Elsevier

American Heart Journal

Volume 156, Issue 4, October 2008, Pages 698-705
American Heart Journal

Clinical Investigation
Outcomes, Health Policy and Managed Care
Long-term economic outcomes associated with intensive versus moderate lipid-lowering therapy in coronary artery disease: Results from the Treating to New Targets (TNT) Trial

https://doi.org/10.1016/j.ahj.2008.05.032Get rights and content

Background

In 10,001 patients with stable coronary artery disease (CAD) enrolled in the Treating to New Targets (TNT) trial, 80 mg/d of atorvastatin (high-dose regimen) reduced the composite primary end point of death from CAD, nonfatal myocardial infarction, resuscitation from cardiac arrest, or stroke by 22% relative to 10 mg/d (low-dose regimen).

Methods

We performed an economic analysis of this trial from the US perspective using hospital bills and Medicare physician fees to estimate costs for cardiovascular hospitalizations in all US patients (n = 5,308). Atorvastatin costs were assigned using a discounted average wholesale price. Cost-effectiveness was calculated as the within-trial incremental cost required to prevent one primary end point event with high-dose atorvastatin.

Results

During a mean 4.9-year follow-up, the high-dose arm had fewer potential end point cardiovascular hospitalizations (35% vs 41%, P < .001) and revascularization procedures (16% vs 22%, P < .001). The high-dose regimen was $1 per day more expensive. At the end of 5 years, cumulative incremental cost for the high-dose arm was $252 (95% CI−$722 to +$1,276). With an absolute reduction in the primary end point of 2.8 per 100 treated with the high-dose regimen, the cost to prevent one additional primary end point event was $8,964.

Conclusion

High-dose atorvastatin treatment of 5 years had only a small net incremental cost because of reduced complications and procedures. The cost to prevent one additional primary end point event with high-dose therapy was similar to that for drug-eluting stents versus bare metal stents in stable CAD and for early invasive versus early conservative therapy in acute coronary syndromes.

Section snippets

Overview of design and primary clinical results in TNT

Patients eligible for TNT were 35 to 75 years of age at entry into the trial (July 1998 to December 1999) and had clinically evident CAD involving a previous MI, previous or current angina with objective evidence of atherosclerosis, or previous coronary revascularization. The qualifying event had to be between 1 month and 5 years before screening.5 At the end of an open-label run-in phase with low-dose atorvastatin, patients were eligible for randomization if their LDL cholesterol levels

Baseline characteristics and clinical outcomes in US patients by intention-to-treat

Baseline demographic and clinical characteristics were very well balanced by randomized treatment assignment within the 5,308 US patients, with 2,656 patients randomized to the low-dose arm and 2,652 patients randomized to the high-dose arm (Table I). There were no significant differences in demographics, clinical history, or baseline lipid values.

Clinical outcome results in the US cohort were consistent with the overall trial, with a significantly lower primary composite end point event rate

Discussion

Our study demonstrates that intensive lipid-lowering therapy with high-dose atorvastatin therapy relative to moderate lipid-lowering therapy with low-dose atorvastatin reduced the costs associated with cardiovascular complications in the US TNT cohort to an extent that recouped almost all the extra cost of therapy. At the end of 5 years, the net cost of the high-dose arm was $252. Furthermore, examination of the patterns of costs and cost savings over time showed that there was approximate cost

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