Table 1 Demographic characteristics of the included studies
Author | Study design | Target Population | Treatment duration | n | Study groups | Age, years | Female, n (%) | BMI, kg/m2 | Total cholesterol, mg/dL | LDL-C, mg/dL | HDL-C, mg/dL | Triglycerides, mg/dL | Lp(a), mg/dL | Lp(a) change, mg/dL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Athyros et al. (2002) [52] | Randomized, open-label trial | Type 2 diabetes and combined hyperlipidemia | 24 weeks | 40 40 40 | Atorvastatin 20 mg/day Fenofibrate 200 mg/day Atorvastatin 20 mg/day + fenofibrate 200 mg/day | 57 (44–67)a 58 (48–69)a 58 (50–68)a | 17 (42.5) 18 (45.0) 17 (42.5) | ND ND ND | 252 ± 17 253 ± 17 255 ± 19 | 161 ± 15 163 ± 15 163 ± 16 | 34.6 ± 3.2 34.8 ± 3.4 35.1 ± 3.5 | 278 ± 24 281 ± 24 278 ± 23 | 18.4 ± 3.7 20.1 ± 5.2 19.2 ± 4.1 | 2.0 –4.0 1.0 |
Bredie et al. (1996) [55] | Randomized, double-blind, placebo-controlled trial | Familial combined hyperlipidemia | 12 weeks | 41 40 | Simvastatin 20 mg/day Gemfibrozil 1200 mg/day | 50.4 ± 10.8 53.4 ± 9.4 | 9 (21.9) 14 (35.0) | 26.6 ± 2.7 27.2 ± 3.0 | 282.2 ± 37.1 290.0 ± 37.8 | 149.6 ± 37.8 157.7 ± 38.2 | 32.4 ± 7.3 35.1 ± 7.7 | 283.4 ± 106.2 285.2 ± 108.0 | 19.6b 18.0b | 6.5 2.7 |
Hansen et al. (1994) [60] | Randomized, cross-over trial | Familial defective apolipoprotein B-100 | 8 weeks | 17 13 | Pravastatin 40 mg/day Gemfibrozil 1200 mg/day | 45.8 ± 17.1 40.8 ± 12.3 | 12 (70.5) 7 (53.8) | ND ND | 320.9 ± 58.0 320.9 ± 46.4 | 247.4 ± 54.1 235.8 ± 42.5 | 46.4 ± 7.7 50.2 ± 19.3 | 115.1 (79.7–168.2)a 141.7 (106.2–230.2)a | 10.5 (3.5–16.7)a 8.3 (3.4–12.9)a | 0.9 1.1 |
Perez-Jimenez et al. (1995) [61] | Randomized, cross-over trial | Patients with heart transplant | 8 weeks | 18 18 | Lovastatin 10 mg/day Bezafibrate 400 mg/day | 54 ± 2 | 2 (11.1) | ND | 302 ± 7 307 ± 5 | 213 ± 5 212 ± 5 | 54 ± 3 51 ± 4 | 170 ± 15 201 ± 17 | 34 ± 9 37 ± 9 | 5.0 –13.0 |
Melenovsky et al. (2002) [51] | Randomized, open-label, cross-over trial | Combined hyperlipidemia | 10 weeks | 15 14 | Fenofibrate 200 mg/day Atorvastatin 10 mg/day | 48.0 ± 6.9 46.4 ± 8.9 | ND ND | 27.7 ± 2.3 27.9 ± 3.2 | 300.0 ± 56.4 283.0 ± 35.9 | 174.7 ± 46.4 165.8 ± 23.2 | 49.4 ± 8.8 47.9 ± 15.8 | 492.4 ± 440.2 465.0 ± 372.8 | 24 ± 29 17 ± 23 | 2.8 1.8 |
Ohrvall et al. (1995) [54] | Randomized, double-blind, cross-over trial | Diabetes and hyperlipo-proteinemia | 4 months | 25 24 | Gemfibrozil 1200 mg/day Simvastatin 10 mg/day | 63.7 (48–78)a | 9 (31.0) | ND | 232.0 ± 40.2 | 152.7 ± 43.3 | 36.7 ± 6.9 | 116.0 ± 52.5 | 37.77 ± 54.75 | –7.0 –2.4 |
Ramires et al. (1995) [62] | Randomized clinical trial | Hyperlipidemia and hyperlipo-proteinemia | 12 weeks | 14 13 | Gemfibrozil 1200 mg/day Lovastatin 40-80 mg/day | 54 ± 7 55 ± 9 | 5 (55.5) 3 (30.0) | ND ND | 298.9 ± 12.3 299.3 ± 11.2 | 209.9 ± 20.8 208.0 ± 11.9 | 31.7 ± 7.3 34.4 ± 6.1 | 295.8 ± 23.0 281.6 ± 20.3 | 29.8 ± 5.7 27.8 ± 4.1 | –7.5 1.4 |
