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Title: Telmisartan Significantly Reduces CV Events in Patients Intolerant to ACE Inhibitors: Presented at ESC
URL: http://www.pslgroup.com/dg/22A692.htm
Doctor's Guide
September 2, 2008


By Chris Berrie

MUNICH, Germany -- September 2, 2008 -- The angiotensin receptor blocker telmisartan significantly reduces the cardiovascular (CV) death, myocardial infarction (MI), and stroke composite in patients with high risk of CV events who are intolerant to standard angiotensin-converting enzyme (ACE) inhibitors, according an international, randomised, double-blind, placebo-controlled study presented here at the European Society of Cardiology 2008 Congress (ESC).

Koon K. Teo, MB, PhD, Department of Medicine (Cardiology), McMaster University, Hamilton, Ontario, presented this study on August 31 on behalf of the Telmisartan Randomised Assessment Study in ACE-Intolerable Subjects With Cardiovascular Disease (TRANSCEND) investigators.

Despite the wide and effective use of ACE inhibitors for lowering blood pressure, there remains the need to provide alternative therapy. Therefore, as Dr. Teo said, "the question is whether telmisartan is superior to placebo in patients at high risk of CV events who are intolerant of ACE inhibitors."

The primary outcome was CV death, MI, stroke, and hospitalisation for chronic heart failure, with the key secondary outcome of CV death, MI, and stroke.

The 5,926 patients entering randomisation (mean age, 66.9 years; male, 57%) showed a history of CV disease or diabetes with end-organ damage and intolerance to ACE inhibitors. Patients were randomised to receive placebo (n = 2,972) or telmisartan 80 mg/day (n = 2,954).

At baseline, there were no significant differences between the patients' concomitant medications, with 79% on antiplatelets, 58% on beta-blockers, 33% on diuretics, 40% on calcium-channel blockers, and 55% on statins.

After the median follow-up of 56 months, Dr. Teo initially noted changes in sitting systolic blood pressure from the pre-run-in assessment, whereby at study end, the telmisartan group showed a 3.2-mm Hg reduction over that for placebo (1.1 mm Hg). He further highlighted the significantly lower diuretic and statin use by study end in the telmisartan group versus the increase with the placebo group (33.7% vs 40.0%; 38.0% vs 45.9%; P < .0001 for both).

For the primary outcome, there was a small beneficial trend in favour of telmisartan (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.81-1.05; P = .2158). However, telmisartan provided a significant improvement for the secondary outcome of CV death, MI, and stroke (HR, 0.87; 95% CI, 0.76-1.00; P = .0475).

The range of prespecified patient subgroups also showed beneficial trends for telmisartan, although no significant effects were reported. Furthermore, Dr. Teo noted, "Telmisartan is well tolerated and there is no excess of adverse events."

Dr. Teo also outlined data combining the Prevention Regimen for Effectively Avoiding Second Strokes (PROFESS) and TRANSCEND studies, where overall, telmisartan showed significant benefit for these patients for both primary (P = .026) and secondary (P = .013) outcomes. He also added here, "There was little effect [of telmisartan] in the first 6 months after randomisation but a 15% relative risk reduction after 6 months," indicating a delayed action for telmisartan (P < .001).

This study was sponsored by Boehringer.


[Presentation title: The TRANSCEND Study: A Randomised, Placebo-Controlled Clinical Trial Evaluating the Effects of Telmisartan in High Risk Individuals Without Heart Failure. Hot Line I. Abstract 238]

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