Table 3.
Baseline and 3 month results in the four groups of patients.
| Parameters | Placebo | Avanafil | Blunorm forte + Avanafil | Blunorm forte | ||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 3 months | Baseline | 3 months | Baseline | 3 months | Baseline | 3 months | |
| N of pts (123) | 30 | 30 | 31 | 30 | 32 | 30 | 30 | 29 |
| Age (years) | 61.3 ± 7.4 | – | 60.1 ± 7.0 | – | 59.1 ± 6.4 | – | 60.8 ± 7.2 | – |
| Smoking status | 8 | 8 | 11 | 10 | 14 | 13 | 10 | 10 |
| Diabetes duration (years) | 8.2 ± 4.1 | – | 8.1 ± 4.0 | – | 8.4 ± 4.3 | – | 8.2. ± 4.1 | – |
| Hypercholesterolemia duration (years) | 7.7 ± 3.8 | – | 7.4 ± 3.5 | – | 7.3 ± 3.4 | – | 7.4 ± 3.5 | – |
| Hypertension duration (years) | 8.1 ± 6.1 | – | 8.3 ± 6.3 | – | 8.4 ± 6.4 | – | 8.3 ± 6.1 | – |
| Weight (Kg) | 79.2 ± 7.5 | 79.5 ± 7.7 | 79.6 ± 7.8 | 79.2 ± 7.5 | 78.9 ± 7.3 | 78.5 ± 7.3 | 78.8 ± 7.4 | 78.2 ± 7.0 |
| Height (m) | 1.68 ± 0.09 | – | 1.67 ± 0.08 | – | 1.68 ± 0.09 | – | 1.66 ± 0.07 | – |
| BMI (Kg/m2) | 28.1 ± 2.0 | 28.2 ± 2.1 | 28.6 ± 2.4 | 28.5 ± 2.3 | 28.0 ± 2.0 | 27.8 ± 1.9 | 28.6 ± 2.4 | 28.4 ± 2.3 |
| WC (cm) | 89.5 ± 2.6 | 89.3 ± 2.4 | 89.2 ± 2.7 | 89.1 ± 2.6 | 88.8 ± 2.1 | 88.6 ± 1.9 | 88.5 ± 1.8 | 88.3 ± 1.7 |
| HC (cm) | 101.5 ± 4.5 | 101.8 ± 4.6 | 101.6 ± 4.6 | 101.2 ± 4.3 | 100.8 ± 4.2 | 100.6 ± 4.0 | 100.5 ± 4.0 | 100.3 ± 4.1 |
| AC (cm) | 93.7 ± 3.5 | 93.4 ± 3.3 | 93.9 ± 3.3 | 93.5 ± 3.4 | 93.1 ± 2.8 | 93.0 ± 2.7 | 93.3 ± 3.3 | 93.2 ± 3.1 |
| SBP (mmHg) | 139.8 ± 5.4 | 139.3 ± 5.7 | 139.2 ± 5.6 | 139.3 ± 5.5 | 139.7 ± 5.2 | 139.5 ± 5.1 | 139.4 ± 5.0 | 139.1 ± 4.9 |
| DBP (mmHg) | 83.1 ± 3.9 | 82.8 ± 3.6 | 83.3 ± 4.0 | 83.9 ± 3.7 | 84.0 ± 3.8 | 82.1 ± 3.0 | 82.9 ± 3.7 | 82.6 ± 3.4 |
| HR (bpm) | 75.5 ± 6.3 | 75.2 ± 6.2 | 76.2 ± 6.9 | 76.4 ± 7.0 | 75.7 ± 6.5 | 74.7 ± 59 | 76.1 ± 6.8 | 75.5 ± 6.3 |
| HbA1c (%) | 7.5 ± 1.1 | 7.3 ± 0.9 | 7.4 ± 1.0 | 7.4 ± 1.0 | 7.5 ± 1.1 | 7.3 ± 0.9 | 7.2 ± 0.8 | 7.3 ± 0.9 |
| FPG (mg/dl) | 139.8 ± 18.7 | 141.1 ± 19.4 | 140.4 ± 18.9 | 139.2 ± 18.5 | 138.7 ± 18.1 | 130.5 ± 15.5*^ | 139.9 ± 18.9 | 131.9 ± 16.9*^ |
| FPI (µU/ml) | 15.4 ± 3.9 | 15.2 ± 3.7 | 15.5 ± 4.0 | 15.3 ± 3.8 | 15.3 ± 3.8 | 15.5 ± 4.0 | 15.2 ± 3.7 | 15.3 ± 3.8 |
| HOMA-IR | 5.3 ± 1.2 | 5.3 ± 1.2 | 5.4 ± 1.3 | 5.3 ± 1.2 | 5.3 ± 1.2 | 5.0 ± 1.0*^ | 5.3 ± 1.2 | 5.0 ± 1.0*^ |
