BACKGROUND/AIM: To evaluate the safety of budesonide in primary biliary cirrhosis. METHODS: 77 primary biliary cirrhosis patients, with stages I-III at entry, were randomized to use either budesonide 6 mg and ursodeoxycholic acid 15 mg/kg (group A), or ursodeoxycholic acid alone (group B) daily for 3 years. In 22 patients, budesonide pharmacokinetics was determined after 3 years. Bone mass density was measured in 62 patients at baseline and 3 years; in 57 patients also liver biopsies were performed. RESULTS: At 3 years, no significant differences in the pharmacokinetics of budesonide were found between the patients with stages 0-I, II and III primary biliary cirrhosis. In group A, bone mass density in femoral neck and lumbar spine were decreased by 3.6% (P = 0.0002) and 2.8% (P = 0.003) from the baseline. In group B, the corresponding decreases were 1.9% (P = 0.029) and 0.7% (P = 0.25), but the differences between the groups were not statistically significant (P = 0.16 for femoral neck and P = 0.08 for lumbar spine). CONCLUSIONS: The plasma concentrations of budesonide do not significantly differ within stages I-III primary biliary cirrhosis patients. The combination of budesonide and ursodeoxycholic acid may decrease bone mass density in the femoral neck and lumbar spine in some primary biliary cirrhosis patients, and bone mass density is recommended to be monitored during budesonide therapy.
RCT Entities:
BACKGROUND/AIM: To evaluate the safety of budesonide in primary biliary cirrhosis. METHODS: 77 primary biliary cirrhosispatients, with stages I-III at entry, were randomized to use either budesonide 6 mg and ursodeoxycholic acid 15 mg/kg (group A), or ursodeoxycholic acid alone (group B) daily for 3 years. In 22 patients, budesonide pharmacokinetics was determined after 3 years. Bone mass density was measured in 62 patients at baseline and 3 years; in 57 patients also liver biopsies were performed. RESULTS: At 3 years, no significant differences in the pharmacokinetics of budesonide were found between the patients with stages 0-I, II and III primary biliary cirrhosis. In group A, bone mass density in femoral neck and lumbar spine were decreased by 3.6% (P = 0.0002) and 2.8% (P = 0.003) from the baseline. In group B, the corresponding decreases were 1.9% (P = 0.029) and 0.7% (P = 0.25), but the differences between the groups were not statistically significant (P = 0.16 for femoral neck and P = 0.08 for lumbar spine). CONCLUSIONS: The plasma concentrations of budesonide do not significantly differ within stages I-III primary biliary cirrhosispatients. The combination of budesonide and ursodeoxycholic acid may decrease bone mass density in the femoral neck and lumbar spine in some primary biliary cirrhosispatients, and bone mass density is recommended to be monitored during budesonide therapy.
Authors: Khurram Bari; Shimul A Shah; Tiffany E Kaiser; Robert M Cohen; Nadeem Anwar; David Kleesattel; Kenneth E Sherman Journal: Liver Transpl Date: 2020-08-19 Impact factor: 5.799
Authors: Raffaele Licinio; Antonio Facciorusso; Nicola Maurizio Castellaneta; Alfredo Di Leo Journal: Am J Gastroenterol Date: 2015-07 Impact factor: 10.864
Authors: Stephan Miehlke; Danila Guagnozzi; Yamile Zabana; Gian E Tontini; Anne-Marie Kanstrup Fiehn; Signe Wildt; Johan Bohr; Ole Bonderup; Gerd Bouma; Mauro D'Amato; Peter J Heiberg Engel; Fernando Fernandez-Banares; Gilles Macaigne; Henrik Hjortswang; Elisabeth Hultgren-Hörnquist; Anastasios Koulaouzidis; Jouzas Kupcinskas; Stefania Landolfi; Giovanni Latella; Alfredo Lucendo; Ivan Lyutakov; Ahmed Madisch; Fernando Magro; Wojciech Marlicz; Emese Mihaly; Lars K Munck; Ann-Elisabeth Ostvik; Árpád V Patai; Plamen Penchev; Karolina Skonieczna-Żydecka; Bas Verhaegh; Andreas Münch Journal: United European Gastroenterol J Date: 2021-02-22 Impact factor: 4.623