Stop Atherosclerosis in Native Diabetics Study

Exclusion Criteria

• •1. New York Heart Association Stage III- IV congestive heart failure.
• •2. SBP \>180 mmHg (2% of population) or patients with known causes of hypertension.
• •3. History of angioedema.
• •4. Any medical condition that study physicians believe would interfere with study participation or evaluation of results.
• •5. Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
• •6. Serum hepatic transaminase levels 2X the upper limit of normal.
• •7. Participation in any clinical trial of any investigational medication within 3 months prior to this trial.
• •8. Renal insufficiency as indicated by serum creatinine \>2.0 for women and \>2.4 for men.
• •9. Diagnosis of primary hyperlipidemia in medical record.
• •10. Secondary hypercholesterolemia due to hypothyroidism or nephrotic syndrome. Patients on stable doses of thyroid replacement therapy will be eligible.
• •11. Presence of malignancy or history of any cancer except skin cancer within the past 5 years.
• •12. Pregnancy or lactation. Premenopausal women will be requested to use birth control methods throughout the study and provided educational materials about the risks of using the study medications during pregnancy.
• •13. Unable to obtain quantifiable carotid measure during screening examination.
• •14. Concomitant long term use of cyclosporins (Sandimmune), macrolide antibiotics (erythromycin -many generic and brand name forms, clarithromycin, Biaxin, and Zithromax), azole antifungals (itraconazole-Sporanox, ritonavir, Norvir, and nelfinavir (Viracept).
• •15. Orthostatic hypotension as defined by the following:
• •1. The individual has a measured fall of \>20 mmHg in systolic BP upon standing associated with symptoms lasting more than one minute (or severe symptoms that would not allow further lowering of BP)
• •2. The standing systolic blood pressure is less than 90 mm.
• •16. Triglyceride level \>350 mg/dl.
• •17. Severe aortic stenosis with valve area \<=1.0 square cm.