Study of Heart and Renal Protection (SHARP)

Area of Science:

• Nephrology
• Cardiology
• Clinical Trials

Background:

• Patients with chronic kidney disease (CKD) face a high risk of vascular disease.
• Previous cholesterol-lowering trials excluded CKD patients, leaving a lack of evidence for their benefit.
• Observational studies in dialysis patients show a negative association between total cholesterol and mortality, questioning cholesterol's role.

Purpose of the Study:

• To assess the efficacy and safety of cholesterol-lowering therapy in patients with CKD.
• To determine if lowering low-density lipoprotein (LDL)-cholesterol prevents vascular events in the CKD population.
• To evaluate the impact of simvastatin and ezetimibe combination therapy on major adverse cardiovascular events.

Main Methods:

• The Study of Heart and Renal Protection (SHARP) is a large-scale randomized trial.
• Approximately 9000 patients with CKD are enrolled.
• Participants receive a combination of simvastatin and ezetimibe or placebo.

Main Results:

• Data on the primary outcomes (vascular events) and safety (toxicity) are being collected.
• Analysis will compare the incidence of major vascular events between the treatment and placebo groups.
• The study aims to provide reliable evidence on the net benefit of cholesterol reduction in CKD.

Conclusions:

• Direct evidence is needed to confirm the benefits of cholesterol reduction in CKD patients.
• The SHARP trial will address the uncertainty regarding the effectiveness and safety of cholesterol-lowering therapy in this population.
• Findings will inform clinical practice guidelines for managing vascular risk in CKD.