Effect of an adherence-enhancing program on health-related quality of life in patients with hypercholesterolemia.

Objective: In patients with hypercholesterolemia, health-related quality of life (HRQoL) is an important outcome. HRQoL has been shown to be associated with adherence to medication and lifestyle recommendations. The objective of the present study was to assess the effect of an adherence-enhancing program on HRQoL. Methods: The ORBITAL (Open-label primary care study: Rosuvastatin-Based compliance Initiatives linked To Achievement of LDL goals) Study was a randomized controlled trial evaluating the effectiveness of an adherence-enhancing program in patients with statin therapy. Patients were enrolled consecutively in 1961 primary care practices in Germany. HRQoL as a secondary outcome was assessed with the generic Short Form (SF)-12 and the EuroQoL (EQ-5D) health status instruments at baseline, 6 and 12 months. Results: A total of 7640 patients were included. HRQoL was inversely related to disease severity in all scales but the mental SF-12 summary scale. Patients in the adherence program had significantly higher physical SF-12 scores during follow-up compared to controls, independent from any lipid-lowering effect. No effect was observed with regard to the mental SF-12 and the EQ-5D scores. The effect of the program on physical SF scores did not meet predefined criteria for clinical relevance. Conclusion: The adherence-enhancing program had a significant benefit on physical HRQoL in patients with statin therapy. However, the benefit was not associated with improved adherence to lipid-lowering therapy on the individual level and thus should rather be understood as unspecific program effect. Also, the observed effect does not appear to be clinically relevant. [Copyright &y& Elsevier]