Obejective Ademetionine 1,4-butanedisulfonate [S-adenosyl-L-methionine (SAMe)/Transmetil®, Abbott] has been available in China for more than 15 years, and it has been shown to reduce serum bilirubin and transaminase levels in viral hepatitis (VH) patients. However, no large-scale studies have focused on the impact of SAMe treatment regimen on reducing the serum total bilirubin (TBil) in VH patients with intrahepatic cholestasis (IHC). The primary purpose of this study was to evaluate the effectiveness of intravenous SAMe (Transmetil®) treatment in reducing the serum TBil by 50%.
Methods This retrospective, multi-center, cross-sectional medical record review involved patients aged ≥18 years. Records of 1 280 hospitalized VH patients at 16 sites diagnosed with IHC who had received intravenous SAMe 1 000 mg or 2 000 mg q.d. for at least 7 days from January 1, 2006 to June 30, 2009, were screened and 905 records were randomly selected.
Results The safety set (SS) included 834 patients and the full analysis set 826 patients. TBil levels after 14 days injection treatment were available for 763 patients. TBil decreased ≥ 50% versus baseline after 14 days treatment in 288 (37.7%) patients (95% CI 34.3%, 41.2%). Twenty-nine non-serious adverse events (non-SAEs) were reported in 19 (2.3%) patients, and 29 SAEs were reported in 10 patients (1.2%). All adverse events (AEs) were considered unrelated to the study drug.
Conclusions This retrospective study shows that intravenous SAMe administration in VH patients with IHC is associated with significant reduction of TBil levels in more than 30% of patients 14 days after treatment initiation.