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Clinical Care/Education/Nutrition

Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes

The Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN)

  1. Robert H. Knopp, MD1,
  2. Michael d’Emden, MD2,
  3. Johan G. Smilde, MD, PHD3,
  4. Stuart J. Pocock, PHD4 and
  5. on behalf of the ASPEN Study Group*
  1. 1Department of Medicine and the Northwest Lipid Research Clinic, University of Washington School of Medicine, Seattle, Washington
  2. 2Department of Medicine, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
  3. 3Department of Internal Medicine, Refaja-Hospital, Stadskanaal, the Netherlands
  4. 4Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, U.K.
  1. Address correspondence and reprint requests to Chief Robert H. Knopp, Harborview Medical Center, 325 Ninth Ave., #359720, Seattle, WA 98104-2499. E-mail: rhknopp{at}u.washington.edu
Diabetes Care 2006 Jul; 29(7): 1478-1485. https://doi.org/10.2337/dc05-2415
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Figures

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    Figure 1—

    Study flow chart. *One patient was randomly assigned to receive placebo, but did not receive any study medication. †Some patients who experienced nonfatal clinical end points remained in the study to complete 4 years of follow-up.

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    Figure 2—

    Cumulative hazards of the primary composite end point (A) and fatal/nonfatal myocardial infarction (B) for the overall study population.

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    Figure 3—

    Cox proportional hazards for the primary composite end point and secondary composite and individual end points for all subjects and the primary and secondary prevention populations. CV, cardiovascular.

Tables

  • Figures
  • Table 1—

    Baseline and on-treatment characteristics of randomized subjects

    All subjects
    Primary prevention
    Secondary prevention
    AtorvastatinPlaceboAtorvastatinPlaceboAtorvastatinPlacebo
    n1,2111,199959946252253
    Age (years)61.1 ± 8.161.0 ± 8.260.5 ± 8.360.4 ± 8.363.1 ± 7.263.2 ± 7.4
        ≥65448 (37)422 (35)332 (35)305 (32)116 (46)117 (46)
    Men796 (66)803 (67)593 (62)594 (63)203 (81)209 (83)
    Race
        Caucasian1,018 (84)1,011 (84)805 (84)792 (84)213 (85)219 (87)
        Black81 (6.7)74 (6.2)73 (7.6)68 (7.2)8 (3.2)6 (2.4)
    BMI (kg/m2)28.9 ± 3.728.8 ± 3.828.9 ± 3.728.8 ± 3.728.9 ± 3.728.9 ± 3.8
    Current smokers147 (12)153 (13)119 (12)132 (14)28 (11)21 (8)
    Median duration of diabetes (years)8.08.08.08.08.010.0
    Blood pressure (mmHg)
        Systolic133.1 ± 16.8133.4 ± 16.4133.0 ± 17.0133.0 ± 16.7133.6 ± 16.0134.9 ± 15.3
        Diastolic76.9 ± 9.176.3 ± 9.077.1 ± 8.876.7 ± 8.876.0 ± 10.074.9 ± 9.6
    History of hypertension671 (55)657 (55)498 (52)499 (53)173 (69)158 (63)
    History of hyperlipidemia343 (28)369 (31)265 (28)275 (29)78 (31)94 (37)
    Glomerular filtration rate (ml/min per 1.73 m2)65.7 ± 11.565.8 ± 11.966.1 ± 11.466.7 ± 11.864.0 ± 11.662.6 ± 11.9
    CVD history
        Myocardial infarction208 (17)187 (16)00208 (83)187 (74)
        Interventional procedure145 (12)170 (14)00145 (58)170 (67)
        Angina200 (17)195 (16)55 (6)47 (5)145 (58)148 (58)
        Peripheral arterial disease101 (8)107 (9)64 (7)53 (6)37 (15)54 (21)
        Cerebrovascular disease61 (5)62 (5)38 (4)32 (3)23 (9)30 (12)
        Arrhythmia108 (9)119 (10)67 (7)77 (8)41 (16)42 (17)
    LDL cholesterol (mg/dl)
        Baseline113 ± 25114 ± 26114 ± 26114 ± 26112 ± 24113 ± 25
        End of treatment (% change)−30.29−1.09−30.48−0.48−29.65−3.31
        P value (% change)<0.0001<0.0001<0.0001
    Total cholesterol (mg/dl)
        Baseline194 ± 31194 ± 31195 ± 31195 ± 31188 ± 26191 ± 29
        End of treatment (% change)−19.70−1.41−19.78−1.38−19.47−1.45
        P value (% change)<0.0001<0.0001<0.0001
    HDL cholesterol (mg/dl)
        Baseline47 ± 1447 ± 1348 ± 1447 ± 1342 ± 1144 ± 12
        End of treatment (% change)2.17−0.181.93−0.332.980.52
        P value (% change)0.00050.0020.143
    Triglycerides (mg/dl)
        Baseline147 (101–208)145 (102–213)145 (99–205)144.5 (103–211)151.5 (104–219)147 (99–219)
        End of treatment (% change)−3.9010.01−4.727.24−0.7920.44
        P value (% change)<0.0001<0.00010.0005
    A1C (%)7.6 ± 1.27.5 ± 1.37.6 ± 1.27.6 ± 1.37.6 ± 1.37.4 ± 1.2
        Baseline7.8 ± 1.47.7 ± 1.47.8 ± 1.47.7 ± 1.47.9 ± 1.57.8 ± 1.4
        End of treatment
    • Data are means ± SD, n (%), mean, or median (interquartile range). End of treatment lipid changes are from a last-observation-carried-forward analysis. To convert from mg/dl to mmol/l for cholesterol, divide by 38.67; for triglycerides, divide by 88.57.

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Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes
Robert H. Knopp, Michael d’Emden, Johan G. Smilde, Stuart J. Pocock
Diabetes Care Jul 2006, 29 (7) 1478-1485; DOI: 10.2337/dc05-2415

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Efficacy and Safety of Atorvastatin in the Prevention of Cardiovascular End Points in Subjects With Type 2 Diabetes
Robert H. Knopp, Michael d’Emden, Johan G. Smilde, Stuart J. Pocock
Diabetes Care Jul 2006, 29 (7) 1478-1485; DOI: 10.2337/dc05-2415
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