Tags

Type your tag names separated by a space and hit enter

The effects of acute doses of fexofenadine, promethazine, and placebo on cognitive and psychomotor function in healthy Japanese volunteers.
Ann Allergy Asthma Immunol. 2003 Apr; 90(4):404-10.AA

Abstract

BACKGROUND

Genetic variations in cross-cultural metabolic capability may attenuate the lack of central nervous system effects of fexofenadine.

OBJECTIVE

To compare the pharmacodynamics of fexofenadine and promethazine versus placebo in Japanese volunteers.

METHODS

In this randomized, crossover, double-blind study, 24 subjects received single doses of fexofenadine 60 mg and 120 mg, promethazine 25 mg, and placebo, with a 6-day washout period between treatments. Objective measures included critical flicker fusion, choice reaction time, and a compensatory tracking task. A line analog rating scale evaluated self-rated sedation. A rapid visual information-processing task evaluated vigilance at baseline and at 2 hours.

RESULTS

Fexofenadine was not significantly different from placebo on any test at any timepoint. In contrast, promethazine impaired critical flicker fusion thresholds (F[3,63] = 5.37, P = 0.0023); increased recognition reaction time (F[3,63] = 13.63, P < 0.0001) and total reaction time (F[3,63] = 12.23, P < 0.0001) components of the choice reaction time test; reduced tracking accuracy (F[3,63] = 14.25, P < 0.0001) and increased reaction times to peripheral stimuli (F[3,63] = 9.29, P < 0.0001) in the compensatory tracking task; reduced the number of valid responses (F[3,63] = 14.86, P < 0.0001) and impaired reaction times (F[3,63] = 12.02, P < 0.0001) in the rapid visual information-processing task test; and impaired subjective ratings of sedation (F[3,63] = 7.55, P = 0.0002), compared with placebo.

CONCLUSIONS

A battery of tests sensitive to impairment by promethazine failed to show any negative cognitive or psychomotor effects with fexofenadine 60 and 120 mg. Fexofenadine is an intrinsically non-impairing antihistamine in Japanese subjects.

Authors+Show Affiliations

HPRU Medical Research Centre, University of Surrey, Egerton Road, Guildford, Surrey, United Kingdom. f.ridout@surrey.ac.ukNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12722962

Citation

Ridout, Fran, and Ian Hindmarch. "The Effects of Acute Doses of Fexofenadine, Promethazine, and Placebo On Cognitive and Psychomotor Function in Healthy Japanese Volunteers." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 90, no. 4, 2003, pp. 404-10.
Ridout F, Hindmarch I. The effects of acute doses of fexofenadine, promethazine, and placebo on cognitive and psychomotor function in healthy Japanese volunteers. Ann Allergy Asthma Immunol. 2003;90(4):404-10.
Ridout, F., & Hindmarch, I. (2003). The effects of acute doses of fexofenadine, promethazine, and placebo on cognitive and psychomotor function in healthy Japanese volunteers. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 90(4), 404-10.
Ridout F, Hindmarch I. The Effects of Acute Doses of Fexofenadine, Promethazine, and Placebo On Cognitive and Psychomotor Function in Healthy Japanese Volunteers. Ann Allergy Asthma Immunol. 2003;90(4):404-10. PubMed PMID: 12722962.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of acute doses of fexofenadine, promethazine, and placebo on cognitive and psychomotor function in healthy Japanese volunteers. AU - Ridout,Fran, AU - Hindmarch,Ian, PY - 2003/5/2/pubmed PY - 2003/5/29/medline PY - 2003/5/2/entrez SP - 404 EP - 10 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 90 IS - 4 N2 - BACKGROUND: Genetic variations in cross-cultural metabolic capability may attenuate the lack of central nervous system effects of fexofenadine. OBJECTIVE: To compare the pharmacodynamics of fexofenadine and promethazine versus placebo in Japanese volunteers. METHODS: In this randomized, crossover, double-blind study, 24 subjects received single doses of fexofenadine 60 mg and 120 mg, promethazine 25 mg, and placebo, with a 6-day washout period between treatments. Objective measures included critical flicker fusion, choice reaction time, and a compensatory tracking task. A line analog rating scale evaluated self-rated sedation. A rapid visual information-processing task evaluated vigilance at baseline and at 2 hours. RESULTS: Fexofenadine was not significantly different from placebo on any test at any timepoint. In contrast, promethazine impaired critical flicker fusion thresholds (F[3,63] = 5.37, P = 0.0023); increased recognition reaction time (F[3,63] = 13.63, P < 0.0001) and total reaction time (F[3,63] = 12.23, P < 0.0001) components of the choice reaction time test; reduced tracking accuracy (F[3,63] = 14.25, P < 0.0001) and increased reaction times to peripheral stimuli (F[3,63] = 9.29, P < 0.0001) in the compensatory tracking task; reduced the number of valid responses (F[3,63] = 14.86, P < 0.0001) and impaired reaction times (F[3,63] = 12.02, P < 0.0001) in the rapid visual information-processing task test; and impaired subjective ratings of sedation (F[3,63] = 7.55, P = 0.0002), compared with placebo. CONCLUSIONS: A battery of tests sensitive to impairment by promethazine failed to show any negative cognitive or psychomotor effects with fexofenadine 60 and 120 mg. Fexofenadine is an intrinsically non-impairing antihistamine in Japanese subjects. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/12722962/The_effects_of_acute_doses_of_fexofenadine_promethazine_and_placebo_on_cognitive_and_psychomotor_function_in_healthy_Japanese_volunteers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61824-8 DB - PRIME DP - Unbound Medicine ER -