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While Alnylams Phase III APOLLO-B study hit both key primary and secondary endpoints, the FDA stated in the documents that the effects of patisiran compared to placebo on both endpoints were small, of questionable clinical meaningfulness, and may not be detectable by patients. Major discussion points during the adcomm meeting included whether these key endpoints were appropriate to ascertain clinical meaningfulness in the ATTR-CM population, and panelists expressed varying opinions on whether the magnitude of the benefit seen in trial data was clinically meaningful

The most common symptoms include: Dizziness or lightheadedness after standing up Blurred vision Weakness or fatigue Fainting or near-fainting (syncope) Feeling unsteady or off-balance Nausea in some cases These symptoms usually happen within a few minutes of changing positions, especially when getting up from bed or a chair

Those seeking evidence-based approaches should explore GLP-1 clinical trial evidence for pharmaceutical options