Table 3. Adverse Events, Clinical Measures, Tobacco Use, and Use of Nonglycemic Medication after Randomization.*.
| Variable | Intensive Therapy (N = 5128) |
Standard Therapy (N = 5123) |
P Value† |
|---|---|---|---|
| Adverse events | |||
| Hypoglycemia — no. (%) | |||
|
| |||
| Requiring medical assistance | 538 (10.5) | 179 (3.5) | <0.001 |
|
| |||
| Requiring any assistance | 830 (16.2) | 261 (5.1) | <0.001 |
|
| |||
| Fatal or nonfatal heart failure — no. (%) | 152 (3.0) | 124(2.4) | 0.10 |
|
| |||
| Motor vehicle accident in which patient was driver — no./total no. (%) |
9/5033 (0.2) | 14/5036 (0.3) | 0.40 |
|
| |||
| Any nonhypoglycemic serious adverse event — no. (%) | 113 (2.2) | 82 (1.6) | 0.03 |
|
| |||
| Fluid retention — no./total no. (%)‡ | 3541/5053 (70.1) | 3378/5054 (66.8) | <0.001 |
|
| |||
| Clinical measures | |||
|
| |||
| Weight gain >10 kg since baseline — no./total no. (%) | 1399/5036 (27.8) | 713/5042 (14.1) | <0.001 |
|
| |||
| Alanine aminotransferase >3 times ULN — no./total no. (%)§ | 51/5065 (1.0) | 77/5061 (1.5) | 0.02 |
|
| |||
| Low-density lipoprotein cholesterol — mg/dl¶ | 90.8±33.5 | 90.6±34.0 | 0.74 |
|
| |||
| Blood pressure — mm Hg¶ | |||
|
| |||
| Systolic | 126.4±16.7 | 127.4±17.2 | 0.002 |
|
| |||
| Diastolic | 66.9±10.5 | 67.7±10.6 | <0.001 |
|
| |||
| Cigarette-smoking status — no. (%) ∥ | 0.54 | ||
|
| |||
| Current (previous 30 days) | 505 (9.8) | 508 (9.9) | |
|
| |||
| Former | 2524 (49.2) | 2467 (48.2) | |
|
| |||
| Never | 2093 (40.9) | 2143 (41.8) | |
|
| |||
| Missing data | 6 (0.1) | 5 (0.1) | |
|
| |||
| Use of nonglycemic medication — no./total no. (%) | |||
|
| |||
| Antihypertensive | 4664/5127 (91.0) | 4714/5123 (92.0) | 0.06 |
|
| |||
| Angiotensin-converting–enzyme inhibitor | 3512/5038 (69.7) | 3621/5037 (71.9) | 0.02 |
|
| |||
| Aspirin | 3736/4950 (75.5) | 3753/4970 (75.5) | 0.98 |
|
| |||
| Beta-blocker | 2395/5038 (47.5) | 2450/5037 (48.6) | 0.27 |
|
| |||
| Statin | 4432/5039 (88.0) | 4425/5054 (87.6) | 0.54 |
*
Plus–minus values are means ±SD. Data within categories are not mutually exclusive. Percentages may not total 100 because of rounding. ULN denotes upper limit of the normal range.
†
P values were calculated with the use of Fisher’s exact test or a two-sample t-test.
‡
Of the patients with fluid retention, 89% had pretibial edema or ankle swelling, 30% had shortness of breath, 12% had congestive heart failure or pulmonary edema, and 24% had nocturia.
§
The ULN for alanine aminotransferase was 65 U per liter for men and 50 U per liter for women.
¶
Data were obtained from last available measurement at the 12-month visit or later.
∥
Smoking status was reported at the last annual visit.