� The results of the TRANSCEND� trial shew 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 topper standard of care (p=0.048), referring to the same termination as that defined as the primary endpoint of the landmark HOPE trial published in 2000.1,2 Therapy with telmisartan was considerably 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 hypertensin II receptor blocker (ARB) - Boehringer Ingelheim's telmisartan - versus placebo, on top of standard therapy (including anti-hypertensives, anti-platelet therapy and statins), in bad individuals wHO cannot tolerate an hypertensin converting enzyme (ACE)-inhibitor.
An 8% simplification of events in the pre-specified primary endpoint made up of the composite of cardiovascular death, myocardial infarction, cerebrovascular accident 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 limb experienced a cardiovascular event versus 504 patients receiving placebo on top of current c. H. 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 yearner 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 just important stride 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 exposure of ticker attack or stroke did not have a proved alternative to the ACE-inhibitor ramipril - a office we faced with one in five high peril patients. We now have the scientific evidence to show that telmisartan protects patients ACEI-intolerant patients against heart attack, stroke and cardiovascular death while screening a placebo-like tolerability. This builds on previous findings of the ONTARGET � trial and gives physicians the confidence of prescribing a do drugs 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 get had myocardial infarction, peripheral arterial stop disease, stroke or transient ischaemic attacks or suffer from diabetes mellitus and additional risk factors).
The trial, a parallel report to the ONTARGET� trial3, which together form the ONTARGET� Trial Programme, investigated the personal 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, merely potentially life threatening, quincke's edema.4-6
Also of promissory note, the risk of exposure reduction of 13% with telmisartan was achieved despite a high gear 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 of exposure. We are proud to have advanced medical knowledge in the cardiovascular sports stadium with our landmark studies ONTARGET� and the parallel of latitude trial TRANSCEND�. We receive followed nigh 50,000 telmisartan patients in clinical trials in the final 5 eld, and at present have have from everyday use of telmisartan summing up to 25 one thousand thousand patient age all over the existence. 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 effort of death worldwide, causing over 17.5 jillion 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 star cause of disability, and is predicted to be the largest cause of disability world-wide by 2020.8 A major stroke is viewed by more than half of those at risk of exposure as being worse than death.9
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be mindful that at that place may be national differences between countries regarding specific medical information, including commissioned uses. Please take score of this when referring to the information provided in this document. This press release is non intended for distribution within the U.S.A.
About telmisartan (Micardis�/Kinzal�/Pritor�)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and is being investigated in the about 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
http://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 below the brand names Kinzalmono�, Kinzalkomb� (combination with hydroDIURIL), and Pritor� and PritorPlus� (combination with hydrochlorothiazide) in markets across Europe. Pritor�, and PritorPlus� is as well 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.
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 school therapeutic value for human and veterinarian medicine.
In 2007, Boehringer Ingelheim posted net gross sales of 10.9 billion euro piece spending peerless fifth of net gross revenue in its largest business segment Prescription Medicines on research and development.
Related links:
Boehringer Ingelheim press tamp - European Society of Cardiology Congress 2008 (ESC)
Ontarget-Telmisartan website (for Healthcare Professionals outside the PLC191% only)
Micardis� website (for Healthcare Professionals outside the U.S. only if)
References:
1. The TRANSCEND Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in bad patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled tryout. Lancet Published online 31 August 2008.
2.The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an
