Model for outcomes assessment of antihistamine use for seasonal allergic rhinitis.
BACKGROUND
Drug selection for optimal treatment of common medical conditions may be difficult and involve many diverse factors.


OBJECTIVE
The efficacy, safety, quality of life, and cost of treatment of seasonal allergic rhinitis with cetirizine, chlorpheniramine, or terfenadine were compared in a prospective, two-phase, randomized, single-blind clinical trial conducted in a managed care setting.


METHODS
In phase I, which lasted 2 weeks, patients were randomized to receive one of the study drugs. In phase II, which lasted 4 weeks, the initial treatment was continued unless patients were dissatisfied, in which case they could be randomly assigned to receive another study drug. In both phases pseudoephedrine could be taken as needed. Patients kept daily diaries of symptoms and costs, and study drugs were evaluated at the end of each phase for efficacy, safety, and effect on quality of life by means of a validated questionnaire. A multiattribute outcomes assessment model for formulary decision making was used to rank the antihistamines.


RESULTS
Physicians' and patients' assessments in phases I and II indicated that cetirizine and chlorpheniramine were significantly more effective than terfenadine (p < 0.05). Incidence of sedation in phase I and phase II was 40.5% and 16.7% for chlorpheniramine, 11.6% and 9.8% for cetirizine, and 6.7% and 5.1% for terfenadine, respectively. At the end of phase I, 28.9% of the patients treated with chlorpheniramine, 50% of the patients treated with terfenadine, and 69.4% of the patients treated with cetirizine were satisfied with their therapy and chose not to switch their medication. Quality of life scores improved most after treatment with cetirizine and least after treatment with terfenadine.


CONCLUSIONS
The result of this trial indicate that antihistamine selection is best made with the use of a multiattribute evaluation that includes quality of life. In this study cetirizine was favored by patients and physicians most often, followed by chlorpheniramine and then terfenadine.
Harvey
R P
RP
Allergy Department, Kaiser-Permanente System, Denver, CO 80231, USA.
Comer
C
C
Sanders
B
B
Westley
R
R
Marsh
W
W
Shapiro
H
H
Wiener
M
M
D000293:Adolescent; D000328:Adult; D017332:Cetirizine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D002744:Chlorpheniramine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003657:Decision Making; D005260:Female; D005569:Formularies as Topic; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016593:Terfenadine / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*
D006634:Histamine H1 Antagonists; D002744:Chlorpheniramine; D016593:Terfenadine; D017332:Cetirizine