XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study
A randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients
Article Figures & Tables
Figures
- Figure 1—
Cumulative incidence of diabetes by study group in all obese patients (IGT or NGT at baseline) and only in obese patients with IGT at baseline. The decrease in the risk of developing diabetes with orlistat plus lifestyle compared with placebo plus lifestyle is indicated. P values shown are for the log-rank test.
- Figure 2—
Weight loss (means ± SEM) during 4 years of treatment with orlistat plus lifestyle changes or placebo plus lifestyle changes in obese patients (LOCF data).
Tables
- Table 1—
Demographic and clinical characteristics of the study participants at baseline ITT population
Placebo + lifestyle Orlistat + lifestyle n 1,637 1,640 Sex (n [%]) Female 905 (55.3) 905 (55.2) Male 732 (44.7) 735 (44.8) Age (years) 43.7 ± 8.0 43.0 ± 8.0 Weight (kg) 110.6 ± 16.5 110.4 ± 16.3 BMI (kg/m2) 37.4 ± 4.5 37.3 ± 4.2 Waist circumference (cm) 115.4 ± 10.4 115.0 ± 10.4 IGT patients (n [%]) 344 (21) 350 (21.3) Whole blood glucose Fasting (mmol/l) 4.6 ± 0.6 4.6 ± 0.6 2 h (mmol/l) 5.5 ± 1.6 5.5 ± 1.6 AUC (mmol · min−1 · l−1) 799 ± 179 804 ± 175 Serum insulin Fasting (pmol/l) 83.6 ± 47.2 86.1 ± 50.1 2 h (pmol/l) 344.9 ± 298.5 370.9 ± 336.7 AUC (nmol · min−1 · l−1) 47.7 ± 28.4 49.7 ± 31.3 Diastolic BP (mmHg) 82.3 ± 10.0 82.0 ± 10.0 Systolic BP (mmHg) 130.4 ± 15.4 130.8 ± 15.8 Total cholesterol (mmol/l) 5.8 ± 1.0 5.8 ± 1.0 LDL cholesterol (mmol/l) 3.8 ± 0.9 3.7 ± 0.9 HDL cholesterol (mmol/l) 1.2 ± 0.3 1.2 ± 0.3 LDL-to-HDL ratio 3.3 ± 1.0 3.2 ± 1.1 Triglycerides (mmol/l) 1.9 ± 1.2 1.9 ± 1.0 Fibrinogen (μmol/l) 11.7 ± 2.0 11.7 ± 2.2 Plasminogen activator inhibitor-1 (U/ml) 22.9 ± 10.0 23.1 ± 10.0 Energy intake (kcal/day) 2,927 ± 1,148 2,909 ± 1,030 Data are means ± SD, unless otherwise noted. AUC, area under the curve, BP, blood pressure.
- Table 2—
The effect of baseline strata on the relative risk of developing type 2 diabetes over 4 years in patients, irrespective of treatment
Variable Hazard ratio 95% CI P Treatment group: orlistat versus placebo 0.63 (0.46–0.87) 0.0052 Glucose tolerance: impaired versus normal 10.60 (7.30–15.40) <0.0001 Sex: male versus female 1.41 (1.02–1.96) 0.0390 Age (years): >44* vs. ≤44 1.44 (1.02–2.04) 0.0383 BMI (kg/m2): ≥37 vs. <37* 1.36 (0.97–1.91) 0.0726 - *
↵* Median.
- *
- 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 + lifestyle Orlistat + lifestyle P between treatments* Placebo + lifestyle Orlistat + lifestyle P 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 3 −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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