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The SHARP Trial

The SHARP Trial. The SHARP Trial Study of Heart And Renal Protection. Reference

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The SHARP Trial

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  1. The SHARP Trial

  2. The SHARP Trial Study of Heart And Renal Protection Reference Sharp Collaborative G. Study of Heart and Renal Protection (SHARP): randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease. Am Heart J. 160:785–794 e10.

  3. Background Statin therapy targeting low-density lipoprotein (LDL) cholesterol reduces the risk of atherosclerotic events. In patients without kidney disease, statin-facilitated reductions in the risk of vascular events are independent of renal mechanisms. In patients with renal impairments, a distinct type of cardiovascular pathology ensues, wherein the dysregulated renal metabolism results in increased risk of arrhythmias and heart failures. Secondary endpoints of clinical trials such as the 4D and the AURORA trials indicate a putative benefit of statins in reducing atherosclerotic outcomes in patients with renal disease. The Sharp Collaborative Group conducted a clinical trial to evaluate the effect of statins in patients with renal impairments. The final results of this study are yet to be published.

  4. Aim To assess the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe 10 mg plus simvastatin 20 mg in patients with chronic kidney disease.

  5. Methods

  6. Results • The mean age of 9438 patients randomized into the study was 61 years. • Out of the total 9438 patients randomized into the study, 3056 patients were on dialysis. • Of the total patients randomized, two-thirds were male, one-fifth had diabetes mellitus, and one-sixth had vascular disease. • At the end of 1-year follow-up, patients on ezetimibe plus simvastatin did not have excess of myopathic, hepatic toxicity, or biliary complications as compared to patients in other treatment arms. • In comparison to patients in the placebo arm, the average LDL cholesterol differences at the end of 1 year and 2.5 years follow-up in patients receiving ezetimibe plus simvastatin were 43 and 33 mg/dL, respectively. • The study planned to complete a 4-year follow-up in August 2010.

  7. Conclusion Final results of the SHARP trial would clarify the efficacy and safety of the combination of ezetimibe and simvastatin in lowering LDL cholesterol and corresponding effects in amelioration of atherosclerotic events in patients with chronic kidney disease. Final results of the SHARP trial would clarify the role of ezetimibe and simvastatin for amelioration of atherosclerotic events in patients with chronic kidney disease.

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