How do you counsel patients on the side effects of sodium phenylbutyrate and taurursodiol?
I explain that the trial suggested that this medication is generally safe and well tolerated. As it says in the package insert "the most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment." (https://www.relyvrio.com/RELYVRIO-US-Prescribing-Informat...
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At this point, I have no patient yet taking the drug combination, so counsel based on the Paganoni et al., PMID 32877582 report indicating that in the active arm gastrointestinal symptoms such as abdominal pain and diarrhea were more frequent than in the placebo arm, and noting that a percentage of study subjects in the active arm stopped participation due to these side effects.
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The most common side effects were gastrointestinal (nausea, diarrhea, abdominal pain) and, when they occurred, they generally did so during the first 3 weeks of treatment. For most patients, these were mild and manageable.
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