TRANSCEND® trial confirms long-term protective benefits and excellent tolerability profile

Boehringer IngelheimThe results of the TRANSCEND® trial demonstrate that Micardis® 80mg (telmisartan) 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 meeting of the European Society of Cardiology (ESC) in Munich, Germany. TRANSCEND® (Telmisartan Randomised AssessmeNt Study in ACE-iNtolerant subjects with cardiovascular Disease) 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 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]

"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 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."

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® trial[3], 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]

About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and is being investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET®, PROTECTION® and PRoFESS® over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan (for more information please visit www.news-landmarktrials.com).

Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and MicardisPlus® (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis®, Bayer HealthCare promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor®, and PritorPlus® is also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET® Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer HealthCare and GlaxoSmithKline.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

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 randomized controlled trial. Lancet Published online 31 August 2008.
[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.
[3] The ONTARGET investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med 2008; 358(15):1547-59.
[4] Israili ZH, Hall WD. Cough and angioedema associated with angiotensin-coverting enzyme inhibitor therapy. A review of the literature and pathophysiology. Ann Intern Med 1992; 117(3):234-42.
[5] Matchar DB, et al. Systematic Review: Comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension. Ann Intern Med 2008; 148:16-29.
[6] Macaulay TE, Dunn SP. Cross-reactivity of ACE-inhibitor-induced angioedema with ARBs. US Pharmacist 2007; 32 (2).
[7] World Health Organization, Fact Sheet 317: Cardiovascular Diseases February 2007. www.who.int/mediacentre/factsheets/fs317/en/index.html (Accessed August 2008)
[8] Murray CJL, Lopez AD. eds. The Global Burden of Disease: A comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. Cambridge; Harvard University Press 2001.
[9] Primary Prevention of Ischemic Stroke. A Guideline from the American Heart Association/American Stroke Association Stroke Council. Stroke 2006; 37:1583-1633.

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