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Evaluation of PXL065 - deuterium-stabilized (R)-pioglitazone in patients with NASH: A phase II randomized placebo-controlled trial (DESTINY-1).

Author: BedossaPierre, BolzeSébastien, CusiKenneth, DewittSheila, DubourgJulie, FouquerayPascale, GrouinJean-Marie, Hallakou-BozecSophie, HarrisonStephen A, MollerDavid E, RatziuVlad, ThangCarole

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
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

Pioglitazone (Pio) is a drug effective for treating non-alcoholic steatohepatitis (NASH), but it can have side effects. PXL065, a deuterium-stabilized version of R-Pio, lacks the PPARγ activity that causes side effects while retaining other beneficial effects. This study aims to evaluate PXL065's efficacy and safety in NASH patients, hoping for a better safety profile than Pio.
Paper Details　
Original Abstract of the Article :
Pioglitazone (Pio) is efficacious in NASH, but its utility is limited by PPARγ-driven side effects. Pio is a mixture of two enantiomers (R, S). PXL065, deuterium-stabilized R-Pio, lacks PPARγ activity but retains non-genomic activity. We tested the hypothesis that PXL065 would have similar efficacy ...See full text at original site
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引用元：
https://doi.org/10.1016/j.jhep.2023.02.004

データ提供：米国国立医学図書館（NLM）

PXL065: A New Hope for NASH Treatment?

Nonalcoholic steatohepatitis (NASH) is a serious liver disease characterized by inflammation and fat accumulation in the liver. Pioglitazone, a drug commonly used to treat type 2 diabetes, has shown promise in treating NASH, but its use is limited by potential side effects associated with its PPARγ activity. This research explores the potential of PXL065, a deuterium-stabilized form of the R-enantiomer of pioglitazone, which lacks PPARγ activity but retains non-genomic activity. The study aims to evaluate the efficacy and safety profile of PXL065 in patients with NASH.

PXL065: A Promising Candidate for NASH Treatment

The study tested the hypothesis that PXL065 would have similar efficacy to pioglitazone but with a better safety profile. While the study is still in Phase II, the preliminary results suggest that PXL065 may offer a promising treatment option for NASH, potentially with fewer side effects than traditional pioglitazone. Further research is needed to confirm these findings and fully assess the long-term efficacy and safety of PXL065.

Navigating NASH Treatment: Exploring New Avenues

This research provides a glimmer of hope for individuals struggling with NASH. PXL065, a novel drug with a potentially improved safety profile, may offer a new therapeutic avenue for treating this complex liver disease. However, it's important to remember that further research is needed to fully assess its long-term effectiveness and safety. Consulting with a healthcare professional is crucial for obtaining accurate information and personalized treatment guidance for NASH.

Dr. Camel's Conclusion

This research offers a hopeful glimpse into the future of NASH treatment. PXL065, a novel drug with a potentially improved safety profile, holds promise as a potential therapeutic option for NASH. However, further research is necessary to fully assess its long-term efficacy and safety. As we continue to explore new frontiers in medicine, we can draw inspiration from the camel's unwavering resilience in the face of desert challenges. The search for effective and safe treatments for complex diseases like NASH continues, driven by the pursuit of improved health and well-being.

Date :
  1. Date Completed 2023-04-18
  2. Date Revised 2023-06-23
Further Info :

Pubmed ID

36804402

DOI: Digital Object Identifier

10.1016/j.jhep.2023.02.004

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・Side Effects of pioglitazone
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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