Limits...
A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis

View Article: PubMed Central - PubMed

ABSTRACT

Aim:: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To further evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.

Methods:: 199 PBC patients were randomly assigned to either 250 mg TUDCA plus UDCA placebo or 250 mg UDCA plus TUDCA placebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline phosphatase (ALP) reduction of more than 25% from baseline.

Results:: At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP reduction of more than 25% from baseline (P = 0.453). The percentage of patients with serum ALP levels declined more than 40% following 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P = 0.699). Both groups showed similar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P > 0.05). The proportion of patients with pruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there's no change in TUDCA group (P = 0.023). Both drugs were well tolerated, with comparable adverse event rates between the 2 groups.

Conclusions:: TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than UDCA.

No MeSH data available.


Changes in serum markers, including ALP, GGT, T-BIL, ALT, and AST, during the administration of TUDCA and UDCA groups. ALP = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma glutamyl transpeptidase, T-Bil = total bilirubin, TUDCA = tauroursodeoxycholic acid, UDCA = ursodeoxycholic acid.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC5134868&req=5

Figure 2: Changes in serum markers, including ALP, GGT, T-BIL, ALT, and AST, during the administration of TUDCA and UDCA groups. ALP = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma glutamyl transpeptidase, T-Bil = total bilirubin, TUDCA = tauroursodeoxycholic acid, UDCA = ursodeoxycholic acid.

Mentions: The time course of the changes in serum biochemical variables is presented in Fig. 2. As the primary efficacy endpoint, 76% of patients in the TUDCA group and 81% of patients in the UDCA group achieved a serum ALP reduction greater than 25% from baseline level following 24 weeks of treatment (P = 0.453). Similarly, at week 24, the proportion of patients who achieved a greater than 40% reduction in ALP levels from baseline was 56% and 53% in the TUDCA and UDCA groups, respectively (P = 0.699).


A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis
Changes in serum markers, including ALP, GGT, T-BIL, ALT, and AST, during the administration of TUDCA and UDCA groups. ALP = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma glutamyl transpeptidase, T-Bil = total bilirubin, TUDCA = tauroursodeoxycholic acid, UDCA = ursodeoxycholic acid.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5134868&req=5

Figure 2: Changes in serum markers, including ALP, GGT, T-BIL, ALT, and AST, during the administration of TUDCA and UDCA groups. ALP = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma glutamyl transpeptidase, T-Bil = total bilirubin, TUDCA = tauroursodeoxycholic acid, UDCA = ursodeoxycholic acid.
Mentions: The time course of the changes in serum biochemical variables is presented in Fig. 2. As the primary efficacy endpoint, 76% of patients in the TUDCA group and 81% of patients in the UDCA group achieved a serum ALP reduction greater than 25% from baseline level following 24 weeks of treatment (P = 0.453). Similarly, at week 24, the proportion of patients who achieved a greater than 40% reduction in ALP levels from baseline was 56% and 53% in the TUDCA and UDCA groups, respectively (P = 0.699).

View Article: PubMed Central - PubMed

ABSTRACT

Aim:: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To further evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.

Methods:: 199 PBC patients were randomly assigned to either 250 mg TUDCA plus UDCA placebo or 250 mg UDCA plus TUDCA placebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline phosphatase (ALP) reduction of more than 25% from baseline.

Results:: At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP reduction of more than 25% from baseline (P = 0.453). The percentage of patients with serum ALP levels declined more than 40% following 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P = 0.699). Both groups showed similar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P > 0.05). The proportion of patients with pruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there's no change in TUDCA group (P = 0.023). Both drugs were well tolerated, with comparable adverse event rates between the 2 groups.

Conclusions:: TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than UDCA.

No MeSH data available.