K Gholami1, N Tavakoli, M Maleki, A Shafiee. 1. Department of Clinical Pharmacy, Faculty of Pharmacy, The Medical Sciences University of Tehran, Iran.
Abstract
OBJECTIVES: To evaluate and compare the efficacy and safety of fenofibrate and lovastatin in patients with type IIa or IIb hyperlipidaemia. METHODS:One hundred patients entered this single-centre, open, comparative trial. After 2 months of diet therapy, 33 patients (16 with type IIa and 17 with type IIb hyperlipidaemia) were randomized to treatment for 3 months with a single daily 300 mg dose of fenofibrate or 20 mg of lovastatin. RESULTS: After 3 months of drug therapy, fenofibrate and lovastatin produced significant reductions in levels of total cholesterol and low-density lipoprotein cholesterol in type IIa hyperlipidaemia. In type IIb, the levels of total cholesterol were significantly decreased by both drugs, but only lovastatin significantly reduced low-density lipoprotein cholesterol in these patients. High-density lipoprotein cholesterol levels were significantly increased by lovastatin in type IIa and fenofibrate in type IIb. Fenofibrate decreased total triglyceride levels in both types of hyperlipidaemia significantly more effectively than lovastatin. The most important and commonly observed adverse effects in the fenofibrate group were dermatological events (three patients), myalgia (two patients) and asymptomatic increase in aminotransferase values (nine patients), while in the lovastatin group cardiovascular events (five patients) were the most common. All five patients had coronary heart disease at baseline. In general terms, both drugs were well tolerated. CONCLUSIONS: Comparison between fenofibrate and lovastatin after 3 months of drug therapy in both types IIa and IIb hyperlipidaemia demonstrated that both drugs produced similar reductions in levels of total cholesterol and low-density lipoprotein cholesterol. However, fenofibrate decreased total triglyceride levels in both types of hyperlipidaemia, more effectively than lovastatin. Thus, fenofibrate is suitable for both primary hypercholesterolaemia and combined hyperlipidaemia.
RCT Entities:
OBJECTIVES: To evaluate and compare the efficacy and safety of fenofibrate and lovastatin in patients with type IIa or IIb hyperlipidaemia. METHODS: One hundred patients entered this single-centre, open, comparative trial. After 2 months of diet therapy, 33 patients (16 with type IIa and 17 with type IIb hyperlipidaemia) were randomized to treatment for 3 months with a single daily 300 mg dose of fenofibrate or 20 mg of lovastatin. RESULTS: After 3 months of drug therapy, fenofibrate and lovastatin produced significant reductions in levels of total cholesterol and low-density lipoprotein cholesterol in type IIa hyperlipidaemia. In type IIb, the levels of total cholesterol were significantly decreased by both drugs, but only lovastatin significantly reduced low-density lipoprotein cholesterol in these patients. High-density lipoprotein cholesterol levels were significantly increased by lovastatin in type IIa and fenofibrate in type IIb. Fenofibrate decreased total triglyceride levels in both types of hyperlipidaemia significantly more effectively than lovastatin. The most important and commonly observed adverse effects in the fenofibrate group were dermatological events (three patients), myalgia (two patients) and asymptomatic increase in aminotransferase values (nine patients), while in the lovastatin group cardiovascular events (five patients) were the most common. All five patients had coronary heart disease at baseline. In general terms, both drugs were well tolerated. CONCLUSIONS: Comparison between fenofibrate and lovastatin after 3 months of drug therapy in both types IIa and IIb hyperlipidaemia demonstrated that both drugs produced similar reductions in levels of total cholesterol and low-density lipoprotein cholesterol. However, fenofibrate decreased total triglyceride levels in both types of hyperlipidaemia, more effectively than lovastatin. Thus, fenofibrate is suitable for both primary hypercholesterolaemia and combined hyperlipidaemia.
Authors: C Stefanutti; A Bucci; S Di Giacomo; N Fraone; A Pace; M Mareri; A Musca; A Mammarella Journal: Clin Drug Investig Date: 2004 Impact factor: 2.859