650 correctly keyed-in characters, number of wrongly keyed-in characters and number of revised characters. Subjective self-ratings (visual analogue sc
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1 Effects of Fexofenadine Hydrochloride on Psychomotor Performance Comparison of Impaired Performance of a Word Processor by Fexofenadine Hydrochloride with that by d-chlorpheniramine Maleate in Healthy Volunteers Akinori URAE*1'2 Mitsuko OKADA*1 Shin IRIE*2 Takanori TANAKA*1,2 Yukiko SUNAMI*2 Seiji NIU*2 Kyoko MATSUKUMA*1,2 Hidetoshi FURUIE*1,2 Hiroshi TSUKIKAWA*1 Yoshisuke NITTA*3 Masako NISHIKAWA*3 and Shigeyuki NAKANO*2 *1 Clinical Pharmacology Center, Medical Co. Ltd Jigyo, Chuo-ku, Fukuoka , Japan *2 Department of Clinical Pharmacology and Therapeutics *3 Aventis Pharma Ltd., Oita Medical University Objective : To confirm the hypothesis that fexofenadine hydrochloride (in the thera peutic dose range) does not impair the quality of life, we assessed the effects of fexofenadine hydrochloride (120 mg-higher than Japanese dose) by using an English word processor. Methods : A double-blind, randomized, placebo-controlled, single dose, Latin square crossover study was conducted in 18 healthy volunteers, including 9 males and 9 females, who used word processors in their daily lives. The ratio of the total number of characters input after drug administration to the number input before drug administration was assessed for the following 4 parameters : number of total keyed-in characters, number of
2 650 correctly keyed-in characters, number of wrongly keyed-in characters and number of revised characters. Subjective self-ratings (visual analogue scale) were also measured. d-chlorpheniramine maleate (6 mg) was used as a positive control drug. Results : For the total number of keyed-in characters and the total number of correctly keyed-in characters, the ratios were significantly lower for subjects with d-chlorpheniramine maleate than those for subjects with placebo (p<0.05, respectively). For the total number of wrongly keyed-in characters and the total number of revised characters, the ratios with d-chlorpheniramine maleate were significantly higher than those with placebo (p < 0.05, respectively). These results indicate that d- chlorpheniramine maleate can be used as the active control drug. The ratios for both the total number of correctly keyed-in characters and the total number of keyed-in charac ters were significantly higher for subjects with fexofenadine hydrochloride than for subjects with d-chlorpheniramine maleate (p <0.05, respectively). The ratio for the total number of revised characters was significantly lower for subjects with fexofenadine hydrochloride than for subjects with d-chlorpheniramine maleate (p < 0.05). The ratio for the total number of wrongly keyed-in characters, however, did not differ significantly between subjects with fexofenadine hydrochloride and d-chlorpheniramine maleate (p= 0.051). There were no significant differences between fexofenadine hydrochloride and placebo in all parameters. One subject on fexofenadine experienced mild headache and drowsiness, which were considered likely to be drug related. Another subject experienced dizziness, which was probably an adverse event in the placebo treatment. There was no report of adverse events related to blood pressure, pulse rate, body temperature, electrocardiographic findings or clinical laboratory results. Conclusion : The impairment of word processor performance caused by fexo fenadine hydrochloride was considerably less than that caused by d-chlorpheniramine maleate, and similar to placebo. These results suggest that fexofenadine does not impair quality of life domains related to activities of daily living. In contrast, d- chlorpheniramine maleate significantly impaired performance, which may reflect impairment in the quality of life. Key words : fexofenadine, d-chlorpheniramine maleate, psychomotor performance, QOL
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10 658 by a classical antihistamine, d-chlorpheniramine. Br. J. Pharmacol., 129 : (2000). 7) Mattila, M. J. and Paakkari, I. : Variations among non-sedating antihistamines : are there real differences? Eur. J. Clin. Pharmacol., 55 : (1999). 8) Hindmarch, I. and Shamsi, Z. : Antihistamines : models to assess sedative properties, assessment of sedation, safety and other side-effects. Clin. Exp. Allergy, 29 Suppl. 3 : (1999). 9) Vermeeren, A. and O'Hanlon, J. F. : Fexo fenadine's effects, alone and with alcohol, on actual driving and psychomotor performance. J. Allergy Clin. Immunol., 101 : (1998). 10) Philpot, E. E. Safety of second generation anti histamines. Allergy Asthma Proc., 21:15-20 (2000). 14) Hindmarch, I., Shamsi, Z., Stanley, N., et al. : A double-blind, placebo-controlled investigation of the effects of fexofenadine, loratadine and promethazine on cognitive and psychomotor function. Br. J. Clin. Pharmacol., 48: (1999).
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