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KMID : 0391020030110010012
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2003 Volume.11 No. 1 p.12 ~ p.22
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Comparison of Efficacy and Safety of Atorvastatin, 5mg and 10mg in the Treatment of Hypercholesterolemia
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Kim Hwa-Min
Lee Hyun-Hee
Lee Jae-Gun
Choi Hye-Jin
Park Chang-Hah
Se Myung-Duk
Jung Jae-Chyun
Cho Han-Gyoon
Choi Sung-Sik
Lee Woo-Seung
Won Kyung-Heon
Kim Seok-Yeon
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Abstract
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Background : Coronary heart disease(CHD) is a major cause of morbidity and mortality in modern era. Hypercholesterolemia is a major risk factor for CHD. Atorvastatin is the most potent drug currently available for lowering low density lipoprotein(LDL) cholesterol. This study compared the efficacy and safety of 6 month therapy with atorvastatin 5mg and 10mg per day. Methods : A total of 114 men and women with serum LDL {cholesterol{geq}130mg/dL;and;triglycerides{leq}400mg/dL} who need therapy according to National Cholesterol Education Program(NCEP) Adult Treatment Panel(ATP) III guideline were followed up for 6 months on outpatient basis. Atorvastatin 5mg was administered to 46 patients and 10mg to 61 patients per day. Lipid parameters were checked for 6 months and compared with baseline(within-treatment) and according to dose(between-treatment). Serum LDL cholesterol, triglycerides, high density lipoprotein(HDL) cholesterol change were checked according to their baseline, age, sex. NCEP ATP III target serum LDL cholesterol concentration achieving rate was compared between two treatment groups. Results : A total of 107 patients completed the 6-month schedule. Of the 107 patients, 29 patients were men and 78 patients were women. Both treatment groups had statistically significant within-treatment mean percent decreases from baseline to 6 month in total cholesterol, triglycerides, LDL cholesterol, LDL cholesterol/HDL cholesterol, and total cholesterol/HDL cholesterol ratio. In between-treatment comparison, both comparator groups had no statistically significant change in all of lipid parameters. LDL cholesterol, triglycerides had statistically significant LDL cholesterol percent decrement according to their baseline level. {{ll}(LDL;cholesterol,{geq}160mg/dL,{leq}160mg/dL);(triglycerides,;{geq}250mg/dL,;150{leq}250mg/dL,;<150mg/dL){gg};Old;age({geq}65)} had statistically significant percent decrement in LDL cholesterol after 6 months in 10mg-administered group, but not in 5mg administered group. Gender had no effect in LDL cholesterol decrement. Absolute change were also included in statistical analysis. Above all-mentioned notions including between-treatment changes, LDL-C, HDL-G, TG chnges according to baseline level, LDL-C changes according to age and sex were same at absolute change comparison. In both comparator groups, NCEP target LDL cholesterol concentration achieving rate was same, considering the same efficacy for LDL cholesterol lowering and baseline LDL cholesterol difference. Atorvastatin 5mg and 10mg were well tolerated for 6 months. Only 3 patients(5%) in 10mg group had mild drug-related adverse effect. 5mg atorvastatin had statistically significant superior safety. Conclusion: In patients with hypercholesterolemia in Korea, both low doses were effective for lowering total cholesterol, LDL cholesterol, triglycerides and well tolerated.(within-treatment) No difference in efficacy was observed between treatment groups. If we hypothesize that both low doses have same efficacy and 5mg atorvastatin have superior safety, and if we consider NCEP 10-year risk for CHD, we can conclude that 5mg atorvastatin can be administered to patients who belong to NCEP 10-year risk<10%, but for patients who belong to NCEP 10-year risk{geq}10%, more than 10mg of atorvastatin should be prescribed.
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KEYWORD
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Atorvastatin, Hypercholesterolemia, LDL cholesterol, Triglycerides
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