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Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain.

Author: Abbas SuleimanAhmed, BeckDenise, MostafaNael M, NaderAhmed, NgJuki, NoertersheuserPeter, PolepallyAkshanth R, WinzenborgInsa

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

Overview

Elagolix, a gonadotropin-releasing hormone receptor antagonist, was studied for managing endometriosis pain. A model was developed to describe the relationship between elagolix exposure and bone mineral density (BMD) changes. The model predicts a 1.45% decrease in BMD with elagolix 150 mg daily for 24 months.
Paper Details　
Original Abstract of the Article :
Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in a dose-dependent manner. It is indicated for management of moderate-to-severe pain associated with endometriosis. A population exposure-response model describing the relationship between elago...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679073/

データ提供：米国国立医学図書館（NLM）

Elagolix for Endometriosis-Associated Pain: A Safety and Efficacy Assessment

This study examines the safety and efficacy of [elagolix], a new medication for managing [endometriosis-associated pain]. Researchers analyzed data from four phase III studies to assess the relationship between elagolix exposure and changes in [bone mineral density (BMD)]. Their findings demonstrate that elagolix can effectively manage endometriosis-associated pain while maintaining a favorable safety profile. The study also provides valuable information about the potential impact of elagolix on BMD, highlighting the need for careful monitoring and management of bone health in patients receiving this medication.

A Balanced Approach to Endometriosis Management

This study provides a comprehensive assessment of elagolix for endometriosis-associated pain. The findings suggest that elagolix is a safe and effective treatment option, with a manageable impact on BMD. The study emphasizes the importance of individualized treatment plans and close monitoring of bone health in patients receiving elagolix.

Living Well with Endometriosis

This research offers hope for individuals struggling with endometriosis-associated pain. The findings suggest that elagolix can effectively manage pain while maintaining a favorable safety profile. It's important to discuss the potential risks and benefits of elagolix with your healthcare provider to determine if it's the right treatment option for you.

Dr.Camel's Conclusion

This study highlights the importance of developing new and safe treatment options for chronic conditions like endometriosis. Like a camel seeking a refreshing oasis, researchers are constantly striving to find new ways to improve patient outcomes. Elagolix offers a promising approach for managing endometriosis-associated pain, providing hope for individuals seeking relief from this debilitating condition.
Date :
  1. Date Completed 2021-11-08
  2. Date Revised 2022-12-07
Further Info :

Pubmed ID

32945631

DOI: Digital Object Identifier

PMC7679073

Related Literature

Article Analysis
・Effects of elagolix
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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