Table 2—

Clinical efficacy of rimonabant

Placebo20 mg rimonabantP value vs. placebo
A1C
    All patients
        n131130
        Mean baseline (%)*7.9 ± 0.77.9 ± 0.8
        Mean change vs. baseline (%)*–0.3 ± 1.2–0.8 ± 1.2
        LS mean change vs. placebo (%)–0.51 ± 0.140.0002
        A1C <6.5% at 6 months16.0 (21)23.8 (31)0.0930
        A1C <7.0% at 6 months35.1 (46)50.8 (66)0.0122
    Patients with A1C ≥8.5%
        n3134
        Mean baseline (%)*8.9 ± 0.38.9 ± 0.5
        Mean change vs. baseline (%)*–0.7 ± 1.7–1.9 ± 1.1
        LS mean change vs. placebo (%)–1.25 ± 0.360.0009
Fasting plasma glucose (mmol/l)
    n126123
    Mean baseline*8.6 ± 1.79.1 ± 2.0
    Mean change vs. baseline*0.1 ± 2.1–0.9 ± 2.3
    LS mean change vs. placebo–0.83 ± 0.250.0012
Body weight (kg)
    n138135
    Mean baseline*96.0 ± 20.996.6 ± 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)
    n131129
    Mean baseline*108 ± 15109 ± 14
    Mean change vs. baseline*–2 ± 5–6 ± 6
    LS mean change vs. placebo–3.7 ± 0.7<0.0001
Adiponectin (μg/ml)
    n128127
    Mean baseline*6.0 ± 3.95.5 ± 3.3
    Mean change vs. baseline*–0.2 ± 2.91.6 ± 4.0
    LS mean change vs. placebo1.60 ± 0.410.0001
HOMA-IR
    n126119
    Mean baseline*7.1 ± 5.87.8 ± 8.9
    Mean change vs. baseline*0.3 ± 7.6–1.9 ± 7.7
    LS mean change vs. placebo–1.9 ± 0.70.0098
Proinsulin/insulin
    n128126
    Mean baseline*0.59 ± 0.360.63 ± 0.49
    Mean change vs. baseline*–0.04 ± 0.39–0.17 ± 0.43
    LS mean change vs. placebo–0.10 ± 0.040.0135
HDL cholesterol (mmol/l)
    n131130
    Mean baseline*1.29 ± 0.281.31 ± 0.33
    Mean % change vs. baseline*3.15 ± 12.1610.05 ± 17.04
    LS mean % change vs. placebo7.30 ± 1.75<0.0001
Triglycerides (mmol/l)
    n131129
    Mean baseline*2.09 ± 1.022.35 ± 1.64
    Mean % change vs. baseline*4.35 ± 58.12–16.33 ± 32.76
    LS mean % change vs. placebo–17.28 ± 5.780.0031
LDL cholesterol (mmol/l)
    n131130
    Mean baseline*3.31 ± 0.853.41 ± 0.93
    Mean % change vs. baseline*1.35 ± 28.14–1.80 ± 26.04
    LS mean % change vs. placebo–1.475 ± 3.1470.6396
LDL particle size (Å)
    n129126
    Mean baseline*268.6 ± 4.7268.3 ± 5.6
    Mean % change vs. baseline*–0.0 ± 1.60.6 ± 1.7
    LS Mean % change vs. placebo0.61 ± 0.180.0008
Non-HDL cholesterol (mmol/l)
    n131130
    Mean baseline*3.78 ± 0.953.99 ± 1.14
    Mean % change vs. baseline*2.72 ± 26.42–4.64 ± 19.55
    LS mean % change vs. placebo–5.535 ± 2.7630.0462
Total cholesterol (mmol/l)
    n131130
    Mean baseline*5.07 ± 0.965.31 ± 1.14
    Mean % change vs. baseline*2.01 ± 17.25–1.43 ± 15.09
    LS mean % change vs. placebo–1.961 ± 1.9030.3037
  • 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.