التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
Tao Wang, Yuehua Liu, Jia Yin, Shi Lian, Ming Li, Zhizhong Zheng, Fanqin Zeng, Shifa Zhang |
| المصدر: |
Pharmacology; 2013, Vol. 90 Issue 1/2, p117-122, 6p, 1 Diagram, 3 Charts |
| مصطلحات موضوعية: |
ITCHING, BLIND experiment, RANDOMIZED controlled trials, CETIRIZINE, CHINESE people, DRUG side effects, MEDICAL protocols, ALTERNATIVE medicine, DISEASES |
| مستخلص: |
Objectives: To assess whether olopatadine hydrochloride (OH) was noninferior to cetirizine in the treatment of cuta-neous pruritus (CP). Patients and Methods: Patients with CP presenting at seven centers in China were randomly al-located 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 reduc-tion of symptom score reducing indices (SSRI). Both inten-tion-to-treat (ITT) and per-protocol populations were ana-lyzed. Results: 174 patients (86 receiving OH and 88 cetiri-zine) 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 noninferior-ity. 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 noninferior-ity. The incidence of adverse events was 47.1% in the OH group and 41.4% in the cetirizine group (p = 0.453). Conclu-sion: 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. [ABSTRACT FROM AUTHOR] |
|
Copyright of Pharmacology is the property of Karger AG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
