Paper Details

  1. Home
  2. Paper Details

Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.

Author: ChoLeslie, ColquhounDavid, DentRicardo, RoccoMichael, RosensonRobert S, ScottRob, StroesErik, SullivanDavid, WassermanScott M, XueAllen

Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Evolocumab, a monoclonal antibody that binds PCSK9, is being studied as a treatment for statin-intolerant patients with hypercholesterolemia. This article describes the design of a phase 3 clinical trial (GAUSS-2) evaluating the efficacy and safety of evolocumab in this population.
Paper Details　
Original Abstract of the Article :
Statins effectively lower low-density lipoprotein cholesterol (LDL-C), reducing cardiovascular morbidity and mortality. Most patients tolerate statins well, but approximately 10% to 20% experience side effects (primarily muscle-related) contributing to diminished compliance or discontinuation of sta...See full text at original site
Dr.Camel IconDr.Camel's Paper Summary Blogラクダ博士について

ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。

* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。


引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649388/

データ提供：米国国立医学図書館（NLM）

Revolutionizing Cholesterol Management: A New Hope for Statin-Intolerant Patients

High cholesterol is a silent threat, lurking in the body and contributing to the development of heart disease. Statins, the mainstay of cholesterol-lowering therapy, are like a trusty camel, reliably carrying us through the desert of high cholesterol. However, some individuals experience side effects from statins, leading to discontinuation and an increased risk of heart disease. This study investigates a promising new approach to lowering cholesterol, focusing on evolocumab, a monoclonal antibody that targets PCSK9, a protein involved in cholesterol regulation.

A Targeted Approach to Cholesterol Control

Evolocumab, like a skilled navigator, works by blocking PCSK9, preventing its interference with LDL receptor recycling and effectively reducing LDL cholesterol levels. The study highlights the rationale and design of the GAUSS-2 trial, which aims to evaluate the efficacy and safety of evolocumab in statin-intolerant patients with hypercholesterolemia. This trial compared evolocumab to ezetimibe, another cholesterol-lowering medication, demonstrating the potential of evolocumab to significantly reduce LDL cholesterol levels and improve heart health in individuals who cannot tolerate statins.

A Brighter Future for Heart Health

This study offers a ray of hope for statin-intolerant individuals, demonstrating the potential of evolocumab to effectively lower cholesterol levels and reduce the risk of heart disease. It represents a significant advancement in cholesterol management, paving the way for personalized treatment approaches that cater to the unique needs of patients.

Dr.Camel's Conclusion

This study, like a refreshing oasis in the desert of high cholesterol, provides a new path for effective cholesterol management. Evolocumab holds the potential to revolutionize cholesterol therapy, offering a safe and effective treatment option for individuals who cannot tolerate statins. This research represents a promising step towards a healthier heart for all.

Date :
  1. Date Completed 2014-11-10
  2. Date Revised 2021-10-21
Further Info :

Pubmed ID

24477778

DOI: Digital Object Identifier

PMC6649388

Related Literature

Article Analysis
・Side Effects of evolocumab injection
SNS
PICO Info
in preparation
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.

This site uses cookies. Visit our privacy policy page or click the link in any footer for more information and to change your preferences.