Objective: To investigate the effectiveness of statin therapy and to compare the effectiveness results of this study with the reported efficacy of the corresponding data from randomized clinical trials in a moderate-to-high risk coronary heart disease (CHD) managed care population.
Methods: Subjects, ≥18 years old, with a new hyperlipidemia diagnosis or a new prescription claim for a lipid-lowering medication (LLM) between January 1, 1999 and March 31, 2001 were followed for 12 months. Subjects were classified into six medication categories of LLM use based partly on efficacy levels on package inserts. CHD risk factors were measured in the 24-month period prior, and subjects were required to have an established CHD or a CHD-related condition, or have two or more CHD risk factors.
Results: The study population consisted of 39,124 hyperlipidemic subjects with moderate-to-high CHD risk; 22,048 (56.4%) were untreated with LLMs. Absolute mean low-density lipoprotein cholesterol (LDL-C) reductions ranged from a 32 mg/dL decrease in the low-efficacy groups to a 57 mg/dL decrease in the high efficacy statin group; percent reductions ranged from a 19% reduction from baseline to a 32% reduction from baseline, respectively. Less than half of subjects (47%) reached LDL goals set forth by NCEP Adult Treatment Panel (ATP III) guidelines, however, the rate of reaching goal increased as statin efficacy increased.
Conclusions: While a dose–response relationship was observed, the effectiveness of statin therapy was less than stated in package labeling and only 72% of the users of the highest efficacy statins reached their ATP III goal. LLM use was inconsistent with that recommended by the NCEP ATP III CHD risk assessment. Hyperlipidemia treatment in the managed care setting remains in need of improvement.