| TC (mg/dl) | 188.1 ± 35.2 | 175.4 ± 33.1 | 186.4 ± 34.8 | 173.1 ± 32.8 | 187.6 ± 34.9 | 175.8 ± 33.7 | 187.3 ± 34.6 | 176.3 ± 33.9 |
| LDL-C (mg/dl) | 119.2 ± 20.9 | 108.4 ± 15.5 | 117.4 ± 19.6 | 106.0 ± 14.3 | 118.4 ± 19.3 | 106.0 ± 14.7 | 119.6 ± 21.3 | 109.0 ± 15.8 |
| HDL-C (mg/dl) | 41.3 ± 6.1 | 41.4 ± 6.2 | 40.9 ± 5.7 | 40.6 ± 5.5 | 41.7 ± 6.4 | 41.3 ± 6.1 | 40.6 ± 5.4 | 40.7 ± 5.6 |
| Tg (mg/dl) | 139.5 ± 23.4 | 128.4 ± 21.7 | 143.7 ± 22.7 | 135.3 ± 22.1 | 138.9 ± 23.1 | 140.1 ± 23.6 | 137.5 ± 22.4 | 135.4 ± 22.2 |
| MMP-2 (ng/ml) | 1267.2 ± 131.5 | 1262.5 ± 127.7 | 1262.7 ± 127.3 | 1257.5 ± 124.8 | 1261.6 ± 125.9 | 1176.8 ± 111.6*^ | 1264.7 ± 128.9 | 1239.1 ± 117.6 |
| MMP-9 (ng/ml) | 492.3 ± 56.5 | 489.7 ± 54.2 | 489.5 ± 54.0 | 484.9 ± 52.1 | 490.7 ± 55.9 | 462.9 ± 40.1*^ | 488.3 ± 53.2 | 483.8 ± 51.7 |
| Testosterone (ng/ml) | 7.2 ± 3.8 | 7.0 ± 3.6 | 7.4 ± 4.0 | 7.2 ± 3.6 | 7.1 ± 3.5 | 7.3 ± 3.7 | 7.1 ± 3.5 | 7.4 ± 3.9 |
| Free Testosterone (pg/ml) | 11.6 ± 4.5 | 11.1 ± 4.2 | 12.3 ± 4.9 | 12.5 ± 5.1 | 11.4 ± 5.3 | 12.7 ± 5.9 | 12.1 ± 5.0 | 12.7 ± 5.5 |
| Dihydrotestosterone (pg/ml) | 1.43 ± 0.53 | 1.40 ± 0.50 | 1.48 ± 0.61 | 1.47 ± 0.59 | 1.46 ± 0.57 | 1.48 ± 0.60 | 1.45 ± 0.58 | 1.45 ± 0.58 |
| SHBG (nmol/l) | 32.8 ± 14.3 | 30.5 ± 12.9 | 33.1 ± 15.7 | 32.5 ± 14.1 | 31.7 ± 12.8 | 31.2 ± 12.1 | 33.2 ± 16.1 | 33.6 ± 16.7 |
| Hs-CRP (mg/l) | 1.3 ± 0.4 | 1.2 ± 0.3 | 1.2 ± 0.5 | 1.1 ± 0.4 | 1.2 ± 0.5 | 0.8 ± 0.3*^ | 1.3 ± 0.6 | 0.9 ± 0.3*^ |
| Nitrites/nitrates µmol/l) | 22.8 ± 6.8 | 24.2 ± 7.3 | 22.2 ± 6.4 | 31.3 ± 10.4* | 21.9 ± 6.1 | 38.4 ± 14.7°^ | 21.6 ± 6.0 | 33.5 ± 10.7*^ |
Data are expressed as mean ± standard deviations.
*p < 0.05 vs Baseline; °p < 0.01 vs Baseline; ^p < 0.05 vs Placebo.
BMI, body mass index; WC, waist circumference; HC, hip circumference; AC, abdominal circumference; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; HbA1c, glycated hemoglobin; FPG, fasting plasma glucose; FPI, fasting plasma insulin; HOMA-IR, homeostasis model assessment-insulin resistance; TC, total cholesterol; LDL-C, low density lipoprotein-cholesterol; HDL-C, high density lipoprotein-cholesterol; Tg, triglycerides; MMP-2, metalloproteinases-2; MMP-9, metalloproteinases-9; SHBG, sex hormone binding globulin; Hs-CRP, high sensitivity-C-reactive protein.