TY - JOUR
T1 - Factors associated with adherence to ursodeoxycholic acid or placebo in patients after bariatric surgery
AU - Guman, Maimoena S. S.
AU - Haal, Sylke
AU - Maurits de Brauw, L.
AU - Hutten, Barbara A.
AU - Nieuwdorp, Prof Max
AU - Nuijen, Bastiaan
AU - Schouten, Ruben
AU - van Veen, Ruben N.
AU - Dijkgraaf, Prof Marcel G. W.
AU - Voermans, Rogier P.
AU - Gerdes, Victor E. A.
N1 - Funding Information: The UPGRADE trial was funded by the Netherlands Organization for Health Research and Development (grant number 848015003), Zambon BV Netherlands, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism. Max Nieuwdorp is supported by a personal ZONMW-VICI grant 2020 [09150182010020]. Funding Information: The UPGRADE trial was funded by the Netherlands Organization for Health Research and Development (grant number 848015003), Zambon BV Netherlands, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism. Max Nieuwdorp is supported by a personal ZONMW-VICI grant 2020 [09150182010020]. Publisher Copyright: © 2022
PY - 2022/6/1
Y1 - 2022/6/1
N2 - Background: Ursodeoxycholic acid (UDCA) reduces symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB). The beneficial effect of UDCA is reduced by poor adherence. Objectives: We aimed to identify factors associated with poor adherence to UDCA or placebo after bariatric surgery. Setting: Outpatient clinic and department for bariatric surgery in three hospitals in the Netherlands. Methods: Patients in the multicenter, double-blind, randomized, placebo-controlled UPGRADE trial were assessed for adherence to 900 mg UDCA or placebo for 6 months through a pill count, inquiries during follow-up, and a questionnaire. Poor adherence was defined as the usage of <300 of 364 pills within a maximum of 8 months postoperatively. Multivariable logistic regression analysis was used to identify factors contributing to poor adherence. Results: In total, 967 patients were included (mean age [standard deviation (SD)]: 45.1 [11.1] years; female: 772 [80%]; RYGB: 889 [92%]; sleeve gastrectomy: 78 [8%]), of whom 357 (37%) were poor adherers. Factors associated with poor adherence were age (OR.97; 95% confidence interval [CI].96–.98, a decrease in age increases the odds for poor adherence), foreign origin (odds ratio [OR] 2.07; 95%CI 1.50–2.84), unemployment (OR 1.73; 95%CI 1.28–2.34), and sleeve gastrectomy (OR 1.79; 95%CI 1.06–3.01). Furthermore, a difference in adherence status was also noted for the centers of surgery. Conclusions: The adherence rate to UDCA and placebo in the UPGRADE trial was suboptimal. Several factors were independently associated with poor adherence. Our findings can help to identify patients who may benefit from extra guidance to improve adherence.
AB - Background: Ursodeoxycholic acid (UDCA) reduces symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB). The beneficial effect of UDCA is reduced by poor adherence. Objectives: We aimed to identify factors associated with poor adherence to UDCA or placebo after bariatric surgery. Setting: Outpatient clinic and department for bariatric surgery in three hospitals in the Netherlands. Methods: Patients in the multicenter, double-blind, randomized, placebo-controlled UPGRADE trial were assessed for adherence to 900 mg UDCA or placebo for 6 months through a pill count, inquiries during follow-up, and a questionnaire. Poor adherence was defined as the usage of <300 of 364 pills within a maximum of 8 months postoperatively. Multivariable logistic regression analysis was used to identify factors contributing to poor adherence. Results: In total, 967 patients were included (mean age [standard deviation (SD)]: 45.1 [11.1] years; female: 772 [80%]; RYGB: 889 [92%]; sleeve gastrectomy: 78 [8%]), of whom 357 (37%) were poor adherers. Factors associated with poor adherence were age (OR.97; 95% confidence interval [CI].96–.98, a decrease in age increases the odds for poor adherence), foreign origin (odds ratio [OR] 2.07; 95%CI 1.50–2.84), unemployment (OR 1.73; 95%CI 1.28–2.34), and sleeve gastrectomy (OR 1.79; 95%CI 1.06–3.01). Furthermore, a difference in adherence status was also noted for the centers of surgery. Conclusions: The adherence rate to UDCA and placebo in the UPGRADE trial was suboptimal. Several factors were independently associated with poor adherence. Our findings can help to identify patients who may benefit from extra guidance to improve adherence.
KW - Adherence
KW - Bariatric surgery
KW - Gallstone
KW - Placebo
KW - Randomized controlled trial
KW - Roux-en-Y gastric bypass
KW - Sleeve gastrectomy
KW - Ursodeoxycholic acid
UR - http://www.scopus.com/inward/record.url?scp=85128318782&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.soard.2022.02.010
DO - https://doi.org/10.1016/j.soard.2022.02.010
M3 - Article
C2 - 35387759
SN - 1550-7289
VL - 18
SP - 755
EP - 761
JO - Surgery for Obesity and Related Diseases
JF - Surgery for Obesity and Related Diseases
IS - 6
ER -