Financial Disclosure: Dr Andrade
has performed consulting services and received grant support in the past from
Merck, Pfizer, and Bristol-Myers Squibb, manufacturers of lipid-lowering drugs.
Author Contributions: Dr Graham had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Graham, Staffa, Shatin,
Andrade, La Grenade, Platt.
Acquisition of data: Staffa, Shatin, Andrade,
Schech, Gurwitz, Chan, Goodman.
Analysis and interpretation of data: Graham,
Staffa, Shatin, Andrade, Schech, La Grenade.
Drafting of the manuscript: Graham.
Critical revision of the manuscript for important
intellectual content: Graham, Staffa, Shatin, Andrade, Schech, La Grenade,
Gurwitz, Chan, Goodman, Platt.
Statistical analysis: Graham, La Grenade, Chan.
Obtained funding: Staffa, Gurwitz.
Administrative, technical, or material support:
Graham, Staffa, Shatin, Andrade, Schech, La Grenade, Gurwitz, Chan, Platt.
Study supervision: Staffa, Shatin, Andrade,
Funding/Support: This study was supported by
2 cooperative agreements, FD-U-002067 (UnitedHealth Group) and FD-U-002068
(HMO consortium of Harvard-Pilgrim Healthplan, Fallon Community Health Plan,
and Health Partners), from the US Food and Drug Administration.
Role of the Sponsor: The Food and Drug Administration
(FDA) did not participate in the design and conduct of the study, in the collection,
analysis, and interpretation of the data, or in the preparation, review, or
approval of the manuscript. Dr Graham and several coauthors are employees
of the FDA but functioned as investigators without direction or interference
by the FDA.
Acknowledgment: We thank Margaret J. Burgess
for her programming assistance and technical support.