Author Contributions: Dr de Groot 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: de Groot, Kastelein, Davidson, Stein.
Acquisition of data: de Groot, Ose, Habib, Schwocho, Stein.
Analysis and interpretation of data: Meuwese, de Groot, Duivenvoorden, Trip, Maritz, Basart, Kastelein, Stein, Zwinderman.
Drafting of the manuscript: Meuwese, de Groot, Duivenvoorden, Stein.
Critical revision of the manuscript for important intellectual content: Duivenvoorden, Trip, Ose, Maritz, Basart, Kastelein, Habib, Davidson, Zwinderman, Schwocho.
Statistical analysis: de Groot, Meuwese, Duivenvoorden, Zwinderman.
Obtained funding: Kastelein, Stein.
Administrative, technical, or material support: de Groot, Duivenvoorden, Trip, Ose, Maritz, Basart, Habib, Kastelein, Davidson, Schwocho, Stein.
Study supervision: Kastelein, de Groot, Stein.
Financial Disclosures: Dr de Groot reports serving as a consultant to Wyeth and being paid lecture fees from MSD. Dr Ose reports receiving consulting fees from Kowa, Merck, and Genzyme. Dr Kastelein reports receiving consulting fees from Sankyo, ISIS, Novartis, Genzyme, Pfizer, Roche, AstraZeneca, Merck, and Schering-Plough; being paid lecture fees from Pfizer, Roche, AstraZeneca, Genzyme, Merck, and Schering-Plough; and receiving grant support from AstraZeneca, Merck, Pfizer, Roche, and Schering-Plough. Dr Schwocho is an employee at Daiichi Sankyo Pharma Development. Dr Stein reports receiving consulting and speakers fees and research funding from Sankyo, AstraZeneca, Merck, Schering-Plough, Roche, Takeda, ISIS, Novartis, Reliant, and Abbott. No other authors reported any financial disclosures.
The CAPTIVATE Investigators (No. of patients randomized): M. Trip, Academisch Medisch Centrum, Amsterdam, the Netherlands (77); E. Stein, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio (60); L. Ose and G. Langslet, Rikshospitalet, Oslo, Norway (54); F. Maritz and M. Pretorius, Karl Bremer Hospital, Bellville, South Africa (54); D. Basart, Vasculair Onderzoek Centrum Hoorn, Hoorn, the Netherlands (40); R. Habib, Centre Cardiovasculaire de Laval, Chomedey Laval, Canada (38); E. Sijbrands and J. Jonker, Andromed Rotterdam, Rotterdam, the Netherlands (38); J. Jonker, Andromed Noord, Groningen, the Netherlands (36); P. Nierop, St. Franciscus Gasthuis, Rotterdam, the Netherlands (35); C. Gagné, Clinic of Lipid Disease of Quebec Inc, Ste-Foy, Canada (29); D. Gaudet, Lipid Research Group, CMGC, Chicoutimi, Canada (29); P. Durrington, Manchester Royal Infirmary, Manchester, England (25); M. Tonkon, Apex Research Institute, Santa Ana, California (25); J. Frohlich, St. Paul's Hospital, Vancouver, Canada (23); J. Davignon, Clinical Research Institute of Montreal, Montreal, Canada (21); R. Knopp, Northwest Lipid Research Clinic, Seattle, Washington (21); A. Jacovides, Health Emporium Midrand Medical Center, Midrand, South Africa (20); M. Eriksson, Huddinge University Hospital, Stockholm, Sweden (20); R. Rosenson, Northwestern University, Chicago, Illinois (20); P. Hopkins, University of Utah, Salt Lake City (19); E. Ros, Hospital Clinic i Provincial, Barcelona, Spain (16); I. Ker, University of Pretoria, Pretoria, South Africa (14); A. Goldberg, Washington University School of Medicine, St. Louis, Missouri (14); L. Leiter, St. Michael's Hospital, Toronto, Ontario, Canada (14); E. Leitersdorf, Hadassah University Hospital, Jerusalem, Israel (13); A. Liem, Oosterscheldeziekenhuis, Goes, the Netherlands (13); P. Kwiterovich, Johns Hopkins University Lipid Clinic, Baltimore, Maryland (13); C. Ballantyne, Baylor Medical College, Houston, Texas (13); Ramautarsing, Andromed Leiden, Leiden, the Netherlands (12); G. Eisma, Stichting Huisartsenlaboratorium, Etten-Leur, the Netherlands (12); A. Visman, Beatrix Ziekenhuis, Gorinchem, the Netherlands (11); M. Davidson, Radiant Research Chicago, Chicago, Illinois (10); N. Holwerda, St. Elisabeth Ziekenhuis, Tilburg, the Netherlands (9); K. Hoogenberg, Martini Ziekenhuis, Groningen, the Netherlands (9); F. Pérez Jiménez, Hospital Universitario Reina Sofia, Cordoba, Spain (7); C. Schop, Ijsselland Ziekenhuis, Capelle a/d Ijssel, the Netherlands (7); J. Betteridge, University College London Medical School, London, England (6); A. Olsson, Linkoping University, Linkoping, Sweden (6); R. Hoogma, Groene Hart Ziekenhuis, Gouda, the Netherlands (5); I. Stoel, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands (4).
Funding/Support: The Daiichi Sankyo Pharma Development (formerly Sankyo Pharma Development) sponsored the study.
Role of the Sponsor: The sponsor participated in discussions regarding study design and protocol development and provided logistical support during the trial. Monitoring of the study was performed by the sponsor, who also maintained the clinical and imaging database. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the academic author.
Independent Statistical Analysis: Initial statistical analysis was performed by Daiichi Sankyo Pharma Development and repeated by an independent statistician (Aeilko H. Zwinderman, PhD, Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, the Netherlands). The results of the analyses of the independent statistician are presented in this article.
Additional Contributions: We gratefully acknowledge the generosity of the study participants as well as the nursing staff and investigators.