García Robles Ana Alejandra, López Briz Eduardo, Fraga Fuentes María Dolores, Asensi Diez Rocío, Sierra Sánchez Jesús Francisco
Servicio de Farmacia, Hospital Universitario y Politécnico La Fe, Valencia.
Servicio de Farmacia, Hospital La Mancha Centro, Alcázar de San Juan, Ciudad Real.
Farm Hosp. 2018 Mar 1;42(2):73-81. doi: 10.7399/fh.10807.
To assess critically oritavancin, a second-generation lipoglycopeptide, for the treatment of Acute Bacterial Skin and Skin Structure Infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.
An evaluation report of oritavancin in Acute Bacterial Skin and Skin Structure Infections was carried out according to the methodology of the Group for drug evaluation, standardization and research in drug selection of the Spanish Society of Hospital Pharmacy (SEFH)1, with the MADRE 4.0 program. A search was made in PubMed, in the web www.clinicaltrials. gov, Embase, PubMed and UptoDate. The European Medication Agency and Food and Drug Administration evaluation reports were also used.
Single-dose oritavancin demonstrated its non-inferiority efficacy versus vancomycin in Acute Bacterial Skin and Skin Structure nfections, with a similar safety profile. Its potential advantage over other therapeutic alternatives lies in its administration in single dose and in its no need for plasma levels monitoring, which would allow its administration on an outpatient basis. Regarding to the other alternative possibilities of oral (linezolid, tedizolid) or IM (teicoplanin) treatment, oritavancin would improve the adherence to the treatment. Although oritavancin could be more efficient in certain scenarios (outpatient treatment versus inpatient treatment with alternatives), there are no convincing studies in this regard so far. On the other hand, alternative drugs above-mentioned, can also allow outpatient treatment, reducing advantages of oritavancin and further increasing cost differences. Therefore, given that the efficacy is similar to the alternatives, a cost minimization analysis could be considered.
Oritavancin is comparable in terms of efficacy and safety to the existing alternatives in Acute Bacterial Skin and Skin Structure Infections, without improvements in the cost-effectiveness ratio, because of the proposed positioning is to consider it for the treatment of vancomycinresistant enterococcal infection in adult patients when the use of linezolid or tedizolid is contraindicated.
严格评估第二代脂糖肽奥利万星用于治疗由敏感革兰氏阳性菌引起的急性细菌性皮肤及皮肤结构感染,包括耐甲氧西林金黄色葡萄球菌感染。
根据西班牙医院药学协会(SEFH)药物评价、标准化及药物选择研究小组的方法,使用MADRE 4.0程序对奥利万星治疗急性细菌性皮肤及皮肤结构感染进行评估报告。在PubMed、www.clinicaltrials.gov网站、Embase、PubMed和UpToDate上进行检索。还使用了欧洲药品管理局和美国食品药品监督管理局的评估报告。
单剂量奥利万星在急性细菌性皮肤及皮肤结构感染中显示出与万古霉素相当的非劣效性疗效,安全性相似。其相对于其他治疗选择的潜在优势在于单剂量给药且无需监测血药浓度,这使得它可以门诊给药。关于口服(利奈唑胺、替地唑胺)或肌内注射(替考拉宁)治疗的其他选择,奥利万星可提高治疗依从性。尽管奥利万星在某些情况下(门诊治疗与使用其他药物的住院治疗相比)可能更有效,但目前尚无这方面令人信服的研究。另一方面,上述替代药物也可允许门诊治疗,则会削弱奥利万星的优势并进一步加大成本差异。因此,鉴于其疗效与其他药物相似,可考虑进行成本最小化分析。
在急性细菌性皮肤及皮肤结构感染中,奥利万星在疗效和安全性方面与现有替代药物相当,但成本效益比并无改善,因为其建议定位是在成人患者使用利奈唑胺或替地唑胺禁忌时,考虑用于治疗耐万古霉素肠球菌感染。