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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*
n 1,295 1,487  567 851  
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 (%) 8.5 3.4 <0.01 9.1 6.5 <0.01 
LDL-to-HDL ratio −0.3 −0.5 <0.01 −0.4 −0.6 <0.01 
Triglycerides (%) −6.3 −6.2 <0.05 2.9 2.4 NS 
Waist circumference (cm) −7.0 −9.6 <0.01 −4.4 −6.4 <0.01 
Venous whole blood glucose (mmol/l)       
 Fasting 0.2 0.1 <0.01§ 0.2 0.1 <0.01 
 2 h −0.4 −0.6 <0.01 −0.2 −0.4 <0.01 
 AUC (mmol · min−1 · l−1)# −27 −51 <0.01 −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) 0.1 0.2 NS −0.5 −0.4 <0.05 
Plasminogen activator inhibitor-1 (U/ml) −3.0 −7.1 <0.01 0.1 −3.0 <0.01 
Year 1
Year 4
Placebo + lifestyleOrlistat + lifestyleP between treatments*Placebo + lifestyleOrlistat + lifestyleP between treatments*
n 1,295 1,487  567 851  
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 (%) 8.5 3.4 <0.01 9.1 6.5 <0.01 
LDL-to-HDL ratio −0.3 −0.5 <0.01 −0.4 −0.6 <0.01 
Triglycerides (%) −6.3 −6.2 <0.05 2.9 2.4 NS 
Waist circumference (cm) −7.0 −9.6 <0.01 −4.4 −6.4 <0.01 
Venous whole blood glucose (mmol/l)       
 Fasting 0.2 0.1 <0.01§ 0.2 0.1 <0.01 
 2 h −0.4 −0.6 <0.01 −0.2 −0.4 <0.01 
 AUC (mmol · min−1 · l−1)# −27 −51 <0.01 −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) 0.1 0.2 NS −0.5 −0.4 <0.05 
Plasminogen activator inhibitor-1 (U/ml) −3.0 −7.1 <0.01 0.1 −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.

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