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BiDil(R) Data to be Presented at American Heart Association Scientific Sessions.


DALLAS -- NitroMed, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: NTMD) announced today that it will present several oral abstracts that feature post-approval analyses of BiDil(R) (isosorbide dinitrate/hydralazine HCI (Human Computer Interaction) Refers to the design and implementation of computer systems that people interact with. It includes desktop systems as well as embedded systems in all kinds of devices. ) data from the Company's landmark African American Heart Failure Trial (A-HeFT), at the American Heart Association's Scientific Sessions 2005, being held from November 13 - 16 in Dallas. BiDil was approved in June of this year by the U.S. Food and Drug Administration for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients.

The BiDil data to be presented further substantiate A-HeFT trial results, which demonstrated that the patients taking BiDil had significantly improved survival, prolonged time to hospitalization for heart failure and substantial improvement in patient-reported functional status, versus those patients who received placebo. The abstract presentations address the questions of: how does BiDil effect patient ventricular function; how is clinical benefit correlated with a blood pressure lowering effect of BiDil; how substantial are the financial savings to the health care system of using BiDil (decreased hospitalizations); and how does BiDil impact patients' quality of life.

The A-HeFT related oral abstracts will be presented during a scientific session titled "Heart Failure: Substudies From Larger Trials" (AOP (Automatic OPerator) An IRC channel host who moderates the topics, keeps online users in check and provides help for newbies unfamiliar with IRC software (mIRC, etc.). Whenever AOPs come into the channel, they inherit operator status. .60.1), taking place at the Dallas Convention Center The Dallas Convention Center, originally the Dallas Memorial Auditorium, is a meeting hall, event/convention center and civic center in the Convention Center District of downtown Dallas, Texas (USA).  on Tuesday, November 15th, from 2:00 to 5:00 pm. The relevant titles follow, and all four will be presented in room C3 at the Dallas Convention Center.

--Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine hydralazine /hy·dral·a·zine/ (hi-dral´ah-zen) a peripheral vasodilator used in the form of the hydrochloride salt as an antihypertensive.

hy·dral·a·zine
n.
 Inhibits Left Ventricular Remodeling in Well-Treated Severe Heart Failure in African-Americans (3:00 pm)

--Beneficial Effects of Isosorbide Dinitrate-Hydralazine on Survival in Heart Failure is Independent of its Blood Pressure Lowering Effect (3:45 pm)

--Cost-Effectiveness of Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Therapy for Black Patients with Heart Failure (4:30 pm)

--Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Improves Quality of Life in African Americans with Heart Failure (4:45 pm)

Notably, A-HeFT data will also be highlighted during a Circulation-sponsored symposium titled "Groundbreaking Studies in the Practice of Cardiovascular Medicine - Circulation Editors' Choices for 2004-2005" (Sunday Morning Program #12). During this symposium, being held on November 13th, Dr. Anne Taylor, Professor of Medicine at the University of Minnesota (body, education) University of Minnesota - The home of Gopher.

http://umn.edu/.

Address: Minneapolis, Minnesota, USA.
 and chairperson of the A-HeFT steering committee, will present BiDil results in a talk titled "The Combination of Isosorbide Dinitrate and Hydralazine in Black Patients with Heart Failure."

BiDil was commercially launched by NitroMed in July 2005. The FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 based the approval of BiDil primarily on results from the A-HeFT trial, which was halted early, in July 2004, due to the significant survival benefit seen with the drug.

NitroMed plans to submit the left ventricular remodeling data presented today to the FDA before year-end, as a supplement to the data that formed the basis of BiDil's regulatory approval.

Manuel Worcel, M.D., F.A.H.A., Chief Medical Officer of NitroMed commented, "As exemplified by our four oral abstract presentations at AHA, scientific and medical community interest in BiDil remains strong. The A-HeFT database continues to be a valuable resource to help us further understand the mechanism and usefulness of BiDil, as we look ahead to the best ways to expand our BiDil franchise and cardiovascular product offerings."

About BiDil

BiDil is indicated for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients, to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status. There is little experience in patients with New York Heart Association (NYHA NYHA New York Heart Association ) class IV heart failure. Most patients in the clinical trial supporting effectiveness, referred to as A-HeFT, received, in addition to BiDil or placebo, a loop diuretic, an angiotensin converting enzyme Noun 1. angiotensin converting enzyme - proteolytic enzyme that converts angiotensin I into angiotensin II
angiotensin-converting enzyme, ACE

peptidase, protease, proteinase, proteolytic enzyme - any enzyme that catalyzes the splitting of proteins into
 inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

BiDil is a fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride. While the exact mechanism of action underlying the beneficial effects of BiDil in the treatment of heart failure is unknown, it is known that isosorbide dinitrate is a vasodilator vasodilator /vaso·di·la·tor/ (-di-la´ter)
1. causing dilatation of blood vessels.

2. a nerve or agent that does this.


va·so·di·la·tor
n.
 with effects on both arteries and veins. The dilator dilator /di·la·tor/ (di-lat´er)
1. a structure that dilates, or an instrument used to dilate.

