Clinical therapeutics

Critical appraisal of the SHARP trial: the results may be dull.

PMID 25453731


The goal of this commentary was to provide a critical analysis of the SHARP (Study of Heart and Renal Protection) trial. Published in 2011, this study has been used by clinicians to justify the prescribing of statins (3-hydroxy-3-methylglutaryl-coenzymexa0A reductase inhibitors) ±ezetimibe in patients with chronic kidney disease. We conducted a critical appraisal of the SHARP trial and associated documents (ie, US Food and Drug Administration review, SHARP protocol). We also examined background reviews and studies conducted before the SHARP trial to provide additional context and background. Our analysis provides clinicians with important criticisms of the SHARP trial, which suggest questionable clinical benefit to lipid-lowering therapy in patients with chronic kidney disease. Our hope is that clinicians limit the broad prescription of statins (±ezetimibe) in all patients with chronic kidney disease (both dialysis and nondialysis) unless there is a valid reason for statin therapy (eg, existing cardiovascular disease).