A Comparison With Gemfibrozil
Objectives: To compare the effects of concentrated n-3 fatty acids (Omacor) and gemfibrozil in patients with severe hypertriglyceridaemia. The primary objective was to measure the change in serum triglyceride (TG), and the secondary objectives were to study the changes in total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), very low density lipoprotein cholesterol (VLDL-C), apolipoproteins and free fatty acids.
Patients and Study Design: 89 patients with severe hypertriglyceridaemia (defined as plasma TG >4.5 mmol/L) were randomised to receive in a double-blind fashion either Omacor, a capsule containing the n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dosage of 4 g/day, or gemfibrozil 1200 mg/day for 12 weeks.
Results: The baseline characteristics of the two randomised groups were similar. Compared with baseline, n-3 fatty acids and gemfibrozil reduced mean TG levels by 28.9 and 51.2%, respectively (p = 0.007). TC was decreased 10.2% with n-3 fatty acids, and 13.0% with gemfibrozil (p = 0.51), and VLDL-C was reduced 11.8 and 19.4% (p = 0.49) with n-3 fatty acids and gemfibrozil, respectively. HDL-C was increased by both compounds; n-3 fatty acids elevated HDL-C by only 1.2%, whereas it was elevated 27.9% by gemfibrozil (p = 0.012).
Conclusions: Our study indicated that both n-3 fatty acids and gemfibrozil markedly decreased TG levels in patients with severe hypertriglyceridaemia. Gemfibrozil, however, decreased TG levels and increased HDL-C significantly more than n-3 fatty acids.
Elevated plasma triglyceride (TG) levels have been the focus of an ongoing debate concerning their role as an independent risk factor for coronary artery disease (CAD). Hypertriglyceridaemia has only recently been considered an independent contributor to CAD.
Both fasting TG levels and high levels of TG-rich lipoprotein remnants predict a predisposition to clinical coronary events, independently of other risk factors, and independently of reduced levels of high density lipoprotein cholesterol (HDL-C).
Hypertriglyceridaemia is also associated with 'small dense' low density lipoprotein cholesterol (LDL-C) particles, which are more susceptible to oxidation, and also predispose to an increased risk of CAD.
Management of hypertriglyceridaemia should focus initially on non-pharmacological modalities of treatment, such as diet, exercise, weight control, reduced alcohol intake and strict glycaemic control. If these measures prove unsuccessful, severely elevated TG levels, in particular, should be treated with lipid-lowering drugs in order to prevent pancreatitis. Such drugs include fibric acid derivatives and nicotinic acid and its analogues. These compounds both decrease TG and increase HDL-C. Some of these compounds have shown modest reductions in fatal and non-fatal myocardial infarctions, but for neither could a decrease in total mortality be demonstrated, although recently it was shown that gemfibrozil therapy resulted in a significant reduction in the risk of major cardiovascular events in patients with coronary disease and low HDL-C levels.
Epidemiological studies suggest that a high dietary intake of n-3 polyunsaturated fatty acids may confer a protective effect against athero-sclerotic disease and reduce serum TG levels.
We investigated in a randomised, double-blind trial the efficacy and tolerability of Omacor (concentrated n-3 fatty acids, Pronova AS) and gemfibrozil in 89 patients with severe hypertriglyceridaemia. The primary objective was to measure the change in serum TG, and the secondary objectives were to study the changes in total cholesterol (TC), HDL-C, very low density lipoprotein cholesterol (VLDL-C), apolipoproteins and free fatty acids. Apolipoproteins were measured to better define risk ratios.
Objectives: To compare the effects of concentrated n-3 fatty acids (Omacor) and gemfibrozil in patients with severe hypertriglyceridaemia. The primary objective was to measure the change in serum triglyceride (TG), and the secondary objectives were to study the changes in total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), very low density lipoprotein cholesterol (VLDL-C), apolipoproteins and free fatty acids.
Patients and Study Design: 89 patients with severe hypertriglyceridaemia (defined as plasma TG >4.5 mmol/L) were randomised to receive in a double-blind fashion either Omacor, a capsule containing the n-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dosage of 4 g/day, or gemfibrozil 1200 mg/day for 12 weeks.
Results: The baseline characteristics of the two randomised groups were similar. Compared with baseline, n-3 fatty acids and gemfibrozil reduced mean TG levels by 28.9 and 51.2%, respectively (p = 0.007). TC was decreased 10.2% with n-3 fatty acids, and 13.0% with gemfibrozil (p = 0.51), and VLDL-C was reduced 11.8 and 19.4% (p = 0.49) with n-3 fatty acids and gemfibrozil, respectively. HDL-C was increased by both compounds; n-3 fatty acids elevated HDL-C by only 1.2%, whereas it was elevated 27.9% by gemfibrozil (p = 0.012).
Conclusions: Our study indicated that both n-3 fatty acids and gemfibrozil markedly decreased TG levels in patients with severe hypertriglyceridaemia. Gemfibrozil, however, decreased TG levels and increased HDL-C significantly more than n-3 fatty acids.
Elevated plasma triglyceride (TG) levels have been the focus of an ongoing debate concerning their role as an independent risk factor for coronary artery disease (CAD). Hypertriglyceridaemia has only recently been considered an independent contributor to CAD.
Both fasting TG levels and high levels of TG-rich lipoprotein remnants predict a predisposition to clinical coronary events, independently of other risk factors, and independently of reduced levels of high density lipoprotein cholesterol (HDL-C).
Hypertriglyceridaemia is also associated with 'small dense' low density lipoprotein cholesterol (LDL-C) particles, which are more susceptible to oxidation, and also predispose to an increased risk of CAD.
Management of hypertriglyceridaemia should focus initially on non-pharmacological modalities of treatment, such as diet, exercise, weight control, reduced alcohol intake and strict glycaemic control. If these measures prove unsuccessful, severely elevated TG levels, in particular, should be treated with lipid-lowering drugs in order to prevent pancreatitis. Such drugs include fibric acid derivatives and nicotinic acid and its analogues. These compounds both decrease TG and increase HDL-C. Some of these compounds have shown modest reductions in fatal and non-fatal myocardial infarctions, but for neither could a decrease in total mortality be demonstrated, although recently it was shown that gemfibrozil therapy resulted in a significant reduction in the risk of major cardiovascular events in patients with coronary disease and low HDL-C levels.
Epidemiological studies suggest that a high dietary intake of n-3 polyunsaturated fatty acids may confer a protective effect against athero-sclerotic disease and reduce serum TG levels.
We investigated in a randomised, double-blind trial the efficacy and tolerability of Omacor (concentrated n-3 fatty acids, Pronova AS) and gemfibrozil in 89 patients with severe hypertriglyceridaemia. The primary objective was to measure the change in serum TG, and the secondary objectives were to study the changes in total cholesterol (TC), HDL-C, very low density lipoprotein cholesterol (VLDL-C), apolipoproteins and free fatty acids. Apolipoproteins were measured to better define risk ratios.
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