Table 6.

Liver function tests at baseline, weeks 4 and 8, and end of study

Parameter (U/L)Value at Screening (Mean ± SD)Change at End of Week 4 (Mean ± SD)Change at End of Week 8 (Mean ± SD)End of Study or LOCF (Mean ± SD)
Alanine aminotransferase17.8 ± 11.0 (n = 503)−0.3 ± 11.2 (n = 373)0.2 ± 13.5 (n = 292)−0.8 ± 12.6 (n = 412)
    % above normal range5.85.14.12.9
Aspartate aminotransferase18.3 ± 9.0 (n = 500)0.8 ± 14.1 (n = 368)0.7 ± 7.8 (n = 292)0.2 ± 11.0 (n = 407)
    % above normal range3.43.53.43.9
Alkaline phosphatase117.4 ± 72.3 (n = 506)4.2 ± 30.0 (n = 374)a8.7 ± 33.3 (n = 295)a11.7 ± 54.0 (n = 414)a
    % above normal range29.131.835.337.7
γ -Glutamyl transpeptidase38.6 ± 54.9 (n = 506)2.3 ± 25.6 (n = 374)3.4 ± 23.7 (n = 294)a4.7 ± 35.1 (n = 414)a
    % above normal range16.815.516.019.6
  • a P < 0.05 versus screening.