Outcomes

Telmisartan Randomised AssessmeNt Study in ACE-iNtolerant subjects with cardiovascular Disease

TRANSCEND^® Trial Results Presented at the annual congress of the European Society for Cardiology, 31 August 2008

The TRANSCEND^® results demonstrate that MICARDIS^® (telmisartan) on top of the best standard of care reduces the risk of cardiovascular death, myocardial infarction/heart attack and stroke in high-risk cardiovascular patients by 13% compared with those patients only receiving best standard of care (p=0.048), referring to the same endpoint as that defined as the primary endpoint of the landmark HOPE trial published in 2000.^1,2 The primary composite endpoint (CV death, MI, stroke and hospitalization for CHF) was reduced by 8% (p=0.22).¹ Therapy with telmisartan was well tolerated and showed a trend towards a lower rate of discontinuation.¹

TRANSCEND^® is the first landmark trial to test and prove the cardiovascular protective effects of an angiotensin II receptor blocker (ARB) - Boehringer Ingelheim’s telmisartan - versus placebo, on top of standard therapy (including anti-hypertensives, anti-platelet therapy and statins), in high-risk individuals who cannot tolerate an angiotensin converting enzyme (ACE)-inhibitor.

Data on 5,926 patients from 40 countries were presented - TRANSCEND^® included a broad cross-section of cardiovascular high risk patients (patients older than 55 years, who have had myocardial infarction, peripheral arterial occlusive disease, stroke or transient ischaemic attacks or suffer from diabetes mellitus and additional risk factors).

An 8% reduction of events in the pre-specified primary endpoint made up of the composite of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure was seen in the trial, which was statistically non-significant with a p-value of 0.216 (HR 0.92).¹ Translated into absolute figures, only 465 patients in the telmisartan arm experienced a cardiovascular event versus 504 patients receiving placebo on top of current best standard of care.

All cardiovascular hospitalisations were significantly reduced with telmisartan (894 vs 980; p=0.025). In general, the data show that the protective effects of telmisartan were more pronounced the longer patients were on treatment.¹

Commenting on the implications of the results for general practitioners, Dr. Sarah Jarvis, Richford Gate Medical Practice, London, said “Until now, physicians treating ACEI-intolerant patients at risk of heart attack or stroke did not have a proven alternative to the ACE-inhibitor ramipril – a situation we faced with one in five high risk patients. We now have the scientific evidence to show that telmisartan protects patients ACEI-intolerant patients against heart attack, stroke and cardiovascular death while showing a placebo-like tolerability. This builds on previous findings of the ONTARGET^® trial and gives physicians the confidence of prescribing a drug with proven efficacy that will be taken as prescribed and not left in the drawer.”

References

1. The TRANSCEND Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. The Lancet 2008; Published online Aug 31. DOI:10.1016/S0140-6736(08)61242-8.

2. The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med 2000; 342:145-53.

For further information, please go to the European Society of Cardiology website.