COMPARATIVE-STUDY OF SCH-434 AND CTM-D IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS

The efficacy and safety of an extended-release combination of loratadi ne plus pseudoephedrine sulfate (SCH 434) was compared with that of a tablet containing chlorpheniramine maleate plus pseudoephedrine sulfat e (CTM-D) in 131 patients with symptomatic seasonal allergic rhinitis. Patients were randomly assigned to receive either SCH 434 (loratadine 5 mg and pseudoephedrine sulfate 120 mg) or CTM-D (chlorpheniramine m aleate 12 mg and pseudoephedrine sulfate 120 mg) twice daily for 2 wee ks. Evaluations were made after 3, 7, and 14 days of treatment. Demogr aphics (age, race, sex, and duration of seasonal allergic rhinitis) an d baseline total symptom scores were comparable between groups. Both c ombination products were effective in relieving the symptoms of allerg ic rhinitis. Improvement in total symptom scores was 54% on day 3 and 65% on day 14 in the SCH 434 group versus 57% on day 3 and 64% on day 14 in the CTM-D group. Individual symptom scores (nasal discharge, stu ffiness, nasal itching, sneezing, and ocular symptoms) responded simil arly. A smaller proportion of patients in the SCH 434 group reported s ide effects, especially dry mouth (7% vs 19%, P=0.07), fatigue (6% vs 25%, P<0.01), and sedation (7% vs 22%, P<0.03). In conclusion, the com bination of loratadine plus pseudoephedrine sulfate was equally as eff ective as a classic antihistamine (chlorpheniramine maleate) plus pseu doephedrine sulfate but had a lower incidence of side effects.