CLINICAL STUDIES
Treating patients with documented atherosclerosis to national cholesterol education program-recommended low-density-lipoprotein cholesterol goals with atorvastatin, fluvastatin, lovastatin and simvastatin
Alan S. Brown, MD*,
Rebecca G. Bakker-Arkema, MS**,
Laurence Yellen, MD ,
Robert W. Henley, Jr., MD ,
Richard Guthrie, MD ,
Cam F. Campbell, MD||,
Michael Koren, MD¶,
William Woo, MD#,
Richard McLain, MS** and
Donald M. Black, MD**
* Midwest Heart Research Foundation, Naperville, Illinois, USA
Cardiology Associates Medical Group, San Diego, California, USA
Cardiovascular Associates of Virginia, Richmond, Virginia, USA
St. Paul Heart Clinic, St. Paul, Minnesota, USA
|| Iowa City Heart Center, Iowa City, Iowa, USA
¶ Jacksonville Cardiovascular Clinic, Jacksonville, Florida, USA
# University of Washington Medical School, Seattle, Washington, USA
** Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Michigan, USA
Manuscript received December 24, 1997;
revised manuscript received April 30, 1998,
accepted May 14, 1998.
Address for correspondence: Rebecca Bakker-Arkema, Parke-Davis Pharmaceutical Research, 2800 Plymouth Road, Ann Arbor, Michigan 48105-1047
Bakker-Arkema{at}wl.com
Objectives. This study compared the efficacy and safety of atorvastatin, fluvastatin, lovastatin, and simvastatin in patients with documented atherosclerosis treated to U.S. National Cholesterol Education Program (NCEP) recommended low-density-lipoprotein (LDL) cholesterol concentration ( 100 mg/dl [2.59 mmol/liter]).
Background. For patients with advanced atherosclerosis, NCEP recommends lipid-lowering drug therapy if LDL cholesterol remains  130 mg/dl (3.36 mmol/liter).
Methods. A total of 318 men or women with documented atherosclerosis and LDL cholesterol 130 mg/dl (3.36 mmol/liter) and 250 mg/dl (6.5 mmol/liter), and triglycerides 400 mg/dl (4.5 mmol/liter) participated in this 54-week, multicenter, open-label, randomized, parallel-group, active-controlled, treat-to-target study. Patients were titrated at 12-week intervals until the LDL cholesterol goal was reached. Number of patients reaching target LDL cholesterol levels and dose to reach target were evaluated.
Results. At the starting doses, atorvastatin 10 mg produced significantly greater decreases (p < 0.05) in plasma LDL cholesterol than the other treatments. Subsequently, the percentage of patients reaching goal at the starting dose was 32% for atorvastatin, 1% for fluvastatin, 10% for lovastatin and 22% for simvastatin. Atorvastatin-treated patients required a lower median dose than other treatments. Median doses at week 54 with the last available visit carried forward were atorvastatin 20 mg/day, fluvastatin 40 mg/day + colestipol 20 g/day, lovastatin 80 mg/day, simvastatin 40 mg/day.
Conclusions. A significantly greater number (p < 0.05) of patients with confirmed atherosclerosis treated with atorvastatin reached the target LDL cholesterol concentration at the starting dose than patients treated with fluvastatin or lovastatin, and significantly fewer (p < 0.05) patients treated with atorvastatin required combination therapy with colestipol to achieve target LDL cholesterol concentrations than all other statins tested.
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Abbreviations and Acronyms
| | ALT | = alanine aminotransferase | | AST | = aspartate aminotransferase | | CHD | = coronary heart disease | | FRR | = Food Record Rating | | HDL | = high-density-lipoprotein | | LDL | = low-density-lipoprotein | | NCEP | = National Cholesterol Education Program |
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