The efficacy of atorvastatin in treating patients with hypercholesterolaemia to target LDL-cholesterol goals: the LIPI-GOAL trial

Objective - LIPI-GOAL is a multicentre, open-label, non-comparative treat-t o-target study, conducted from March 1998 to May 1999, that assessed the pe rcentage of patients reaching 1992 European Atherosclerosis Society (EAS) l ow-density lipoprotein cholesterol (LDL-C) targets with atorvastatin 10-80 mg/day in subjects with hypercholesterolaemia, defined as LDL-C > 160 mg/dl after a 12-week step I diet. Methods and results - Patients were treated towards the following LDL-C goa ls: < 135 mg/dl in patients with atherosclerotic disease present and/or cor onary heart disease (CHD) risk > 40%/10 years, or LDL-C < 155 mg/dl in all others. All subjects started treatment with atorvastatin IO mg/day for 6 we eks. The dose was doubled every 6 weeks, to 20, 40, or 80 mg/day at weeks 1 2, 18, and 24, respectively, if targets were not reached. Of 587 patients s creened for participation, 473 were enrolled and 419 (59% male; mean age 61 years) were available for efficacy evaluation. Fifty-five percent had athe rosclerotic disease and/or CHD risk > 40%/10 years. Dose titration was not needed in 303 patients (72%) who reached LDL-C target with atorvastatin IO mg/day. Among 116 patients who were subsequently treated with higher atorva statin dosages, 47 reached LDL-C target with 20 mg/day, 15 with 40 mg/day, and 6 with 80 mg/day. Therefore, 88.5% of subjects reached LDL-C goal in an intention-to-treat analysis. In general, atorvastatin was well tolerated. Conclusions - Most patients at high risk for CHD reached LDL-C goals with a torvastatin 10-80 mg/day. Seventy-two % of patients reached target with ato rvastatin 10 mg/day, which may simplify clinical management and should enco urage better adherence to recommendations.