Table 2.
Clinical efficacy of rimonabant
| Placebo | 20 mg rimonabant | P value vs. placebo | |
|---|---|---|---|
| A1C | |||
| All patients | |||
| n | 131 | 130 | |
| Mean baseline (%)* | 7.9 ± 0.7 | 7.9 ± 0.8 | |
| Mean change vs. baseline (%)* | –0.3 ± 1.2 | –0.8 ± 1.2 | |
| LS mean change vs. placebo (%)† | — | –0.51 ± 0.14 | 0.0002 |
| A1C <6.5% at 6 months | 16.0 (21) | 23.8 (31) | 0.0930 |
| A1C <7.0% at 6 months | 35.1 (46) | 50.8 (66) | 0.0122 |
| Patients with A1C ≥8.5% | |||
| n | 31 | 34 | |
| Mean baseline (%)* | 8.9 ± 0.3 | 8.9 ± 0.5 | |
| Mean change vs. baseline (%)* | –0.7 ± 1.7 | –1.9 ± 1.1 | |
| LS mean change vs. placebo (%)† | — | –1.25 ± 0.36 | 0.0009 |
| Fasting plasma glucose (mmol/l) | |||
| n | 126 | 123 | |
| Mean baseline* | 8.6 ± 1.7 | 9.1 ± 2.0 | |
| Mean change vs. baseline* | 0.1 ± 2.1 | –0.9 ± 2.3 | |
| LS mean change vs. placebo† | — | –0.83 ± 0.25 | 0.0012 |
| Body weight (kg) | |||
| n | 138 | 135 | |
| Mean baseline* | 96.0 ± 20.9 | 96.6 ± 21.1 | |
| Mean change vs. baseline* | –2.8 ± 4.8 | –6.7 ± 5.5 | |
| LS mean change vs. placebo† | — | –3.84 ± 0.61 | <0.0001 |
| Waist circumference (cm) | |||
| n | 131 | 129 | |
| Mean baseline* | 108 ± 15 | 109 ± 14 | |
| Mean change vs. baseline* | –2 ± 5 | –6 ± 6 | |
| LS mean change vs. placebo† | — | –3.7 ± 0.7 | <0.0001 |
| Adiponectin (μg/ml) | |||
| n | 128 | 127 | |
| Mean baseline* | 6.0 ± 3.9 | 5.5 ± 3.3 | |
| Mean change vs. baseline* | –0.2 ± 2.9 | 1.6 ± 4.0 | |
| LS mean change vs. placebo† | — | 1.60 ± 0.41 | 0.0001 |
| HOMA-IR | |||
| n | 126 | 119 | |
| Mean baseline* | 7.1 ± 5.8 | 7.8 ± 8.9 | |
| Mean change vs. baseline* | 0.3 ± 7.6 | –1.9 ± 7.7 | |
| LS mean change vs. placebo† | — | –1.9 ± 0.7 | 0.0098 |
| Proinsulin/insulin | |||
| n | 128 | 126 | |
| Mean baseline* | 0.59 ± 0.36 | 0.63 ± 0.49 | |
| Mean change vs. baseline* | –0.04 ± 0.39 | –0.17 ± 0.43 | |
| LS mean change vs. placebo† | — | –0.10 ± 0.04 | 0.0135 |
| HDL cholesterol (mmol/l) | |||
| n | 131 | 130 | |
| Mean baseline* | 1.29 ± 0.28 | 1.31 ± 0.33 | |
| Mean % change vs. baseline* | 3.15 ± 12.16 | 10.05 ± 17.04 | |
| LS mean % change vs. placebo† | — | 7.30 ± 1.75 | <0.0001 |
| Triglycerides (mmol/l) | |||
| n | 131 | 129 | |
| Mean baseline* | 2.09 ± 1.02 | 2.35 ± 1.64 | |
| Mean % change vs. baseline* | 4.35 ± 58.12 | –16.33 ± 32.76 | |
| LS mean % change vs. placebo† | — | –17.28 ± 5.78 | 0.0031 |
| LDL cholesterol (mmol/l) | |||
| n | 131 | 130 | |
| Mean baseline* | 3.31 ± 0.85 | 3.41 ± 0.93 | |
| Mean % change vs. baseline* | 1.35 ± 28.14 | –1.80 ± 26.04 | |
| LS mean % change vs. placebo† | — | –1.475 ± 3.147 | 0.6396 |
| LDL particle size (Å) | |||
| n | 129 | 126 | |
| Mean baseline* | 268.6 ± 4.7 | 268.3 ± 5.6 | |
| Mean % change vs. baseline* | –0.0 ± 1.6 | 0.6 ± 1.7 | |
| LS Mean % change vs. placebo† | — | 0.61 ± 0.18 | 0.0008 |
| Non-HDL cholesterol (mmol/l) | |||
| n | 131 | 130 | |
| Mean baseline* | 3.78 ± 0.95 | 3.99 ± 1.14 | |
| Mean % change vs. baseline* | 2.72 ± 26.42 | –4.64 ± 19.55 | |
| LS mean % change vs. placebo† | — | –5.535 ± 2.763 | 0.0462 |
| Total cholesterol (mmol/l) | |||
| n | 131 | 130 | |
| Mean baseline* | 5.07 ± 0.96 | 5.31 ± 1.14 | |
| Mean % change vs. baseline* | 2.01 ± 17.25 | –1.43 ± 15.09 | |
| LS mean % change vs. placebo† | — | –1.961 ± 1.903 | 0.3037 |
Data are means ±
*
SD or
†
SE or percent (n). Mean changes versus placebo are least-squares (LS) mean changes from the ANCOVA analysis (see research design and methods). Data are from the ITT population (last observation carried forward) excluding postrescue medication data.