Redukcja stężenia cholesterolu LDL za pomocą kombinacji ezetymibu z simwastatyną wśród pacjentów z przewlekłą chorobą nerek – wyniki badania SHARP (Study of Heart and Renal Protection) Letter to the Editor

Abstract

Chronic kidney disease (CKD) is connected with increase in incidence of atherosclerotic events. The dataabout prevention of atherosclerotic diseases among people with CKD is not sufficient. The aim of SHARP study (Study of Heart and Renal Protection) was to assess the effects of reducing LDL cholesterol by an average of about 1 mmol/L in CKD patients. The SHARP enrolled patients with advanced CKD (blood creatinine concentration ≥1.7 mg/dL (≥150 μmol/L) in men or ≥1.5 mg/dL (≥130 μmol/L) in women) with no known history of myocardial infarction or coronary revascularization. Patients were randomized to three study groups: ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm randomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcomes were major atherosclerotic events, defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Allocation to simvastatin plus ezetimibe produced a 17% reduction in major atherosclerotic events (11,3% vs 13,4%; p=0,0021). There were also significant reductions in non-haemorrhagic stroke (p=0,01) and arterial revascularisation procedures (p=0,0036). The simvastatin and ezetimib therapy was found safe in patients with CKD. Reduction of LDL cholesterol with simvastatin plus ezetimibe safely reduced the incidence of major atherosclerotic events in patients with CKD.