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Landmark Trial ONTARGET(R) Proves Telmisartan is as Protective as Ramipril and Better Tolerated in a Broad High-Risk Cardiovascular Population - from ONTARGET(R) it May be Concluded That Telmisartan can Prevent Every 5th Serious Cardiovascular Event

Tuesday, April 1, 2008 General News
INGELHEIM, Germany, March 31 The results of the landmarkONTARGET(R) Trial have proven that telmisartan, brand name MICARDIS(R), amodern angiotensin II receptor blocker (ARB), is as protective as the currentgold standard, ramipril, in reducing the risk of cardiovascular death,myocardial infarction, stroke, and hospitalisation for congestive heartfailure in a broad cross-section of high-risk cardiovascular patients and withbetter tolerability.(1) These cardiovascular events occurred in 16.66% ofpatients receiving telmisartan versus 16.46% of patients receivingramipril.(1) The relative risk (ratio of the probability of the eventoccurring in the telmisartan group versus the ramipril group) was 1.01, with a95% CI of 0.94 -1.09.

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In 2000, the HOPE trial showed that the cardiovascular risk for patientstreated with ramipril is reduced by approximately 20% compared withplacebo.(2) This meant that every fifth serious cardiovascular event in ahigh risk group of patients was prevented. A similar effect can now beattributed to telmisartan. The 25,620 high-risk patients in the ONTARGET(R)trial were already receiving standard care such as statins to lowercholesterol, antiplatelet therapy, betablockers and otherantihypertensives.(3)

Telmisartan was also shown to be significantly better tolerated thanramipril, a widely used angiotensin converting enzyme inhibitor (ACE), withrespect to typical ACE-inhibitor side-effects.(1) Although patients with anACE-inhibitor intolerance had been excluded from the trial, 360 patients inthe ramipril treatment arm stopped their treatment because they experiencedcough versus only 93 patients in the telmisartan arm.

25 patients stopped their treatment in the ramipril arm because ofangioneurotic edema, versus only 10 in the telmisartan arm.(1)

The ONTARGET(R) data also show that telmisartan is associated with ahigher treatment compliance.(1) Besides efficacy, tolerability and complianceare also important factors to consider as they are crucial for effectivelong-term treatment for the prevention of serious cardiovascular events.

Telmisartan is now the only angiotensin II receptor blocker (ARB) to haveproven cardio & vascular protective benefits beyond blood pressure reductionin this high-risk population.(1) Until now, only the ACE-inhibitor ramiprilhad shown these protective effects.(2)

ONTARGET(R) also studied the value of combining telmisartan withramipril, to answer a key question for the clinical community - doescombining an ACE inhibitor and an ARB, i.e. the dual renin-angiotensin system(RAS) blockade, offer even better protection compared to single blockade? Theresults announced today indicate that there is no additional protectivebenefit achieved for the overall patient population, if ramipril andtelmisartan are combined.

Implications of the ONTARGET(R) Trial

"The ONTARGET(R) Trial shows that telmisartan is a well-toleratedtreatment in high-risk cardiovascular patients that is as effective asramipril in preventing heart attacks, stroke, hospitalisations for heartfailure and deaths," said Professor Salim Yusuf, lead investigator of theONTARGET(R) Trial Programme and Director of the Population Health ResearchInstitute at McMaster University, Hamilton, Canada. "The ONTARGET resultshave important implications for the management of patients withcardiovascular diseases. We now have a new treatment option for high-riskpatients which is effective and better tolerated."

Largest ARB outcome trial ever

ONTARGET(R) is a randomised, double-blind clinical trial, which evaluated25,620 high-risk cardiovascular patients with normal or controlled bloodpressure over an observation period of up to 6 years.

"We are proud to have started ONTARGET(R), the lar
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