Table 3—

Mean change from baseline of cardiovascular risk factors at years 1 and 4 in all patients (observed data)

Year 1
Year 4
Placebo + lifestyleOrlistat + lifestyleP between treatments*Placebo + lifestyleOrlistat + lifestyleP between treatments*
n1,2951,487567851
Diastolic BP (mmHg)−2.6−3.6<0.01−1.9−2.6<0.01
Systolic BP (mmHg)−5.2−7.3<0.01−3.4−4.9<0.01
Total cholesterol (%)−1.3−8.8<0.01−2.3−7.9<0.01
LDL cholesterol (%)−1.6−11.4<0.01−5.1−12.8<0.01
HDL cholesterol (%)8.53.4<0.019.16.5<0.01
LDL-to-HDL ratio−0.3−0.5<0.01−0.4−0.6<0.01
Triglycerides (%)−6.3−6.2<0.052.92.4NS
Waist circumference (cm)−7.0−9.6<0.01−4.4−6.4<0.01
Venous whole blood glucose (mmol/l)
 Fasting0.20.1<0.01§0.20.1<0.01
 2 h−0.4−0.6<0.01−0.2−0.4<0.01
 AUC (mmol · min−1 · l−1)#−27−51<0.013−14<0.01
Serum insulin (pmol/l)
 Fasting−17.0−26.5<0.01−20.6−32.0<0.01
 2 h−107.5−157.4<0.01−76.7−115.4<0.01
 AUC (nmol · min−1 · l−1)#−11.0−14.6<0.01−8.4−10.9<0.01
Fibrinogen (μmol/l)0.10.2NS−0.5−0.4<0.05
Plasminogen activator inhibitor-1 (U/ml)−3.0−7.1<0.010.1−3.0<0.01
  • *

    * P values apply to analyses by LOCF ITT, BLCF ITT, and observed data, except where indicated;

  • LOCF and BLCF = NS;

  • LOCF and observed = NS;

  • §

    § BLCF P < 0.05;

  • BLCF = NS;

  • observed = NS;

  • #

    # calculated by trapezoid rule, including all areas above the line y = 0, from measurements immediately before and 30, 60, 90, and 120 min after dose. AUC, area under the curve; BP, blood pressure.