SHARP: Study of Heart and Renal Protection
|Funding:||Merck Sharp & Dohme Corp.|
|Collaborators:||Clinical Trials Service Unit (CTSU), University of Oxford|
|Project Team:||Boby Mihaylova, Iryna Schlackow, 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)
Within the programme of work on the economic analyses of SHARP the following areas have been developed:
- A long-term disease model of CKD progression and cardiovascular complications in CKD. Heart 2017 Aug; doi: 10.1136/heartjnl-2016-310970; user-friendly model interface also available online.
- Impact of CKD stage and cardiovascular complications on the annual cost of hospital care in the UK: Am J Kidney Dis 2014 Jul;64(1):40-8
- Impacts of CKD stage and cardiovascular complications on health-related quality of life. Results presented within the manuscript on long-term disease model Heart 2017 Aug; doi: 10.1136/heartjnl-2016-310970
- Cost-effectiveness of 5-year treatment with ezetimibe/simvastatin in people with CKD at different vascular disease risk & severity of kidney disease: Am J Kidney Dis 2016 Apr;67(4):576-84
- Impact of educational attainment on health outcomes in CKD (in collaboration with Rachael Morton and Alan Cass, University of Sydney). Am J Kidney Dis. 2016 Jan;67(1):31-9
The following topics are currently in development
- Evaluation of lifetime cost-effectiveness of statin-based treatments in CKD
- Impact of household income on health outcomes in CKD (in collaboration with Rachael Morton and Alan Cass, University of Sydney)
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.
Schlackow I., Kent S., Herrington W., Emberson J., Haynes R., Reith C., Wanner C., Fellström B., Gray A., Landray MJ., Baigent C., Mihaylova B., SHARP Collaborative Group None. A policy model of cardiovascular disease in moderate-to-advanced chronic kidney disease Heart 2017 Aug 5. doi: 10.1136/heartjnl-2016-310970. [Epub ahead of print]