Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Metabolic and Anti-Inflammatory Effects of Combined Ezetimibe and Simvastin Therapy, as Compared to Simvastatin Alone, in Patients With Chronic Proteinuric Nephropathy
Brief 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).


Options:
A: Inclusion Criteria:

* Diabetes mellitus type 1 or type 2
* With or without established microalbuminuria (albumin-to-creatinine ratio (ACR)2,5-25 mg/mmol for men, and 3,5-25 mg/mmol for women, according to ISH and ESC recommended criteria)
* Glomerular filtration rate (GFR) between 15-60 ml/min/1.73m2 (measured the last 6 months) or GFR \>75ml/min/1.73m2. The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
* Age 18-80 years

Exclusion Criteria:

* Definite history of myocardial infarction, coronary revascularisation procedure or stroke. (i.e, a strong clinical indication for statin treatment)
* Functioning renal transplant, or living donor-related transplant planned.
* Patients on dialysis.
* Poor metabolic control, i.e HbA1c \> 9%
* Definite history of chronic liver disease, or abnormal liver function (i.e ALT \>1,5 x ULN or, if ALT not available, AST \> 1,5 x ULN).
* Evidence of active inflammatory muscle disease (e.g dermatomyositis, polymyositis), or CK\>3 x ULN;
* Definite previous adverse reaction to a statin or to ezetimibe
* Definite previous adverse reaction to acetylsalicylic acid.
* Definite previous adverse reaction to an ACE-inhibitor.
* Need for concomitant treatment with a strong inhibitor of CYP3A4, such as itrokonazole, ketokonazole, erythromycin, clarithromycin, HIV-protease inhibitors or nefazodone (i.e. agents that may markedly elevate simvastatin levels).
B: Inclusion Criteria:

* hyperlipidemia
* urinary protein
* diabetes

Exclusion Criteria:

* previous rosuvastatin treatment \< 6 months prior to Visit 1
* statin intolerance
* severe hypertension
C: Inclusion Criteria:

* age \>18 years
* LDL-cholesterol \> 100 mg/dl (without concomitant hypolipidemic drugs) in patients whit high cardiovarscular risk for the concomitant presence of:
* proteinuric chronic nephropathy defined as creatinine clearance \> 20 ml/min/1,73 m2 combined to a urinary protein excretion rate \> 0,3 g/24h, without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
* hypertension defined as a systolic or diastolic blood pressure \> 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)

Exclusion Criteria:

* previous or concomitant treatment with steroids, anti-inflammatory and immunosuppressive agents
* evidence or suspicion of renovascular disease, obstructive uropathy, type I diabetes mellitus, vasculitides, history of poor tolerance or allergy to ACEi and ATA, statin or EZE, drug abuse or pregnancy
* inability to fully understand the purposes/risks of the study and to provide a written informed consent
D: Inclusion Criteria:

* Type 2 diabetes
* Persistent microalbuminuria
* Fasting plasma cholesterol \> 5.5 mmol/liter
* Fasting plasma triglycerides \< 4.5 mmol/liter
* Fasting HbA1c \< 10 %
* Fasting serum C-peptide \> 0.49 nmol/liter
* Blood pressure \< 155/95

Exclusion Criteria:

* Signs of primary kidney disease
* Signs of primary hepatic disease
* Signs of insufficiently treated cardiac disease

Answer: C