Author + information
- Received May 8, 2004
- Revision received July 9, 2004
- Accepted July 13, 2004
- Published online November 2, 2004.
- ↵*Reprint requests and correspondence:
Dr. Michael J. Koren, Jacksonville Center for Clinical Research, 4085 University Boulevard South, Suite 1, Jacksonville, Florida 32216
Objectives This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings.
Background Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a “real-world” setting.
Methods A total of 2,442 CHD patients with hyperlipidemia were randomized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average. Atorvastatin-group patients were titrated to LDL-C goals of <80 mg/dl (2.1 mmol/l) or a maximum atorvastatin dose of 80 mg/day. Usual-care patients received any treatment deemed appropriate by their regular physicians. End point assessments were complete in 958 atorvastatin-group and 941 usual-care patients. Partial assessments occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss. The primary efficacy parameter was time to first cardiovascular event.
Results A total of 289 (23.7%) patients in the atorvastatin group compared with 333 (27.7%) patients in the usual care group experienced a primary outcome (hazard ratio, 0.83; 95% confidence interval 0.71 to 0.97, p = 0.02). This reduction in morbidity was largely due to fewer non-fatal myocardial infarctions (4.3% vs. 7.7%, p = 0.0002). Levels of LDL-C were reduced more (34.3% vs. 23.3%, p < 0.0001) and National Cholesterol Education Program goals (LDL-C <100 mg/dl) more likely met at end-of-study visits (72.4% vs. 40.0%) in patients receiving atorvastatin compared with those receiving usual care.
Conclusions An aggressive, focused statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD.
Parke-Davis and Pfizer Pharmaceuticals funded the study. Drs. Koren and Hunninghake were clinical investigators in the trial who were consulted on study design, collected subject information, assisted in all aspects of data analysis, and drafted the manuscript. The sponsors initiated the study design and also participated in all aspects of logistical support during the trial, statistical and data analyses, and manuscript preparation. Pfizer Pharmaceuticals reviewed the final manuscript and assisted with editing and revisions, but the authors retained final decisions on content.
- Received May 8, 2004.
- Revision received July 9, 2004.
- Accepted July 13, 2004.
- American College of Cardiology Foundation