Outcomes, Health Policy, and Managed Care Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT) Shelby D. Reed, PhD, a Jasmina I. Radeva, MA, a Kevin P. Weinfurt, PhD, a John J. V. McMurray, MD, c Marc A. Pfeffer, MD, PhD, d Eric J. Velazquez, MD, b Jennifer S. Allsbrook, BSPH, a Leah E. Masselink, BA, a Mary Ann Sellers, MSN, b Robert M. Califf, MD, b and Kevin A. Schulman, MD, a for the VALIANT Investigators Durham, NC, Glasgow, Scotland, and Boston, Mass Background In a multinational clinical trial, valsartan was statistically not inferior to captopril in reducing mortality and cardiovascular morbidity after myocardial infarction (MI) in patients with signs of heart failure and/or left ventricular dys- function. We conducted a prospective economic evaluation to compare within-trial resource use, costs, and quality of life in patients receiving valsartan, captopril, or both after MI. Methods We assigned country-specific unit costs to resource use data for 14 703 patients and measured health-related quality of life in a subset of 4524 patients. We used the nonparametric bootstrap method to compare rates of resource use and costs, and a piecewise linear mixed-effects regression analysis to compare longitudinal measures of quality of life. Results There were no significant differences in rates of resource use between the valsartan and captopril groups. During an average follow-up of 2 years, total costs for patients receiving valsartan were significantly higher than for patients receiving captopril (US$14 103 vs US$13 038; 95% CI US$369-US$1875). The cost differential was caused primarily by the cost of the study medications (US$1056 for valsartan vs US$165 for captopril; 95% CI US$867 to US$912). Quality of life did not differ significantly between groups. Conclusions For most patients at high risk after MI, the availability of generic captopril confers a cost advantage over valsartan because of lower medication costs. The difference will be smaller or nonexistent in settings where brand-name ACE inhibitors are prescribed. (Am Heart J 2005;150:323- 9.) VALIANT tested the hypothesis that inhibition of the renin-angiotensin system with an angiotensin re- ceptor–blocker (ARB) alone or in combination with an angiotensin-converting enzyme (ACE) inhibitor would reduce the risk of death more than or as much as an ACE inhibitor alone. 1 VALIANT evaluated 14 703 patients exhibiting evidence of heart failure, left ventricular dysfunction, or both within 10 days after myocardial infarction (MI) who were randomized to treatment with valsartan, captopril, or both. Patients were recruited to the study from December 1998 to June 2001 in 24 countries on 6 continents. Prespecified tests of non- inferiority demonstrated that valsartan was statistically not inferior to a previously proven regimen using captopril in reducing the risk of mortality and cardio- vascular morbidity in this population of patients. 2 VALIANT provided safety and efficacy data to support the use of valsartan as an alternative to ACE inhibitors in patients at high risk for cardiovascular events after MI. We sought to provide additional information on the relative effects of valsartan, captopril, and the combination of both on within-trial resource use, costs, and quality of life. Methods VALIANT incorporated a prospective economic evaluation, which included all patients enrolled from the 24 countries participating in the trial. The institutional review board of Duke University Medical Center approved the study, and subjects gave informed consent. Investigators used a case report form at every study visit to collect information on hospitalizations, inpatient and outpatient procedures, stays at rehabilitation From the a Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, b Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, c Department of Cardiology, Western Infirmary, Glasgow, Scotland, and d Cardiovascular Division, Brigham and Women’s Hospital, Boston, Mass. This work was supported by the Novartis Pharmaceuticals Corporation (East Hanover, NJ), the manufacturer of valsartan. Submitted April 13, 2004; accepted August 29, 2004. Reprint requests: Kevin A. Schulman, MD, Center for Clinical and Genetic Economics, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail: kevin.schulman@duke.edu 0002-8703/$ - see front matter n 2005, Mosby, Inc. All rights reserved. doi:10.1016/j.ahj.2004.08.037