Clarinex - Side Effects & Drug Interactions

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** Mean reduction in TSS averaged over the 2-week treatment period.

There were no significant differences in the effectiveness of CLARINEX Tablets 5 mg across subgroups of patients defined by gender, age, or race.

Perennial Allergic Rhinitis:

The clinical efficacy and safety of CLARINEX Tablets 5 mg were evaluated in over 1,300 patients 12 to 80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/ day of CLARINEX in 2 double-blind, randomized, placebo-controlled clinical trials of 4 weeks' duration conducted in the United States and internationally. In one of these studies CLARINEX Tablets 5 mg once daily was shown to significantly reduce symptoms of perennial allergic rhinitis (Table 3).

PRODUCT INFORMATION

CLARINEX ® (desloratadine)

TABLETS, REDITABS ® TABLETS

Table 3

TOTAL SYMPTOM SCORE (TSS) Changes in a 4 Week Clinical Trial in Patients with Perennial Allergic Rhinitis

Treatment Mean Change from Placebo Group Baseline* Baseline** Comparison

(n) (sem) (sem) (P-value)

CLARINEX 5.0 mg (337) 12.37 (0.18) -4.06 (0.21) P= 0.01

Placebo (337) 12.30 (0.18) -3.27 (0.21)

*At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms, each symptom scored 0 to 3 where 0= no symptom and 3= severe symptoms) of at least 10 was required for trial eligibility. TSS ranges from 0= no symptoms to 24= maximal symptoms. ** Mean reduction in TSS averaged over the 4-week treatment period.

Chronic Idiopathic Urticaria:

The efficacy and safety of CLARINEX Tablets 5 mg once daily was studied in 416 chronic idiopathic urticaria patients 12 to 84 years of age, of whom 211 received CLARINEX. In two double-blind, placebo-controlled, randomized clinical trials of six weeks' duration, at the pre-specified one-week primary time point evaluation, CLARINEX Tablets significantly reduced the severity of pruritus when compared to placebo (Table 4). Secondary endpoints were also evaluated and during the first week of therapy CLARINEX Tablets 5 mg reduced the secondary endpoints, "Number of Hives" and the "Size of the Largest Hive," when compared to placebo.

Table 4

PRURITUS SYMPTOM SCORE (TSS) Changes in the First Week of a Clinical Trial in Patients with Chronic Idiopathic Urticaria

Treatment Mean Change from Placebo Group Baseline Baseline* Comparison

(n) (sem) (sem) (P-value)

CLARINEX 5.0 mg (115) 2.19 (0.04) -1.05 (0.07) P< 0.01

Placebo (110) 2.21 (0.04) -0.52 (0.07)

Pruritus scored 0 to 3 where 0= no symptom to 3= maximal symptom. *Mean reduction in pruritus averaged over the first week of treatment.