View source for TRANSCEND Study Misses Primary Endpoint

''August 31, 2008 by Scott P. Williams'' [mailto:swilliams@wikidoc.org]

'''ESC Congress 2008- Munich, DE''':  Researchers from McMaster University reported that the angiotensin-receptor blocker (ARB), [[telmisartan]], while well tolerated by patients and associated with a modest reduction in the secondary outcome of cardiovascular death, [[AMI|myocardial infarction]], and [[stroke]], failed to meet its primary endpoint. These results were presented by Dr. Koon Teo, on behalf of the TRANSCEND (Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease) Study investigators, as part of the Hot Line at the ESC 2008 Congress. The full results were published online today in ''The Lancet''.

The TRANSCEND Study was composed of 5926 patients who are unable to tolerate [[angiotensin-converting enzyme]] ([[ACE]]) inhibitors. Following a three-week run-in period patients were randomized to either 80 mg/day of telmisartan (n=2954) or placebo (n=2972). Patients were recruited at 630 centers located in 40 countries. The duration of follow up was a median of 56 months, with a maximum and minimum of 64 and 51 months, respectively.

[[Telmisartan]] was well tolerated by patients. 23.8% (n=705) of patients in the placebo group permanently discontinued study drug compared to 21.6% (n=639) of patients who received [[telmisartan]] (p=0.055). The most frequent reason for study drug discontinuation was [[hypotensive]] symptoms, which was more frequent in patients who received [[telmisartan]] (0.54% [n=16] vs. 0.98% [n=29]). Patients who received [[telmisartan]] had a lower mean [[blood pressure]] than patients who received [[placebo]] in this study.

The trial’s primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, [[stroke]], or hospitalization for [[heart failure]]. 17.0% (n=504) of patients who received placebo sustained this composite outcome compared to 15.7% (n=465) of patients who received [[telmisartan]] (hazard ratio 0.92, 95% CI 0.81–1.05, p=0.216). 14.8% (n=440) of patients in the placebo group and 13.0% (n=384) of patients in the [[telmisartan]] group suffered a secondary efficacy outcome, a composite of cardiovascular death, myocardial infarction, and [[stroke]] (0.87, 0.76–1.00, p=0.048 unadjusted; p=0.068 after adjustment for multiplicity of comparisons and overlap with primary endpoint).

The TRANSCEND Study investigators call telmisartan’s lack of effect on hospitalization for heart failure “unexpected and puzzling” and consider this an area in need of further research.

The statistically significant 13% reduction in the composite occurrence of cardiovascular death, myocardial infarction, and stroke suggests that[[telmisartan]] could prove valuable in reducing the occurrence of major cardiovascular events among patients who are unable to tolerate the standard therapy of [[ACE inhibitor]]s.

The TRANSCEND Study was supported by a grant from Boehringer Ingelheim. Additionally, Dr. S. Yusuf was supported by the Heart and Stroke Foundation of Ontario, and a Senior Scientist Award from the Canadian Institutes of Health Research.

Reviewed by [[C. Michael Gibson]], M.S., M.D.

==References==
*[http://www.escardio.org/congresses/esc2008/congress-reports/Pages/238-239-yusuf-swedberg.aspx ESC Congress 2008 Hot Line I Press Release]
*[http://www.thelancet.com/journals/lancet/article/PIIS0140673608612428/abstract?isEOP=true Trial summary in ''The Lancet'']

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