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

Stefan N Willich1, Heike Englert, Frank Sonntag

  • 1Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany. stefan.willich@charite.de

European Journal of Cardiovascular Prevention and Rehabilitation : Official Journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology
|January 29, 2009
PubMed

Insights

A compliance program did not significantly improve lipid control in most patients taking rosuvastatin over 12 months. However, it showed early benefits for statin-naive individuals, enhancing low-density lipoprotein cholesterol (LDL-C) management.

Area of Science:

  • Cardiology
  • Pharmacology
  • Public Health

Background:

  • Lipid control is crucial for cardiovascular disease prevention.
  • Rosuvastatin is a widely used statin for lowering low-density lipoprotein cholesterol (LDL-C).
  • Patient adherence to statin therapy can impact treatment efficacy.

Purpose of the Study:

  • To evaluate the effectiveness of a compliance-enhancing program in improving lipid control among patients treated with rosuvastatin.
  • To assess whether additional support influences the achievement of LDL-C goals.

Main Methods:

  • A randomized trial involving 8108 patients treated with rosuvastatin (10 mg daily, with potential uptitration to 20 mg).
  • Patients were assigned to receive rosuvastatin with or without a compliance-enhancing program for 12 months.
  • Lipid profiles and LDL-C goal achievement (<115 mg/dl) were assessed at 3, 6, and 12 months.

Main Results:

  • The compliance-enhancing program showed no significant overall improvement in LDL-C goal achievement compared to rosuvastatin alone over 12 months.
  • Both groups achieved similar rates of LDL-C goals at 3, 6, and 12 months (ranging from 68% to 72%).
  • A statistically significant benefit was observed in the statin-naive subgroup at 3 and 6 months, indicating early effectiveness.

Conclusions:

  • Rosuvastatin 10/20 mg daily is effective in achieving LDL-C goals for most patients within 3 months.
  • The compliance-enhancing program demonstrated limited overall efficacy over 12 months.
  • The program was effective in statin-naive patients during the initial treatment phase.
Abstract

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