Table 2.
Efficacy results in the m-ITT population
| Parameters | BL (n=44) | AM (n=42) | Placebo (n =44) | BL vs placebo | AM vs placebo | BL vs AM | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
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| Baseline | End of study | Δ from baseline | Baseline | End of study | Δ from baseline | Baseline | End of study | Δ from baseline | P-value difference | (CI 95%) | ||
| LDL-C (mg/dL) | 146.4±18.1 | 107.3±17.2 | −39.1±17.8 | 147.5±16.3 | 120.4±18.8 | −27.0±14.6 | 143.6±15.0 | 149.3±19.5 | 5.7±15.0 | <0.001 −43.8 (−50.1; −37.5) |
<0.001 −31.1 (−37.7; −24.9) |
0.000 −12.5 (−18.9; −6.1) |
| TC (mg/dL) | 237.0±21.3 | 191.2±20.2 | −45.9±21.5 | 234.6±18.0 | 204.9±22.2 | −29.7±18.0 | 235.6±17.9 | 238.0±21.5 | 2.4±18.4 | <0.001 −47.7 (−55.2; −40.1) |
<0.001 −32.3 (−39.9; −24.6) |
0.000 −15.4 (−23.1; −7.7) |
| HDL-C (mg/dL) | 66.8±17.2 | 62.2±17.0 | −4.6±8.6 | 65.1±13.3 | 63.4±13.6 | −1.7±6.3 | 70.0±16.2 | 68.1±14.9 | −1.9±7.9 | 0.044 −3.2 (−6.3; −0.1) |
0.831 −0.3 (−3.5; 2.8) |
0.075 −2.8 (−6.0; 0.3) |
| Tg (mg/dL) | 118.9±51.6 | 108.5±46.5 | −10.4±38.2 | 110.8±41.5 | 105.7±37.0 | −5.1±29.7 | 110.5±41.9 | 103.5±40.3 | −7.0±33.5 | 0.953 −0.4 (−13.2; 12.4) |
0.789 1.8 (−11.2; 14.7) |
0.744 −2.1 (−15.1; 10.8) |
Notes: Data are expressed as mean ± SD. A statistically (P<0.05) but not clinically significant reduction in HDL cholesterol was found in the test product BL group, but not in the Armolipid Plus® group compared to placebo.
Abbreviations: BL, Body Lipid; AM, Armolipid Plus®; TC, total cholesterol; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; Tg, triglycerides; SD, standard deviation; CI, confidence interval; m-ITT, modified intent-to-treat.