Bairaktari et al. (1999) [50] | Open-label trial | Mixed hyperlipidemia | 16 weeks | 45 46 | Atorvastatin 10 mg/day Fenofibrate 200 mg/day | 49 ± 8 46 ± 10 | 16 (35.5) 15 (32.6) | 26.8 ± 4 27.4 ± 3 | 278 ± 34 282 ± 37 | 198 ± 29 199 ± 36 | 40 ± 11 36 ± 16 | 271 ± 59 269 ± 60 | 14 ± 12 11.8 ± 10.5 | 1.2 –1.8 |
Davidson et al. (2009) [53] | Randomized, double-blind trial | Dyslipidemia | 12 weeks | 74 73 73 | Atorvastatin 40 mg/day Fenofibrate 145 mg/day Atorvastatin 40 mg/day + fenofibrate 100 mg/day | 56.3 ± 9.8 56.4 ± 10.5 54.9 ± 10.7 | 39 (52.7) 33 (45.2) 33 (45.2) | ND ND ND | 254.4 ± 44.2 251.9 ± 47.5 252.0 ± 40.1 | 165.0 ± 37.7 166.6 ± 46.7 156.2 ± 33.6 | 42.7b 41.2b 43.3b | 265.1b 227.3b 270.2b | 69.0 ± 67.5 66.0 ± 65.3 76.8 ± 74.5 | 9.3 5.1 6.9 |
Greten et al. (1994) [64] | Randomized, double-blind trial | Primary hypercholesterolemia | 12 weeks | 64 67 | Fluvastatin 40 mg/day Bezafibrate 400 mg/day | 53.0 (18–75)a 51.8 (22–70)a | 37 (57.8) 37 (55.2) | 24.6 (18.6–31.2)a 24.7 (16.9–31.6)a | 352.7 ± 89.4 340.3 ± 76.7 | 268.9 ± 88.5 257.4 ± 75.6 | 55.2 ± 12.2 55.2 ± 12.6 | 143.2 ± 48.0 138.0 ± 59.4 | 12.0 ± 16.5 14.0 ± 30.0 | 1.0 0.4 |
Kehely et al. (1995) [56] | Randomized, double-blind trial | Mixed hyperlipidemia | 3 months | 53 27 26 | Placebo Simvastatin 20 mg/day Bezafibrate 400 mg/day | ND 52 ± 9 49 ± 10 | ND 11 (40.7) 4 (15.3) | ND ND ND | 298.5 ± 51.8 | 189.0 ± 54.9 | 42.5 ± 8.1 | 286.9 ± 122.2 | 19.8 ± 2.8 | 5.7 –2.5 |
May et al. (2008) [57] | Randomized, double-blind, placebo-controlled trial | Diabetes and mixed dyslipidemia | 12 weeks | 100 100 100 | Fenofibrate 160 mg/day Simvastatin 20 mg/day Fenofibrate 160 mg/day + Simvastatin 20 mg/day | 61.6 ± 11.5 | 135 (45.0) | ND | ND ND ND | ND ND ND | ND ND ND | ND ND ND | 4.0 (2.0–6.0)a 4.0 (2.0–6.0)a 5.0 (3.0–9.0)a | 1.0 1.0 0.0 |
Ramires et al. (1997) [63] | Randomized clinical trial | Hypercholesterolemia and hyperlipoproteinemia | 12 weeks | 14 13 | Gemfibrozil 1200 mg/day Lovastatin 40-80 mg/day | 54 ± 7 55 ± 9 | 5 (36.0) 6 (59.0) | ND ND | 306 ± 13 307 ± 11 | 215 ± 21 213 ± 12 | 33 ± 7 35 ± 6 | 294 ± 23 280 ± 20 | 51 ± 10 48 ± 7 | –13.0 –2.0 |
Saougos et al. (2007) [65] | Clinical trial | Hyperlipidemia | 2 months | 50 50 | Rosuvastatin 10 mg/day Fenofibrate 200 mg/day | 54.6 ± 14.6 55.9 ± 11 | 31 (62.0) 30 (60.0) | 25.8 ± 4.2 34.3 ± 7 | 297.7 ± 50.2 235.8 ± 34.8 | 208.8 ± 42.5 146.9 ± 34.8 | 58.0 ± 11.6 50.2 ± 11.6 | 141.7 ± 53.1 239.1 ± 53.1 | 4.0 (2.0–7.4)a 3.8 (2.0–7.9)a | 0.0 0.1 |
Vigna et al. (1999) [58] | Randomized, double-blind trial | Men with mixed hyperlipidemia | 2 months | 15 15 | Gemfibrozil 1200 mg/day Simvastatin 20 mg/day | 53.6 ± 11.7 50.9 ± 9.9 | 0 (0.0) 0 (0.0) | 26.7 ± 1.9 25.0 ± 2.5 | 280.2 ± 30.1 281.2 ± 38.8 | 208.5 ± 30.1 206.7 ± 37.8 | 46.1 ± 9.9 44.4 ± 8.2 | 46.1 ± 9.9 44.4 ± 8.2 | 25.7 ± 22.6 9.2 ± 11.8 | –4.3 2.1 |
de Lorgeril et al. (1999) [59] | Randomized, double-blind trial | Dyslipidemic coronary patients | 12 weeks | 32 32 | Fenofibrate 200 mg/day Simvastatin 20 mg/day | ND | ND | ND | 278.4 ± 27.0 278.4 ± 27.0 | 193.3 ± 27.0 197.2 ± 23.2 | 46.4 ± 11.6 46.4 ± 7.7 | 186.0 ± 79.7 168.2 ± 88.5 | 34 ± 62 32 ± 39 | –6.0 –2.0 |