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Title: Telmisartan Fails to Protect Poststroke Patients Against Second Event When Compared to Placebo: Presented at ESC

"Telmisartan Fails to Protect Poststroke Patients Against Second Event When Compared to Placebo: Presented at ESC"

By Ed Susman NICE, France -- May 20, 2008 -- The angiotensin-receptor blocker telmisartan, when administered immediately after a stroke, did not provide significant protection from a second event, researchers reported here at the 17th Annual Meeting of the European Stroke Conference (ESC). The trial achieved a reduction in mean blood pressure of 3.5 mm Hg early after a stroke in patients who were treated for about 2.5 years. The researchers said that treatment, as given in this study, may be of insufficient intensity and duration to reliably evaluate whether blood pressure lowering is of clinical value after a stroke. Investigator Salim Yusuf, MD, Professor of Medicine, McMaster University, Hamilton, Ontario presented the results of the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial, in a late breaker session on May 14. The study randomised 10,146 patients to receive telmisartan 80 mg a day and 10,186 patients to receive placebo. The trial results, which covered several areas of stroke treatment, were described in 3 presentations, each dealing with a different aspect of the trial. The researchers recruited 20,332 patients diagnosed with a non-embolic ischaemic stroke at 695 centres in 35 countries on 6 continents. Overall, 8.7% of the patients receiving telmisartan had a second stroke in the 2.5-year study, Dr. Yusuf said in his plenary discussion. About 9.2% of patients receiving placebo had a second stroke during this period, which is a 5% reduction with telmisartan, a difference that failed to reach statistical significance ([P = .23).

Major vascular events -- cardiovascular death, myocardial infarction, stroke, or new or worsening heart failure -- occurred in 13.5% of patients on telmisartan and 14.4% of patients on placebo (P = .11). The rate of new diabetes occurred in 125 patients on telmisartan and 151 patients on placebo (P = .10).

An ad hoc analysis of the study found that 3.4% of telmisartan patients and 3.2% of placebo patients had a second cerebrovascular event during the first 6 months after the stroke (P = .38). But in the following 2 years, the stroke rate was 5.3% for telmisartan patients and 6% for placebo patients (P = .029). However, Dr. Yusuf noted that this difference was not significant, as it was not a pre-specified endpoint.

"This analysis suggests little early benefit but potential later benefit with telmisartan which increases over time," Dr. Yusuf explained.

He said that the trial suffered from a lack of patient adherence to the medical regimen and the counter-balancing of the use of other hypertensive medications in the placebo group to control blood pressure, as warranted, which lowered the blood pressure differential between the 2 groups and may have impacted the results.

Funding for this study was provided by Boehringer Ingelheim Pharmaceuticals, Inc.

[Presentation title: Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) Trial: Telmisartan Versus Placebo.]

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