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THOMAS E. DELEA, M.S.I.A., is Senior Research Consultant; CHARU TANEJA, M.P.H., is Research Associate; and AARON MOYNAHAN, M.A., is Consultant Programmer, Policy Analysis Inc. (PAI), Brookline, MA. SIMU K. THOMAS, PH.D., is Global Head of Neuroscience, Health Economics and Outcomes Research; and FERIDE FRECH-TAMAS, M.P.H., is Director, Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, NJ. GERRY OSTER, PH.D., is Vice President, PAI.

Address correspondence to Mr. Delea at Policy Analysis Inc. (PAI), Four Davis Court, Brookline, MA 02245 (tdelea{at}pai2.com).

Purpose. The objective of this study was to compare cardiovascular and renal events in patients with hypertension receiving the angiotensin II-receptor blocker valsartan versus those receiving the angiotensin-converting-enzyme lisinopril or the ß-blocker metoprolol succinate in an extended-release formulation. Methods. A retrospective study was conducted using a health insurance claims database spanning the period from January 1997 through December 2003 and representing approximately 40 million members enrolled in over 70 health plans across the United States. Study subjects included all persons in the database with two or more outpatient prescriptions for valsartan, lisinopril, or extended-release metoprolol and two or more prior claims with a diagnosis of hypertension. Those with a history of major cardiovascular or renal events (diagnosis of myocardial infarction, stroke, heart failure, ventricular arrhythmias, or cardiac arrest; coronary revascularization procedure; diagnosis of renal failure; or dialysis or kidney transplantation) or using other antihypertensive medications except diuretics during the 12 months before treatment with valsartan, lisinopril, or extended-release metoprolol were excluded. Risks of major cardiovascular or renal event during follow-up were analyzed using Cox proportional hazards regression. Results. A total of 29,357 antihypertensive patients were identified who initiated therapy with valsartan (n = 6,645), lisinopril (n = 17,320), or extended-release metoprolol (n = 5,392). In multivariate analyses, therapy with valsartan was associated with a significantly lower risk of a major cardiovascular or renal event versus extended-release metoprolol (heart rate [HR], 0.70; 95% confidence interval [CI], 0.56–0.87; p = 0.0015). Patients receiving valsartan had a nominally lower risk of a major cardiovascular or renal event than those receiving lisinopril, although this difference was not statistically significant (HR, 0.89; 95% CI, 0.74–1.07; p = 0.1987). Conclusion. Results of this observational study suggest that the use of valsartan may reduce the risk of major cardiovascular and renal events compared with extended-release metoprolol. Index terms: Angiotensin-converting-enzyme inhibitors; Cardiac drugs; Drug comparisons; Hypertension; Hypotensive agents; Lisinopril; Metoprolol succinate; Sustained-action medications; Valsartan