drugset / Trial / NCT00861731
Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether, in patients with chronic proteinuric nephropathy and dyslipidemia, ezetimibe-simvastatin combined therapy is more effective than statin alone to achieve the optimum lipid control, and if this translates to an improvement of the markers of vascular damage. Thirty hypertensive patients in stable therapy with RAS inhibitors, with low-density lipoprotein (LDL) cholesterol superior to 100 mg/ml, are treated with three different hypolipidemic regimens: Simvastatin alone (40 mg/day) or ezetimibe/simvastatin combined therapy (10/20 or 10/40 mg/day).
Timeline
- Start
- 2008-11
- Primary completion
- 2009-07
- Completion
- 2009-07
Publications
- Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Zinellu A, Sotgia S, Sotgiu E, Assaretti S, Baralla A, Mangoni AA, Satta AE, Carru C. Cholesterol lowering treatment restores blood global DNA methylation in chronic kidney disease (CKD) patients. Nutr Metab Cardiovasc Dis. 2017 Sep;27(9):822-829. doi: 10.1016/j.numecd.2017.06.011. Epub 2017 Jun 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ezetimibe | Unknown | 10 mg | — |
| Comparator | Simvastatin | Small molecule | 20 mg | — |
| Comparator | Simvastatin | Small molecule | 40 mg | — |