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Inappropriate claims from non-equivalent medications in osteoarthritis: a position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis Osteoarthritis and Musculoskeletal Diseases (ESCEO)

机译:骨关节炎中非等价药物的不当主张:一份由骨质疏松症骨关节炎和肌肉骨骼疾病的欧洲临床和经济方面协会(ESCEO)批准的立场文件

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摘要

Osteoarthritis (OA) is a progressive joint disease, that occurs frequently in the aging population and is a major cause of disability worldwide. Both glucosamine and chondroitin are biologically active molecules that are substrates for proteoglycan, an essential component of the cartilage matrix. Evidence supports the use of glucosamine and chondroitin as symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) with impact on OA symptoms and disease-modifying effects in the long term. Glucosamine and chondroitin are administered in exogenous form as a sulfate salt and multiple formulations of these agents are available, both as prescription-grade products and nutritional supplements. However, while all preparations may claim to deliver a therapeutic level of glucosamine or chondroitin not all are supported by clinical evidence. Only patented crystalline glucosamine sulfate (pCGS) is shown to deliver consistently high glucosamine bioavailability and plasma concentration in humans, which corresponds to demonstrated clinical efficacy. Similarly, clinical evidence supports only the pharmaceutical-grade chondroitin sulfate. The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) advocates, through careful consideration of the evidence base, that judicious choice of glucosamine and chondroitin formulation is essential to maximize clinical benefit, patient adherence and satisfaction with treatment. In future, the ESCEO recommends that complex molecules with biological activity such as pCGS may be treated as “biosimilars” akin to the European Medicines Agency guidance on biological medicinal products. It seems likely that for all other complex molecules classed as SYSADOAs, the recommendation to use only formulations clearly supported by the evidence-base should apply.Electronic supplementary materialThe online version of this article (10.1007/s40520-017-0861-1) contains supplementary material, which is available to authorized users.
机译:骨关节炎(OA)是一种进行性关节疾病,在老年人口中经常发生,并且是全世界致残的主要原因。氨基葡萄糖和软骨素都是具有生物活性的分子,它们是蛋白聚糖(软骨基质的基本组成部分)的底物。有证据支持使用氨基葡萄糖和软骨素作为骨关节炎的症状性慢效药物(SYSADOAs),长期影响OA症状和缓解疾病的作用。葡萄糖胺和软骨素以硫酸盐形式外源性给药,这些药物有多种配方,既可以作为处方级产品也可以作为营养补品。但是,尽管所有制剂都可以声称可提供治疗水平的葡糖胺或软骨素,但并非所有证据都得到临床证据的支持。仅获得专利的结晶硫酸葡萄糖胺(pCGS)可以在人体内始终如一地提供较高的葡萄糖胺生物利用度和血浆浓度,这与已证明的临床疗效相对应。同样,临床证据仅支持药物级硫酸软骨素。欧洲骨质疏松症,骨关节炎和肌肉骨骼疾病的临床和经济方面协会(ESCEO)提倡通过仔细考虑证据基础,明智地选择葡萄糖胺和软骨素制剂对于最大化临床获益,患者依从性和治疗满意度至关重要。未来,ESCEO建议将具有生物活性的复杂分子(例如pCGS)视为“生物类似物”,类似于欧洲药品管理局有关生物医药产品的指南。对于所有其他归类为SYSADOAs的复杂分子,似乎仅适用证据明确支持的配方的建议也应适用。电子补充材料本文的在线版本(10.1007 / s40520-017-0861-1)包含补充信息资料,可供授权用户使用。

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