Leceta Amalia, Sologuren Ander, Valiente Román, Campo Cristina, Labeaga Luis
Medical Department, Faes Farma SA, 48940-Leioa, Bizkaia, Spain.
Clinical Research Department, Faes Farma SA, 48940-Leioa, Bizkaia, Spain.
Drugs Context. 2017 Feb 3;6:212500. doi: 10.7573/dic.212500. eCollection 2017.
Bilastine is a safe and effective commonly prescribed non-sedating H-antihistamine approved for symptomatic treatment in patients with allergic disorders such as rhinoconjunctivitis and urticaria. It was evaluated in many patients throughout the clinical development required for its approval, but clinical trials generally exclude many patients who will benefit in everyday clinical practice (especially those with coexisting diseases and/or being treated with concomitant drugs). Following its introduction into clinical practice, the Medical Information Specialists at Faes Farma have received many practical queries regarding the optimal use of bilastine in different circumstances.
Queries received by the Medical Information Department and the responses provided to senders of these queries.
The most frequent questions received by the Medical Information Department included the potential for drug-drug interactions with bilastine and commonly used agents such as anticoagulants (including the novel oral anticoagulants), antiretrovirals, antituberculosis regimens, corticosteroids, digoxin, oral contraceptives, and proton pump inhibitors. Most of these medicines are not usually allowed in clinical trials, and so advice needs to be based upon the pharmacological profiles of the drugs involved and expert opinion. The pharmacokinetic profile of bilastine appears favourable since it undergoes negligible metabolism and is almost exclusively eliminated via renal excretion, and it neither induces nor inhibits the activity of several isoenzymes from the CYP 450 system. Consequently, bilastine does not interact with cytochrome metabolic pathways. Other queries involved specific patient groups such as subjects with renal impairment, women who are breastfeeding or who are trying to become pregnant, and patients with other concomitant diseases. Interestingly, several questions related to topics that are well covered in the Summary of Product Characteristics (SmPC), which suggests that this resource is not being well used.
Overall, this analysis highlights gaps in our knowledge regarding the optimal use of bilastine. Expert opinion based upon an understanding of the science can help in the decision-making, but more research is needed to provide evidence-based answers in certain circumstances.
比拉斯汀是一种安全有效的常用非镇静性H1抗组胺药，被批准用于治疗过敏性疾病，如鼻结膜炎和荨麻疹的症状。在其获批所需的整个临床开发过程中，对许多患者进行了评估，但临床试验通常会排除许多在日常临床实践中会受益的患者（尤其是那些患有合并症和/或正在接受联合用药治疗的患者）。在其引入临床实践后，法伊斯·法玛公司的医学信息专家收到了许多关于比拉斯汀在不同情况下最佳使用方法的实际问题。
医学信息部收到的问题以及对这些问题发送者的回复。
医学信息部收到的最常见问题包括比拉斯汀与常用药物（如抗凝剂（包括新型口服抗凝剂）、抗逆转录病毒药物、抗结核治疗方案、皮质类固醇、地高辛、口服避孕药和质子泵抑制剂）之间药物相互作用的可能性。这些药物中的大多数通常不允许用于临床试验，因此建议需要基于相关药物的药理学特征和专家意见。比拉斯汀的药代动力学特征似乎良好，因为其代谢可忽略不计，几乎完全通过肾脏排泄，并且它既不诱导也不抑制CYP 450系统中几种同工酶的活性。因此，比拉斯汀不与细胞色素代谢途径相互作用。其他问题涉及特定患者群体，如肾功能损害患者、哺乳期或试图怀孕的女性以及患有其他合并症的患者。有趣的是，有几个问题与产品特性摘要（SmPC）中涵盖得很好的主题相关，这表明该资源没有得到很好的利用。
总体而言，该分析突出了我们在比拉斯汀最佳使用方面的知识差距。基于对科学的理解的专家意见有助于决策，但在某些情况下还需要更多研究来提供基于证据的答案。
