Publication: Dose-expanded study in the reinforcement of efficacy of simvastatin
Issued Date
2002-04-01
Resource Type
ISSN
01252208
Other identifier(s)
2-s2.0-0036347761
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.85, No.4 (2002), 438-445
Suggested Citation
Apichati Vichayanrat Dose-expanded study in the reinforcement of efficacy of simvastatin. Journal of the Medical Association of Thailand. Vol.85, No.4 (2002), 438-445. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/20505
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Dose-expanded study in the reinforcement of efficacy of simvastatin
Author(s)
Other Contributor(s)
Abstract
Two hundred and twenty two hyperlipidemic patients were recruited for a 12-week prospective, 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 ATP II guideline and ADA position statement, subjects were categorized into three groups according to LDL-C goals; group I: 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 respectively 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.