Boehringer Ingelheim GmbH

Telmisartan (MICARDIS(R)) as Effective as Ramipril But With Better Long-Term Tolerability in High-Risk Cardiovascular Asian Patients

Beijing (ots/PRNewswire) - New results from the landmark ONTARGET(R) Trial show that, in Asian patients at high risk of cardiovascular disease (CVD), telmisartan (MICARDIS(R)) 80mg is as effective as, and significantly better tolerated than, ramipril 10mg in reducing the risk of cardiovascular death, heart attack, stroke and hospitalisation for congestive heart failure.(1) These preliminary results were presented today at the 19th Great Wall - International Cardiology Congress (GW-ICC) in Beijing, China.

Telmisartan and ramipril were equally protective in Asian and non-Asian populations.(1) Of note, telmisartan was significantly better tolerated than ramipril in this Asian population, with 19.9% patients stopping their treatment permanently with ramipril compared with only 14.4% patients treated with telmisartan (p=0.0004). Even though only patients considered tolerant of both treatments were selected to enter ONTARGET(R), 5.9% of patients on ramipril stopped their treatment due to cough - an adverse reaction to ACE-inhibitors - compared with only 1.4% of patients treated with telmisartan.(1) Analysis will be conducted in the near future to further examine these interesting findings.

Commenting on the results, Professor Tony Dans, the ONTARGET(R) Trial coordinator for the Philippines, University of the Philippines College of Medicine said, "The new ONTARGET data are very important for treatment of Asian patients at risk of cardiovascular disease. Long-term efficacy and tolerability of treatment in these patients is of prime importance to ensure that they remain on their medication and are well protected. Telmisartan is shown to be a very good treatment option for these high-risk patients."

The ONTARGET(R) Trial involved over 25,620 patients globally, including 3,137 patients from 79 centres across the Asia-Pacific region, including 33 in China alone (other countries were Hong Kong, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand).(1,2) Patients were already receiving standard care such as statins, antiplatelet therapy and also betablockers and other antihypertensive treatment, ensuring well-controlled blood pressure from the beginning of the trial. All patients were considered to be tolerant of ACE-inhibitors.(2)

ACE-intolerance in Asia Pacific

Worldwide, 10-39% of patients are intolerant to widely used ACE-inhibitors, such as ramipril.(3-5) This effect is more pronounced in the Asia-Pacific region, with studies showing that nearly half of Chinese patients are intolerant to ACE-inhibitors.(6,7)

Professor Liu Lisheng, the ONTARGET(R) Trial coordinator for China and President of the World Hypertension League, explained, "Worldwide, cardiovascular disease accounts for 31.5% of all deaths among women and 26.8% of all deaths among men. China alone has 160 million patients with hypertension and 160 million with high cholesterol. However, the majority of patients with cardiovascular disease do not receive appropriate treatment for many reasons, such as inappropriate life style, low disease awareness and intolerance to medication. The ambitious ONTARGET(R)/TRANSCEND(R) Trial programme is the first head-to-head trial between ACE-inhibitors and ARBs evaluating the efficacy and tolerability of these two different treatments on long-term prognosis of cardiovascular diseases and provides the medical community and the public with sufficient evidence of both cardiovascular diseases treatment and prevention."

The ONTARGET Trial Programme - global results

The ONTARGET(R) Trial Programme comprises two parallel studies, ONTARGET(R) and TRANSCEND(R) - data from the global patient dataset were presented earlier this year:

- The ONTARGET(R) Trial results show that telmisartan 80mg is as effective as the previous gold standard, ramipril 10mg, in protecting against CV death, heart attack, stroke and hospitalisation for congestive heart failure, is better tolerated and associated with higher treatment compliance - whereas the combination of both treatments, telmisartan and ramipril, did not provide an additional benefit.(2)

- The TRANSCEND(R) Trial results show that telmisartan 80mg significantly reduces the risk of CV death, heart attack and stroke (by 13%) in ACE-intolerant patients already receiving current best standard care.(8) The composite endpoint of CV death, heart attack, stroke and hospitalisation for congestive heart failure was non-significantly reduced by 8% (p=0.22).

Global burden of CVD

CVD is the leading cause of death worldwide, causing over 17.5 million deaths per year.(9) Half of the world's CVD burden is predicted to occur in the Asia-Pacific region.(10) In 2002, over 2.3 million people in China died from CVD-related causes, the highest number of deaths for one country in the world.(11) Global deaths from CVD are predicted to reach approximately 25 million by 2020.(12) CVD is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.(12)

NOTES TO EDITORS

Please be advised

This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.

About telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))

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(R), PROTECTION(R) and PRoFESS(R), 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(R) and MICARDISPLUS(R) (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(R), Bayer HealthCare promotes telmisartan under the brand names Kinzalmono(R), Kinzalkomb(R) (combination with hydrochlorothiazide), and Pritor(R) and PritorPlus(R) (combination with hydrochlorothiazide) in markets across Europe. Pritor(R) and PritorPlus(R) is also marketed by GlaxoSmithKline in selected markets.

The sponsor of the ONTARGET(r) 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 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.

For more information please visit http://www.boehringer-ingelheim.com

Related links: http://www.news-ontarget.com http://www.ontarget-telmisartan.com http://www.micardis.com

References

(1) Dans A. Tolerance of telmisartan and ramipril amongst Asians - The ONTARGET Trial. Presented at the 19th Great Wall International Congress of Cardiology, Beijing, China, 23 October 2008.

(2) The ONTARGET investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med 2008; 358(15):1547-59.

(3) Israili ZH, Hall WD. Cough and angioedema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and pathophysiology. Ann Intern Med 1992; 117(3):234-42.

(4) 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.

(5) Macaulay TE, Dunn SP. Cross-reactivity of ACE-inhibitor-induced angioedema with ARBs. US Pharmacist 2007; 32(2).

(6) Woo J, Chan TY. A high incidence of cough associated with combination therapy of hypertension with isradipine and lisinopril in Chinese subjects. B J Clin Pract 1991; 45(3):178-80.

(7. Woo KS, Norris R, Nicholls G. Racial difference in incidence of cough with angiotensin-converting enzyme inhibitors. Am J Cardiol. 1995; 75(14):967-8.

(8) 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. Lancet8 2008; 372:1174-118.

(9) .World Health Organization, Fact Sheet 317: Cardiovascular Diseases February 2007. http://www.who.int/mediacentre/factsheets/fs317/en/index.html (Accessed August 2008).

(10) Lawes CM et al. Blood pressure and cardiovascular disease in the Asia Pacific region. J Hypertens 2003; 21(4):673-5.

(11) World Health Organization, The Atlas of Heart Disease and Stroke 2004. http://www.who.int/cardiovascular_diseases/resources/atl as/en/index.html Accessed October 2008.

(12) 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.

Contact:

Contact: Dr. Reinhard Malin, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +
49-6132-77-97296, 77-90815, Fax: + 49-6132-72-6601, E-mail:
press@boehringer-ingelheim.com



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