Table 1

Demographic characteristics (FAS)

CharacteristicsIntensive therapy (n = 2,518)Standard therapy (n = 2,524)
Male1,200 (47.7)1,203 (47.7)
Age (years)*63.0 ± 10.863.2 ± 10.4
Height (cm)158.9 ± 9.6159.0 ± 9.5
Weight (kg)65.2 ± 13.964.9 ± 13.7
BMI25.7 ± 4.325.6 ± 4.4
Abdominal circumference (cm)90.4 ± 10.690.4 ± 11.1
Lipid-lowering agents
 None1,105 (43.9)1,040 (41.2)
 1 drug1,406 (55.8)1,481 (58.7)
 ≥2 drugs7 (0.3)3 (0.1)
Statin
 No1,201 (47.7)1,155 (45.8)
 Yes1,317 (52.3)1,369 (54.2)
Smoking§462 (18.3)480 (19.0)
Family history
 Diabetes1,334 (53.0)1,308 (51.8)
 Coronary artery disease325 (12.9)318 (12.6)
 Cerebrovascular disease494 (19.6)530 (21.0)
Duration of diabetes (years)12.8 ± 8.613.0 ± 9.0
Diabetic complications
 Neuropathy777 (30.9)781 (30.9)
 Nephropathy1,358 (53.9)1,290 (51.1)
Hypertension1,777 (70.6)1,797 (71.2)
Peripheral artery disease (Fontaine class I)125 (5.0)110 (4.4)
Other complications and medical history1,971 (78.3)2,021 (80.1)
Compliance with statin use from provisional enrollment to full enrollment
 None13 (0.5)5 (0.2)
 <5011 (0.4)6 (0.2)
 50–7536 (1.4)28 (1.1)
 ≥752,448 (97.2)2,477 (98.1)
Funduscopy
 Simple retinopathy1,683 (66.8)1,669 (66.1)
 Preproliferative retinopathy423 (16.8)485 (19.2)
 Proliferative retinopathy390 (15.5)355 (14.1)
 Other16 (0.6)10 (0.4)
HbA1c (%)*7.8 ± 1.37.8 ± 1.3
LDL-C (mg/dL)#106.2 ± 26.7106.1 ± 25.9
Blood pressure (mmHg)
 Systolic134.6 ± 16.8134.6 ± 16.3
 Diastolic74.9 ± 11.574.8 ± 11.1
Estimated glomerular filtration rate (mL/min/1.73 m2)74.0 ± 20.674.6 ± 20.3
  • Data are mean ± SD or n (%).

  • *Values were obtained at the time of consent.

  • †BMI is the weight in kilograms divided by the square of the height in meters.

  • ‡Values were obtained at provisional enrollment.

  • §Not including past smokers.

  • ‖Diagnosed by ophthalmologists based on the modified Davis classification.

  • ¶Includes 17 patients who had a history of laser therapy but no funduscopic findings at enrollment. The remaining nine patients were found to be retinopathy negative after enrollment.

  • #Values were calculated using the Friedewald equation; LDL-C = total cholesterol − (HDL-C + triglyceride/5).