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Table 4 Summary of blood lipid parameters at baseline and on days 14 and 28

From: Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial

  Day Number Total cholesterol (mmol/L) LDL-C (mmol/L) HDL-C (mmol/L) Triglycerides (mmol/L)
Mean SD Mean SD Mean SD Mean SD
Healthy volunteers
 Placebo 1 12 4.70 0.964 2.78 0.853 1.38 0.298 1.189 0.3600
14 12 4.78 1.209 3.03 1.112 1.29 0.223 1.031 0.3635
28 12 4.73 1.097 2.87 0.934 1.38 0.322 1.233 0.4302
 Volixibat 0.5 mg 1 10 4.17 0.933 2.39 0.861 1.35 0.314 0.976 0.3523
14 10 4.07 0.686 2.23 0.726 1.31 0.307 1.013 0.3370
28 9 3.99 0.854 2.29 0.851 1.37 0.274 0.936 0.2013
 Volixibat 1 mg 1 9 4.28 0.628 2.43 0.650 1.34 0.274 0.863 0.3278
14 9 3.87 0.650 2.22 0.655 1.29 0.215 0.962 0.6851
28 9 3.97 0.552 2.22 0.576 1.33 0.300 1.024 0.5973
 Volixibat 5 mg 1 8 4.53 0.865 2.81 0.781 1.25 0.227 1.476 0.6576
14 8 4.21 0.825 2.50 0.725 1.23 0.276 1.294 0.7138
28 6 4.58 1.102 2.77 0.967 1.33 0.350 1.522 0.5151
 Volixibat 10 mg 1 8 5.44 0.637 3.04 0.641 1.86 0.421 0.875 0.4316
14 8 4.94 0.774 2.66 0.715 1.80 0.518 0.914 0.5547
28 8 4.98 0.504 2.59 0.559 1.94 0.346 1.055 0.5934
Patients with T2DM
 Placebo 1 3 4.60 0.964 2.83 0.874 1.07 0.115 2.260 1.0817
14 3 4.37 0.586 2.57 0.404 1.03 0.153 2.527 1.1007
28 3 5.03 1.266 2.93 0.603 1.13 0.153 3.070 2.4333
 Volixibat 10 mg 1 8 4.69 1.037 3.01 0.926 1.25 0.245 1.725 0.5263
14 8 4.20 1.135 2.46 1.086 1.25 0.214 2.074 0.8015
28 8 4.68 0.924 2.84 0.890 1.29 0.275 1.933 0.5337
  1. HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, N number of patients for whom data were available, SD standard deviation, T2DM type 2 diabetes mellitus
  2. On day 1 (baseline), measurements of faecal bile acids and serum markers were taken before participants received the first dose of study drug; data are from the pharmacodynamic analysis set