Trial Shows Two Medications Equally Effective In Reducing Cardiovascular Event Risk - Newer Medication Is Better Tolerated With Fewer Side Effects

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Apr 2008 - 2:00 PDT

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Results of the landmark ONTARGET Trial (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) demonstrate that MICARDIS (80 mg - once daily), a modern angiotensin II receptor blocker (ARB), is as protective as the current gold standard, ramipril (an angiotensin converting enzyme (ACE) inhibitor), in reducing the risk of cardiovascular death, heart attack, stroke, and hospitalization for congestive heart failure in high-risk patients. 1

In previous studies, ramipril, the current gold standard treatment, has been proven to reduce 20 per cent of cardiovascular events like heart attack and stroke.2

ONTARGET shows that while providing the same benefit as ramipril (10mg), MICARDIS (80 mg - once daily) offered significantly better tolerability with respect to ACE inhibitor ramipril's side effects, and was associated with a higher treatment compliance.1 Besides efficacy, tolerability and compliance are also important factors to consider as they are crucial for effective long-term treatment for the prevention of serious cardiovascular events. In fact, studies show that between 10 and 39 per cent of patients are intolerant of ACE inhibitors.3,4,5

"The ONTARGET Trial shows that telmisartan is a well-tolerated treatment in high-risk cardiovascular patients that is as effective as ramipril in preventing heart attacks, stroke, hospitalizations for heart failure and deaths", said Prof. Salim Yusuf, lead investigator of the ONTARGET Trial Programme and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada. "The ONTARGET results have important implications for the management of patients with cardiovascular diseases. We now have a new treatment option for high-risk patients which is effective and better tolerated."

MICARDIS (80 mg - once daily) is now the only ARB to have proven broad cardio and vascular protective benefits beyond blood pressure reduction in this high-risk population.1* Until now, only the ACE-inhibitor ramipril had shown these protective effects.2

"All people who have cardiovascular disease or diabetes with organ target damage and physicians managing these diseases should be interested in the results of this important trial," said Dr. Gilles Dagenais, cardiologist at the Laval University Heart and Lung Institute, Quebec City, and one of the Canadian National Coordinators of the ONTARGET trial. "If it's possible to have access to a medication that can prevent serious cardiovascular events but with fewer side effects and better compliance than what's currently available, it will also have a great impact on their quality of life."

According to Dr. Peter Lin, Toronto area general practitioner, "most patients stop taking their medications because of side effects, so many do not get cardiovascular protection. This study showed the newer medication has less side effects while protecting the patient from heart attack, stroke and death. More patients taking the medication means more patients are protected."

About ONTARGET

ONTARGET, led out of McMaster University in Hamilton, Ontario is the largest ARB outcomes trial ever conducted evaluating 25,620 patients from 40 countries (in Canada there were over 2,500 patients involved). It is a randomised, double-blind clinical trial of high-risk cardiovascular patients with normal or controlled blood pressure over an The results announced at the American College of Cardiology International Scientific Meeting during the Late Breaking Clinical Trials section, and simultaneously published online in the New England Journal of Medicine indicate that cardiovascular events including cardiovascular death, myocardial infarction, stroke, and hospitalisation for congestive heart failure occurred in 16.66 per cent of patients receiving MICARDIS (80 mg - once daily) versus 16.46 per cent of patients receiving ramipril. 1 The relative risk (ratio of the probability of the event occurring in the MICARDIS (80 mg - once daily) group versus the ramipril group) was 1.01, with a 95 per cent CI of 0.94 -1.09.

Although patients with an ACE-inhibitor intolerance had been excluded from the trial, 359 patients in the ramipril treatment arm stopped their treatment because they experienced cough versus only 93 patients in the MICARDIS arm. Twenty-five patients stopped their treatment in the ramipril arm because of angioneurotic edema, versus only 10 in the MICARDIS (80mg-once daily) arm. 1

ONTARGET also studied the value of combining MICARDIS (80 mg - once daily) with ramipril, to answer a key question for the clinical community - does combining an ACE inhibitor and an ARB, i.e. the dual renin-angiotensin system (RAS) blockade, offer even better protection compared to single blockade? The results indicate that there is no additional protective benefit achieved for the overall patient population, if ramipril and MICARDIS (80 mg - once daily) are combined.

*Please note MICARDIS is indicated in Canada for mild-moderate essential hypertension only. While presenting the scientific results of the ONTARGET study, Boehringer Ingelheim does not recommend the use of MICARDIS in patients that do not fulfill the criteria of the prescribing information.

Addressing the world's largest healthcare burden

Cardiovascular disease (CVD) is the leading cause of death worldwide, causing over 17.5 million deaths per year.6 Over seven million people die from a heart attack and 5.7 million die from a stroke every year.6 Global deaths from CVD are predicted to reach approximately 25 million by 2020.7 Cardiovascular disease is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.7 A major stroke is viewed by more than half of those at risk as being worse than death.8

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 137 affiliates in 47 countries and 38,400 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. For more information please visit http://www.boehringer-ingelheim.com

Related links:

http://www.news-ontarget.com
http://www.ontarget-telmisartan.com
ww.micardis.com

References

1. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Eng J Med. Published online 31 Mar 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. Israili ZH, Hall WD; Cough and angioedema associated with angiotensin-coverting enzyme inhibitor therapy. A review of the literatue and pathophysiology. Ann Intern Med 1992 1; 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. World Health Organization, Fact Sheet 317: Cardiovascular Diseases February 2007. Click here (Accessed March 2008)

7. 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.

8. 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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