Table 2.
Baseline values and % change from baseline at 1-year follow-up in the control and Lovaza groups in the intention to treat analysis
| Control (n = 130) | Lovaza (n = 138) | Difference in % Change Lovaza minus Control | ||||
|---|---|---|---|---|---|---|
| Value at baseline Mean±SD | Value at 1-year Follow-up Mean±SD | Value at baseline Mean±SD | Value at 1-year Follow-up Mean±SD | Mean (95% CI) | P Value* | |
| Clinical Variable | ||||||
| Systolic BP (mmHg) | 124.4±14.8 | 122.9±15.5 | 124.9±14.6 | 124.2±15.4 | −1.4 (−4.5 to 1.7) | .39 |
| Diastolic BP (mmHg) | 72.5±8.9 | 69.5±9.0 | 73.1±9.9 | 71.1±10.0 | 0.0 (−3.5 to 3.5) | .99 |
| Waist circumference (cm) | 106.7±11.2 | 107.4±10.8 | 106.9±10.2 | 108.2±10.1 | −0.2 (−1.4 to 1.0) | .71 |
| Body mass index (kg/m2) | 30.6±3.7 | 30.2±3.9 | 30.8±3.6 | 31.3±7.0 | 0.0 (−1.8 to 1.9) | .98 |
| Inflammatory markers | ||||||
| hs-CRP (mg/L)† | 0.8 [0.4, 2.5]† | 0.9 [0.4, 2.9]† | 0.9 [0.5, 2.7]† | 1.2 [0.4, 2.7]† | −30.3‡ | .023 |
| WBC (109 cells/L) | 6.6±1.9 | 6.3±1.9 | 6.8±2.3 | 6.3±1.7 | −5.2 (−9.8 to −0.5) | .029 |
| Monocytes (cells/μL) | 541±169 | 506.1±178.2 | 516±168 | 490.1±142.9 | −3.1 (−8.8 to 2.7) | .29 |
| Neutrophils (cells/μL) | 4215±1721 | 4019.1±1610.9 | 4169±1322 | 3879.5±1409.3 | −9.5 (−16.4 to −2.7) | .007 |
| Lymphocytes (cells/μL) | 1629±539 | 1520.8±538.0 | 1840±1806 | 1697.7±822.2 | 3.0 (−1.8 to 7.7) | .22 |
| Platelets (cells/μL) | 195±49 | 180.1±45.2 | 190±54 | 177.9±46.0 | 8.0 (−11.8 to 27.8) | .43 |
| Lipid profile§ | ||||||
| Total cholesterol (mg/dL) | 151.2±37.1 | 151.1±37.5 | 151.8±34.0 | 150.6±42.4 | −2.9 (−7.3 to 1.5) | .19 |
| Triglyceride (mg/dL) | 116 [79, 162]† | 145.8±115.5 | 121 [81, 179]† | 122.4±77.7 | −15.9 (−24.0 to −7.9) | <.001 |
| HDL-C (mg/dL) | 46.6±14.4 | 45.2±14.2 | 46.8±14.3 | 46.9±14.7 | 1.9 (−2.3 to 6.1) | .38 |
| LDL-C (mg/dL) | 78.2±28.3 | 78.2±29.0 | 77.7±26.9 | 79.5±33.5 | −2.1 (−9.9 to 5.7) | .60 |
| Biochemical profile | ||||||
| Glucose (mg/dL) | 108.6±7.3 | 109.8±36.7 | 104.6±27.2 | 111.4±40.2 | 5.8 (−0.8 to 12.4) | .09 |
| HbA1c (%) | 6.3±1.1 | 6.3±1.3 | 6.1±0.8 | 6.2±1.1 | 1.1 (−1.4 to 3.6) | .38 |
BP, blood pressure; HbA1c, hemoglobin A1c; HDL-C, high density lipoprotein cholesterol; hs-CRP, high-sensitivity C-reactive protein; LDL-C, low density lipoprotein cholesterol; WBC, white blood cell count.
P Value is for an unpaired t-test for the between group difference in % change for Lovaza minus Control except for hs-CRP which is calculated using a Mann-Whitney U due to % change in hs-CRP being abnormally distributed; therefore, the absolute difference in medians is shown and a 95% CI is not generated in this situation.
Values represented as median [Interquartile range].
Absolute difference in median % change between the two groups.
Multiply by 0.02586 to convert cholesterol values to mmol/L and by 0.01129 to convert triglyceride to mmol/L..