Telmisartan Does Not Significantly Reduce Risk of Recurrent Stroke, Cardiovascular Events

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Title: Telmisartan Does Not Significantly Reduce Risk of Recurrent Stroke, Cardiovascular Events
URL: http://www.pslgroup.com/dg/22AD72.htm
Doctor's Guide
September 4, 2008

NEW YORK -- September 4, 2008 -- Telmisartan does not significantly reduce the risk of a subsequent stroke, of the composite outcome of major cardiovascular events, or of new-onset diabetes, according to a study published in the August 27 issue of the New England Journal of Medicine.

According to background information from the article, several trials have raised the possibility of an additional mechanism, independent of blood-pressure lowering, by which blockers of the renin-angiotensin system may be beneficial in patients with stroke.

However, those studies generally enrolled patients several months or years after a stroke, and the potential benefit of the use of renin-angiotensin system blockers soon after a stroke has not been clearly established.

Salim Yusuf, Population Health Research Institute, McMaster University, Hamilton, Ontario, and colleagues evaluated the effects of therapy with the angiotensin-receptor blocker (ARB) telmisartan, initiated 4 months after a stroke and continued for 2.5 years.

The multicentre trial involved 20,332 patients aged 55 years or older who recently had an ischaemic stroke. They were randomly assigned to receive either telmisartan 80 mg QD (n = 10,146) or placebo (n = 10,186).

The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events and new-onset diabetes. The median interval from stroke to randomisation was 15 days.

During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group compared with 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 [HR] in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86-1.04; P = .23).

Major cardiovascular events occurred in 1,367 patients (13.5%) in the telmisartan group and 1,463 patients (14.4%) in the placebo group (HR, 0.94; 95% CI, 0.87-1.01; P = .11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (HR, 0.82; 95% CI, 0.65-1.04; P = .10).

The authors note that there were 3 major limitations to their study: (1) lower adherence to telmisartan compared with other, larger trials, (2) more patients in the placebo group versus the telmisartan group received nonstudy blood pressure–lowering medications, and (3) the duration of the trial may have been too short.

"I think that if we had a longer mean follow-up, the effects of the telmisartan would have been greater," study coauthor Ralph L. Sacco, MD, Miller School of Medicine, University of Miami, Miami, Florida, told DocGuide.

"Our subgroup analysis showed that the treatment was significantly better for prevention of stroke recurrence among those randomised [to telmisartan] after 6 months, indicating a possible bigger effect later."

Although the primary outcomes were not met, Dr. Sacco told DocGuide the study showed that physicians "may not need to add ARBs early after stroke to prevent a recurrence, but their benefits for long-term risk reduction are still important, especially when this trial is evaluated in the context of other important trials with ARBs."

SOURCE: New England Journal of Medicine

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