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)
Article Figures & Tables
Figures
- 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.
- Figure 2—
Cumulative hazards of the primary composite end point (A) and fatal/nonfatal myocardial infarction (B) for the overall study population.
- 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
- Table 1—
Baseline and on-treatment characteristics of randomized subjects
All subjects Primary prevention Secondary prevention Atorvastatin Placebo Atorvastatin Placebo Atorvastatin Placebo n 1,211 1,199 959 946 252 253 Age (years) 61.1 ± 8.1 61.0 ± 8.2 60.5 ± 8.3 60.4 ± 8.3 63.1 ± 7.2 63.2 ± 7.4 ≥65 448 (37) 422 (35) 332 (35) 305 (32) 116 (46) 117 (46) Men 796 (66) 803 (67) 593 (62) 594 (63) 203 (81) 209 (83) Race Caucasian 1,018 (84) 1,011 (84) 805 (84) 792 (84) 213 (85) 219 (87) Black 81 (6.7) 74 (6.2) 73 (7.6) 68 (7.2) 8 (3.2) 6 (2.4) BMI (kg/m2) 28.9 ± 3.7 28.8 ± 3.8 28.9 ± 3.7 28.8 ± 3.7 28.9 ± 3.7 28.9 ± 3.8 Current smokers 147 (12) 153 (13) 119 (12) 132 (14) 28 (11) 21 (8) Median duration of diabetes (years) 8.0 8.0 8.0 8.0 8.0 10.0 Blood pressure (mmHg) Systolic 133.1 ± 16.8 133.4 ± 16.4 133.0 ± 17.0 133.0 ± 16.7 133.6 ± 16.0 134.9 ± 15.3 Diastolic 76.9 ± 9.1 76.3 ± 9.0 77.1 ± 8.8 76.7 ± 8.8 76.0 ± 10.0 74.9 ± 9.6 History of hypertension 671 (55) 657 (55) 498 (52) 499 (53) 173 (69) 158 (63) History of hyperlipidemia 343 (28) 369 (31) 265 (28) 275 (29) 78 (31) 94 (37) Glomerular filtration rate (ml/min per 1.73 m2) 65.7 ± 11.5 65.8 ± 11.9 66.1 ± 11.4 66.7 ± 11.8 64.0 ± 11.6 62.6 ± 11.9 CVD history Myocardial infarction 208 (17) 187 (16) 0 0 208 (83) 187 (74) Interventional procedure 145 (12) 170 (14) 0 0 145 (58) 170 (67) Angina 200 (17) 195 (16) 55 (6) 47 (5) 145 (58) 148 (58) Peripheral arterial disease 101 (8) 107 (9) 64 (7) 53 (6) 37 (15) 54 (21) Cerebrovascular disease 61 (5) 62 (5) 38 (4) 32 (3) 23 (9) 30 (12) Arrhythmia 108 (9) 119 (10) 67 (7) 77 (8) 41 (16) 42 (17) LDL cholesterol (mg/dl) Baseline 113 ± 25 114 ± 26 114 ± 26 114 ± 26 112 ± 24 113 ± 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) Baseline 194 ± 31 194 ± 31 195 ± 31 195 ± 31 188 ± 26 191 ± 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) Baseline 47 ± 14 47 ± 13 48 ± 14 47 ± 13 42 ± 11 44 ± 12 End of treatment (% change) 2.17 −0.18 1.93 −0.33 2.98 0.52 P value (% change) 0.0005 0.002 0.143 Triglycerides (mg/dl) Baseline 147 (101–208) 145 (102–213) 145 (99–205) 144.5 (103–211) 151.5 (104–219) 147 (99–219) End of treatment (% change) −3.90 10.01 −4.72 7.24 −0.79 20.44 P value (% change) <0.0001 <0.0001 0.0005 A1C (%) 7.6 ± 1.2 7.5 ± 1.3 7.6 ± 1.2 7.6 ± 1.3 7.6 ± 1.3 7.4 ± 1.2 Baseline 7.8 ± 1.4 7.7 ± 1.4 7.8 ± 1.4 7.7 ± 1.4 7.9 ± 1.5 7.8 ± 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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