Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II.

OBJECTIVE: Lowering low-density lipoprotein cholesterol (LDL-C) levels can reduce vascular clinical endpoints in outcome studies. Despite this evidence, previous cross-sectional analyses reported a mean LDL-C target attainment of <50%. This non-interventional, longitudinal study aimed to asses the rate of target attainment by intensified LDL-C lowering therapy in a high-risk population under routine medical care. DESIGN: This was an open-label, non-interventional, observational, non-comparative longitudinal study. METHODS: A total of 1682 outpatients at high cardiovascular risk, not at LDL-C target despite statin therapy, were documented. Treating physicians administered an intensified therapy at their discretion. In all, 794 patients completed all the examinations at baseline after 3 and 12 months. The achieved LDL-C reductions was evaluated based on expert consensus reflecting the 2007 guidelines issued by the European Society of Cardiology (ESC) on cardiovascular disease prevention. REGISTRATION: www.clinicaltrials.gov , identification number NCT 01381679 RESULTS: In the study, 40.3% achieved the individual LDL-C target of <.8 mmol/L (70 mg/dl) or <2.5 mmol/L (100 mg/dl); 73% received a simvastatin/ezetimibe fixed-dose combination; 3% received add-on ezetimibe and 23% statin therapy at maintained or increased doses; 1% received no drug treatment at all. LDL-C declined after 12 months by -31.0% (ratio 0.69, 95% CI 0.67-0.71, p<0.001), triglycerides by -11.8% (ratio 0.88, 95% CI 0.85-0.91, p<0.01) and high-density lipoprotein cholesterol (HDL-C) increased by 11.9% (ratio 1.12, 95% CI 1.10-1.14, p<0.01). CONCLUSION: Intensified therapy was effective, but target attainment was still low at 40.3% or 13.9% with regard to the new 2011 guidelines issued by the European Atherosclerosis Society (EAS) and the ESC on dyslipidemias. Enhanced screening of LDL-C levels and the use of statins at highest tolerated dose and concomitant combination therapy is recommended in order to achieve LDL-C targets outlined by current guidelines. Limitations include the design as a non-interventional study. However, this study reflects real life conditions.