Landmark Trial Ontarget® Proves Telmisartan is as Protective as Ramipril and Better Tolerated in a Broad High-Risk Cardiovascular Population
30 April 2008 09:36
The results of the landmark ONTARGET Trial have proven that telmisartan, brand name MICARDIS, a modern Angiotensin II Receptor Blocker (ARB), is as protective as the current gold standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke, and hospitalisation for congestive heart failure in a broad cross-section of high-risk cardiovascular patients and with better tolerability.
These cardiovascular events occurred in 16.66% of patients receiving telmisartan versus 16.46% of patients receiving ramipril. The relative risk (ratio of the probability of the event occurring in the telmisartan group versus the ramipril group) was 1.01, with a 95% CI of 0.94 -1.09.
Telmisartan was also shown to be significantly better tolerated than ramipril, a widely used angiotensin converting enzyme inhibitor (ACE), with respect to typical ACE-inhibitor side-effects. 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 telmisartan arm.
25 patients stopped their treatment in the ramipril arm because of angioneurotic edema, versus only 10 in the telmisartan arm.
The ONTARGET data also show that telmisartan is associated with a higher treatment compliance. 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.
Telmisartan is now the only angiotensin II receptor blocker (ARB) to have proven cardio & 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.
ONTARGET also studied the value of combining telmisartan 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 announced today indicate that there is no additional protective benefit achieved for the overall patient population, if ramipril and telmisartan are combined.
LARGEST ARB OUTCOME TRIAL EVER
ONTARGET is a randomised, double-blind clinical trial, which evaluated 25,620 high-risk cardiovascular patients with normal or controlled blood pressure over an observation period of up to six years.
"We are proud to have started ONTARGET, the largest outcome cardiovascular trial ever undertaken with an ARB. It included high-risk cardiovascular patients with a history of coronary heart disease, stroke, transient ischaemic attack, peripheral vascular disease or diabetes with target organ damage. The trial has an extremely robust data base that will enable the medical community to answer questions where no scientific proof was available before. With 99.8% of patients followed over these years, this is one of the best managed landmark trials ever. We owe this excellent management of the trial to the investigators in over 700 centres across 40 countries led by Professor Salim Yusuf and his team at McMaster University, Hamilton, Canada," said Dr Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim, responsible for research, development and medicine.
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