During the double-blind period, follow-up visits occurred at week 12 and at months 6, 9, and 12 in the 1st year and every 6 months thereafter. At the end of the run-in phase (week 0), those patients with a mean LDL cholesterol <130 mg/dl (3.4 mmol/l) (determined at weeks −4 and −2) were randomized to double-blind therapy with either atorvastatin 10 or 80 mg/day. To ensure that all patients at baseline achieved LDL cholesterol levels consistent with the current guidelines for the treatment of stable CHD, patients with LDL cholesterol between 130 and 250 mg/dl (3.4–6.5 mmol/l) and triglycerides ≤600 mg/dl (6.8 mmol/l) entered an 8-week open-label period with atorvastatin 10 mg/day. While the American Diabetes Association (ADA)-recommended goal of therapy remains at an LDL cholesterol <100 mg/dl, the potential for a more aggressive LDL cholesterol goal of <70 mg/dl (1.8 mmol/l) has been proposed as a treatment option in patients with type 2 diabetes and overt cardiovascular disease ( 12).Īny previously prescribed lipid-regulating drugs were discontinued at screening, and all patients required a wash-out period of 1–8 weeks (8 weeks for those who had and 1 week for those who had not previously received lipid-regulating drugs). Recent cardiovascular outcomes trials have raised the issue of lower optimal treatment targets for patients with CHD ( 14, 15). Due to the high cardiovascular risk conferred by type 2 diabetes, current treatment recommendations consider patients with diabetes to be CHD risk equivalents ( 11, 12, 13) and have established an LDL cholesterol goal of <100 mg/dl (2.6 mmol/l) in these patients. Lowering elevated LDL cholesterol levels with statins has demonstrated significant reductions in cardiovascular events in patients with diabetes and CHD ( 7, 8, 9, 10). LDL cholesterol is similar to that in the general population, although the LDL particles are smaller, denser, and more atherogenic. There were no significant differences between the treatment groups in the rates of treatment-related adverse events and persistent elevations in liver enzymes.ĬONCLUSIONS-Among patients with clinically evident CHD and diabetes, intensive therapy with atorvastatin 80 mg significantly reduced the rate of major cardiovascular events by 25% compared with atorvastatin 10 mg.ĭyslipidemia is a major contributor to the increased CHD risk in patients with type 2 diabetes ( 5, 6) and is characterized by elevated levels of triglycerides and low levels of HDL cholesterol. Significant differences between the groups in favor of atorvastatin 80 mg were also observed for time to cerebrovascular event (0.69, P = 0.037) and any cardiovascular event (0.85, P = 0.044). A primary event occurred in 135 patients (17.9%) receiving atorvastatin 10 mg, compared with 103 patients (13.8%) receiving atorvastatin 80 mg (hazard ratio 0.75, P = 0.026). RESULTS-End-of-treatment mean LDL cholesterol levels were 98.6 mg/dl with atorvastatin 10 mg and 77.0 mg/dl with atorvastatin 80 mg. The primary end point was the time to first major cardiovascular event, defined as death from CHD, nonfatal non–procedure-related myocardial infarction, resuscitated cardiac arrest, or fatal or nonfatal stroke. Patients were followed for a median of 4.9 years. RESEARCH DESIGN AND METHODS-A total of 1,501 patients with diabetes and CHD, with LDL cholesterol levels of <130 mg/dl, were randomized to double-blind therapy with either atorvastatin 10 ( n = 753) or 80 ( n = 748) mg/day. The objective of our study was to investigate whether similar benefits of high-dose intensive atorvastatin therapy can be achieved in patients with CHD and diabetes. OBJECTIVE-The Treating to New Targets study showed that intensive lipid-lowering therapy with atorvastatin 80 mg/day provides significant clinical benefit beyond that afforded by atorvastatin 10 mg/day in patients with stable coronary heart disease (CHD).
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