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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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.
Authors: G M Walsh; L Annunziato; N Frossard; K Knol; S Levander; J M Nicolas; M Taglialatela; M D Tharp; J P Tillement; H Timmerman Journal: Drugs Date: 2001 Impact factor: 9.546
Authors: Eli O Meltzer; Daniel L Hamilos; James A Hadley; Donald C Lanza; Bradley F Marple; Richard A Nicklas; Claus Bachert; James Baraniuk; Fuad M Baroody; Michael S Benninger; Itzhak Brook; Badrul A Chowdhury; Howard M Druce; Stephen Durham; Berrylin Ferguson; Jack M Gwaltney; Michael Kaliner; David W Kennedy; Valerie Lund; Robert Naclerio; Ruby Pawankar; Jay F Piccirillo; Patricia Rohane; Ronald Simon; Raymond G Slavin; Alkis Togias; Ellen R Wald; S James Zinreich Journal: Otolaryngol Head Neck Surg Date: 2004-12 Impact factor: 3.497
Authors: Eli O Meltzer; Daniel L Hamilos; James A Hadley; Donald C Lanza; Bradley F Marple; Richard A Nicklas; Claus Bachert; James Baraniuk; Fuad M Baroody; Michael S Benninger; Itzhak Brook; Badrul A Chowdhury; Howard M Druce; Stephen Durham; Berrylin Ferguson; Jack M Gwaltney; Michael Kaliner; David W Kennedy; Valerie Lund; Robert Naclerio; Ruby Pawankar; Jay F Piccirillo; Patricia Rohane; Ronald Simon; Raymond G Slavin; Alkis Togias; Ellen R Wald; S James Zinreich Journal: J Allergy Clin Immunol Date: 2004-12 Impact factor: 10.793