo ( n = 26), starting at 0.6 mg with 0.6‐mg weekly increments to 3.0 mg, with nutritional and physical activity counselling. A 600‐kcal (23.7 g fat) liquid meal test was performed at baseline, after the first dose and after 12 weeks. The primary endpoint was the 12‐week maximum postprandial gallbladder ejection fraction (GBEF max ), measured over 240 minutes after starting the meal. Results Baseline characteristics were similar between groups (mean ± SD overall age 47.6 ± 10.0 years, BMI 32.6 ±3.4 kg/m 2 , 50% women). Mean 12‐week GBEF max (treatment difference −3.7%, 95% confidence interval [CI] −13.1, 5.7) and area under the GBEF curve in the first 60 minutes (−390% × min, 95% CI −919, 140) did not differ for liraglutide 3.0 mg ( n = 23) vs placebo ( n = 24). The median (range) time to GBEF max was 151 (11‐240) minutes with liraglutide 3.0 mg and 77 (22‐212) minutes with placebo. Similar findings were noted after the first 0.6‐mg liraglutide dose. Gastrointestinal disorders, notably nausea and constipation, were the most frequently reported adverse events. Conclusions Treatment with liraglutide did not affect the GBEF max but appeared to prolong the time to GBEF max .