title: Considerations in Applying the Results of Randomized Controlled Clinical Trials to the Care of Older Adults With Kidney Disease in the Clinical Setting: The SHARP Trial.
abstract: The Study of Heart and Renal Protection (SHARP) found that treatment with ezetemibe and low-dose simvastatin reduced the incidence of major atherosclerotic events in patients with kidney disease. Due to the paucity of evidence-based interventions that lower cardiovascular morbidity in this high-risk population, the SHARP trial will likely have a large impact on clinical practice. However, applying the results of clinical trials conducted in select populations to the care of individual patients in real-world settings can be fraught with difficulty. This is especially true when caring for older adults with complex comorbidity and limited life expectancy. These patients are often excluded from clinical trials, frequently have competing health priorities, and may be less likely to benefit and more likely to be harmed by medications. We discuss key considerations in applying the results of the SHARP trial to the care of older adults with CKD in real-world clinical settings using guiding principles set forth by the American Geriatrics Society's Expert Panel on the Care of Older Adults with Multimorbidity. Using this schema, we emphasize the importance of evaluating trial results in the unique context of each patient's goals, values, priorities, and circumstances.
authors.affiliation: Department of Medicine, Seattle, WA; Division of Hospitalist Medicine, Harborview Medical Center, University of Washington, Seattle, WA; and Hospital and Specialty Medicine Service, Nephrology Section, VA Puget Sound Healthcare System, and Department of Medicine, Division of Nephrology, University of Washington, Seattle, WA.
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Butler
authors.affiliation: Department of Medicine, Seattle, WA; Division of Hospitalist Medicine, Harborview Medical Center, University of Washington, Seattle, WA; and Hospital and Specialty Medicine Service, Nephrology Section, VA Puget Sound Healthcare System, and Department of Medicine, Division of Nephrology, University of Washington, Seattle, WA. Electronic address: ann.ohare@va.gov.
authors.forename: Ann M
authors.initials: AM
authors.lastname: O'Hare
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D050197:Atherosclerosis / Q000209:etiology / Q000517:prevention & control*; D000066491:Clinical Decision-Making / Q000379:methods*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000627:therapeutic use*; D005260:Female; D006299:Health Services for the Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000628:therapy; D012307:Risk Factors; D019821:Simvastatin / Q000627:therapeutic use*
chemical_list: D000924:Anticholesteremic Agents; D019821:Simvastatin; D000069438:Ezetimibe
keywords: Cholesterol; Clinical trials; Ezetimibe; Guidelines; Kidney disease; Lipids; Older adults; SHARP; Statin