Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events

doi:10.1056/NEJMoa0804593

Volume 359:1225-1237		September 18, 2008		Number 12

Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events

Salim Yusuf, M.B., B.S., D.Phil., Hans-Christoph Diener, M.D., Ph.D., Ralph L. Sacco, M.D., Daniel Cotton, M.S., Stephanie Ôunpuu, Ph.D., William A. Lawton, B.A., Yuko Palesch, Ph.D., Reneé H. Martin, Ph.D., Gregory W. Albers, M.D., Philip Bath, F.R.C.P., Natan Bornstein, M.D., Bernard P.L. Chan, M.D., Sien-Tsong Chen, M.D., Luis Cunha, M.D., Ph.D., Björn Dahlöf, M.D., Ph.D., Jacques De Keyser, M.D., Ph.D., Geoffrey A. Donnan, M.D., Conrado Estol, M.D., Ph.D., Philip Gorelick, M.D., Vivian Gu, M.D., Karin Hermansson, D.M.Sc., Lutz Hilbrich, M.D., Markku Kaste, M.D., Ph.D., Chuanzhen Lu, M.D., Thomas Machnig, M.D., Prem Pais, M.D., Robin Roberts, M.Tech., Veronika Skvortsova, M.D., Philip Teal, M.D., Danilo Toni, M.D., Cam VanderMaelen, Ph.D., Thor Voigt, M.D., Michael Weber, M.D., Byung-Woo Yoon, M.D., Ph.D., for the PRoFESS Study Group

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ABSTRACT

Background Prolonged lowering of blood pressure after a strokereduces the risk of recurrent stroke. In addition, inhibitionof the renin–angiotensin system in high-risk patientsreduces the rate of subsequent cardiovascular events, includingstroke. However, the effect of lowering of blood pressure witha renin–angiotensin system inhibitor soon after a strokehas not been clearly established. We evaluated the effects oftherapy with an angiotensin-receptor blocker, telmisartan, initiatedearly after a stroke.

Methods In a multicenter trial involving 20,332 patients whorecently had an ischemic stroke, we randomly assigned 10,146to receive telmisartan (80 mg daily) and 10,186 to receive placebo.The primary outcome was recurrent stroke. Secondary outcomeswere major cardiovascular events (death from cardiovascularcauses, recurrent stroke, myocardial infarction, or new or worseningheart failure) and new-onset diabetes.

Results The median interval from stroke to randomization was15 days. During a mean follow-up of 2.5 years, the mean bloodpressure was 3.8/2.0 mm Hg lower in the telmisartan group thanin the placebo group. A total of 880 patients (8.7%) in thetelmisartan group and 934 patients (9.2%) in the placebo grouphad a subsequent stroke (hazard ratio in the telmisartan group,0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Majorcardiovascular events occurred in 1367 patients (13.5%) in thetelmisartan group and 1463 patients (14.4%) in the placebo group(hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onsetdiabetes occurred in 1.7% of the telmisartan group and 2.1%of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04;P=0.10).

Conclusions Therapy with telmisartan initiated soon after anischemic stroke and continued for 2.5 years did not significantlylower the rate of recurrent stroke, major cardiovascular events,or diabetes. (ClinicalTrials.gov number, NCT00153062 [ClinicalTrials.gov] .)

Source Information

The authors' affiliations are listed in the Appendix.

Drs. Yusuf, Diener, and Sacco contributed equally to this article.

This article (10.1056/NEJMoa0804593) was published at www.nejm.org on August 27, 2008.

Address reprint requests to Dr. Yusuf at the Population Health Research Institute, Hamilton Health Sciences and McMaster University, 237 Barton St. East, Hamilton, ON L8L 2X2, Canada, or at yusufs{at}mcmaster.ca.

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Related Letters:

Telmisartan for Prevention of Cardiovascular Events
Doumas M., Papademetriou V., Fichet J., Bressolle C., Fournier R. O., Achard J.-M., Fournier A., Yusuf S., Diener H.-C., Sacco R. L.
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N Engl J Med 2009; 360:302-303, Jan 15, 2009. Correspondence

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