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Effects of Fexofenadine, Diphenhydramine, and Alcohol on Driving Performance: A Randomized, Placebo-Controlled Trial in the Iowa Driving Simulator

John M. Weiler, MD; John R. Bloomfield, PhD; George G. Woodworth, PhD; Angela R. Grant, BS; Teresa A. Layton, BSN; Timothy L. Brown, MS; David R. McKenzie, MS; Thomas W. Baker, MS; and Ginger S. Watson, PhD
[+] Article, Author, and Disclosure Information

From the University of Iowa, Iowa City, Iowa; and Hoechst Marion Roussel, Inc., Kansas City, Missouri.

Disclosure: Dr. Weiler serves as a consultant and Dr. Woodworth has provided consulting services to Hoechst Marion Roussel, Inc.

Acknowledgments: The authors thank the following for their assistance in the conduct or analysis of the study: Susan Quinn, Sue Ellen Salisbury, Elizabeth Lawler, Cindy Mitchell, Emily Meis, Kathy Phipps, Suzanne Sack, Jagadish Boggavarapu, Dixie Ecklund and the Clinical Research Center staff, Twila Finkelstein, Julie Qidwai, Christopher Miller, Joss Nichols, Brent Caven, Mark Young, Dawn Kenyon, Kristen Rassbach, Brad Graham, Chris McMillan, Nick Taiber, Sneha Viratia, Srinivas Maddhi, Rohit Goal, Lucas Davisson, Brian Berentsen, Shaheen Bahauddin, Peter Grant, Katie Enstrom, Omar Ahmad, Imran Pirwani, Ludovic Moineau, Yiannis Papelis, Matthew Schikore, Tim Van Fossen, Dave Bronder, Shawn Allen, Rachel Nador, Steven Zellers, Ianos Schmidt, Paul Debbins, and Dave Muller.

Grant Support: By a grant from Hoechst Marion Roussel, Inc., and by grant M01-RR-59 from the National Center for Research Resources, General Clinical Research Centers Program, National Institutes of Health.

Requests for Single Reprints: John M. Weiler, MD, Department of Internal Medicine, University of Iowa, 200 Hawkins Drive, T307GH, Iowa City, IA 52242-1081; e-mail, john-weiler@uiowa.edu.

Requests To Purchase Bulk Reprints (minimum, 100 copies): Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.

Current Author Addresses: Dr. Weiler: University of Iowa Hospitals and Clinics, T307, 200 Hawkins Drive, Iowa City, IA 52242.

Dr. Woodworth: Department of Statistics, University of Iowa, 241 Schaeffer Hall, Iowa City, IA 52242.

Ms. Grant: 1660 Fulmer Street, Ann Arbor, MI 48103.

Ms. Layton: University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242.

Mr. Brown: 4133 SC, University of Iowa, Iowa City, IA 52242.

Mr. McKenzie: Quintiles, Inc., Box 9708, Kansas City, MO 64134-0708.

Mr. Baker: Aventis Pharmaceuticals, Inc., Box 9627, Kansas City, MO 64134-0627.

Dr. Watson: National Advanced Driving Simulator, 2401 Oakdale Boulevard, University of Iowa, Iowa City, IA 52242.

Author Contributions: Conception and design: J.M. Weiler, J.R. Bloomfield, A.R. Grant, G.G. Woodworth, D.R. McKenzie, T.W. Baker.

Analysis and interpretation of the data: J.M. Weiler, J.R. Bloomfield, A.R. Grant, T.L. Brown, G.G. Woodworth, G.S. Watson.

Drafting of the article: J.M. Weiler, T.A. Layton, D.R. McKenzie, T.W. Baker, G.S. Watson.

Critical revision of the article for important intellectual content: J.M. Weiler, J.R. Bloomfield, A.R. Grant, G.G. Woodworth, D.R. McKenzie, T.W. Baker, G.S. Watson.

Final approval of the article: J.M. Weiler, G.G. Woodworth, T.A. Layton, T.L. Brown, T.W. Baker, G.S. Watson.

Provision of study materials or patients: J.M. Weiler, T.W. Baker.

Statistical expertise: G.G. Woodworth, D.R. McKenzie.

Obtaining of funding: J.M. Weiler, J.R. Bloomfield, D.R. McKenzie, T.W. Baker.

Administrative, technical, or logistic support: A.R. Grant, T.A. Layton.

Collection and assembly of data: J.M. Weiler, J.R. Bloomfield, A.R. Grant, T.A. Layton, T.L. Brown.

Ann Intern Med. 2000;132(5):354-363. doi:10.7326/0003-4819-132-5-200003070-00004
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Allergic rhinitis afflicts more than 39 million persons in the United States (1). Only about 4.8 million persons (12%) take prescription drugs for this condition; most go without treatment or self-treat with over-the-counter medications, which generally contain a first-generation antihistamine. These medications may be effective but carry potential risks, including drowsiness and impairment in performing everyday tasks (26). These adverse events may be sufficient to dissuade some persons from treating their symptoms. Other patients take these sedating drugs, become impaired, and try nonetheless to perform complex tasks; as a result, they are more likely to be involved in collisions (2, 78).

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Grahic Jump Location
Figure 1.
Maintenance of following distance for individual participants with near-best, near-worst, and near-median coherence scores.

Initial and final transients are removed. The lower the score, the more erratic the following distance. The best driver (coherence, 0.99) varied about ±2.5 m, the worst driver (coherence, 0.54) varied about ±35 m, and the median driver (coherence, 0.89) varied about ±10 m.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Change from baseline in visual analogue drowsiness scores.

Participants rated drowsiness on a scale from “wide awake” to “extremely drowsy,” which corresponded to a score of 1 to 100 on a 159-mm scale.

Grahic Jump Location




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Summary for Patients

Antihistamines and Driving Performance

The summary below is from the full report titled “Effects of Fexofenadine, Diphenhydramine, and Alcohol on Driving Performance. A Randomized, Placebo-Controlled Trial in the Iowa Driving Simulator.”. It is in the 7 March 2000 issue of Annals of Internal Medicine (volume 132, pages 354-363). The authors are J.M. Weiler, J.R. Bloomfield, G.G. Woodworth, A.R. Grant, T.A. Layton, T.L. Brown, D.R. McKenzie, T.W. Baker, and G.S. Watson.


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