dal-PLAQUE study: Hope for CETP inhibition?

Slides (presentatie) - 23 apr. 2012

dal-PLAQUE study: Hope for CETP inhibition?

Deze presentatie is gehouden door:
Prof. Zahi Fayad, Mount Sinai School of Medicine, New York, USA
tijdens de CardioVasculaire Conferentie op 15 maart 2012

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dal-PLAQUE study: Hope for CETP inhibition?

Utility of atherosclerosis imaging in the evaluation of drug therapies

dal-PLAQUE - Background

Initial Experience with CETPi

Erik SG Stroes & Diederik F van Wijk Lancet 2011; 378: 1529-1530

Lipid – Efficacy (% change from baseline)

dal-PLAQUE - Rationale


Measuring atherosclerosis MRI

MRI - Logistics

Niacin MRI regression - Oxford study

Niacin MRI Regression - Oxford Study

Measuring atherosclerosis PET/CT

FDG-PET/CT scan reproducibility

Evaluating 18F-FDG-PET images of atherosclerosis

PET indices derived from the regions of interest (ROI)

Attenuation of plaque inflammation by simvastatin by 18FDG PET/CT @ 3 months

dal-PLAQUE study design and timeline of imaging assessments

dal-PLAQUE Sites: Multicenter FDG-PET & MRI Study

dal-PLAQUE - Key Inclusion Criteria

dal-PLAQUE - Predefined Endpoints

Baseline characteristics (Intent-to-Treat [ITT]) - Demography and CHD risk factors

Baseline characteristics (ITT) - Plasma lipid profile

Mean change from baseline in plaque burden at 24 Months (MRI) and inflammation at 6 Months (PET/CT)

Summary of MRI & PET endpoints

Sample MRI Images from a patient at baseline and treated with dalcetrapib 600 mg for 24 Months showing regression in Total Vessel Area (TVA)

Raw mean data limited to subjects that provided imaging data for all MRI imaging time points

MRI Lumen Area – average carotid (ITT) No change with dalcetrapib vs significant increase with placebo

Raw mean data limited to subjects that provided imaging data for all PET imaging time points

Association between HDL-C and arterial inflammation as measured by MDS TBR on PET/CT

Association between atherosclerotic burden (TVA on MRI) and arterial inflammation (MDS TBR on FDG-PET/CT)

Changes in lipids, lipoproteins, and hs-CRP during the study period

Inflammatory Markers: Change from Baseline to 24 Months

Safety variables

dal-PLAQUE – Overall conclusions

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