Table 1 Characteristics of randomized controlled trials investigating efficacy of intensive lipid lowering in primary prevention settings
Study | Country | Participants | Intervention | Compariason | Baseline LDL-C level, mean (SD)a | Main findings [n (%), intervention vs. comparison] |
|---|---|---|---|---|---|---|
LRC-CPPT, 1984 [27] | North America | 3806 participants, mean follow-up duration 7.4 years, age 30–59 years, women proportion 0% | Bile acid sequestrant cholestyramine resin 24 g/day (n = 1906) | Placebo (n = 1900) | 205.3 mg/dL | LDL-C reduction percentageb22.4% vs. 2.8% CHD eventn = 155 (8.1%) vs. n = 187 (9.8%) All-cause mortalityn = 68 (3.6%) vs. n = 71 (3.7%) |
HHS, 1987 [29] | Finland | 4081 participants, mean follow-up duration 5.0 years, mean age 47.2 years, diabetes proportion 2.6% | Gemfibrozil 600 mg twice/day (n = 2051) | Placebo (n = 2030) | 189.2 mg/dL | LDL-C reduction percentage 8.7% vs. -2.9% CHD eventn = 56 (2.7%) vs. n = 84 (4.1%) |
ACAPS, 1994 [16] | United States | 919 participants, mean follow-up duration 3.0 years, mean age 61.7 years, women proportion 48.5%, diabetes proportion 2.3% | Lovastatin 20–40 mg/day (n = 460) | Placebo (n = 459) | 155.6 mg/dL | LDL-C reduction percentage 28.0% vs. -3.5% CHD eventn = 5 (1.1%) vs. n = 5 (1.1%)All-cause mortalityn = 1 (0.2%) vs. n = 8 (1.7%) |
WOSCOPS, 1995 [17] | Scotland | 6595 participants, mean follow-up duration 4.9 years, mean age 55.2 years, women proportion 0%, diabetes proportion 1.2% | Pravastatin 40 mg/day (n = 3302) | Placebo (n = 3293) | 192.0 mg/dL | LDL-C reduction percentage 26.0% vs. 1.6% CHD eventn = 173 (5.2%) vs. n = 248 (7.5%) All-cause mortalityn = 106 (3.2%) vs. n = 135 (4.1%) |
AFCAPS/TexCAPS, 1998 [18] | United States | 6605 participants, mean follow-up duration 6.5 years, mean age 58.0 years, women proportion 15.1%, diabetes proportion 2.3% | Lovastatin 20–40 mg/day (n = 3304) | Placebo (n = 3301) | 150.0 mg/dL | LDL-C reduction percentage 25.0% vs. -1.5% CHD eventn = 116 (3.5%) vs. n = 183 (5.5%) |
Sasaki et al., 2002 [31] | Japan | 1085 participants, mean follow-up duration 6.5 years, mean age 58.0 years, women proportion 15.1%, diabetes proportion 2.3% | Pravastatin 10–20 mg/day (n = 587) | Usual care c (n = 498) | 200.0 mg/dL | LDL-C reduction percentage 22.8% vs. 14.0% CHD eventn = 5 (0.9%) vs. n = 13 (2.6%) All-cause mortalityn = 4 (0.7%) vs. n = 2 (0.4%) |
ASCOT-LLA, 2003 [17] | United Kingdom, Ireland | 10,305 participants, mean follow-up duration 3.3 years, mean age 63.0 years, women proportion 18.8%, diabetes proportion 24.6% | Atorvastatin 10 mg/day (n = 5168) | Placebo (n = 5137) | 131.5 mg/dL | LDL-C reduction percentage 35.0% vs. 0.0% CHD eventn = 273 (5.3%) vs. n = 346 (6.7%) All-cause mortalityn = 185 (3.6%) vs. n = 212 (4.1%) |
CARDS, 2004 [21] | United Kingdom, Ireland | 2838 participants, mean follow-up duration 3.9 years, mean age 61.6 years, women proportion 32.0%, diabetes proportion 100% | Atorvastatin 10 mg/day (n = 1428) | Placebo (n = 1410) | 117.6 mg/dL | LDL-C reduction percentage 38.8% vs. -2.6% CHD eventn = 62 (4.3%) vs. n = 92 (6.5%) All-cause mortalityn = 61 (4.3%) vs. n = 82 (5.8%) |
Beishuizen et al., 2004 [20] | Netherlands | 182 participants, mean follow-up duration 2.0 years, mean age 58.5 years, women proportion 52.8%, diabetes proportion 100% | Cerivastatin 0.4 mg/day (2001 replaced with Simvastatin 20 mg/day) (n = 103) | Placebo (n = 79) | 137.3 mg/dL | LDL-C reduction percentage 25.0% vs. -6.5% CHD eventn = 0 (0.0%) vs. n = 4 (5.1%) All-cause mortalityn = 3 (2.9%) vs. n = 4 (5.1%) |
