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-to-target study, conducted from March 1998 to May 1999, that assessed the percentage of patients reaching 1992 European Atherosclerosis Society (EAS) low-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 goals: < 135 mg/dl in patients with atherosclerotic disease present and/or coronary heart disease (CHD) risk >40%/10 years, or LDL-C < 155 mg/dl in all others. All subjects started treatment with atorvastatin 10 mg/day for 6 weeks. The dose was doubled every 6 weeks, to 20, 40, or 80 mg/day at weeks 12, 18, and 24, respectively, if targets were not reached. Of 587 patients screened for participation, 473 were enrolled and 419 (59% male; mean age 61 years) were available for efficacy evaluation. Fifty-five percent had atherosclerotic disease and/or CHD risk >40%/10 years. Dose titration was not needed in 303 patients (72%) who reached LDL-C target with atorvastatin 10 mg/day. Among 116 patients who were subsequently treated with higher atorvastatin 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 atorvastatin 10-80 mg/day. Seventy-two % of patients reached target with atorvastatin 10 mg/day, which may simplify clinical management and should encourage better adherence to recommendations.