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Ardelyxs revamped New Drug Application included data from the Phase III PHREEDOM, BLOCK and AMPLIFY studies, all of which met their primary efficacy endpoints

A meta-analysis showed that the increase in bone fracture risk was primarily driven by results from the CANVAS trial that included older patients with increased risk of CVD and a low baseline eGFR, and suggested that it may be related to indirect effects such as falls resulting from AEs related to volume depletion [72]

2023 Jul;20(7):463-474

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