FIELD, 2005 [28] | Australia, New Zealand and Finland | 9795 participants, mean follow-up duration 5.0 years, mean age 62.2 years, women proportion 77.7%, diabetes proportion 100% | Fenofibrate 200 mg/day(n = 4895) | Placebo (n = 4900) | 118.7 mg/dL | LDL-C reduction percentage 20.8% vs. 15.3% CHD eventn = 356 (7.3%) vs. n = 323 (6.6%) All-cause mortalityn = 454 (9.3%) vs. n = 508 (10.4%) |
ASPEN, 2006 [22] | Multi-countries | 1905 participants, mean follow-up duration 4.0 years, mean age 60.5 years, women proportion 52.8%, diabetes proportion 100% | Atorvastatin, 10 mg/day (n = 959) | Placebo (n = 946) | 114.0 mg/dL | LDL-C reduction percentage 30.5% vs. 0.5% CHD eventn = 73 (7.6%) vs. n = 73 (7.7%) All-cause mortalityn = 44 (4.6%) vs. n = 41 (4.3%) |
MEGA, 2006 [32] | Japan | 7832 participants, mean follow-up duration 5.3 years, mean age 58.3 years, women proportion 67.5%, diabetes proportion 20.5% | Pravastatin 10–20 mg/day (n = 3866) | Usual care (n = 3966) | 156.6 mg/dL | LDL-C reduction percentage 19.0% vs. 2.0% CHD eventn = 66 (1.7%) vs. n = 101 (2.5%) All-cause mortalityn = 55 (1.4%) vs. n = 79 (2.0%) |
JUPITER, 2008 [23] | Multi-countries | 17,802 participants, mean follow-up duration 1.9 years, mean age 66.0 years, women proportion 38.2% | Rosuvastatin 20 mg/day (n = 8901) | Placebo (n = 8901) | 108.0 mg/dL | LDL-C reduction percentage 49.1% vs. -1.9% CHD eventn = 109 (1.2%) vs. n = 187 (2.1%) All-cause mortalityn = 198 (2.2%) vs. n = 247 (2.8%) |
Heljic et al., 2009 [24] | Sarajevo | 95 participants, mean follow-up duration 1.0 years, mean age 60.1 years, women proportion 57.9%, diabetes proportion 100% | Simvastatin 40 mg (n = 45) | Placebo (n = 50) | 167.8 mg/dL | LDL-C reduction percentage 20.0% vs. 5.0%CHD eventn = 3 (6.7%) vs. n = 7 (14.0%) |
SHARP, 2011 [30] | Multi-countries | 9270 participants, mean follow-up duration 4.9 years, mean age 62.0 years, women proportion 37.4%, diabetes proportion 12.3% | Simvastatin 20 mg plus ezetimibe 10 mg/day (n = 4650) | Placebo (n = 4620) | 107.1 mg/dL | LDL-C reduction percentage 39.0% vs. 0.7% CHD eventn = 213 (4.6%) vs. n = 230 (5.0%) All-cause mortalityn = 1142 (24.6%) vs. n = 1115 (24.1%) |
HOPE-3, 2016 [25] | Multi-countries | 12,705 participants, mean follow-up duration 5.6 years, mean age 65.8 years, women proportion 46.2%, diabetes proportion 5.8% | Rosuvastatin 10 mg/day (n = 6361) | Placebo (n = 6344) | 127.8 mg/dL | LDL-C reduction percentage 31.0% vs. 1.5% CHD eventn = 105 (1.7%) vs. n = 140 (2.2%) All-cause mortalityN = 334 (5.3%) vs. n = 357 (5.6%) |
EMPATHY, 2018 [33] | Japan | 5042 participants, mean follow-up duration 3.1 years, mean age 63.1 years, women proportion 52.3%, diabetes proportion 100% | Target of LDL-C level lower than 70 mg/dL (n = 2518) | Target of LDL-C level lower than 100 mg/dL (n = 2524) | 106.1 mg/dL | LDL-C reduction percentage 22.2% vs. 0.0% CHD eventn = 129 (5.1%) vs. n = 153 (6.1%) All-cause mortalityN = 41 (1.6%) vs. n = 34 (1.3%) |
Kitas et al., 2019 [26] | United Kingdom | 3002 participants, mean follow-up duration 2.5 years, mean age 61.0 years, women proportion 87.4%, diabetes proportion 100% | Atorvastatin 40 mg/day (n = 1504) | Placebo (n = 1498) | 123.7 mg/dL | LDL-C reduction percentage 30.9% vs. 6.9% CHD eventn = 15 (1.0%) vs. n = 24 (1.6%) All-cause mortalityN = 25 (1.7%) vs. n = 27 (1.8%) |