Published Online: November 15, 2010. doi:10.1001/jama.2010.1735
Author Contributions: Dr Kowey 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: Kowey, Reiffel, Ellenbogen, Naccarelli, Pratt.
Acquisition of data: Kowey, Reiffel, Ellenbogen, Naccarelli.
Analysis and interpretation of data: Kowey, Reiffel, Ellenbogen, Naccarelli, Pratt.
Drafting of the manuscript: Kowey, Reiffel, Ellenbogen, Naccarelli, Pratt.
Critical revision of the manuscript for important intellectual content: Kowey, Reiffel, Ellenbogen, Naccarelli, Pratt.
Statistical analysis: Reiffel.
Obtained funding: Reiffel, Pratt.
Administrative, technical, or material support: Kowey, Reiffel, Ellenbogen, Pratt.
Study supervision: Kowey, Reiffel, Ellenbogen, Naccarelli, Pratt.
Financial Disclosures: Dr Kowey reports serving as a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Blue Ash Pharmaceuticals, Gilead, HUYA Biosciences, sanofi-aventis, Solvay, AstraZeneca, Johnson & Johnson, Merck, Astellas, Pfizer, Sequel, Medtronic, Boston Scientific, St Jude Medical, GlaxoSmithKline, Boehringer Ingelheim, and Otsuka; serving on the speakers bureau of sanofi-aventis; holding stock in Cardionet; and receiving honoraria from GlaxoSmithKline. Dr Reiffel reports receiving a research grant from GlaxoSmithKline; receiving honoraria from sanofi-aventis, Gilead, GlaxoSmithKline, and sanofi-aventis; expects receiving honoraria from and Boehringer Ingelheim; and serving as a consultant for or on the advisory boards of Gilead and GlaxoSmithKline. Dr Ellenbogen reports receiving research grants from Boston Scientific Corp, Biosense Webster, Medtronic Inc, St Jude Medical, and Sanofi Aventis; serving on the speakers bureau of Boston Scientific, St Jude Medical, Biotronik, and Medtronic Inc; expects receiving honoraria from Boehringer Ingelheim; receiving honoraria from Boston Scientific Corp, St Jude Medical, Biosense Webster, and sanofi-aventis; serving as a consultant to or on the advisory boards of Boston Scientific Corp, Biosense Webster, Medtronic Inc, sanofi-aventis, St Jude Medical, Cardionet, Modest, Atritech, EBR, Biotronik, Sorin Biomedical, and GlaxoSmithKline. Dr Naccarelli reports receiving research support from GlaxoSmithKline, Boston Scientific Corp, sanofi-aventis, Boehringer Ingelheim, and GlaxoSmithKline; serving as a consultant for or on the advisory boards of Astellas, GlaxoSmithKline, Medtronic, Boston Scientific Corp, Pfizer, Xention, sanofi-aventis, Gilead, Novartis, Portola, AstraZeneca, Bristol-Myers Squibb, Merck, Biosense-Webster, Ortho-McNeil-Janssen, Blue Ash Pharmaceuticals, St Jude's Medical, and Daiichi-Sankyo. Dr Pratt reports serving as a consultant for or on the advisory boards of Merck, Modest; sanofi-aventis, and GlaxoSmithKline.
Study Design and Publication Committee: Drs Kowey, Reiffel, Ellenbogen, Naccarelli, and Pratt.
A list of the investigators is available here.
Funding/Support: Funding for this study was provided by GlaxoSmithKline.
Role of the Sponsor: The sponsor, Reliant Pharmaceuticals (acquired by GlaxoSmithKline in 2007), designed this clinical trial in collaboration with Drs Kowey, Reiffel, Ellenbogen, Naccarelli, and Pratt. The sponsor conducted the statistical analysis, reviewed the manuscript, and provided minor comments. Editorial support, in the form of development, assembling tables and figures, collating author comments, copyediting, fact checking, and referencing, was performed by Cactus Communications Inc, coordinated by Donald Samulack, PhD, United States, and Elvira D’souza, India, and funded by GlaxoSmithKline.
Independent Statistical Analysis: Todd MacKenzie, PhD, associate professor of biostatistics, Dartmouth Medical School, received the analytic data and the raw data, conducted an independent analysis of the data, and verified the results of the efficacy end points, vital statistics, and adverse events. Dr MacKenzie also processed the data to obtain another version of the primary end point, defined as time to recurrence of atrial fibrillation or flutter, and also recommended inclusion of an analysis in which participants were not censored at the time of use of antiarrhythmic agents. Dr MacKenzie verified that the results presented herein were provided by him. This independent statistical analysis was funded by GlaxoSmithKline.
Additional Contributions: We thank the following employees of GlaxoSmithKline for their assistance with study management and critical review of the manuscript: Rose Snipes, MD, Susan Johnson, MD, Grace Pagano, MS, Rosemary Schroyer, MS, Mayadah Shabbout, MS, Debby Mattioli, RN, BSN, Amy Meadowcroft, PharmD, and Doug Wicks, MPH, CMPP, all of whom are employees of GlaxoSmithKline. We also thank Mss Schroyer and Shabbout for providing statistical analysis.