Loratadine (SCH29851) 40 mg once daily versus terfenadine 60 mg twice daily in the treatment of seasonal allergic rhinitis.

Seventy patients received loratadine 40 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study. Four nasal and four non-nasal symptoms associated with allergic rhinitis were evaluated. At the endpoint (the last evaluable visit), the mean total scores of combined nasal and non-nasal symptoms decreased (improved) from the baseline by 51.8% and 55.7% with loratadine and terfenadine, respectively, but increased (worsened) by 6.1% with placebo. There was a significant difference between both the loratadine and terfenadine treatment groups and the placebo group (P = 0.001) but not between the active medication groups (P = 0.608). Overall therapeutic response was good or excellent in 14 of the 23 patients given loratadine, in 18 of the 24 given terfenadine and in none of the 23 given placebo. The difference between each active medication group and the placebo group was significant (P less than or equal to 0.01) but there was no significant difference between the two active treatment groups (P greater than 0.35). No loratadine patient had any adverse side-effects. Sedating effects occurred in one terfenadine patient, headache in one placebo patient and two terfenadine patients (one terfenadine patient with severe headache discontinued treatment), and dyspepsia in two placebo patients. No anti-cholinergic effects occurred in this study. Loratadine 40 mg once daily was effective and safe in the relief of symptoms of allergic rhinitis.

Protective effect of cetirizine in patients suffering from pollen asthma.

In a double-blind study, 29 patients suffering from pollen asthma were administered placebo for 14 days and were compared with 28 patients administered cetirizine, a new drug displaying a potent and selective H1 antagonism and inhibiting effect on infiltrating cells. FEV1 and FVC were measured before and after treatment. A subjective self-assessment by the patients included daily ENT and pulmonary scores, and beta 2 consumption. The peak flow was also measured every day as well as the rescue drug administration. In the placebo group, the FEV1, FVC, and peak flow values decreased significantly and the ENT and pulmonary scores became worse. Most of the patients in this group dropped out despite the high use of fenoterol and terfenadine. In the cetirizine group, FEV1, FVC, and peak flow values remained close to the predicted values; the ENT and pulmonary scores improved significantly despite low beta 2 consumption. The number of dropouts was low and the administration of corticosteroids was exceptionally limited.

Evaluation of the efficacy and safety of loratadine in perennial allergic rhinitis.

Loratadine, a new nonsedating antihistamine, was evaluated for efficacy and safety in 228 patients with perennial allergic rhinitis. Taken at a dose of 10 mg once daily, loratadine was significantly more effective than placebo and comparable to terfenadine, 60 mg taken twice daily, in reducing combined symptom scores in this patient population. Efficacy was maintained throughout the 28-day course of treatment. The overall incidence of side effects with loratadine was low (14%) with few occurrences of sedation (3%) and dry mouth (4%).

A multicentric study of loratadine, terfenadine and placebo in patients with seasonal allergic rhinitis.

This multicentric study compared 14-day treatment with loratadine (Clarityne) 10 mg once daily, terfenadine 60 mg twice daily and placebo in outpatients with seasonal allergic rhinitis. Of 275 patients enrolled, 256 (87 in the loratadine group, 89 in the terfenadine group and 80 in the placebo group) were evaluable for efficacy and 266 (90, 91 and 85 in respective groups) were evaluable for safety. Investigators graded the severity of 4 nasal and 4 nonnasal signs/symptoms and investigators and patients rated overall disease condition and therapeutic response on treatment days 3, 7 and 14; patients recorded when signs/symptoms of rhinitis were relieved, as well. Hematology and blood chemistry tests were conducted before and after therapy, and patients were questioned throughout the study about possible adverse experiences. At all visits, loratadine and terfenadine were significantly superior to placebo (p less than or equal to 0.004), and the two active medications were statistically comparable, based on mean totals of sign/symptom severity scores and ratings of overall disease condition and therapeutic response. By patients' last valid visit, mean totals of sign/symptoms severity scores improved by 56% and 53% for loratadine and terfenadine groups, respectively, but exacerbated by 5% for the placebo group. Moreover, an excellent or a good therapeutic response was observed in 58/87 (67%) loratadine-treated patients and 58/89 (65%) terfenadine-treated patients, as compared to 13/80 (16%) placebo-treated patients (p less than 0.01). A total of 61/76 (30%) patients in the loratadine group and 57/78 (73%) in the terfenadine group versus 22/71 (31%) in the placebo group experienced relief within the first 3 days of therapy (p less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Comparative effects of loratadine and terfenadine in the treatment of chronic idiopathic urticaria.

Loratadine is a new selective peripheral histamine H1-receptor antagonist, that is orally effective, long-acting, and devoid of significant central and autonomic nervous system activity. Its safety and efficacy were evaluated in a 28-day study conducted in patients with chronic idiopathic urticaria. Patients were randomly assigned to one of three treatment groups (loratadine, 10 mg OD; terfenadine, 60 mg BID; or placebo). Evaluation of efficacy included weekly assessments of the individual disease signs and symptoms, the overall disease condition, and therapeutic response to treatment. Throughout the 28-day treatment period progressive improvement was observed in the loratadine and terfenadine treatment groups; however, at each evaluation, loratadine was significantly more effective than placebo (P less than .01) and clinically more effective than terfenadine in reducing disease signs and symptoms. Terfenadine was significantly more effective than placebo at day 7 and endpoint (last valid visit). The overall therapeutic response at the endpoint of treatment was rated as marked or complete relief of symptoms in 64%, 52%, and 25% of the patients in the loratadine, terfenadine, and placebo treatment groups, respectively. Loratadine was well tolerated and comparable to terfenadine and placebo in incidence of adverse experiences. Sedation was reported in one patient each in the terfenadine and placebo treatment groups and an anticholinergic side effect (dry mouth) in one terfenadine-treated patient. No sedative or anticholinergic side effects were observed in patients receiving loratadine. We concluded that loratadine, 10 mg, once daily is a safe and effective treatment for symptomatic relief of chronic idiopathic urticaria.