Background: Previous studies investigating the effectiveness of compliance programs in patients with cardiovascular risk factors have been inconclusive and have not included economic analyses. The primary aim of this Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study is to determine the long-term cost-effectiveness of a compliance-enhancing intervention in patients with hypercholesterolemia (HC). Secondary objectives include the assessment of compliance, cardiovascular events, and health-related quality of life.
Study design: A total of 7598 patients (56% men, age 60 +/- 10 years, and 44% women, 64 +/- 10 years) with HC requiring statin therapy according to the Second Joint European Guidelines were recruited at presentation to 1961 primary care physicians in Germany. Patients were randomized to rosuvastatin therapy with or without a compliance-enhancing program (including standardized contacts between the study center and patients, 9 mailings, 6 telephone calls, and access to a Web page and hotline) for 12 months. Following the intervention phase, there will be a 24-month observational period with patients receiving usual care. Baseline and 6-monthly follow-up assessments are to be obtained from patients and their physicians using standardized questionnaires to evaluate medical and economic parameters. Cumulative direct and indirect disease-related costs (including resource utilization for ambulatory, hospital, rehabilitative, and nursing care, medication, physiotherapy, and transportation, and loss of productivity) will be compared applying a societal perspective.
Conclusions: The results of this ORBITAL study will provide a basis to develop cost-effective compliance strategies and eventually improve medical care for patients with HC.