Long-term safety and efficacy of rupatadine in Japanese patients with perennial allergic rhinitis: a 52-week open-label clinical trial.

IF 2.4
Journal of Drug Assessment Pub Date : 2019-06-05 eCollection Date: 2019-01-01 DOI:10.1080/21556660.2019.1614005
Kimihiro Okubo, Takamasa Suzuki, Ayaka Tanaka, Hiroshi Aoki
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引用次数: 4

Abstract

Objective: Long-term safety and efficacy of 10- and 20-mg rupatadine in Japanese patients with perennial allergic rhinitis (PAR) were investigated in a 52-week open-label study (JapicCTI-152952, clinicaltrials.jp). Methods: The rupatadine dose was fixed to 10 mg once daily for the first 2 weeks. Thereafter, the study investigator was allowed to increase the dosage to 20 mg if the response was insufficient. Safety was evaluated on the basis of treatment-emergent adverse events, laboratory findings, and vital sign measurements. The primary efficacy endpoint was changed from baseline to Week 2 in the total 4 nasal symptom score. Secondary efficacy endpoints included changes over time in ocular symptoms, patient and physician clinical overall impression, and patient quality-of-life. Results: Seventy-two immunoglobulin E positive patients (mean age = 32.1 years), consisting of 58 adults (age ≥ 18 years) and 14 adolescents (12-17 years), were enrolled. Ninety-four treatment-emergent adverse events were reported in 48 patients (66.7%), including nine adverse drug reactions in nine patients (12.5%). The most frequently reported adverse drug reaction was somnolence (9.7%). The primary and secondary efficacy endpoints demonstrated a statistically significant clinical benefit with rupatadine. The rupatadine dose was increased from 10 to 20 mg in 36 patients (50.0%), which resulted in better symptom management. Conclusions: Rupatadine 10- and 20-mg once-daily doses were well tolerated in long-term use. Updosing to 20 mg is a reasonable option in PAR patients whose symptoms cannot be controlled effectively by the 10-mg dose.

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鲁帕他定在日本常年性变应性鼻炎患者中的长期安全性和有效性:一项为期52周的开放标签临床试验
目的:在一项为期52周的开放标签研究中,研究10 mg和20 mg鲁帕他定治疗日本常年性变应性鼻炎(PAR)患者的长期安全性和有效性。方法:鲁帕他定剂量固定为10 mg,每日1次,治疗前2周。此后,如果反应不足,研究人员被允许将剂量增加到20mg。安全性是根据治疗中出现的不良事件、实验室结果和生命体征测量来评估的。在总4个鼻症状评分中,主要疗效终点从基线改为第2周。次要疗效终点包括眼部症状随时间的变化、患者和医生的临床总体印象以及患者的生活质量。结果:纳入免疫球蛋白E阳性患者72例(平均年龄32.1岁),其中成人58例(年龄≥18岁),青少年14例(12-17岁)。48例患者报告94例治疗后出现的不良事件(66.7%),其中9例患者报告药物不良反应(12.5%)。最常见的不良反应是嗜睡(9.7%)。主要和次要疗效终点显示鲁帕他定具有统计学意义的临床获益。36例(50.0%)患者鲁帕他定剂量从10 mg增加到20 mg,改善了症状管理。结论:鲁帕他定10mg和20mg每日一次长期使用耐受性良好。对于不能通过10mg剂量有效控制症状的PAR患者,将剂量提高到20mg是一个合理的选择。
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来源期刊
Journal of Drug Assessment
Journal of Drug Assessment PHARMACOLOGY & PHARMACY-
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