Impact of a compliance program on cholesterol control: results of the randomized ORBITAL study in 8108 patients treated with rosuvastatin.
OBJECTIVE
To determine whether a compliance-enhancing program could increase the level of lipid control in patients treated with rosuvastatin.


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) >or=115 mg/dl if statin-naive or else >or=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.


CONCLUSIONS
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.
Willich
Stefan N
SN
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany. stefan.willich@charite.de
Englert
Heike
H
Sonntag
Frank
F
Völler
Heinz
H
Meyer-Sabellek
Wolfgang
W
Wegscheider
Karl
K
Windler
Eberhard
E
Katus
Hugo
H
Müller-Nordhorn
Jacqueline
J
D000368:Aged; D015415:Biomarkers / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood*; D005060:Europe; D005260:Female; D005464:Fluorobenzenes / Q000009:adverse effects / Q000627:therapeutic use*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010353:Patient Education as Topic; D015397:Program Evaluation; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium