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European Heart Journal Advance Access originally published online on August 25, 2005
European Heart Journal 2005 26(21):2344; doi:10.1093/eurheartj/ehi465
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Ezetimibe coadministered with fenofibrate: some safety questions

Javier Borja

J. Uriach y Compañía, S.A.
Polígon Industrial Riera de Caldes
Avinguda Camí Reial, 51-57
Palau-solità i Plegamans
08184 Barcelona
Spain
Tel: +34 902 471 511
Fax: +34 938 646 606
E-mail address: fv-borja{at}uriach.com

I would like to comment on some questions in reference to the article of Dr Farnier and co-workers on the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidemia.1

First, criteria of clinical and/or laboratory muscle-related adverse events are not referenced and are not in accordance with the recently published criteria of the ACC/AHA/NHLBI clinical advisory on the use and safety of statins.2 It should be convenient to know why these criteria were used.

Secondly, consecutive elevations of CK>10xULN without muscle symptoms or CK>5xULN with muscle symptoms were reasonably defined as adverse events of clinical interest. On one hand, neither time between consecutive determinations of CK nor whether the study drugs should be withdrawn after the first CK elevation are not specified. It should be considered that the levels of the CK decrease ~39% per day after the cause is stopped3 and, thus, depending on the time elapsed between two consecutive determinations, an elevation of CK attributable to the study drugs could be missed. It should be interesting for the reader that what was the time allowed in the study protocol between the first elevation of CK and the second determination. On the other, it should be mentioned that the ACC/AHA/NHLBI clinical advisory on the use and safety of statins2 considers that muscle symptoms with increased CK levels are criteria of myositis and advise that in this situation the drug should be discontinued immediately. Of course, it is referred to statins but in the case of fibrates, it does not seem different. For this reason, it is surprising that patients with a first elevation of CK>5xULN with muscle symptoms were allowed to continue being treated with the study medications. This question should be clarified by authors.

Conflict of interest: none declared.

References

  1. Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ, Mitchel YB, Gumbiner B, for the Ezetimibe Study Group. Efficacy and safety of the coadministration of ezetimibe with fenofibrate in patients with mixed hyperlipidemia. Eur Heart J 2005;26:897–905.[Abstract/Free Full Text]
  2. Allison RC, Bedsole LD. The other medical causes of rhabdomyolysis. Am J Med Sci 2003;326:79–88.[Medline]
  3. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol 2002;40:567–572.[Free Full Text]

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[Abstract] [Full Text] [PDF]

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