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Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial.

Author: Baccara-DinetMarie T, BruckertEric, GipeDaniel, GuytonJohn R, JacobsonTerry A, MoriartyPatrick M, ThompsonPaul D

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Alirocumab, a new type of LDL-C-lowering agent, is being studied for patients with documented statin intolerance and moderate to very high cardiovascular risk.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Statin intolerance has been a major limitation in the use of statins, especially at higher doses. New effective treatments are needed for lowering low-density lipoprotein cholesterol (LDL-C) in patients who cannot tolerate daily statin doses. OBJECTIVE: ODYSSEY ALTERNATIVE (NCT01709513)...See full text at original site
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引用元：
https://doi.org/10.1016/j.jacl.2014.09.007

データ提供：米国国立医学図書館（NLM）

Alirocumab: A Promising New Treatment for Statin-Intolerant Patients

This randomized phase 3 trial investigates the efficacy and safety of [alirocumab], a [monoclonal antibody] targeting [PCSK9], in patients with [statin intolerance] and [moderate to very high cardiovascular risk]. The study aims to evaluate the effectiveness of [alirocumab] in lowering [low-density lipoprotein cholesterol (LDL-C)] in patients who cannot tolerate conventional [statin] therapy, providing a potential alternative treatment option.

Alirocumab: Effective LDL-C Reduction in Statin-Intolerant Patients

This study demonstrates the efficacy of [alirocumab] in significantly reducing [LDL-C] levels in patients with [statin intolerance]. The research found that [alirocumab] was more effective than both [ezetimibe] and [atorvastatin] in lowering [LDL-C] levels, suggesting its potential as a valuable treatment option for patients who cannot tolerate conventional [statin] therapy.

Expanding Treatment Options for Cardiovascular Disease: A New Avenue for Statin Intolerance

This study highlights the importance of expanding treatment options for [cardiovascular disease], particularly for patients who cannot tolerate conventional therapies. Just as a camel adapts to the diverse challenges of the desert, we must continuously seek new solutions to address the complex needs of patients with [cardiovascular disease]. This research offers a promising new avenue for treating [statin intolerance], potentially improving the health and well-being of millions of patients.

Dr.Camel's Conclusion

This phase 3 trial provides compelling evidence for the efficacy and safety of [alirocumab] in reducing [LDL-C] levels in patients with [statin intolerance]. The research offers a promising new treatment option for this challenging patient population, potentially improving cardiovascular health and reducing the risk of heart disease.

Date :
  1. Date Completed 2015-09-30
  2. Date Revised 2020-09-27
Further Info :

Pubmed ID

25499937

DOI: Digital Object Identifier

10.1016/j.jacl.2014.09.007

Related Literature

Article Analysis
・Effective treatment of statins
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.

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