Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events

Yusuf, Salim; Diener, Hans-Christoph; Sacco, Ralph L.; Cotton, Daniel; Ounpuu, Stephanie; Lawton, William A.; Palesch, Yuko; Martin, Renée H.; Albers, Gregory W.; Bath, Philip M.W.; Bornstein, Natan; Chan, Bernard P.L.; Chen, Sien-Tsong; Cunha, Luis; Dahlöf, Björn; De Keyser, Jacques; Donnan, Geoffrey A.; Estol, Conrado; Gorelick, Philip; Gu, Vivian; Hermansson, Karin; Hillbrich, Lutz; Kaste, Markku; Lu, Chuanzhen; Machnig, Thomas; Pais, Prem; Roberts, Robin; Skvortsova, Veronika; Teal, Philip; Toni, Danilo; VanderMaelen, Cam; Voight, Thor; Weber, Michael; Yoon, Byung-Woo

Abstract

Background

Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin–angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin–angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.

Methods

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

Results

The median interval from stroke to randomization was 15 days. During a mean followup of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P = 0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan 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-onset diabetes 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 an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)

Citation

Voigt, T., Hilbrich, L., Bath, P., Martin, R. H., Ôunpuu, S., Yusuf, S., …Yoon, B. (2008). Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events. New England Journal of Medicine, 359(12), 1225-1237. https://doi.org/10.1056/nejmoa0804593

• Journal Article Type: Article
• Online Publication Date: Sep 18, 2008
• Publication Date: Sep 18, 2008
• Deposit Date: Sep 11, 2008
• Publicly Available Date: Sep 11, 2008
• Journal: New England Journal of Medicine
• Print ISSN: 0028-4793
• Electronic ISSN: 1533-4406
• Publisher: Massachusetts Medical Society
• Peer Reviewed: Peer Reviewed
• Volume: 359
• Issue: 12
• Pages: 1225-1237
• DOI: https://doi.org/10.1056/nejmoa0804593
• Keywords: General Medicine
• Public URL: http://eprints.nottingham.ac.uk/id/eprint/952
• Publisher URL: http://content.nejm.org/cgi/content/full/359/12/1225
• Copyright Statement: Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf