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Emerging Treatments and Technologies

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

  1. Jarl S. Torgerson, MD, PHD1,
  2. Jonathan Hauptman, MD2,
  3. Mark N. Boldrin, MS2 and
  4. Lars Sjöström, MD, PHD1
  1. 1Department of Body Composition and Metabolism, Sahlgrenska University Hospital, Göteborg, Sweden
  2. 2Hoffmann-La Roche, Nutley, New Jersey
  1. Address correspondence and reprint requests to Professor Lars Sjöström, Department of Body Composition and Metabolism, Vita Stråket 15, Sahlgrenska University Hospital, S-413 45 Göteborg, Sweden. E-mail: lars.sjostrom{at}medfak.gu.se
Diabetes Care 2004 Jan; 27(1): 155-161. https://doi.org/10.2337/diacare.27.1.155
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Figures

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  • Figure 1—
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    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—
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    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

  • Figures
  • Table 1—

    Demographic and clinical characteristics of the study participants at baseline ITT population

    Placebo + lifestyleOrlistat + lifestyle
    n1,6371,640
    Sex (n [%])
     Female905 (55.3)905 (55.2)
     Male732 (44.7)735 (44.8)
    Age (years)43.7 ± 8.043.0 ± 8.0
    Weight (kg)110.6 ± 16.5110.4 ± 16.3
    BMI (kg/m2)37.4 ± 4.537.3 ± 4.2
    Waist circumference (cm)115.4 ± 10.4115.0 ± 10.4
    IGT patients (n [%])344 (21)350 (21.3)
    Whole blood glucose
     Fasting (mmol/l)4.6 ± 0.64.6 ± 0.6
     2 h (mmol/l)5.5 ± 1.65.5 ± 1.6
     AUC (mmol · min−1 · l−1)799 ± 179804 ± 175
    Serum insulin
     Fasting (pmol/l)83.6 ± 47.286.1 ± 50.1
     2 h (pmol/l)344.9 ± 298.5370.9 ± 336.7
     AUC (nmol · min−1 · l−1)47.7 ± 28.449.7 ± 31.3
    Diastolic BP (mmHg)82.3 ± 10.082.0 ± 10.0
    Systolic BP (mmHg)130.4 ± 15.4130.8 ± 15.8
    Total cholesterol (mmol/l)5.8 ± 1.05.8 ± 1.0
    LDL cholesterol (mmol/l)3.8 ± 0.93.7 ± 0.9
    HDL cholesterol (mmol/l)1.2 ± 0.31.2 ± 0.3
    LDL-to-HDL ratio3.3 ± 1.03.2 ± 1.1
    Triglycerides (mmol/l)1.9 ± 1.21.9 ± 1.0
    Fibrinogen (μmol/l)11.7 ± 2.011.7 ± 2.2
    Plasminogen activator inhibitor-1 (U/ml)22.9 ± 10.023.1 ± 10.0
    Energy intake (kcal/day)2,927 ± 1,1482,909 ± 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

    VariableHazard ratio95% CIP
    Treatment group: orlistat versus placebo0.63(0.46–0.87)0.0052
    Glucose tolerance: impaired versus normal10.60(7.30–15.40)<0.0001
    Sex: male versus female1.41(1.02–1.96)0.0390
    Age (years): >44* vs. ≤441.44(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 + 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<0.05‡2.92.4NS
    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.

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XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study
Jarl S. Torgerson, Jonathan Hauptman, Mark N. Boldrin, Lars Sjöström
Diabetes Care Jan 2004, 27 (1) 155-161; DOI: 10.2337/diacare.27.1.155

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XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study
Jarl S. Torgerson, Jonathan Hauptman, Mark N. Boldrin, Lars Sjöström
Diabetes Care Jan 2004, 27 (1) 155-161; DOI: 10.2337/diacare.27.1.155
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