OBJECTIVES: In the secondary prevention of cardiovascular disease patient compliance with established risk-reducing factors remains inadequate. The primary objective of the ORBITAL Study is to evaluate the impact of a compliance enhancing program in patients receiving statin therapy on long-term disease-related outcomes and costs. Here the design and results of the pilot phases are presented. METHODS: Approximately 7000 patients eligible for statin therapy (Joint European Guidelines) will be enrolled nationwide in primary care practices in Germany. Patients will be randomised into an intervention group (12-month rosuvastatin plus compliance program) and a control group (12-month rosuvastatin alone). Disease-related costs, quality of life, cardiovascular events, and compliance will be assessed every 6 months during the 36 months follow-up. The compliance program was developed based on previous studies, expert advice, and pilot testing, and includes a start package with a video and an information brochure, followed by mailings and telephone calls. The program addresses factors such as diet and lifestyle in addition to compliance with pharmacotherapy. The information brochure and telephone calls were evaluated in two subsequent pilot phases. RESULTS: In the first pilot phase, 23 of 25 contacted patients in a cardiac rehabilitation center considered the brochure to be easy to understand although some criticized the use of too many medical terms. 17% of patients considered the brochure to be too long. In the second pilot phase, 70 patients were randomised into intervention (n=37) or control (n=33) groups. The majority of the intervention patients expressed high satisfaction with the telephone calls although 10% indicated the calls contained too much information and should be shortened. CONCLUSION: With regard to the compliance initiatives evaluated, the importance of not overloading patients with information became apparent. Therefore, the compliance enhancing program was revised accordingly for the main phase of the ORBITAL Study, which started in May 2002 and is scheduled to run for 3 years.