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How often do patients experience gastrointestinal problems while taking darolutamide?



Based on the information available, there is no specific data indicating the exact frequency of gastrointestinal (GI) problems experienced by patients while taking darolutamide. Darolutamide is a second-generation androgen receptor inhibitor (ARI) used for treating non-metastatic castration-resistant prostate cancer [1].

Adverse events (AEs) associated with darolutamide were evaluated in the ARAMIS trial, a randomized, double-blind, placebo-controlled, multicenter phase 3 study [2]. The study reported that the most common AEs (≥10%) in the darolutamide group were fatigue, pain in extremity, and rash [2].

Regarding GI-specific AEs, the ARAMIS trial reported that diarrhea occurred in 15.9% of patients in the darolutamide group and 14.2% in the placebo group [2]. Nausea was reported in 12.2% of patients in the darolutamide group and 10.6% in the placebo group [2]. These GI AEs were not listed among the most common adverse reactions leading to discontinuation of darolutamide [2].

In summary, while there is no specific data on the frequency of GI problems experienced by patients while taking darolutamide, diarrhea and nausea were reported at a slightly higher rate in patients receiving darolutamide compared to placebo [2].

Sources:
[1] DrugPatentWatch.com. Darolutamide. <https://www.drugpatentwatch.com/drugs/darolutamide>.
[2] Fizazi, Karim et al. "N Engl J Med. 2019 Mar 7;380(10):934-944. doi: 10.1056/NEJMoa1817345."



Follow-up:   How common are GI issues with darolutamide use? Do patients frequently report GI problems on darolutamide? What's the occurrence rate of GI side effects with darolutamide?





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