Standard versus intensive statin therapy for hypercholesterolemic patients with diabetic retinopathy
- Conditions
- Hypercholesterolemia complicated with diabetic retinopathy
- Registration Number
- JPRN-UMIN000003486
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5000
Not provided
Patients to whom any of the following criteria apply will be excluded from the study: at interim registration: 1) patients with history of hypersensitivity to statins 2) patients with history of drug-induced muscle disorder 3) patients with history of coronary arterial diseases (MI, angina pectoris, coronary revascularization) 4) patients with history of stroke (including revascularization) 5) patients complicated with symptomatic PAD (Fontaine class II or above) 6) hypertensive patients with diastolic BP of 120 mmHg or more or systolic BP of 200 mmHg or more, or patients with hypertensive emergency 7) patients with NYHA functional class IIM or more 8) patients with cardiac valvulopathy who have serious hemodynamic abnormality 9) patients under treatment with at least 2 different lipid-lowering drugs 10) patients with familial hypercholesterolemia 11) patients with serious complications e.g. malignant tumors or patients with limited life expectancy (however, patients who are decided free of relapse without treatment of malignant tumors over five years before obtaining their informed consent are able to be enrolled) 12) patients with renal transplant or patients under dialysis 13) patients who are pregnant or who are at risk of pregnancy, or those who desire to become pregnant during their participation in the study 14) other patients deemed unsuitable by the principal investigator or investigator. At official registration: The study will be discontinued in patients who have undergone prespecified examinations during the observation period and satisfy any of the following criteria: 1) patients with apparent ischemia in ECG at rest 2) patients with AST of 100 IU/L or above or ALT of 100 IU/L or above 3) patients with serum creatinine of 2.0 mg/dL or more or eGFR of 30 mL/min/1.73 m2 or less 4) patients with nephrotic syndrome 5) patients with serum triglyceride of 1000 mg/dL or more 6) other patients deemed unsuitable by the principal investigator or investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ipid-control will be conducted with statin monotherapy in patients with hypercholesterolemia complicated with diabetic retinopathy. Using time until the onset of cardiovascular diseases/death as an endpoint, it will be determined whether the inhibitory effect of the intensive lipid-control therapy on the onset of cardiovascular diseases is superior to that of the standard one. Cardiovascular diseases include the following: - cardiac event: MI, unstable angina pectoris requiring unscheduled hospitalization, coronary revascularization (PTCA, CABG) - cerebral event: cerebral infarction, cerebrovascular revascularization - Renal event: initiation of permanent dialysis, 2-fold or more increase in serum creatinine (and > 1.5 mg/dL) - vascular event: aortic/peripheral arterial diseases (onset of aortic dissection, mesenteric artery thrombosis, or arteriosclerosis obliterans-related severe ischemia (ulcer) of lower limbs, or finger/leg amputation)
- Secondary Outcome Measures
Name Time Method 1) Efficacy will be assessed using the following evaluation parameters: - total deaths - onset of individual cardiac, cerebral, renal, vascular events - onset of stroke (cerebral infarction, cerebral hemorrhage, subarachnoid haemorrhage) - changes (measured value, rate) in CKD-related parameters (eGFR, urinary albumin, urinary protein) 2) Safety of the therapies will be evaluated using incidence rates of adverse events as an evaluation parameter.