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Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study

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284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss.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.

Trial
Journal Ref. Koren MJ, Hunninghake DB, Investigators A: Journal of the American College of Cardiology 2004, 44:1772-1779.
Intervention Drug - Arorvastatin to maximum 80mg/day
Number of sites 16
Countries involved USA
Sample size 2442
Type of statistical analyses ITT
Risk of bias Overall: Unclear details
Participant characteristics Age: 61 (31-78)
Condition: coronary heart disease
Baseline severity: CHD defined as MI > 3 months prescreening etc LDL-C levels 110mg/dl to 200 mg/dl for patients receiving no lipid regulating therapy.
Duration of trial 7 years: July 6th 1995 to July 17th 2002: patients median period of 54.3 (mean 51.5 months, SE = 0.37)
Primary outcome Time from randomization to first occurance of a primary cardiovascular event
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
34 1217 23 1225 0.92 %
p < 0.0001 Effect measures are % reduction in LDL-C levels
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4 2 2 2 4 3 2 4 5