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First landmark ARB trial against placebo shows telmisartan reduces the risk of cardiovascular death, heart attack and stroke in ACE-intolerant high-risk patients1

TRANSCEND®, parallel trial to ONTARGET®, confirms long-term protective benefits and excellent tolerability profile of telmisartan 80mg1 on top of current best standard of care

Munich, Germany, 31st August, 2008 /PRNewswire/ – The results of the TRANSCEND® trial demonstrate that telmisartan 80mg reduces the risk of cardiovascular death, myocardial infarction/heart attack and stroke in high-risk cardiovascular patients by 13% compared with those patients already 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 Therapy with telmisartan was well tolerated and showed a trend towards a lower rate of discontinuation.1

The new data on 5,926 patients from 40 countries were presented today at the annual congress of the European Society of Cardiology (ESC) in Munich, Germany. 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.

An 8% reduction of events in the pre-specified primary endpoint made up of the composite of cardiovascular death, myocardial infarction, stroke and hospitalisation 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

"Earlier this year, the ONTARGET® Trial showed that telmisartan is as protective as, but better tolerated than the ACE-inhibitor ramipril. The TRANSCEND® results represent a moderate but important step forward for high-risk patients who cannot tolerate an ACE-inhibitor," commented Professor Salim Yusuf, lead investigator of the ONTARGET® Trial Programme and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada.

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 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."

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).

The trial, a parallel study to the ONTARGET® trial3, which together form The ONTARGET® Trial Programme, investigated the effects of telmisartan 80mg in 5,926 patients intolerant to widely-prescribed ACE-inhibitors. Worldwide, 10-39% of patients with hypertension are intolerant to ACE-inhibitors4-6 which often leads to discontinuation of treatment leaving patients unprotected. Side effects associated with ACE-inhibitors include intolerable cough and rare, but potentially life threatening, angioedema.4-6

Also of note, the risk reduction of 13% with telmisartan was achieved despite a high proportion of patients receiving proven therapies such as statins, antiplatelet agents or betablockers.

"While cardiovascular treatment has improved substantially over the last ten years, telmisartan still further reduced cardiovascular risk. We are proud to have advanced medical knowledge in the cardiovascular arena with our landmark studies ONTARGET® and the parallel trial TRANSCEND®. We have followed almost 50,000 telmisartan patients in clinical trials in the last 5 years, and now have experience from daily use of telmisartan summing up to 25 million patient years all over the world. This makes the medication one of the best-researched cardiovascular drugs with an outstanding efficacy and safety/tolerability profile," commented Dr Andreas Barner, vice-chairman of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine.

Cardiovascular disease (CVD) is the leading cause of death worldwide, causing over 17.5 million deaths per year.7 7.6 million people die from a heart attack and 5.7 million die from a stroke every year.7 Global deaths from CVD are predicted to reach approximately 25 million by 2020.8 CVD is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.8 A major stroke is viewed by more than half of those at risk as being worse than death.9

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

Notes to Editors/references are detailed in pdf attached see link above

Contact Info


Corporate Division Communications
Boehringer Ingelheim GmbH
55216 Ingelheim, Germany
Phone: + 49 - 6132 - 77 97296, 77- 8271
Fax: + 49 - 6132 - 72 6601
press@boehringer-ingelheim.com

Related Links

www.news-ontarget.com
www.ontarget-telmisartan.com
www.micardis.com
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Prof. Peter Sleight
Dept of Cardiovascular Medicine
Oxford, UK, comments on the outcome of the TRANSCEND trial

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Dr. Sarah Jarvis
Richford Gate Medical Practice
London UK, comments on the importance of tolerabilty in CVD treatment

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