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Table 3 Changes in parameters after 24 weeks of treatment with ezetimibe plus rosuvastatin versus rosuvastatin monotherapy

From: Ezetimibe combination therapy with statin for non-alcoholic fatty liver disease: an open-label randomized controlled trial (ESSENTIAL study)

  

Ezetimibe + rosuvastatin (n=31)

 

Rosuvastatin alone (n=33)

Difference between groups

 

Baseline

Post-treatment

p-value

Baseline

Post-treatment

p-value

p-value

BMI, kg/m2

26.6 (6.4)

26.2 (5.8)

0.002

28.3 (3.6)

27.9 (3.7)

0.001

0.675

Waist circumference, cm

94.0 (15.0)

91.0 (13.0)

<0.001

96.0 (12.5)

93.5 (14.0)

<0.001

0.269

Seated SBP, mmHg

127.0 (10.4)

127.2 (12.7)

0.936

128.3 (13.0)

126.2 (11.5)

0.341

0.450

Seated DBP, mmHg

81.5 (7.3)

80.0 (10.1)

0.409

82.0 (9.8)

78.2 (8.7)

0.020

0.354

ALT, IU/l

40.0 (31.0)

40.0 (24.0)

0.459

31.0 (21.0)

32.0 (26.0)

0.563

0.471

AST, IU/l

25.0 (14.0)

26.0 (15.0)

0.681

24.0 (11.0)

27.0 (18.0)

0.727

0.462

Platelets, ×103/μl

265.0 (87.0)

259.0 (82.0)

0.175

255.0 (80.0)

248.0 (75.5)

0.003

0.357

Alk Phos, U/l

64.0 (21.0)

63.0 (18.0)

0.642

71.0 (36.0)

70.0 (32.5)

0.326

0.510

GGT, U/l

43.0 (35.0)

32.0 (41.0)

0.125

36.0 (33.5)

33.0 (27.5)

0.957

0.861

Total bilirubin, mg/dl

0.6 (0.3)

0.6 (0.4)

0.871

0.7 (0.4)

0.7 (0.4)

0.165

0.600

Glucose, mg/dl

116.0 (29.0)

116.0 (40.0)

0.378

115.0 (33.5)

120.0 (25.0)

0.957

0.345

Insulin, uU/ml

12.5 (9.3)

12.7 (6.9)

0.931

15.0 (8.0)

15.5 (12.1)

0.993

0.911

HbA1c, %

6.4 (0.6)

6.5 (0.8)

0.167

6.5 (1.1)

6.5 (1.4)

0.055

0.445

FFA, mmol/l

480.0 (314.0)

506.0 (318.0)

0.433

515.0 (279.5)

403.0 (316.5)

0.059

0.545

HOMA-IR

3.6 (3.7)

3.5 (3.0)

0.814

4.0 (3.5)

4.7 (3.3)

0.925

0.691

HOMA-beta

87.0 (65.6)

91.7 (81.2)

0.299

99.6 (59.6)

94.0 (81.6)

0.957

0.098

Triglycerides, mg/dl

177.0 (139.0)

138.0 (77.0)

<0.001

217.0 (157.0)

135.0 (71.0)

<0.001

0.175

HDL, mg/dl

45.0 (16.0)

44.0 (10.0)

0.045

42.0 (7.5)

41.0 (11.0)

0.948

0.109

LDL, mg/dl

116.0 (66.4)

55.0 (37.2)

<0.001

109.8 (42.9)

66.4 (28.3)

<0.001

0.111

CRP, mg/l

1.4 (1.7)

0.8 (1.2)

0.036

1.5 (1.4)

0.8 (1.6)

0.008

0.805

tPAI-1, ng/ml

17.8 (10.2)

12.5 (17.3)

0.116

21.7 (14.4)

17.5 (12.2)

0.016

0.217

IL-1 β, pg/ml

0.045 (0.085)

0.077 (0.111)

0.144

0.063 (0.082)

0.076 (0.124)

0.296

0.843

IL-8, pg/ml

3.3 (2.5)

2.6 (2.1)

0.122

3.7 (2.3)

2.9 (2.1)

0.088

0.866

IL-18, pg/ml

163.6 (73.8)

146.2 (52.0)

0.003

168.2 (73.8)

162.6 (76.8)

0.042

0.210

  1. Data are expressed as median (IQR) with p-values from Wilcoxon signed-rank test. p-value difference was determined using per-protocol analysis
  2. Abbreviations: BMI body mass index, SBP systolic blood pressure, DBP diastolic blood pressure, ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyl transferase, FFA free fatty acids, HOMA-IR homeostatic model assessment of insulin resistance, HDL high-density lipoprotein, LDL low-density lipoprotein, CRP C-reactive protein, tPAI total plasminogen activator inhibitor, IL interleukin