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Patterns of Ezetimibe Use in the U.S. and Canada

A distinct difference in prescribing practices between the two countries raises questions about what influences clinical decision making.

Ezetimibe, which inhibits intestinal cholesterol absorption, was approved for use in the U.S. and Canada based on its LDL-lowering effects. Because of a lack of evidence that it improves health outcomes, however, ezetimibe has not been recommended for use as a first-line agent for primary or secondary coronary disease prevention. Both ezetimibe and the combination of ezetimibe with simvastatin were aggressively marketed, and — despite the lack of outcomes data — total sales of products containing ezetimibe reached $5 billion for the year 2007. Investigators used prescription data from the U.S. and Canada to study trends in prescribing and expenditures for ezetimibe in the two countries.

Between January 2002 and December 2006, the number of prescriptions for any lipid-lowering agent increased substantially both in Canada (from 3719 to 7401 per 100,000 population) and in the U.S. (from 3927 to 6827 per 100,000 population). As a proportion of all lipid-lowering agents, prescriptions of any product containing ezetimibe rose from less than 1% in both countries in 2002 to 3.4% in Canada and 15.2% in the U.S. By contrast, the proportion of prescriptions of any product containing a statin was stable in Canada over time but dropped from 86.5% to 80.8% in the U.S. By 2006, monthly expenditures for drugs containing ezetimibe in the U.S. exceeded $261 million, more than four times the expenditures in Canada per 100,000 population.

Comment: By the end of 2006, more than one in six prescriptions for lipid-lowering medications in the U.S. were for ezetimibe, an increase that was accompanied by a decline in statin use, despite the lack of evidence that ezetimibe improves meaningful health outcomes and the robust evidence for the effectiveness of statins. The reasons for the marked difference in the adoption of ezetimibe between the U.S. and Canada cannot be ascertained from this study, but may result from more pronounced formulary restrictions in Canada or regulation prohibiting direct-to-consumer advertising, which was employed extensively in the marketing of ezetimibe in the U.S. Considering the results of ENHANCE (Journal Watch Cardiology Mar 30 2008; summary and letter to readers), the extent to which ezetimibe was adopted in the U.S. has arguably been substantially greater than the evidence would support.

— Frederick A. Masoudi, MD, MSPH

Published in Journal Watch Cardiology April 2, 2008

Citation(s):

Jackevicius CA et al. Use of ezetimibe in the United States and Canada. N Engl J Med 2008 Apr 24; 358. (http://dx.doi.org/10.1056/NEJMsa0801461)