Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in patients with hypertriglyceridemia

被引:335
作者
BakkerArkema, RG
Davidson, MH
Goldstein, RJ
Davignon, J
Isaacsohn, JL
Weiss, SR
Keilson, LM
Brown, WV
Miller, VT
Shurzinske, LJ
Black, DM
机构
[1] CLIN RES INST MONTREAL,MONTREAL,PQ H2W 1R7,CANADA
[2] CHICAGO CTR CLIN RES 3,CHICAGO,IL
[3] CHRIST HOSP,CARDIOVASC RES CTR,CINCINNATI,OH 45219
[4] SAN DIEGO ENDOCRINE & MED CLIN INC,SAN DIEGO,CA
[5] CTR LIPIDS,PORTLAND,ME
[6] EMORY UNIV,SCH MED,DIV ARTEIOROSCLOROSIS & LIPED METAB,ATLANTA,GA
[7] GEORGE WASHINGTON UNIV,MED CTR,LIPID RES CLIN,WASHINGTON,DC 20037
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 1996年 / 275卷 / 02期
关键词
D O I
10.1001/jama.275.2.128
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective.-To assess the lipid-lowering effect of atorvastatin (a new 3-hydroxy-3-methylglutaryl coenzyme A [HMG-CoA] reductase inhibitor) on levels of serum triglycerides and other lipoprotein fractions in patients with primary hypertriglyceridemia, determine if atorvastatin causes a redistribution of triglycerides in various lipoprotein fractions, and assess its safety by reporting adverse events and clinical laboratory measurements. Design.-Randomized double-blind, placebo-controlled, parallel-group, multicenter trial. Setting.-Community- and university-based research centers. Patients.-A total of 56 patients (aged 26 to 74 years) with a mean baseline triglyceride level of 6.80 mmol/L (603.3 mg/dL) and a mean baseline low-density lipoprotein cholesterol (LDL-C) level of 3.07 mmol/L (118.7 mg/dL). Interventions.-Cholesterol-lowering diet (National Institutes of Health National Cholesterol Education Program Step I Diet) and either 5 mg, 20 mg, or 80 mg of atorvastatin, or placebo. Main Outcome Measures.-Percent change from baseline in total triglycerides for three dose levels of atorvastatin compared with placebo. Results.-Mean reductions in total triglycerides between 5 mg, 20 mg, and 80 mg of atorvastatin and placebo after 4 weeks of treatment were -26.5%, -32.4%, -45.8%, and -8.9%, respectively. Mean reductions in LDL-C were -16.7%, -33.2%, -41.4%, and -1.4%, respectively, and very low-density lipoprotein cholesterol (VLDL-C) were -34.3%, -45.9%, -57.7%, and -5.5%, respectively. Similar mean changes in total apolipoprotein B (apo B) (-16.9%, -32.8%, -41.7%, and +1.0%), apo B in LDL (-14.8%, -29.8%, -42.0%, and -3.1%), and apo B in VLDL (-23.8%, -35.8%, -34.4%, and +11.7%) were observed. In addition, comparable mean changes in LDL triglycerides (-22.5%, -30.7%, -39.9%, and +3.9%) and VLDL triglycerides (-28.1%, -34.0%, -47.3%, and -10.8%) were seen. Conclusions.-In atorvastatin treatment groups, total serum triglyceride levels decreased in a dose-dependent manner; reductions in the 20-mg and 80-mg groups were statistically significant (P<.05) compared with placebo. Atorvastatin did not cause a redistribution of triglycerides but consistently lowered triglycerides in all lipoprotein fractions. Atorvastatin was well tolerated.
引用
收藏
页码:128 / 133
页数:6
相关论文
共 24 条
[1]   PLASMA TRIGLYCERIDE AND CORONARY HEART-DISEASE [J].
AUSTIN, MA .
ARTERIOSCLEROSIS AND THROMBOSIS, 1991, 11 (01) :2-14
[2]   COMBINATION-DRUG THERAPY FOR FAMILIAL COMBINED HYPERLIPIDEMIA [J].
EAST, C ;
BILHEIMER, DW ;
GRUNDY, SM .
ANNALS OF INTERNAL MEDICINE, 1988, 109 (01) :25-32
[3]  
FESKANICH D, 1988, J AM DIET ASSOC, V88, P1263
[4]   FAMILIAL LIPOPROTEIN DISORDERS IN PATIENTS WITH PREMATURE CORONARY-ARTERY DISEASE [J].
GENEST, JJ ;
MARTINMUNLEY, SS ;
MCNAMARA, JR ;
ORDOVAS, JM ;
JENNER, J ;
MYERS, RH ;
SILBERMAN, SR ;
WILSON, PWF ;
SALEM, DN ;
SCHAEFER, EJ .
CIRCULATION, 1992, 85 (06) :2025-2033
[5]  
GOH EH, 1977, J BIOL CHEM, V252, P2822
[6]   2 DIFFERENT VIEWS OF THE RELATIONSHIP OF HYPERTRIGLYCERIDEMIA TO CORONARY HEART-DISEASE - IMPLICATIONS FOR TREATMENT [J].
GRUNDY, SM ;
VEGA, GL .
ARCHIVES OF INTERNAL MEDICINE, 1992, 152 (01) :28-34
[7]  
GRUNDY SM, 1991, DRUG TREATMENT HYPER, P139
[8]  
HAINLINE A, 1982, LIPID LIPOPROTEIN AN, P5
[9]   EPIDEMIOLOGY AS A GUIDE TO CLINICAL DECISIONS - THE ASSOCIATION BETWEEN TRIGLYCERIDE AND CORONARY HEART-DISEASE [J].
HULLEY, SB ;
ROSENMAN, RH ;
BAWOL, RD ;
BRAND, RJ .
NEW ENGLAND JOURNAL OF MEDICINE, 1980, 302 (25) :1383-1389
[10]   RETEST RELIABILITY OF PLASMA-CHOLESTEROL AND TRIGLYCERIDE - THE LIPID RESEARCH CLINICS PREVALENCE STUDY [J].
JACOBS, DR ;
BARRETTCONNOR, E .
AMERICAN JOURNAL OF EPIDEMIOLOGY, 1982, 116 (06) :878-885