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Clinical trial update: focus on the ONTARGET study.

Fitchett D - Vasc Health Risk Manag (2007)

Bottom Line: In contrast, studies of ARBs in patients with hypertension, heart failure, and renal disease have not consistently shown a reduction of CV outcomes.The ONTARGET and TRANSCEND studies are designed to determine whether the ARB telmisartan is similar (or non-inferior) or superior to the ACEi ramipril in the reduction of CV events in patients with established CV disease or diabetes with target organ damage.Although it is possible that enhanced benefits will be observed with dual therapy, the outcomes with ARB monotherapy remain uncertain.

View Article: PubMed Central - PubMed

Affiliation: Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. fitchettd@smh.toronto.on.ca

ABSTRACT
The renin angiotensin system (RAAS) plays an important role in the pathophysiology of cardiovascular (CV) disease. Modulation of RAAS with angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), and aldosterone inhibitors reduces a range of adverse CV outcomes in patients with or at risk of CV disease. Currently, there is incomplete evidence to show all RAAS modulators provide vascular protection by reducing the incidence of myocardial infarction (MI), stroke and CV death. In patients at high risk for CV events, studies with ACEi designed to test for long-term vascular protection, showed benefit. In contrast, studies of ARBs in patients with hypertension, heart failure, and renal disease have not consistently shown a reduction of CV outcomes. However, none of these studies was specifically designed to examine the impact of ARBs on the vascular protective outcomes of CV death, non-fatal MI, and stroke. The ONTARGET and TRANSCEND studies are designed to determine whether the ARB telmisartan is similar (or non-inferior) or superior to the ACEi ramipril in the reduction of CV events in patients with established CV disease or diabetes with target organ damage. The ONTARGET study has enrolled 25,620, and TRANSCEND 5,776 subjects. The subjects in both trials are similar to those studied in the HOPE study, yet there is greater ethnic diversity, a higher proportion of patients with cerebro-vascular disease, and a greater use of beta blockers and lipid-lowering treatment. The studies completed recruitment in 2004, and are due to complete follow-up and report the results in 2008. The ONTARGET and TRANSCEND studies will provide valuable comparative data on the efficacy of telmisartan and ramipril and their combination in patients at high risk for CV events. Although it is possible that enhanced benefits will be observed with dual therapy, the outcomes with ARB monotherapy remain uncertain.

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Related in: MedlinePlus

ONTARGET and TRANSCEND study designs. aAnkle brachial index.
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Related In: Results  -  Collection


getmorefigures.php?uid=PMC2350133&req=5

fig1: ONTARGET and TRANSCEND study designs. aAnkle brachial index.

Mentions: The study design is shown in Figure 1. After evaluation for eligibility, subjects entered a 3-week run-in period receiving open label study drugs in escalating doses. Patients who were adherent to and tolerated the study medication were randomized to the treatment groups as shown in Figure 1. During the follow-up period of 3.5–5.5 years, events comprising the primary, secondary, and other outcomes are recorded and confirmed by a central adjudicator. The study has an 89% power of showing the non-inferiority of telmisartan compared with ramipril that ensures telmisartan has at least 50% of the ramipril effect at the upper 95th% confidence limit.


Clinical trial update: focus on the ONTARGET study.

Fitchett D - Vasc Health Risk Manag (2007)

ONTARGET and TRANSCEND study designs. aAnkle brachial index.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2350133&req=5

fig1: ONTARGET and TRANSCEND study designs. aAnkle brachial index.
Mentions: The study design is shown in Figure 1. After evaluation for eligibility, subjects entered a 3-week run-in period receiving open label study drugs in escalating doses. Patients who were adherent to and tolerated the study medication were randomized to the treatment groups as shown in Figure 1. During the follow-up period of 3.5–5.5 years, events comprising the primary, secondary, and other outcomes are recorded and confirmed by a central adjudicator. The study has an 89% power of showing the non-inferiority of telmisartan compared with ramipril that ensures telmisartan has at least 50% of the ramipril effect at the upper 95th% confidence limit.

Bottom Line: In contrast, studies of ARBs in patients with hypertension, heart failure, and renal disease have not consistently shown a reduction of CV outcomes.The ONTARGET and TRANSCEND studies are designed to determine whether the ARB telmisartan is similar (or non-inferior) or superior to the ACEi ramipril in the reduction of CV events in patients with established CV disease or diabetes with target organ damage.Although it is possible that enhanced benefits will be observed with dual therapy, the outcomes with ARB monotherapy remain uncertain.

View Article: PubMed Central - PubMed

Affiliation: Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. fitchettd@smh.toronto.on.ca

ABSTRACT
The renin angiotensin system (RAAS) plays an important role in the pathophysiology of cardiovascular (CV) disease. Modulation of RAAS with angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), and aldosterone inhibitors reduces a range of adverse CV outcomes in patients with or at risk of CV disease. Currently, there is incomplete evidence to show all RAAS modulators provide vascular protection by reducing the incidence of myocardial infarction (MI), stroke and CV death. In patients at high risk for CV events, studies with ACEi designed to test for long-term vascular protection, showed benefit. In contrast, studies of ARBs in patients with hypertension, heart failure, and renal disease have not consistently shown a reduction of CV outcomes. However, none of these studies was specifically designed to examine the impact of ARBs on the vascular protective outcomes of CV death, non-fatal MI, and stroke. The ONTARGET and TRANSCEND studies are designed to determine whether the ARB telmisartan is similar (or non-inferior) or superior to the ACEi ramipril in the reduction of CV events in patients with established CV disease or diabetes with target organ damage. The ONTARGET study has enrolled 25,620, and TRANSCEND 5,776 subjects. The subjects in both trials are similar to those studied in the HOPE study, yet there is greater ethnic diversity, a higher proportion of patients with cerebro-vascular disease, and a greater use of beta blockers and lipid-lowering treatment. The studies completed recruitment in 2004, and are due to complete follow-up and report the results in 2008. The ONTARGET and TRANSCEND studies will provide valuable comparative data on the efficacy of telmisartan and ramipril and their combination in patients at high risk for CV events. Although it is possible that enhanced benefits will be observed with dual therapy, the outcomes with ARB monotherapy remain uncertain.

Show MeSH
Related in: MedlinePlus