Table 1.
Summary of clinical studies links TG/TRLPs with CVD
| Study | Study design | Sample size | Study population | Baseline lipid level (mgl/dL) | Follow-up | Key findings |
|---|---|---|---|---|---|---|
| [25] Faerge-Man et al. 2009 | meta-analysis (2 prospective, randomized, multicenter trials) |
N = 15,779 | with clinically evident coronary heart disease or a history of myocardial infarction | / | / | slightly increased TG levels are associated with higher risk of recurrence of CVEs in statin-treated patients |
| [24] Varbo et al. 2013 | meta-analysis (3 studies) |
N = 73,513 | white subjects of Danish descent from Copenhagen, of whom 11,984 had ischemic heart disease | / | / | the elevated nonfasting remnant cholesterol and TRLPs that are causally related to increased risk for ischemic heart disease |
| [32] Puri et al. 2016 | meta-analysis (9 clinical trials) |
N = 4957 | with coronary disease | / | / | Plaque progression overall was closely tied with changes in non-HDLC and appeared to associate with TG levels only beyond 200 mg/dL |
| [33] DAIS 2001 | multicenter, double-blind, placebo-controlled, randomized trial | Fen (N = 207) Pla (N = 211) |
with type 2 diabetes aged. 40–65 years, with or without previous coronary intervention | LDL(mean): 130.7(Fen) 132.6(Pla), HDL(mean): 39.1(Fen) 40.6(Pla), TG(median): 229.4(Fen) 214.3(Pla) |
3 years | Fenofibrate could decreased significantly progression in minimum lumen diameter and percentage diameter stenosis (localised. coronary-artery disease) |
| [34] FIELD Study 2005 | multicenter, Controlled, randomized trial |
Fen (N = 4895, n = 944) Pla (N = 4900, n = 1776) |
with type 2 diabetes | LDL(mean): 118.7(Fen)118.1(Pla),HDL(mean): 42.5(Fen)42.5(Pla), TG(median): 152.8(Fen) 151.9 (Pla) |
5 years | Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events but reduce total cardiovascular events |
| [36] HATS Study 2007 | double-blind placebo-controlled with a two-by-two factorial design |
N + S (N = 33) Antioxidant vitamins (N = 39) N-S + A (N = 40) all placebos (N = 34) |
with clinical coronary disease and at least three stenoses of at least 30% of the luminal diameter or one stenosis of at least 50% | LDL:127(P)132(N + S)117(A)124(N-S + A), HDL: 32(P)31(N + S) 32(A)30(N-S + A), TG:203(P)202(N + S) 207(A)236(N-S + A) |
3 years | Niacin plus Simvastatin provided marked clinical and angiographically measurable benefits in patiients with coronary disease and low HDL levels |
| [39] ACCORD Study 2010 | multicenter, randomized trial | F + S (N = 2765) Pla + Sim (N = 2753) Subgroup: F + S (N = 485) Pla + Sim (N = 456) |
with type 2 diabetes | LDL:100.0 ± 30.3(F + S) 101.1 ± 31.0(Pla), HDL:38.0 ± 7.8(F + S) 38.2 ± 7.8(Pla), TG(mean):164(F + S)160(Pla) |
4.7 years | The use of combination fibrate–statin therapy,did not reduce cardiovascullar risk in the majority of patients with type 2 diabetes, rather than statin therapy alone, but can reduce the CVD risk in subgroup with elevated TG levels (≥204 mg/dL) and decreased HDL-C (≤ 34 mg/dL) |
| [37] AIM-HIGH Study 2011 | randomized trial | N + S(or plus Eze) (N = 1718) Pla + Sim(or plus Eze) (N = 1696) |
with 45 years of age or older and established cardiovascular disease | LDL(mean): 74.0 ± 22.7(Nia) 74.2 ± 23.4(Pla), HDL(mean): 34.9 ± 5.6(Nia) 34.5 ± 5.6(Pla), TG(median): 163(Nia)167.5 (Pla) |
36 months | No incremental benefit of niacin in reducing cardiovascular events, despite significant increases in HDL-C levels and decreases in triglyceride levels |
| [38] HPS2-THRIVE Study 2013 | multicenter randomized trial | ERN/LRPT (N = 12,838) Pla (N = 12,835) |
with established cardiovascular disease | on the background of LDL-lowering therapy, LDL(mean):63.4, HDL(mean):44.1, TG (median): 126.7 |
3.9 years | adding ERN/LRPT to simvastatin 40 mg daily (or plus ezetimibe) increased the risk of myopathy |
| [41] FIRST Study 2014 | multicenter, double-blind, placebo-controlled trial |
FA135mg + Ato (N = 340) Pla + Ato (N = 342) |
with mixed dyslipidemia and a history of coronary heart disease or risk equivalent | LDL(mean): 84.0(F+A)84.5(Pla),HDL(mean): 40.1(F+A)39.6(Pla),TG(median): 205.0(F+A) 193.0 (Pla) |
104 weeks | FA plus Atorvastatin did not decrease cIMT progression in high-risk patients with mixed dyslipidemia and may achieve a clinical benefit in patients with TG level of ≥175 mg /dL |
Abbreviations: CVEs cardiovascular events, TRLPs triglyceride-rich lipoproteins, LDL low-density lipoprotein, HDL high-density lipoprotein, TG triglyceride, Fen Fenofibrate, Pla Placebo, FA fenofibric acid, Ato Atorvastatin, Nia niacin, Eze ezetimib, ERN/LRPT Extended release niacin plus laropiprant, F+A fenofibric acid plus Atorvastatin, F+S Fenofibrate+Simvastatin, N+S Niacin+Simvastatin, N-S+A Niacin–Simvastatin+Antioxidants, n the sample size of starting other lipid-lowering therapy (statin) in both groups in FIELD study