Clinical trial update: focus on the ONTARGET study.

Area of Science:

• Cardiovascular Medicine
• Pharmacology
• Nephrology

Background:

• The renin-angiotensin system (RAAS) is crucial in cardiovascular disease pathophysiology.
• RAAS modulators like ACE inhibitors and ARBs reduce adverse cardiovascular outcomes.
• Evidence for vascular protection from all RAAS modulators, particularly ARBs, is incomplete.

Purpose of the Study:

• To compare the efficacy of telmisartan (ARB) versus ramipril (ACE inhibitor) in reducing cardiovascular events.
• To evaluate telmisartan's non-inferiority or superiority to ramipril in high-risk patients.
• To assess the impact of ARB monotherapy on vascular protection outcomes.

Main Methods:

• The ONTARGET study enrolled 25,620 patients; the TRANSCEND study enrolled 5,776 patients.
• Participants had established cardiovascular disease or diabetes with target organ damage.
• Patient populations included greater ethnic diversity and higher rates of cerebrovascular disease compared to previous trials.

Main Results:

• Recruitment for both studies was completed in 2004, with results expected in 2008.
• The studies provide valuable comparative data on telmisartan and ramipril efficacy.
• Outcomes with angiotensin receptor blocker monotherapy remain uncertain, though dual therapy may offer enhanced benefits.

Conclusions:

• ONTARGET and TRANSCEND studies will offer crucial comparative data on RAAS modulators.
• The findings will clarify the role of telmisartan and ramipril in managing high-risk cardiovascular patients.
• Further insights into ARB monotherapy's vascular protective effects are anticipated.