Published Online: March 25, 2007 (doi:10.1001/jama.297.12.1362).
Author Contributions: Dr Nissen and the Cleveland Clinic Cardiovascular Coordinating Center had full and independent access to all of the data in the study, and Dr Nissen takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Nissen, Howey, Wang, Gomez.
Acquisition of data: Nissen, Howey, McErlean, Wang, Gomez, Russo.
Analysis and interpretation of data: Nissen, Nicholls, Wolski, Howey, Wang, Gomez.
Drafting of the manuscript: Nissen, Nicholls, Wang.
Critical revision of the manuscript for important intellectual content: Nissen, Nicholls, Wolski, Howey, McErlean, Gomez, Russo.
Statistical analysis: Nicholls, Wolski, Howey, Wang, Gomez.
Obtained funding: Nissen.
Administrative, technical, or material support: Nissen, Howey, McErlean.
Study supervision: Nissen, Howey, Russo.
Financial Disclosures: Dr Nissen reports having received research support from AstraZeneca, Eli Lilly, Pfizer, Sanofi-Aventis, Sankyo, and Takeda through the Cleveland Clinic Cardiovascular Coordinating Center. He also reports consulting for many pharmaceutical companies but requiring them to donate all honoraria and speaking fees directly to charity so that he does not receive income or a tax deduction. Dr Nicholls reports having received honoraria for lecturing from AstraZeneca, Merck Schering-Plough, and Pfizer, consulting fees from Anthera Pharmaceuticals and AstraZeneca, and research support from LipidSciences. Drs Howey, Wang, and Ms Gomez are employees of Eli Lilly. No other financial disclosures were reported.
Data and Safety Monitoring Board: James H. Stein, MD, University of Wisconsin, Madison (Chair); Kerry Lee, PhD, Duke Clinical Research Institute; Paul D. Thompson, MD, Hartford Hospital, Hartford, Conn; Christie M. Ballantyne, MD, Baylor College of Medicine, Houston, Tex; William Weintraub, MD, Emory Center for Outcomes Research, Atlanta, Ga; Robert L. Frye, Mayo Clinic, Rochester, Minn; and David Waters, MD, San Francisco General Hospital, San Francisco, Calif.
Investigators: Neem Research Group, Columbia, SC (James Allison, MD); Regional Physicians Research, High Point, NC (Gordon Arnold, MD); Cardiology Associates of North Mississippi, Tupelo (Barry Bertolet, MD); McLaren Regional Medical Center, Flint, Mich (David Brill, MD); Hillcrest Clinical Research, Simpsonville, SC (Robert Broker, MD); Altru Health Systems Hospital, Grand Forks, ND (James Brosseau, MD); Pulmonary & Research Associates, Spokane, Wash (Timothy Bruya, MD); Geisinger Clinc, Danville, Pa (Richard Butcher, MD); New West Physicians Clinical Research, Golden, Colo (Kenneth Cohen, MD); Wenatchee Valley Medical Center, Wenatchee, Wash (Steven Kaster, MD); South Denver Cardiology Associates, Littleton, Colo (J. Kern Buckner, MD); Dairyland Medical Center, Red Lion, Pa (Drake DeHart, DO); Scripps Clinic Rancho Bernardo, San Diego, Calif (Margaret Drehobl, MD); Radiant Research, Greer, SC (William Ellison, MD); Village Family Practice, Houston, Tex (Harold Fields, MD); Great Lakes Medical Research, Westfield, NY (Mark Hagen, MD); Research Institute of Middle America, Jeffersonville, Ind (D. Marty Denny, MD); Clinical Research Consultants, Hoover, Ala (Carol Johnson, MD); Health Trends Research, Baltimore, Md (Boris Kerzner, MD); Bend Memorial Clinic, Bend, Ore (Matthew Lasala, MD); Progressive Clinical Research, Vista, Calif (Jon LeLevier, MD); PAB Clinical Research, Brandon, Fla (Daniel Lorch, MD); Holston Medical Group, Kingsport, Tenn (Jerry Miller, MD); Morelli Family Practice, Stoneboro, Pa (Joseph Morelli, MD); Wichita Clinic, Wichita, Kan (Roberta Loeffler, MD); Crystal Lake Health Center, Benzonia, Mich (Richard Nielsen, MD); Rockville Internal Medicine Group, Rockville, Md (Alan Pollack, MD); Ranch View Family Medicine, Highlands