Dal-VESSEL Trial: Difference between revisions

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==Methods==
==Methods==
==Results==
==Results==
Baseline flow-meddiated dilatation at the right brachial artery after 5 minutes of cuff occlusion, an endpoint that increases the vascular levels of endothelin and reactive oxygen species with a decrease of eNOS expression and nitrous oxide release, was almost equal in patients receiving placebo and those receiving dalcetrapib at approximately 4%.  Changes did not significantly with both groups either. Similarly, hyperemia, an assessment of blood flow velocity, was not significantly different in either groups or when comparing to baseline hyperemia.
Blood pressure levels throughout the study at 4,12, and 36 weeks did not significantly differ either compared to baseline in any group or even between groups. However, it was shown that the % of patients who are considered "non-dippers", i.e. those who do not have a nocturnal decrease in blood pressures, were decreased with dalcetrapib, while increased in placebo group.
At baseline, HDL was almost similar in both placebo and dalcetrapib.  There was a significant gradual increase in HDL levels ranging between 25-31% during week 4-36 (p<0.0001). In converse, CETP activity decreased gradually as well from a 51% decrease at week 4 to a 56% decrease at week 36 of dalcetrapib therapy (p<0.0001).
With dalcetrapib, Apo-A1 levels increased and triglyceride levels decreased signifincantly.
==Conclusion==

Revision as of 01:55, 20 September 2013

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Objectives

To assess the therapeutic and adverse effects of dalcetrapib on endothelial function, blood pressure, inflammatory markers, and lipid levels in patients with coronary heart disease (CHD) or CHD risk equivalents

Timeline

Methods

Results

Baseline flow-meddiated dilatation at the right brachial artery after 5 minutes of cuff occlusion, an endpoint that increases the vascular levels of endothelin and reactive oxygen species with a decrease of eNOS expression and nitrous oxide release, was almost equal in patients receiving placebo and those receiving dalcetrapib at approximately 4%. Changes did not significantly with both groups either. Similarly, hyperemia, an assessment of blood flow velocity, was not significantly different in either groups or when comparing to baseline hyperemia.

Blood pressure levels throughout the study at 4,12, and 36 weeks did not significantly differ either compared to baseline in any group or even between groups. However, it was shown that the % of patients who are considered "non-dippers", i.e. those who do not have a nocturnal decrease in blood pressures, were decreased with dalcetrapib, while increased in placebo group.

At baseline, HDL was almost similar in both placebo and dalcetrapib. There was a significant gradual increase in HDL levels ranging between 25-31% during week 4-36 (p<0.0001). In converse, CETP activity decreased gradually as well from a 51% decrease at week 4 to a 56% decrease at week 36 of dalcetrapib therapy (p<0.0001).

With dalcetrapib, Apo-A1 levels increased and triglyceride levels decreased signifincantly.

Conclusion