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

American Heart Association's Scientific Sessions 2005
BIOWIRE2KDALLAS--(BUSINESS WIRE)--Nov. 11, 2005--NitroMed, Inc. (NASDAQ: NTMD) announced today that it will present several oral abstracts that feature post-approval analyses of BiDil(R) (isosorbide dinitrate/hydralazine HCI) 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.60.1), taking place at the Dallas Convention Center 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 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 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 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) 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 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 with effects on both arteries and veins. The dilator properties of nitrates result from the release of nitric oxide that leads to the relaxation of vascular smooth muscle. 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 (CDC), 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 (SLE) including glomerulonephritis. If SLE-like symptoms occur, discontinuation of BiDil should be considered. Residua 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 patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness and tingling, which may be related to an antipyridoxine effect. Caution should be exercised if BiDil is used with MAO inhibitors, alcohol, sildenafil, 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.
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 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: http://www.bidil.com/.
BiDil is a registered trademark of NitroMed, Inc.

Double the pleasure

Treating his sexual woes also boosts her satisfaction
By Brian Alexander
MSNBC contributor
Updated: 3:31 p.m. ET Nov. 10, 2005
When Dr. Irwin Goldstein, a well-known expert in sexual medicine, presented recent research findings to a scientific meeting, he said: “It is rare for me to stand in front of an audience and say, ‘This is a manuscript that has changed my life.' But this one has done that.”
At first glance the study, printed in the Journal of Sexual Medicine (edited by Goldstein), seems like the most obvious thing in the world. When you hear the results, you say to yourself, “Well, duh!”
The results showed that female sexual partners in committed relationships with men who were treated with an impotence drug (in this case Levitra, made by Bayer, which also sponsored the study) had better sex. That’s the “duh” part. But get this: The women didn’t just like sex better because they could, you know, have sex. They liked sex better because their own bodies worked better. Lubrication improved. Orgasm improved. Desire improved.
In case you’re still not catching on, the women’s bodies reacted as if they were receiving the drug, as if they were the ones being treated. So a drug they didn’t even take affected their bodies.
“Her physiology is linked to him,” Goldstein says. “Men share problems with women, and the solutions … It totally intrigues me. I can change someone’s physiology without treating them. It’s the wildest thing!”
In fact, the better a man’s response to the drug, the better her response to him.
There’s a concept in the world of physics called “entanglement.” It refers to the weird fact that subatomic particles have “partners” — other subatomic particles — with which they can be entangled, sometimes over great distances. If a physicist tinkers with one particle, the change affects the other particle. Strange but true.
I find Goldstein’s study a strong indicator that humans can be entangled, that the romantic ideal extolled by poets and Dr. Phil exists in real life. We really do change when we fall in love. We become a unit, at least sexually. “There are no other physiologic abilities of men and women that are shared, and that is what is so fascinating about these data,” Goldstein says.
One sexual unit?He is reluctant to speculate beyond his data, but when I asked if he knew if the effect could work the other way, he says that he has some evidence that when he successfully treats women who suffer from dyspareunia, or pain with intercourse, their men get better erections and have more sexual satisfaction. And he suspects that male partners of women with low libido have poorer erections and that if those women could be treated, the men would improve, too.
Is this really possible? Do we really meld into one sexual unit?
Could be, says Jerry Phelps, a psychologist at the University of California, San Diego, who has studied and treats couples with sexual problems.
When Phelps worked with postmenopausal women who were counseled on the changes they might experience, given treatment options for any sexual dysfunction, and taught how to talk it all over with their partners, both partners benefited.
Phelps, who also treats young people at the school’s counseling center, says the theory isn’t just for middle-aged marrieds. “I would like to see joint treatment in most cases [of sexual dysfunction]," he says. “I would encourage the partner to be included,” whether the caregiver is a psychologist, psychiatrist, urologist or ob-gyn.
'A couple's condition'Goldstein says much of the existing paradigm for treating sexual dysfunction “is hopeless! It is penis-focused, male-oriented. There’s no involvement of the couple. That must change. Correct management is to treat this as a couple’s condition.”
He suggests using infertility medicine as an example. “When people cannot have a child," he says, "the medical conclusion is you must evaluate both members. But when a man has erectile dysfunction, we’re only treating the man!”
He’s not just being a romantic, either. One of the findings of his research is that in addition to all the good stuff that happened to the female partners of men treated for impotence, they also suffered more pain with intercourse than they did before the drug gave their man the woody of a titan. So by treating both people, women could be counseled on what to expect and ways to prevent pain.
I am not a scientist, nor a medical doctor, so I’m perfectly willing to go beyond the data to speculate on what’s going on, and here’s what I think. I think, and the questions submitted over and over again to Sexploration show, that people in long-term, committed relationships really are “entangled” in most if not all aspects of life.
It's always about youThis might seem obvious, yet we often deny it. We use the phrase “It’s not about you,” when we talk to our partners, but it’s ALWAYS about them. If we change jobs, it’s not just us being affected. If we suddenly feel depressed, we’re not the only ones suffering. Sexually speaking, if we gain lots of weight, dress like a slob, it’s not just about us. We don’t have to look at ourselves.
Accepting the joys of love — great sex being one — also means recognizing the responsibilities and one of those responsibilities is keeping yourself appealing to your partner. Sounds shallow, yes. But doing it shows you care about your partner. Your partner gains self-esteem as you do. Your partner loses it when you do. He feels sexy when you do. She feels in the mood when you do.
“This is intuitive, yes,” says Goldstein. “But that is what’s intriguing, that this is part of a relationship, the sharing of psychological issues. We get into each other's head.”
When Viagra first came out, Goldstein recalls, Pfizer was surprised that, even though the drug was a blockbuster, sales were lower than expected. Turned out many men with impotence weren’t going to get it on their own. Those who did were often spurred by their wives who recognized that his sexual problem was her problem, too.
So remember, it’s not only that we want to get into each other’s pants. It’s that we already inhabit them.
Brian Alexander is a California-based writer who covers sex, relationships and health. He is a contributing editor at Glamour and the author of "Rapture: How Biotech Became the New Religion" (Basic Books).
Sexploration appears every other Thursday.
© 2005 MSNBC Interactive


URL: http://msnbc.msn.com/id/9979638/