Baycol Clinical Trials and Studies
Baycol Information
Baycol Clinical Trials and Studies
Baycol (cerivastatin sodium tablets) has been studied in controlled trials in North America, Europe, Israel, and South Africa and has been shown to be effective in reducing plasma total cholesterol (Total-C) and LDL cholesterol (LDL-C) in heterozygous familial and non-familial forms of hypercholesterolemia and in mixed hyperlipidemia. Over 2,800 patients with Type IIa and IIb hypercholesterolemia were treated with Baycol in trials of 4 to 104 weeks duration. In a 24= week, randomized, double- b.i.d. placebo-controlled US trial in 934 patients with primary hypercholesterolemia, Baycol (cerivastatin sodium tablets) 0.05 to 0.3 mg once daily produced dose-related reductions in plasma LDL-C and Total-C. Significant reductions in mean total-C and LDL-C were evident after one week, peaked at four weeks, and were maintained for the duration of the trial. Reductions in plasma triglycerides (TG) and increases in HDL-C were also observed.
In a separate dose-scheduling study, Baycol (cerivastatin sodium tablets) was given as either a 0.2- mg dose once daily with dinner or at bedtime or as a 0.1= mg dose twice daily (morning and evening), Mean LDL-C reduction in response to Baycol dosed once with dinner or at bedtime was about 4% greater than the mean reduction in response to twice daily (divided) dosing (p< 0.05).
