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The ENHANCE Study and Marketing Ezetimibe
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To the Editor: As investigators of the ENHANCE study, we read with great interest the 3 critical lessons pertaining to our study in the Commentary by Drs Greenland and Lloyd-Jones.1 We appreciate the second and third lessons about the US media and the scientific and patient-oriented organizations, and we share the authors' concerns and opinions in this regard.
However, the authors' assertions regarding Lesson 1 ("Drug Trials Should Not Be Done for Marketing Purposes Only") are inaccurate. The idea, design, and sample size calculation for ENHANCE arose from discussions between the principal investigator and other investigators. Both sponsors were approached by us for support to execute the study.
We considered ENHANCE the logical next step in clinical research in familial hypercholesterolemia (FH) after ASAP2 and LIPIDS,3 2 preceding studies in patients with heterozygous FH that were carried out at the academic hospitals of Amsterdam and Nijmegen in the Netherlands. LIPIDS . . . [Full Text of this Article]
Fatima Akdim, MD;
John J. P. Kastelein, MD, PhD
j.j.kastelein@amc.uva.nl
Department of Vascular Medicine
Academic Medical Center
University of Amsterdam
Amsterdam, the Netherlands
Daniel Gaudet, MD, PhD
Community Genomic Medicine Center and Lipid Clinic
Chicoutimi University Hospital
Montreal University
Chicoutimi, Quebec, Canada
RELATED ARTICLE
Critical Lessons From the ENHANCE Trial
Philip Greenland and Donald Lloyd-Jones
JAMA. 2008;299(8):953-955.
EXTRACT
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RELATED LETTER
The ENHANCE Study and Marketing Ezetimibe—Reply
Philip Greenland and Donald Lloyd-Jones
JAMA. 2008;299(23):2747-2748.
EXTRACT
| FULL TEXT
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