Q&A

Ezetimibe plus atorvastatin lowers cholesterol

J Fam Pract. 2003 September;52(9):664-688
By
Wendy S. Madigosky, MD
Kevin Y. Kane, MD, MSPH
Author and Disclosure Information

  • BACKGROUND: Ezetimibe is a new medication that prevents intestinal absorption of cholesterol. This trial assessed reductions in LDL cholesterol levels from coadministration of ezetimibe and atorva-statin compared with those of each drug alone.
  • POPULATION STUDIED: The researchers conducting this trial enrolled 628 (primarily white) individuals aged 18 years with hypercholesterolemia (calculated LDL 145–250 mg/dL) and triglycerides 350 mg/dL.
  • STUDY DESIGN AND VALIDITY: This industry-sponsored randomized, double-blind, placebo-controlled trial consisted of 3 phases. Screening included a 2- to 12-week washout of previous lipid-altering drug therapy and instruction in a National Cholesterol Education Program Step I (or stricter) diet.
  • OUTCOMES MEASURED: The investigators measured percent change in direct LDL cholesterol from baseline to final measurement. Secondary outcomes included change from baseline to final measurement of calculated LDL, total cholesterol, triglyceride, HDL cholesterol, and several other lipid-related variables. Patient-oriented outcomes, such as rates of death, stroke, or myocardial infarction were not addressed. Cost-effectiveness of the combination was not evaluated.
  • RESULTS: Demographics and baseline characteristics were similar across treatment groups. Ninety-two percent of subjects completed the 12-week study. When the treatment groups were pooled together, the combination of ezetimibe with atorvastatin resulted in a greater mean decrease in direct LDL cholesterol than atorvastatin alone (–54.5% vs –42.4%; P<.01) or ezetimibe alone (–54.5% vs –18.4%; P<.01). This combination also resulted in statistically significant reductions in total cholesterol (–9%), triglycerides (–8%), and an increase in HDL cholesterol (3%) compared with atorvastatin alone.
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PRACTICE RECOMMENDATIONS

Ezetimibe plus atorvastatin lowers low-density lipoprotein (LDL) cholesterol more than either alone. When combined with low-dose atorvastatin (10 mg), ezetimibe achieves reductions similar to those seen with atorvastatin (80 mg) alone in LDL cholesterol, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, and triglycerides.

Despite these modest reductions in cholesterol, this study does not provide evidence that this combination lessens cardiovascular morbidity or mortality. With this caveat, adding ezetimibe to atorvastatin may be a reasonable alternative for patients already on high-dose atorvastatin who either can’t reach target cholesterol levels or experience significant side effects.

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