Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
The primary purpose of this study is to test the effectiveness and tolerability of Niaspan®
 to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in
 people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan®
 slows down further development of kidney damage.
Diabetic nephropathy is the leading cause of end stage kidney disease in the United States.
 Patients with chronic kidney disease have a markedly increased risk of death from
 cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown
 to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease
 have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to
 lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL
 particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal
 function.
Inclusion Criteria:

 -  Diagnosis of type 2 diabetes

 -  Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min
 using the four variable MDRD (Modification of Diet in Renal Disease Study Group)
 formula

 -  Presence of microalbuminuria or proteinuria less than 3.5 g/d

 -  Diagnosis of hyperlipidemia currently treated with a "statin" drug

 Exclusion Criteria:

 -  Not meeting inclusion criteria

 -  HDL-C > 40 mg/dL for men, > 50 mg/dL for women

 -  TG (triglycerides) < 150 mg/dL and > 800 mg/dL

 -  Documented intolerance to Niaspan or Aspirin

 -  Treatment with other lipid-lowering agents (fibrates, BAS [bile acid sequestrants], or
 ezetimibe)

 -  Elevated transaminases (AST or ALT >1.3 x ULN)

 -  Unstable type 2 diabetes (FBG >200 mg/dL or HbA1c >9.5%)

 -  Known seropositivity for Hepatitis B, C, or HIV

 -  Documented history of malignancy

 -  Age < 18 years

 -  Pregnant women or nursing mothers

 -  Inability to give informed consent

 -  Start or change in "statin" dose < 2 months ago