Treatment with α-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading
Table 1
Demographic and clinical data of the patients randomized at week 4 to treatment with -lipoic acid (600 mg qd) or withdrawal of -lipoic acid for 16 weeks (Phase 2).
-Lipoic acid treatment
-Lipoic acid withdrawal
value
16
17
—
Sex (% male)
31.3 (13.2–54.8)
35.3 (16.6–58.0)
0.549
Age (years)
57.5 ± 10
59.0 ± 11
0.620
BMI (kg/m²)
27.1 ± 3.6
26.9 ± 4.4
0.898
Systolic blood pressure (mm Hg)
121 ± 10
121 ± 9
0.902
Diastolic blood pressure (mm Hg)
72 ± 9
76 ± 9
0.265
Heart rate (bpm)
76 ± 7
77 ± 7
0.540
Diabetes duration (years)
10.4 ± 7.8
13 ± 5.0
0.259
HbA1c (%)
9.3 ± 3.0
8.1 ± 1.4
0.150
Serum creatinine (mg/dL)
0.82 ± 0.19
0.86 ± 0.23
0.620
OADs (%)
56.3 (33.3–77.3)
41.2 (21.2–63.6)
0.303
OADs and insulin (%)
43.8 (22.7–66.7)
58.8 (36.4–78.8)
0.303
Retinopathy with prior photocoagulation (%)
6.3 (0.3–26.4)
5.9 (0.3–25.0)
0.742
Nephropathy (%)
12.5 (2.3–34.4)
11.8 (2.1–32.6)
0.676
Hypertension (%)
37.5 (17.8–60.9)
52.9 (31.1–74.0)
0.295
Hyperlipidemia (%)
25.0 (9.0–48.4)
29.4 (12.4–52.2)
0.543
Reduced sensation to monofilament (%)
62.5 (39.1–82.2)
58.8 (36.4–78.8)
0.812
Abnormal VPT on right hallux (%)
18.8 (5.3–41.7)
52.9 (31.1–74.0)
0.046
Abnormal VPT on left hallux (%)
31.3 (13.2–54.8)
47.1 (26.0–68.9)
0.284
Decreased/absent ankle reflex right (%)
43.8 (22.7–66.7)
52.9 (31.1–74.0)
0.429
Decreased/absent ankle reflex left (%)
62.5 (39.1–82.2)
58.8 (36.4–78.8)
0.556
Values are mean ± SD or percentages with 95% CI. OADs: oral antidiabetic drugs; VPT: vibration perception threshold.
