Trial expected to show best proven treatment for heart attacks, strokes and diabetes

The results of the ONTARGET trial, sponsored by Boehringer Ingelheim and conducted in 41 countries, including South Africa, are eagerly anticipated as the trial draws to a close.

Designed to offer new hope to patients, ONTARGET is the largest cardiovascular trial ever undertaken with an angiotensin blocker (ARB). The team of investigators was led by Dr. Salim Yusuf of McMaster University Medical Centre in Ontario, Canada. The five and a half year study followed 31 546 patients in 41 countries. The aim was to investigate whether by combining two different agents - MICARDIS (telmisartan) and ramipril - cardiovascular-related death and disease in high risk patients could be reduced.

“The ONTARGET trial programme is about the end result, namely identifying the best possible treatment for those affected by cardiovascular disease,” says Professor James Ker, deputy dean of the Faculty of Health Sciences at Pretoria University.

For the first time, ONTARGET – Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial – is investigating the clinical benefits of a dual approach to blocking the renin-angiotensin system (RAS) with the angiotensin recepter blocker MICARDIS and the angiotensin converting enzyme (ACE)-inhibitor ramipril, aiming to prove that this combination reduces cardiovascular-related deaths and disease in high risk patients even further than ramipril alone.

While large-scale clinical trials have shown that suppression of the RAS improves cardiovascular outcomes in high-risk patients, the cardiovascular protective effects of ARBs combined with an ACE inhibitor – have not been studied in such a broad high risk population, nor has the efficacy of ARBs in ACE-intolerant patients. ONTARGET investigates whether the combination of the ARB MICARDIS and ramipril has a favourable impact on the cardiovascular outcome besides the blood pressure lowering effect of either agent. Possible additional benefits of a dual blockade with MICARDIS and ramipril will be improved blood vessel elasticity and fewer patients developing diabetes and diabetic nephropathy (kidney disease associated with long standing diabetes).

The concept of a cardiovascular protective effect independent of lowered blood pressure was first explored in the HOPE trail, which revealed that ramipril was effective in preventing major cardiovascular events in high risk patients without hypertension.

The primary endpoints are to establish whether a combination of 80 mg of MICARDIS and 10 mg of ramipril daily is more effective in reducing myocardial infarction, stroke, heart failure and cardiovascular death compared with 10 mg of Ramipril alone; and if 80 mg of MICARDIS daily is at least as effective as 10 mg of ramipril daily for this endpoint.

The secondary endpoints are to determine whether the treatments have any impact on reducing the incidence of newly diagnosed congestive heart failure (CHF), revascularisation procedures, newly diagnosed diabetes mellitus, cognitive decline and dementia, as well as new onset of atrial fibrillation.

“It is anticipated that the results of this trial will have a tremendous impact on the way medicine is practiced, not just in South Africa but across the world,” concludes Professor Ker.

Enquiries:Sue Taylor
Boehringer Ingelheim
(011) 348-2485