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(Stroke. 2009;40:3541.)
© 2009 American Heart Association, Inc.

Original Contributions

Effect of Telmisartan on Functional Outcome, Recurrence, and Blood Pressure in Patients With Acute Mild Ischemic Stroke

A PRoFESS Subgroup Analysis

Philip M. W. Bath, MD, FRCP; Reneé H. Martin, PhD; Yuko Palesch, PhD; Daniel Cotton, MS; Salim Yusuf, MB, BS, DPhil; Ralph Sacco, MD; Hans-Christoph Diener, MD, PhD; Danilo Toni, MD; Conrado Estol, MD, PhD; Robin Roberts, MSc for the PRoFESS Study Group

From the Stroke Trials Unit (P.M.W.B.), University of Nottingham, UK; Department of Biostatistics, Bioinformatics, and Epidemiology (R.H.M., Y.P.), Medical University of South Carolina, Columbia, SC; Biostatistics (D.C.), Boehringer Ingelheim Pharmaceuticals, Ridgefield, Conn; Population Health Research Institute (S.Y.), McMaster University, Hamilton, Canada; Division of Neurology (R.S.), University of Miami, Miami, Fla; Department of Neurology (H.-C.D.), University Duisburg-Essen, Germany; Emergency Department Stroke Unit (D.T.), Sapienza University of Rome, Italy; Neurological Center & Research Unit (C.E.), Buenos Aires, Argentina; Department of Clinical Epidemiology (R.R.), McMaster University, Hamilton, Canada.

Correspondence to Philip Bath, Stroke Trials Unit, University of Nottingham, City Hospital campus, Nottingham NG5 1PB, UK. E-mail philip.bath{at}nottingham.ac.uk

Background and Purpose— High blood pressure (BP) is common in acute ischemic stroke and associated independently with a poor functional outcome. However, the management of BP acutely remains unclear because no large trials have been completed.

Methods— The factorial PRoFESS secondary stroke prevention trial assessed BP-lowering and antiplatelet strategies in 20 332 patients; 1360 were enrolled within 72 hours of ischemic stroke, with telmisartan (angiotensin receptor antagonist, 80 mg/d, n=647) vs placebo (n=713). For this nonprespecified subgroup analysis, the primary outcome was functional outcome at 30 days; secondary outcomes included death, recurrence, and hemodynamic measures at up to 90 days. Analyses were adjusted for baseline prognostic variables and antiplatelet assignment.

Results— Patients were representative of the whole trial (age 67 years, male 65%, baseline BP 147/84 mm Hg, small artery disease 60%, NIHSS 3) and baseline variables were similar between treatment groups. The mean time from stroke to recruitment was 58 hours. Combined death or dependency (modified Rankin scale: OR, 1.03; 95% CI, 0.84–1.26; P=0.81; death: OR, 1.05; 95% CI, 0.27–4.04; and stroke recurrence: OR, 1.40; 95% CI, 0.68–2.89; P=0.36) did not differ between the treatment groups. In comparison with placebo, telmisartan lowered BP (141/82 vs 135/78 mm Hg, difference 6 to 7 mm Hg and 2 to 4 mm Hg; P<0.001), pulse pressure (3 to 4 mm Hg; P<0.002), and rate-pressure product (466 mm Hg.bpm; P=0.0004).

Conclusion— Treatment with telmisartan in 1360 patients with acute mild ischemic stroke and mildly elevated BP appeared to be safe with no excess in adverse events, was not associated with a significant effect on functional dependency, death, or recurrence, and modestly lowered BP.

Key Words: acute stroke • blood pressure • ischemic stroke • outcome • randomized controlled trial • telmisartan