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Dates: 2011-2014
Funding: Merck Sharp & Dohme Corp.
Collaborators: Clinical Trials Service Unit (CTSU), University of Oxford
Project Team: Boby Mihaylova, Iryna Sclackow, Seamus Kent, Alastair Gray
Further Information Boby Mihaylova

The Study of Heart and Renal Protection (SHARP) is an international multi-centre randomized controlled trial to determine the effects of lowering LDL cholesterol with a combination of simvastatin (20mg daily) and the cholesterol-absorption inhibitor ezetimibe (10mg daily) on the risk of major atherosclerotic events (myocardial infarction or coronary death, ischaemic stroke, or any revascularisation) among patients with Chronic Kidney Disease (CKD) who do not have a history of myocardial infarction or coronary revascularisation. The study also assessed the effect of lowering cholesterol on the rate of loss of renal function in pre-dialysis patients. About 9000 patients were randomised into the study (around 6,000 of whom were not on dialysis and 3,000 on dialysis at randomisation) and all patients were followed for at least 4 years. The study showed that over a median duration of 4.9 years, allocation to ezetimibe/simvastatin produced a mean reduction of 0.85 mmol/L (33mg/dL) in LDL cholesterol, which yielded a significant 17% (RR 0.83, 95% CI 0.74-0.94) proportional reduction in major atherosclerotic events (p=0.002)

Study website: http://www.sharpinfo.org/


Within the programme of work on the economic analyses of SHARP the following areas are being developed:

  • Evaluate the cost-effectiveness of ezetimibe/simvastatin in people with CKD at different vascular disease risk and severity of kidney disease in SHARP
  • Impacts of severity of kidney disease and cardiovascular complications on health-related quality of life
  • An annual hospital care cost related to CKD stage and cardiovascular complications in CKD
  • A long-term disease model of CKD progression and cardiovascular complications in CKD
  • Evaluate the lifetime cost-effectiveness LDL-cholesterol lowering with statin-based regimens in CKD
  • (in collaboration with Rachael Morton and Alan Cass, University of Sydney) Impact of socio-economic factors on health outcomes in Chronic Kidney Disease

PUBLICATIONS

Mihaylova B, Schlackow I, Herrington W, Lozano-Kühne J, Kent S, Emberson J, Reith C, Haynes R, Cass A, Craig J, Gray A, Collins R, Landray M, Baigent C., on behalf of the SHARP Collaborative Group. Cost-effectiveness of Simvastatin Plus Ezetimibe for Cardiovascular Prevention in CKD: Results of the Study of Heart and Renal Protection (SHARP).  American Journal of Kidney Diseases. 2015; 67(4): 576-584.

Morton RL, Schlackow I, Staplin N, Gray A, Cass A, Haynes R, Emberson J, Herrington W, Landray M, Baigent C, Mihaylova B., on behalf of the SHARP Collaborative Group. Impact of educational attainment on health outcomes in moderate-to-severe chronic kidney disease. American Journal of Kidney Diseases. 2015; 67(1): 31-39.

Kent S, Schlackow I, Lozano-Kuhne J, Reith C, Emberson J, Haynes R, Gray A, Cass A, Baigent C, Landray MJ, Herrington W, Mihaylova B., on behalf of the SHARP Collaborative Group. What is the impact of chronic kidney disease stage and cardiovascular disease on the annual cost of hospital care in moderate-to-severe kidney disease? BMC Nephrol. 2015;16(1):65.