Ciprofibrate versus gemfibrozil in the treatment of primary hyperlipidaemia.
The efficacy and short-term safety of ciprofibrate and gemfibrozil were compared in a 12-week, double-blind, randomised study. One-hundred-and-ten primary, type II hyperlipidaemic patients were randomised to receive either ciprofibrate, 100 mg/day once daily, or gemfibrozil, 1200 mg/day twice daily. Treatment efficacy was measured by complete lipid and lipoprotein profiles and by plasma fibrinogen levels. Tolerability was assessed by drug compliance and safety was evaluated by laboratory safety parameters, physical examination and evaluation of adverse events. Mean reductions of plasma TC and low density lipoprotein cholesterol levels were similar in the two treatment groups. In contrast, the mean relative reduction of plasma total triglyceride and very low density lipoprotein triglyceride levels was significantly higher in patients receiving gemfibrozil as compared with ciprofibrate (P < 0.05). The absolute reduction of the last two parameters was higher in the ciprofibrate group compared with the gemfibrozil group; furthermore, the mean concentrations of these parameters were within normal limits at the end of the study. The clinical relevance of the statistically significant difference mentioned should, therefore, be questioned. Ciprofibrate therapy significantly reduced (-8.33%) and gemfibrozil therapy significantly increased (+6.97%) plasma fibrinogen levels (P < 0.001 compared with baseline in each case). Adverse events were rare, mild and equally distributed between the two treatment groups. Laboratory safety parameters did not show any significant changes. Ciprofibrate and gemfibrozil have comparable short-term efficacy and safety profiles. Furthermore, ciprofibrate reduces fibrinogen levels and benefits from a once daily regimen.
Knipscheer
H C
HC
Centre for Thrombosis, Hemostasis, Academic Medical Centre of the University of Amsterdam, The Netherlands.
de Valois
J C
JC
van den Ende
B
B
Wouter ten Cate
J
J
Kastelein
J J
JJ
D000328:Adult; D000368:Aged; D002995:Clofibric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D058607:Fibric Acids; D005340:Fibrinogen / Q000378:metabolism; D005500:Follow-Up Studies; D015248:Gemfibrozil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000097:blood / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008074:Lipoproteins / Q000097:blood / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
D058607:Fibric Acids; D000960:Hypolipidemic Agents; D008074:Lipoproteins; D002995:Clofibric Acid; D005340:Fibrinogen; C019304:ciprofibrate; D015248:Gemfibrozil