Ranch, Colo (Gary Post, MD); Center for Clinical Research, Lexington, Ky (Neil Farris, MD); Cleveland Clinic, Cleveland, Ohio (Michael Rocco, MD); PharmaQuest, Greensboro, NC (John Russo, MD); Internal Medicine Research, Portland, Ore (W. Michael Ryan, MD); Holston Medical Group, Bristol, Tenn (James Schrenker, MD); CMVS Research Institute, Jupiter, Fla (Michael Stein, MD); St Joseph's Medical Center, Stockton, Calif (Shaukat Shah, MD); North Central Research, Mansfield, Ohio (David Subich, MD); Genesis Research International, Longwood, Fla (Raul Tamayo, MD); Iowa Heart Center, West Des Moines (William Wickemeyer, MD); Maine Research Associates, Auburn (Robert Weiss, MD); Founders Medical Practice, Philadelphia, Pa (Gary Yeoman, DO); Cardiology Research Associates, Boca Raton, Fla (David Mishkel, MD); Alpha Medical Research, Oviedo, Fla (Neil Patterson, MD); Medical Arts Research Collaborative, Excelsior Springs, Mo (James LaSalle, MD); University of Kansas Medical Center, Kansas City (Charles Porter, MD); Neem Research Group, Charlotte, NC (William Long, MD); Fayetteville Diagnostic Clinic, Fayetteville, Ark (James Salmon, MD); Great Lakes Family Care, Cadillac, Mich (William George, MD); Southgate Medical Group, West Seneca, NY (Brian Snyder, MD); Crystal Lake Health Center, Interlochen, Mich (Mark Barber, DO); Metrolina Medical Research, Charlotte, NC (George Read, MD); FPA Clinical Research, Kissimmee, Fla (Christopher Chappel, MD); Tricities Medical Research, Bristol, Tenn (David Morin, MD); New Hanover Medical Research, Wilmington, NC (Robert Hutchins, MD); Cedar-Crosse Research Center, Chicago, Ill (Danny Sugimoto, MD); Radiant Research, Philadelphia, Pa (Barry Packman, MD); Redrock Research Center, Las Vegas, Nev (Rachakonda Prabhu, MD); Neem Research Group of Raleigh, Raleigh, NC (John Yacono, MD); New Hope Research of Oregon, Portland (Patrick Rask, MD); and Piedmont Medical Research, Winston-Salem, NC (Stephen Bissette, MD). Each investigator was paid according to the study site agreement, with specific per-patient reimbursement milestones based on work performed. Payment was provided by the Cleveland Clinic Department of Finance and Contracts, under contract to the study sponsor (Eli Lilly and Co).
Funding/Support: This study was funded by Eli Lilly and Co.
Role of the Sponsor: Eli Lilly and Co participated actively in designing the study, developing the protocol, and provided logistical support during the trial. Monitoring of the study was performed by a contract research organization, Omnicare, under contract with the sponsor. The sponsor maintained the trial database. Primary statistical analysis was performed by statisticians employed by Eli Lilly. The manuscript was prepared by Dr Nissen and modified after consultation with the coauthors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the academic authors.
Independent Statistical Analysis: After completion of the trial, as specified in the study contract, a complete copy of the database was transferred to the Cleveland Clinic Cardiovascular Coordinating Center. An independent statistician, Kathy Wolski, MPH, received the entire raw data set, reviewed the analytic plan for appropriateness and accuracy, and independently confirmed all of the analyses prior to inclusion in the manuscript. All discrepancies in results were successfully resolved through consultation between Ms Wolski and statisticians employed by the sponsor.
Acknowledgment: We thank Craig Balog, BS (statistical programmer, Cleveland Clinic Cardiovascular Coordinating Center), and Kendra Jones, MS (statistical programmer, Eli Lilly and Co), Denise Mason, RN, Debbie Davey, RN, and Claire Pothier, MPH (project management, Cleveland Clinic). None of the individuals acknowledged received special compensation for their contributions.