Hepatic Concerns: What OB/GYNs Should Know From OASIS 4
A panelist explains that although liver function was closely monitored due to potential concerns about the investigational therapy and concurrent endocrine treatments, no serious hepatotoxicity was observed during the trial. However, continued monitoring in longer-term and real-world settings remains important to confirm the treatment’s liver safety profile.
In addition to the adverse effects previously discussed, concerns were raised about the potential impact of this class of drugs on liver function. This concern stemmed in part from earlier observations of mild liver-related effects with similar compounds, such as phalanxanitent. As a result, liver function was closely monitored during the trial, particularly because endocrine therapies such as tamoxifen and aromatase inhibitors are also known to affect liver health by potentially causing steatosis, which can elevate liver enzyme levels.
Given the possibility of combined liver stress from endocrine therapy and the investigational drug, a specific safety protocol was implemented in the study. This included regular monitoring of liver enzymes and the formation of a dedicated committee to evaluate any potential liver-related adverse events. The committee conducted a thorough review of liver function data throughout the course of the study to ensure patient safety and to identify any emerging patterns of hepatotoxicity.
Ultimately, no cases of severe liver function alteration were attributed to the treatment during the trial. While minor fluctuations in liver enzymes were observed, none were considered clinically significant or directly linked to the use of the investigational therapy. These findings suggest that the treatment does not pose a liver safety risk within the observed duration and patient population. Nevertheless, ongoing monitoring in extended studies and real-world settings will be essential to confirm this safety profile over the long-term, particularly in patients who may be receiving multiple therapies with overlapping metabolic effects.
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