Impact of a compliance program on cholesterol control: results of the randomized ORBITAL study in 8108 patients treated with rosuvastatin

Aim To determine whether a compliance-enhancing program could increase the level of lipid control in patients treated with rosuvastatin. Methods and results A total of 8108 patients (56% men, mean age 59 years; 44% women, mean age 63 years) with low-density lipoprotein cholesterol (LDL-C) >= 115 mg/dl if statin-naive or else >= 125 mg/dl were randomized to rosuvastatin 10 mg daily either with or without a compliance-enhancing program for 12 months. Patients not achieving the goal after 3 months were uptitrated to rosuvastatin 20 mg daily thereafter. At 3, 6, and 12 months, rosuvastatin plus compliance initiatives were similarly effective to rosuvastatin alone in terms of 1998 European LDL-C goal of less than 115 mg/dl achievement (72 vs. 70%, 71 vs. 69%, 68 vs. 68%) and changes in the lipid profile. Significant differences were observed in the subgroup of statin-naive patients at 3 and 6 months (80 vs. 76% and 78 vs. 73%, P<0.01). The frequency of adverse events and relevant changes in laboratory data were consistent with the known safety profile of rosuvastatin. Conclusion Rosuvastatin 10/20 mg daily enables the majority of patients to achieve LDL-C less than 115 mg/dl within 3 months. The compliance-enhancing program was only effective in statin-naive patients at early time points, but had no overall effect over 12 months. Eur J Cardiovasc Prev Rehabil 16:180-187 (C) 2009 The European Society of Cardiology