Table 4.
Effect of bezafibrate and omega-3 fatty acids on the HOMA, plasma hsCRP and lymphocyte cytokine release in insulin-sensitive and insulin-resistant patients with isolated hypertriglyceridemiaa
| Assay results | Omega-3 fatty acid-treated patients | Bezafibrate-treated patients | |||
|---|---|---|---|---|---|
| Insulin-sensitive subjects (n = 15) | Insulin-resistant subjects (n = 19) | Insulin-sensitive subjects (n = 17) | Insulin-resistant subjects (n = 18) | ||
| HOMA | |||||
| Baseline | 1.4 ± 0.3 | 5.2 ± 0.6*** | 1.5 ± 0.2 | 5.9 ± 0.5*** | |
| Before randomization | 1.3 ± 0.2 | 5.1 ± 0.5*** | 1.6 ± 0.2 | 5.8 ± 0.4*** | |
| After 4 weeks of treatment | 1.3 ± 0.2 (−0.2) | 5.6 ± 0.6 (+9.8)*** | 1.4 ± 0.3 | 4.5 ± 0.3 (−22.4)***# | |
| After 12 weeks of treatment | 1.4 ± 0.2 (−7.7) | 5.2 ± 0.4 (+2.0)*** | 1.3 ± 0.2 | 2.5 ± 0.3 (−56.9)***###$$$^^^ | |
| hsCRP (mg/L) | |||||
| Baseline | 2.9 ± 0.3 | 3.6 ± 0.5 | 2.9 ± 0.3 | 3.7 ± 0.6 | |
| Before randomization | 2.8 ± 0.4 | 3.3 ± 0.4 | 2.6 ± 0.4 | 3.8 ± 0.5 | |
| After 4 weeks of treatment | 2.3 ± 0.3 (−17.8) | 2.8 ± 0.3 (−22.2) | 2.1 ± 0.2 (−19.2) | 2.3 ± 0.3 (−39.5)### | |
| After 12 weeks of treatment | 2.2 ± 0.3 (−21.4) | 2.8 ± 0.4 (−22.2) | 1.6 ± 0.2 (−38.4)## | 1.0 ± 0.3 (−73.6)*###$$$^^^ | |
| Interleukin-2 release (ng/mL) | |||||
| Baseline | 4.6 ± 0.5 | 6.9 ± 0.8*** | 4.5 ± 0.7 | 6.8 ± 0.4*** | |
| Before randomization | 4.3 ± 0.5 | 6.5 ± 0.7*** | 4.4 ± 0.5 | 7.0 ± 0.7*** | |
| After 4 weeks of treatment | 3.8 ± 0.5 (−11.6) | 5.3 ± 0.6 (−18.5)*** | 3.4 ± 0.5 (−22.7)# | 5.0 ± 0.7 (−28.6)***## | |
| After 12 weeks of treatment | 3.7 ± 0.4 (−14.0) | 5.2 ± 0.5 (−19.8)*** | 3.1 ± 0.6 (−29.5)## | 2.5 ± 0.4 (−64.3)###$$$^^^ | |
| Interferon-γ release (ng/mL) | |||||
| Baseline | 54.3 ± 7.8 | 73.8 ± 6.4*** | 53.1 ± 6.2 | 74.5 ± 7.4*** | |
| Before randomization | 53.2 ± 7.5 | 73.7 ± 8.3*** | 52.8 ± 7.3 | 74.3 ± 6.9*** | |
| After 4 weeks of treatment | 43.1 ± 5.8 (−19.0) | 61.2 ± 6.5 (−17.0)*** | 41.3 ± 5.7 (−21.8)# | 54.7 ± 5.0 (−26.4)**## | |
| After 12 weeks of treatment | 42.9 ± 6.5 (−19.4) | 59.9 ± 6.8 (−18.7)*** | 38.4 ± 8.0 (−27.3)# | 30.1 ± 5.3 (−59.5)###$$$^^^ | |
| TNF-α release (pg/mL) | |||||
| Baseline | 338.5 ± 34.4 | 445.1 ± 40.4** | 345.9 ± 30.2 | 458.6 ± 40.2*** | |
| Before randomization | 337.4 ± 32.1 | 440.8 ± 35.6** | 340.2 ± 31.1 | 455.6 ± 41.7*** | |
| After 4 weeks of treatment | 274.3 ± 25.1 (−18.7) | 356.2 ± 50.2 (−19.2)** | 274.5 ± 29.1 (−19.3) | 328.4 ± 35.5 (−27.3)## | |
| After 12 weeks of treatment | 273.9 ± 30.5 (−18.8) | 353.8 ± 40.7 (−19.7)** | 259.8 ± 25.3 (−23.6)# | 225.9 ± 41.2 (−50.4)###$$^^^ | |
*p < 0.05, **p < 0.01, ***p < 0.001 vs. insulin-sensitive patients in the same treatment group; # p < 0.05, ## p < 0.01, ### p < 0.001 vs. respective value before randomization; $$ p < 0.01, $$$ p < 0.001 indicate that the effect was stronger than after the 4-week treatment; p < 0.001 indicates the effect of bezafibrate at the end of the study was stronger than the effect of omega-3 fatty acids in the same subgroup of patients
Each value represents the mean±SD. Values in parenthesis represent the percentage change from the respective values on the day of randomization
aOnly data of patients who completed the study were included in the final analyses