Cardiovascular Protection

The efficacy and safety of MICARDIS^® has been evaluated in one of the most comprehensive cardiovascular (CV) trial programmes for an angiotensin II receptor blocker (ARB).

The ONTARGET^® Trial Programme^1-4 is the largest clinical study programme to date to investigate the use of an ARB (MICARDIS^®) and an angiotensin-converting enzyme (ACE) inhibitor (ramipril) alone or in combination for preventing CV morbidity and mortality.   In addition, five out of the ten trials included in the PROTECTION^® Trial Programme⁵ evaluated the use of MICARDIS^® in the treatment of hypertension.

The ONTARGET^® Trial Programme – The Facts

The landmark clinical trial programme in cardiovascular protection comprising the parallel ONTARGET^® and TRANSCEND^® studies

Together, these studies have enrolled 31,456 patients at high CV risk from all inhabited continents and different ethnicities.^1-6

ONTARGET^® showed that MICARDIS^® is as protective as 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 with a controlled blood pressure and with better tolerability.⁵

Initial results from ONTARGET^® indicated that there is no additional cardioprotective benefit when MICARDIS^® is used in combination with ramipril and the combination is less well tolerated than either agent used as monotherapy.⁵

The TRANSCEND^® study showed that MICARDIS^® on top of the best standard of care reduces the risk of cardiovascular death, myocardial infarction and stroke in high-risk cardiovascular patients by 13% compared with those patients only receiving best standard of care (p=0.048), referring to the same endpoint as that defined as the primary endpoint of the landmark HOPE trial published in 2000.^6,7 The primary composite endpoint (CV death, MI, stroke and hospitalization for CHF) was reduced by 8% (p=0.22).⁶

A further seven sub-studies of the ONTARGET^® trial programme will evaluate the additional functional and morphological effects of MICARDIS^® and ramipril therapy, identify possible blood markers for CV risk and estimate the economics of treatment^1-3

The PROTECTION Trial Programme – The Facts

Ten clinical trials, that included more than 6,500 patients from 32 countries

Investigated the effects of MICARDIS^® in preventing target-organ damage and treating hypertension, especially in high-risk and difficult-to-treat patient populations

Included patients with risk factors such as hypertension, diabetes and early end-organ diseases

Data from the VIVALDI,⁹  AMADEO,¹⁰ TRENDY,¹¹ DETAIL,^12,13 INNOVATION¹⁴ studies add to the existing information on the effect of ARBs and other antihypertensive drugs in patients at high risk for end-stage renal disease

PRISMA I & II,^15,16 SMOOTH,¹⁷ ATHOS,¹⁸ ARBs-FDC¹⁹ provide new evidence on the benefits of effective 24-hour blood pressure control for protection against the morning blood pressure surge, particularly in high-risk populations