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Cardiovascular Outcomes in the Irbesartan Diabetic Nephropathy Trial of Patients with Type 2 Diabetes and Overt Nephropathy

Tomas Berl, MD; Lawrence G. Hunsicker, MD; Julia B. Lewis, MD; Marc A. Pfeffer, MD, PhD; Jerome G. Porush, MD; Jean-Lucien Rouleau, MD; Paul L. Drury, MD, FRACP; Enric Esmatjes, MD; Donald Hricik, MD; Chirag R. Parikh, MD; Itamar Raz, MD; Philippe Vanhille, MD; Thomas B. Wiegmann, MD; Bernard M. Wolfe, MD, FRCPC; Francesco Locatelli, MD; Samuel Z. Goldhaber, MD; Edmund J. Lewis, MD, Collaborative Study Group*
[+] Article and Author Information

From University of Colorado Medical School, Denver, Colorado; University of Iowa College of Medicine, Iowa City, Iowa; Vanderbilt University College of Medicine, Nashville, Tennessee; Brigham and Women's Hospital, Boston, Massachusetts; Brookdale University Hospital and Medical Center, Brooklyn, New York; University of Toronto, Toronto, Ontario, Canada; Auckland Diabetes Centre, Auckland, New Zealand; Hospital Clinic, University of Barcelona, Barcelona, Spain; Case Western Reserve University School of Medicine, Cleveland, Ohio; Hadassah University, Jerusalem, Israel; Centre Hospitalier de Valenciennes, Valenciennes, France; University of Kansas City Medical Center and College of Health Sciences, Veterans Affairs Medical Center, Kansas City, Kansas; University of Western Ontario, London, Ontario, Canada; Monzoni Hospital, Lecco, Italy; and Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois.


Acknowledgments: The authors thank Deborah Anzalone, MD, and her staff at Bristol-Myers Squibb for their outstanding support throughout this study and Zafie Craft for her expert administrative assistance.

Grant Support: By Bristol-Myers Squibb Pharmaceutical Research Institute and Sanofi-Synthelabo.

Potential Financial Conflicts of Interest:Consultancies: T. Berl (Bristol-Myers Squibb), L.G. Hunsicker (Bristol-Myers Squibb and Sanofi-Synthelabo), J.B. Lewis (Bristol-Myers Squibb), M.A. Pfeffer (Bristol-Myers Squibb), J.G. Porush (Bristol-Myers Squibb), J.-L. Rouleau (Bristol-Myers Squibb), S.Z. Goldhaber (Bristol-Myers Squibb); Honoraria: T. Berl (Pfizer), L.G. Hunsicker (Bristol-Myers Squibb and Sanofi-Synthelabo), J.B. Lewis (Bristol-Myers Squibb), M.A. Pfeffer (Bristol-Myers Squibb), J.-L. Rouleau (Bristol-Myers Squibb), B.M. Wolfe (Bristol-Myers Squibb); Stock ownership or options (other than mutual funds): L.G. Hunsicker (Bristol-Myers Squibb); Expert testimony: M.A. Pfeffer (Bristol-Myers Squibb); Grants received: T. Berl (Pfizer), L.G. Hunsicker (Bristol-Myers Squibb and Sanofi-Synthelabo), J.B. Lewis (Bristol-Myers Squibb), M.A. Pfeffer (Bristol-Myers Squibb), J.G. Porush (Bristol-Myers Squibb), J.-L. Rouleau (Bristol-Myers Squibb), B.M. Wolfe (Bristol-Myers Squibb).

Requests for Single Reprints: Edmund J. Lewis, MD, Rush-Presbyterian-St. Luke's Medical Center, The Collaborative Study Group (CSG), 1750 West Harrison, Rawson Building, Room 522, Chicago, IL 60612; e-mail, csg@rush.edu.

Current Author Addresses: Drs. Berl and Parikh: University of Colorado, 4200 East 9th Avenue, Denver, CO 80262.

Dr. Hunsicker: University of Iowa College of Medicine, 200 Hawkins Drive, Iowa City, IA 52242-1081.

Dr. J.B. Lewis: Vanderbilt University, 21st and Garland Avenues, Nashville, TN 37232-2372.

