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FDA guidance on antihyperglyacemic therapies for type 2 diabetes: One decade later.

Author: GeorgeJyothis T, InzucchiSilvio E, JohansenOdd Erik, MarxNikolaus, McGuireDarren K, RosenstockJulio

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

In 2008, the FDA introduced a guidance document requiring cardiovascular (CV) safety assessments for new antihyperglycemic medications for type 2 diabetes. This guidance has led to numerous CV outcome trials, which have shown that some new drugs, such as empagliflozin, liraglutide, and canagliflozin, can reduce the risk of CV death or major adverse CV events (MACE) in patients with established atherosclerotic cardiovascular disease (ASCVD). The guidance has also increased the cost of developing new medications for type 2 diabetes. The author proposes modifications to the guidance to reduce costs and maintain a balance between innovation and patient safety.
Paper Details　
Original Abstract of the Article :
In 2008, the US Food and Drug Administration (FDA) issued a guidance to industry statement concerning evaluation of the cardiovascular (CV) safety of new antihyperglycaemic therapies for type 2 diabetes. Fifteen CV outcome trials assessing three novel classes of antihyperglycaemic therapies, DPP-4 i...See full text at original site
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引用元：
https://doi.org/10.1111/dom.13645

データ提供：米国国立医学図書館（NLM）

Antihyperglycemic Therapies: A Decade of Progress and Challenges

Type 2 diabetes, a chronic condition affecting millions worldwide, requires careful management and treatment. This study reflects on a decade of progress in antihyperglycemic therapies, focusing on the US Food and Drug Administration's (FDA) guidance issued in 2008 concerning the cardiovascular (CV) safety evaluation of new antihyperglycemic medications. The research analyzes the impact of this guidance on clinical trial design and the development of novel therapies.

Cardiovascular Safety: A Priority in Diabetes Treatment

The study highlights the importance of ensuring cardiovascular safety in the development of new antihyperglycemic therapies. It's like navigating a desert landscape, where ensuring safety and stability is paramount. The research underscores the evolution of the treatment paradigm for type 2 diabetes, driven by rigorous clinical trials and the pursuit of cardiovascular benefits.

Navigating the Desert of Diabetes

Type 2 diabetes requires a multifaceted approach, encompassing lifestyle modifications, medication management, and regular monitoring. This research emphasizes the ongoing commitment to improving treatment options for those living with this chronic condition.

Dr.Camel's Conclusion

This study reflects on the evolution of antihyperglycemic therapies over the past decade. It's like navigating a desert, where progress is made through careful planning, perseverance, and a commitment to finding the right path.

Date :
  1. Date Completed 2020-03-30
  2. Date Revised 2020-03-30
Further Info :

Pubmed ID

30690856

DOI: Digital Object Identifier

10.1111/dom.13645

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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