Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus

Inclusion Criteria

• •Age Requirement:
• •* Patients aged 18 years or older.
• •Glycemic Status:
• •Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria:
• •* Fasting glucose less than 126 mg/dL.\*
• •* HbA1c less than 6.5%.
• •* Plasma glucose less than 200 mg/dL after 2 hours during a 75 g oral glucose tolerance test (OGTT).\*Note: For fasting glucose, two measurements of 126 mg/dL or greater within 3 months are required for a diagnosis of diabetes.
• •Cardiovascular Disease:
• •Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following:
• •* Coronary Heart Disease (CHD):
• •* Documented history of myocardial infarction (MI).
• •* History of coronary revascularization.
• •* 50% stenosis of a major epicardial coronary artery confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography.
• •* Cerebrovascular Disease:
• •\>History of stroke of atherosclerotic origin.
• •* History of carotid revascularization.
• •\>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound.
• •* Symptomatic Peripheral Arterial Disease (PAD):
• •\>Intermittent claudication with an ankle-brachial index (ABI) of 0.90 at rest.
• •* Intermittent claudication with ≥50% stenosis of a peripheral artery (excluding the carotid artery) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound.
• •* History of revascularization of peripheral arteries (excluding carotid arteries).
• •* Lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding trauma or osteomyelitis).
• •Dietary Requirements:
• •Patients must be on a stable diet prior to randomization and able to adhere to the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Change (TLC) diet or an equivalent throughout the study.
• •Informed Consent:
• •Subjects or their legal representatives must provide written informed consent to the study protocol and clinical follow-up schedule.
• •An informed consent form approved by the institutional review board (IRB)/ethics committee of the study site must be signed.