A Multicenter, Double-Blind, Randomized, Noninferiority Comparison of 14 Days’ Treatment with Oral Olopatadine 10 mg or Cetirizine 10 mg in Chinese Adults with Cutaneous Pruritus

Abstract

Objectives: To assess whether olopatadine hydrochloride (OH) was noninferior to cetirizine in the treatment of cutaneous pruritus (CP). Patients and Methods: Patients with CP presenting at seven centers in China were randomly allocated to double-blind treatment with 5 mg of OH orally twice a day or cetirizine 10 mg orally once a day for 2 weeks. Patients were followed up on days 7 and 14. Noninferiority was predefined as a 20% maximum difference in the reduction of symptom score reducing indices (SSRI). Both intention-to-treat (ITT) and per-protocol populations were analyzed. Results: 174 patients (86 receiving OH and 88 cetirizine) were included in the ITT population. In the ITT population, the mean reduction in SSRI was 0.640 ± 0.274 in the OH group and 0.603 ± 0.289 in the cetirizine group. The one-sided 97.5% CI (–0.047) met the criteria for noninferiority. Noninferiority was also demonstrated for SSRI in the per-protocol population, with reductions of 0.640 ± 0.271 with OH and 0.596 ± 0.287 with cetirizine (97.5% CI –0.043).The total effectiveness rate (TER) was similar in the OH (90.0%) and cetirizine (80.0%) groups. The corresponding one-sided 97.5% CI (–1.0%) also demonstrated noninferiority. The incidence of adverse events was 47.1% in the OH group and 41.4% in the cetirizine group (p = 0.453). Conclusion: The efficacy of OH was noninferior to that of cetirizine in controlling itching indicating that it can be considered as a clinically relevant alternative therapy to cetirizine for the management of CP in adult Chinese patients.