Dose-Expanded Study in the Reinforcement of Efficacy
of Simvastatint
APICHATI VICHAYANRAT, M.D.*
Affiliation : * Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.
Principle investigator, for the study investigators of DESIRES-Z.
t Simvastatin = Zocor®, MSD
AbstractTwo hundred and twenty two hyperlipidemic patients were recruited for a 12-week pro
spective, multicenter, open-label, titrate-to-goal study to evaluate the efficacy and safety of 20 to
40 mg per day of simvastatin in a Thai population. The efficacy on lipid lowering was evaluated
at 4 weeks and 8 weeks after medication. Based on NCEP AT P II guideline and ADA position
statement, subjects were categorized into three groups according to LDL-C goals; group 1: patients
without CHD and with <2 CHD risk factors, group II: patients without CHD and with :;:::2 CHD risk
factors and group III: CHD patients or diabetic patients with :;:::1 risk factors. Significant changes
of all lipid parameters from baselines were noted at 4 weeks after medication except for HDL-C
levels. Reduction of serum LDL-C, TC and TG by 40 per cent, 29 per cent and 16 per cent res
pectively and increase of serum HDL-C by 5 per cent were observed at 8 weeks of therapy (p<0.05).
At 4 weeks after taking simvastatin 20 mg/day, 78.9 per cent of patients in group I, 67.4 per cent
in group II and 40.9 per cent in group III achieved LDL-C goals. Seventeen per cent of the patients
who were evaluated at 8 weeks increased the simvastatin dosage to 40 mg per day in the second
month of treatment. At 8 weeks of therapy with simvastatin 20-40 mg/day, 90.1 per cent of
patients in group I, 77.4 per cent in group II and 66.7 per cent in group III achieved LDL-C goals.
Adverse symptoms during therapy, mostly mild, developed in 6.3 per cent of the 222 patients.
Conclusion : Simvastatin 20-40 mg/day was effective and well tolerated in managing lipid
parameters in Thai patients similar to other ethnic populations.
Keywords : Simvastatin, HMG CoA Reductase Inhibitor, Lipid Lowering, Cholesterol, LDL-C,
HDL-C, Triglyceride
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