M van Dam1, A F Stalenhoef2, J Wittekoek1, M D Trip1, M H Prins3, J J Kastelein4. 1. Department of Vascular Medicine, Academic Medical Centre, G1-146, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. 2. Department of Medicine, Division of General Internal Medicine, University Hospital Nijmegen, Nijmegen, The Netherlands. 3. Department of Clinical Epidemiology and Biostatistics, Academic Medical Centre, University of Amsterdam, The Netherlands. 4. Department of Vascular Medicine, Academic Medical Centre, G1-146, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. E.VANDONGEN@AMC.UVA.NL.
Abstract
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.
RCT Entities:
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 acidseicosapentaenoic 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.
Authors: K Kugiyama; H Doi; K Takazoe; H Kawano; H Soejima; Y Mizuno; R Tsunoda; T Sakamoto; T Nakano; K Nakajima; H Ogawa; S Sugiyama; M Yoshimura; H Yasue Journal: Circulation Date: 1999-06-08 Impact factor: 29.690
Authors: M de Lorgeril; S Renaud; N Mamelle; P Salen; J L Martin; I Monjaud; J Guidollet; P Touboul; J Delaye Journal: Lancet Date: 1994-06-11 Impact factor: 79.321