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Real world evidence in effectiveness, safety, and cost savings of generic levothyroxine: a systematic review
Endocrine ( IF 3.7 ) Pub Date : 2021-07-28 , DOI: 10.1007/s12020-021-02833-8
Jingjing Qian 1 , Kaniz Afroz Tanni 1
Affiliation  

Purpose

Generic levothyroxine, approved through Abbreviated New Drug Application (ANDA), is available for generic substitution. But ANDA does not require nonclinical or clinical data to establish safety and efficacy. Post-marketing evidence in generic equivalence for marketed levothyroxine products is limited. We conducted a systematic review to synthesize evidence in effectiveness, safety, and cost savings between patients using generic and branded levothyroxine.

Methods

We systematically searched published literature from Medline, International Pharmaceutical Abstracts, APA PsycInfo, and CINAHL from inception through 04/18/2021. Included studies were limited to post-marketing empirical studies including patients who used levothyroxine products, with direct comparison between generic and brand levothyroxine, and published in English. Risk of bias was assessed using the National Institute of Health Study Quality Assessment Tools. Two reviewers independently extracted data and conducted quality assessment for included studies. Given that the nine studies are so diverse, a meta-analysis was not possible. Therefore we provided a narrative review of the included studies.

Results

Of 349 studies identified, nine met the inclusion criteria. Six studies compared thyrotropin levels and adverse events between generic and brand users and provided mixed findings. In addition, generic users may generate prescription cost savings for payers but had suboptimal medication adherence than brand users.

Conclusion

Findings from this systematic review highlighted the limited and mixed evidence in real-world clinical and economic outcomes for generic levothyroxine. Continuous post-marketing monitoring and assessment of generic drugs are warranted to ensure treatment effectiveness, patient safety, and achieve financial savings in prescription costs.



中文翻译:

通用左旋甲状腺素有效性、安全性和成本节约的真实世界证据:系统评价

目的

通过缩写新药申请 (ANDA) 批准的仿制药左旋甲状腺素可用于仿制药替代。但 ANDA 不需要非临床或临床数据来确定安全性和有效性。上市后左旋甲状腺素产品仿制药等效性的上市后证据有限。我们进行了一项系统评价,以综合使用仿制药和品牌左旋甲状腺素的患者在有效性、安全性和成本节约方面的证据。

方法

我们系统地检索了 Medline、International Pharmaceutical Abstracts、APA PsycInfo 和 CINAHL 从开始到 2021 年 4 月 18 日的已发表文献。纳入的研究仅限于上市后实证研究,包括使用左旋甲状腺素产品的患者,直接比较仿制药和品牌左旋甲状腺素,并以英文发表。使用美国国立卫生研究院质量评估工具评估偏倚风险。两名评价员独立提取数据并对纳入研究进行质量评估。鉴于这九项研究如此多样化,荟萃分析是不可能的。因此,我们对纳入的研究进行了叙述性审查。

结果

在确定的 349 项研究中,9 项符合纳入标准。六项研究比较了普通用户和品牌用户之间的促甲状腺激素水平和不良事件,并提供了不同的结果。此外,普通用户可能会为付款人节省处方成本,但与品牌用户相比,药物依从性较差。

结论

本系统评价的结果强调了通用左旋甲状腺素在真实世界临床和经济结果中的有限和混合证据。有必要对仿制药进行持续的上市后监测和评估,以确保治疗效果、患者安全并节省处方成本。

更新日期:2021-07-28
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