Centre Roger Barri d'Asmologia i Allèrgia, Barcelona, Spain.
Expert Rev Clin Pharmacol. 2008 May;1(3):381-9. doi: 10.1586/17512433.1.3.381.
A new fast-dissolving tablet (FDT) formulation of ebastine has been developed that dissolves rapidly in the mouth without the need for water. This new formulation of ebastine FDT offers an opportunity to tailor prescribing in a way that meets patient's preferences. The aim of the reported study was to evaluate the preferences of allergic rhinitis patients who were given either a placebo version of ebastine FDT or a placebo version of ebastine regular tablet (RT). Allergic rhinitis patients from Germany, Italy and Mexico, who were regular consumers of oral antihistamines, were recruited to a randomized, crossover study comparing placebo forms of ebastine FDT and ebastine RT. Patients were interviewed at home and were given both a FDT and RT (10 and 20 mg doses were used with a 1:1 ratio). Data on patient preferences were recorded by an interviewer and analyzed using descriptive statistics. A total of 420 individuals participated (140 in each country), 70% with intermittent and 24% with persistent allergic rhinitis. Using a rating scale of 0-10 and comparing mean values, ebastine FDT was statistically significantly better than RT for: sensation on dissolving (8.30 FDT vs 6.79 RT); taste it leaves in the mouth (8.10 FDT vs 6.60 RT); initial taste (8.07 FDT vs 6.63 RT); and texture (7.85 FDT vs 7.20 RT). Rapidity of dissolution was rated 8.67 for FDT. With the same scale, RT rated statistically significantly better than ebastine FDT for: appearance (7.46 RT vs 6.85 FDT); size (7.38 RT vs 7.06 FDT); and shape (7.55 RT vs 7.24 FDT). General evaluation was statistically significantly better for ebastine FDT (8.21 FDT vs 7.05 RT). Overall, 83% of patients preferred ebastine FDT to RT, 92% considered it to be more innovative, 90% that it was suitable to be taken without water and that it was technologically advanced, and 87% that it was suitable for taking at any time and anywhere, and that it had a refreshing taste. Ebastine FDT formulation is preferred to the RT by the majority of allergic rhinitis patients, rating most highly for dissolution, taste and texture.
一种新的埃巴斯汀速溶片（FDT）制剂已经被开发出来，它可以在口中迅速溶解，无需用水。这种新的埃巴斯汀 FDT 制剂为满足患者的需求提供了一种定制处方的机会。本研究旨在评估接受埃巴斯汀 FDT 安慰剂或埃巴斯汀普通片（RT）安慰剂的过敏性鼻炎患者的偏好。从德国、意大利和墨西哥招募经常使用口服抗组胺药的过敏性鼻炎患者，参加一项比较埃巴斯汀 FDT 安慰剂和埃巴斯汀 RT 安慰剂的随机交叉研究。在家中对患者进行访谈，并给他们服用 FDT 和 RT（使用 1:1 比例的 10 毫克和 20 毫克剂量）。通过访谈者记录患者偏好数据，并使用描述性统计进行分析。共有 420 人参与（每个国家 140 人），70%为间歇性过敏性鼻炎，24%为持续性过敏性鼻炎。使用 0-10 的评分量表并比较平均值，埃巴斯汀 FDT 在以下方面明显优于 RT：溶解时的感觉（FDT 为 8.30，RT 为 6.79）；口中残留的味道（FDT 为 8.10，RT 为 6.60）；初始味道（FDT 为 8.07，RT 为 6.63）；质地（FDT 为 7.85，RT 为 7.20）。FDT 的溶解速度评分为 8.67。使用相同的量表，RT 在以下方面明显优于埃巴斯汀 FDT：外观（RT 为 7.46，FDT 为 6.85）；大小（RT 为 7.38，FDT 为 7.06）；形状（RT 为 7.55，FDT 为 7.24）。总体评价明显优于埃巴斯汀 FDT（FDT 为 8.21，RT 为 7.05）。总体而言，83%的患者更喜欢埃巴斯汀 FDT 而非 RT，92%认为它更具创新性，90%认为它适合无需用水服用，技术先进，87%认为它适合随时随地服用，味道清新。大多数过敏性鼻炎患者更喜欢埃巴斯汀 FDT 制剂，对溶解、味道和质地的评价最高。
