Alagebrium Demonstrates Important Cardiac Benefits in Diastolic Dysfunction and Endothelial Function Studies
16 November 2005 - 3:35AM
PR Newswire (US)
- PEDESTAL and Endothelial Function Data Presented at the American
Heart Association Scientific Sessions 2005 - PARSIPPANY, N.J., Nov.
15 /PRNewswire-FirstCall/ -- Alteon Inc. (AMEX:ALT) announced today
that data demonstrating the ability of its lead A.G.E. Crosslink
Breaker alagebrium to improve overall cardiac function are being
presented today at the American Heart Association Scientific
Sessions in Dallas, TX, by two independent research teams. Data
presented from the Phase 2a PEDESTAL trial in diastolic dysfunction
demonstrated the ability of alagebrium to improve measures of
diastolic function, including a significant reduction in left
ventricular mass. A second Phase 2a study found the compound to
significantly improve endothelial function. Both studies point to
the importance of the continued development of alagebrium and
A.G.E. Crosslink Breakers as a novel class of compounds that may
help reduce cardiovascular risk. The poster presentation
"Improvements in Diastolic Function Among Patients with Advanced
Systolic Heart Failure Utilizing Alagebrium, an Oral Advanced
Glycation End-product Crosslink Breaker" describes the key findings
from Alteon's diastolic dysfunction trial, known as PEDESTAL
(Patients with Impaired Ejection Fraction and Diastolic
Dysfunction: Efficacy and Safety Trial of Alagebrium). Twenty-two
patients were treated in an open-label two dose (35 mg and 210 mg
bid) regiment and followed by echocardiography. The data revealed
absolute improvements from a combined analysis of both dose groups
in Doppler measures of diastolic function, including the early/late
(E/A) atrial filling phase ratio (3.3+/-1.4vs. 2.6+/-1.4) (p=0.18),
deceleration time (DT) (148+/-33 vs. 188+/-60), (p=0.04),
isovolumetric relaxation time (IVRT) (88+/-11.9 vs. 113.1+/-31)
(p=0.04) and concomitant reduction of left atrial pressure
(25.0+/-8 vs. 19+/-8) (p=0.11). In addition, regression of left
ventricular mass (g) (297+/-57 vs. 246.+/-51) (p=0.002) and left
ventricular end-diastolic volume (ml) (297+/-57 vs. 246+/- 51) was
achieved. Author Vinay Thohan, M.D., Assistant Professor of
Medicine, Methodist DeBakey Heart Center, Houston, TX, concluded,
"Alagebrium had important benefits among patients with systolic
heart failure and diastolic dysfunction. These benefits included
improved measures of diastolic function, hemodynamics and cardiac
remodeling. Future investigations aimed at evaluating the expected
clinical improvements are warranted." In the study, "Improved
Flow-Mediated Arterial Vasodilation by Advanced Glycation Crosslink
Breaker, Alagebrium Chloride (ALT-711), in Older Adults with
Isolated Systolic Hypertension," conducted at Johns Hopkins
University School of Medicine under grants from the National Heart,
Lung and Blood Institute and the Society of Geriatric Cardiology,
13 adults with isolated systolic hypertension on stable
antihypertensive therapy received a 2-week placebo run-in followed
by 8 weeks of oral alagebrium (210 mg bid). Data measurements were
taken after placebo run-in and after 8 weeks of therapy. Treatment
with alagebrium reduced carotid augmentation index (AI), a measure
of arterial stiffness, by 37% (0.3+/-0.04 to 0.2+/-0.05, p=0.007)
and carotid augmented pressure from 16.4+/-10 to 9.6+/-9 mmHg (p
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