2. dilator muscle.


di·la·tor
n.
1.
 properties of nitrates result from the release of nitric oxide that leads to the relaxation of vascular smooth muscle Vascular smooth muscle refers to the particular type of smooth muscle found within, and composing the majority of the wall of blood vessels.

Vascular smooth muscle contracts or relaxes to both change the volume of blood vessels and the local blood pressure, a mechanism that
. Hydralazine is an arterial vasodilator.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies experienced a significant 43 percent decrease in the risk of mortality (P=.012) (absolute mortality rate: BiDil, 6.2% vs. placebo, 10.2%), a 39 percent reduction in the risk of first hospitalization for heart failure (P less than .001) (absolute first hospitalization rate: BiDil, 16.4% vs. placebo, 24.4%) and a statistically significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire, which is a self-report of the patient's functional status, versus patients taking placebo in addition to current standard therapies.

Heart Failure Burden in Black Patients

Heart failure, or end-stage cardiovascular disease, affects approximately five million Americans, including an estimated 750,000 African Americans. Each year, over 550,000 people are diagnosed with heart failure for the first time, and there is no cure for this disease - with more than 50 percent of patients dying within five years of diagnosis. With respect to heart failure, blacks are affected at a rate greater than that of the corresponding non-black population, presenting with the disease earlier and dying sooner. According to the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  (CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
), African Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range.

Important Safety Information

BiDil is contraindicated in patients who are allergic to organic nitrates. Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors (e.g., Viagra(R)/RevatioTM, Levitra(R), Cialis(R) could result in severe hypotension.

Treatment with hydralazine may produce a clinical picture simulating systemic lupus erythematosus Systemic Lupus Erythematosus Definition

Systemic lupus erythematosus (also called lupus or SLE) is a disease where a person's immune system attacks and injures the body's own organs and tissues. Almost every system of the body can be affected by SLE.
 (SLE SLE systemic lupus erythematosus.

SLE
abbr.
systemic lupus erythematosus


Systemic lupus erythematosus (SLE) 
) including glomerulonephritis glomerulonephritis: see nephritis. . If SLE-like symptoms occur, discontinuation of BiDil should be considered. Residua re·sid·u·a  
n.
Plural of residuum.
 have been detected many years after discontinuation of hydralazine. Symptomatic hypotension may occur with even small doses of BiDil. BiDil should be used with caution in volume depleted or hypotensive hypotensive /hy·po·ten·sive/ (-ten´siv) marked by low blood pressure or serving to reduce blood pressure.

hy·po·ten·sive
adj.
1. Of or characterized by low blood pressure.

2.
 patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Hydralazine hydrochloride has been associated with peripheral neuritis neuritis (nrī`tĭs, ny , evidenced by paresthesia paresthesia /par·es·the·sia/ (par?es-the´zhah) morbid or perverted sensation; an abnormal sensation, as burning, prickling, formication, etc.

par·es·the·sia or par·aes·the·sia
n.
, numbness and tingling Numbness and Tingling Definition

Numbness and tingling are decreased or abnormal sensations caused by altered sensory nerve function.
Description

The feeling of having a foot "fall asleep" is a familiar one.
, which may be related to an antipyridoxine effect. Caution should be exercised if BiDil is used with MAO inhibitors, alcohol, sildenafil sildenafil /sil·den·a·fil/ (sil-den´ah-fil?) a phosphodiesterase inhibitor that relaxes the smooth muscle of the penis, facilitating blood flow to the corpus cavernosum; used as the citrate salt to treat erectile dysfunction. , vardenafil or tadalafil.

Headache (50%) and dizziness (32%) were the two most frequent adverse events and were more than twice as frequent in the BiDil group.

Viagra is a registered trademark and Revatio is a trademark of Pfizer, Inc.; Levitra is a registered trademark of Bayer HealthCare, GlaxoSmithKline, and Schering-Plough; Cialis is a registered trademark of Lilly ICOS LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
.

About NitroMed, Inc.

NitroMed of Lexington, Massachusetts is a research-based emerging pharmaceutical company and the maker of BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine that may be prescribed in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. BiDil was approved by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark A-HeFT (African American Heart Failure Trial) clinical trial, and is marketed by NitroMed through a nationwide, dedicated sales force.

The Company is committed to the development of novel pharmaceuticals and safer, more effective versions of existing drugs to treat underserved patient populations. NitroMed's development efforts are primarily directed at expanding its cardiovascular franchise.

Forward Looking Statements

Statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's expectations about the new clinical data regarding BiDil, the benefits of BiDil and its plans to make BiDil available to patients who can gain from its therapeutic benefits, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: unanticipated difficulties in obtaining regulatory approval with regard to new clinical data, maintaining existing regulatory approvals to market and sell BiDil; the Company's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; adverse side effects experienced by patients taking BiDil; the Company's ability to obtain or maintain intellectual property protection and required licenses; the Company's ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil and other factors discussed in its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2005, which is filed with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

For full prescribing information, visit: www.BiDil.com.

BiDil is a registered trademark of NitroMed, Inc.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Nov 11, 2005
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