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; Ginger S. Watson, PhD
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.
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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.
Sedating antihistamines may impair driving performance as seriously as alcohol.
To compare the effects of fexofenadine, diphenhydramine, alcohol, and placebo on driving performance.
Randomized, double-blind, double-dummy, four-treatment, four-period crossover trial.
The Iowa Driving Simulator.
40 licensed drivers with seasonal allergic rhinitis who were 25 to 44 years of age.
One dose of fexofenadine (60 mg), diphenhydramine (50 mg), alcohol (approximately 0.1% blood alcohol concentration), or placebo, given at weekly intervals before participants drove for 1 hour in the Iowa Driving Simulator.
The primary end point was coherence, a continuous measure of participants' ability to match the varying speed of a vehicle that they were following. Secondary end points were drowsiness and other driving measures, including lane keeping and response to a vehicle that unexpectedly blocked the lane ahead.
Participants had significantly better coherence after taking alcohol or fexofenadine than after taking diphenhydramine. Lane keeping (steering instability and crossing the center line) was impaired after alcohol and diphenhydramine use compared with fexofenadine use. Mean response time to the blocking vehicle was slowest after alcohol use (2.21 seconds) compared with fexofenadine use (1.95 seconds). Self-reported drowsiness did not predict lack of coherence and was weakly associated with minimum following distance, steering instability, and left-lane excursion.
Participants had similar performance when treated with fexofenadine or placebo. After alcohol use, participants performed the primary task well but not the secondary tasks; as a result, overall driving performance was poorer. After participants took diphenhydramine, driving performance was poorest, indicating that diphenhydramine had a greater impact on driving than alcohol did. Drowsiness ratings were not a good predictor of impairment, suggesting that drivers cannot use drowsiness to indicate when they should not drive.
Weiler JM, Bloomfield JR, Woodworth GG, et al. Effects of Fexofenadine, Diphenhydramine, and Alcohol on Driving Performance: A Randomized, Placebo-Controlled Trial in the Iowa Driving Simulator. Ann Intern Med. 2000;132:354–363. doi: 10.7326/0003-4819-132-5-200003070-00004
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Published: Ann Intern Med. 2000;132(5):354-363.
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