SAFETY AND EFFICACY OF TERFENADINE PSEUDOEPHEDRINE VERSUS CLEMASTINE PHENYLPROPANOLAMINE IN THE TREATMENT OF SEASONAL ALLERGIC RHINITIS

A double-blind, randomized, placebo-controlled, parallel trial was con ducted to compare the efficacy and safety of terfenadine, 60 mg (immed iate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-releas e) (T/Ps) and clemastine fumarate, 1.34 mg (immediate-release)/phenylp ropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom s cores recorded in the diaries of 175 patients showed that both therapi es had a highly significant overall treatment effect when compared wit h placebo (P less-than-or-equal-to .02). The overall level of improvem ent, as well as improvement of individual symptoms, was similar with t he two therapies. Total symptom scores assigned by physicians to 170 p atients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies wer e also similar on physicians' evaluations of overall effectiveness. Bo th therapies relieved most histamine-mediated symptoms as well as nasa l congestion, although only T/Ps showed improvement of the latter symp tom in both the patients' diaries and physicians' evaluations. Among 1 78 patients, drowsiness and fatigue occurred more often in the C/Ph gr oup (25% and 11.7% for the two adverse events, respectively) than in t he T/Ps group (10.2% and 1.7%, respectively). The incidence of insomni a and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, res pectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in th e treatment of symptoms of seasonal allergic rhinitis. In addition, wh en used as recommended by current labeling, T/Ps offers a safe, effect ive alternative to C/Ph, particularly where drowsiness and fatigue may be problematic, but at the expense of developing insomnia and dry-mou th symptoms.