Drs. Pfeffer and Goldhaber: Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.

Dr. Porush: Brookdale University Hospital and Medical Center, 1 Brookdale Plaza, Brooklyn, NY 11212.

Dr. Rouleau: Toronto General Hospital, 200 Elizabeth, EN 13-212, Toronto, Ontario M5G 2C4, Canada.

Dr. Drury: Auckland Diabetes Centre, 5th Floor, 48 Greys Avenue, Auckland, New Zealand 1005.

Dr. Esmatjes: Hospital Clinic, University of Barcelona, Villarroel, 170, E-08036, Barcelona, Spain.

Dr. Hricik: University Hospital of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106.

Dr. Raz: Hadassah Hospital, Ein Kerem, Jerusalem, Israel.

Dr. Vanhille: Hospital de Valenciennes, Avenue Desandronin, Valenciennes, France 59322.

Dr. Wiegmann: Veterans Affairs Medical Center, 4901 Linwood, Kansas City, MO 64128.

Dr. Wolfe: University of Western Ontario, 1151 Richmond Street, London, Ontario N6A 5B8, Canada.

Dr. Locatelli: A. Manzoni Hospital, Via D'remo 9/11, Lecco, Italy 23900.

Dr. E.J. Lewis: Rush-Presbyterian-St. Luke's Medical Center, The Collaborative Study Group (CSG), 1750 West Harrison, Rawson Building, Room 522, Chicago, IL 60612.

Author Contributions: Conception and design: T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.G. Porush, J.-L. Rouleau, P.L. Drury, I. Raz.

Analysis and interpretation of the data: T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.G. Porush, J.-L. Rouleau, P.L. Drury, I. Raz, S.Z. Goldhaber.

Drafting of the article: T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.G. Porush.

Critical revision of the article for important intellectual content: T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.G. Porush, J.-L. Rouleau, P.L. Drury, T.B. Wiegmann, F. Locatelli, S.Z. Goldhaber.

Final approval of the article: T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.-L. Rouleau, P.L. Drury, E. Esmatjes, D.E. Hricik, I. Raz, P. Vanhille, B.M. Wolfe, F. Locatelli, S.Z. Goldhaber.

Provision of study materials or patients: T. Berl, L.G. Hunsicker, J.G. Porush, J.-L. Rouleau, P.L. Drury, E. Esmatjes, D.E. Hricik, I. Raz, P. Vanhille, T.B. Wiegmann, B.M. Wolfe, F. Locatelli.

Statistical expertise: L.G. Hunsicker, C.R. Parikh.

Administrative, technical, or logistic support: T. Berl, T.B. Wiegmann.


Ann Intern Med. 2003;138(7):542-549. doi:10.7326/0003-4819-138-7-200304010-00010
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The baseline characteristics of the three groups are shown in Table 1. A flow diagram of the study is shown in the Appendix Figure.

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Figures

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Figure.
Time to first cardiovascular composite event as a function of treatment assignment.P

The numbers of patients at risk in each treatment group at 6-month intervals are shown on the x-axis. There was no statistically significant overall difference among treatment groups ( > 0.05) or for any specific pairwise comparison.

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Appendix Figure. Administrative censoring took place on 21 December 2000. Final analysis was by intention to treat. Enrollment period was 1 March 1996 to 25 February 1999. BP = blood pressure.
Flow diagram for the Irbesartan Diabetic Nephropathy Trial.
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Summary for Patients

Effects of Blood Pressure Drugs in Patients with Diabetes and Kidney Disease

The summary below is from the full report titled “Cardiovascular Outcomes in the Irbesartan Diabetic Nephropathy Trial of Patients with Type 2 Diabetes and Overt Nephropathy.” It is in the 1 April 2003 issue of Annals of Internal Medicine (volume 138, pages 542-549). The authors are T. Berl, L.G. Hunsicker, J.B. Lewis, M.A. Pfeffer, J.G. Porush, J.-L. Rouleau, P.L. Drury, E. Esmatjes, D. Hricik, C.R. Parikh, I. Raz, P. Vanhille, T.B. Wiegmann, B.M. Wolfe, F. Locatelli, S.Z. Goldhaber, and E.J. Lewis, for the Collaborative Study Group.

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