Efficacy of leukotriene receptor antagonist with an anti-H1 receptor antagonist for treatment of chronic idiopathic urticaria.

BACKGROUND

Chronic idiopathic urticaria (CIU) is often difficult to treat. Although histamine-releasing activity is detectable for up to 50% of CIU patients, antihistamine therapy provides only a limited response.

OBJECTIVE

This study aimed to assess the clinical efficacy of combined leukotriene receptor antagonist (LRA) and H1 antihistamine, H1 and H2 antihistamine, and two H1 antihistamines as a synergistic therapeutic regimen for treating CIU compared with a matched placebo modality.

METHODS

A total of 120 newly diagnosed adult patients were evaluated. Patients were single blinded and randomly assigned to one of four medication groups that received the following regimens for 4 weeks: Group A, combination of sedating H1 antihistamine and non-sedating H1 antihistamine; Group B, combination of H1 antihistamine and H2 antihistamine; Group C, combination of H1 antihistamine and LRA; and Group D, matched placebo medication. The primary measure of treatment efficacy was the daily urticaria activity score (UAS) of 'wheal and itch'. A positive therapeutic response was defined as a reduction to < 25% of baseline weekly UAS, while a relapse was a return to > 75% of baseline weekly UAS.

RESULTS

In all, 107 patients completed the trial medication. At the end of 4 weeks, the UAS score as a response to treatment was 23.3% for Group A, 63.3% for Group B, 53.3% for Group C, and no real change for the placebo treatment group.

CONCLUSIONS

The combination of LRA and H1 receptor antagonist is promising for CIU treatment and is reasonably well tolerated by patients. The combination of H1- and H2-receptor antagonists provided the greatest treatment efficacy by the measures used in this small study.