Clinical Response to BiDil(R) Evaluated by Baseline Blood Pressure; Results Presented at American College of Cardiology Meeting.

ATLANTA -- Today, NitroMed, Inc. (NASDAQ:NTMD) announced data from a continuing analysis of patients treated with BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride) in the African American Heart Failure Trial (A-HeFT). The data suggest that BiDil decreases systolic blood pressure (SBP) in black heart failure patients with higher baseline SBP (>126 mmHg) but not in those with lower baseline SBP (<=126 mmHg). The beneficial effects of BiDil on clinical outcomes in A-HeFT were shown to be independent of baseline SBP. When differentiating patients by baseline SBP above or below the median (126 mmHg) in A-HeFT, the significant benefits demonstrated for BiDil on mortality and morbidity were similar for both groups. The results were presented today in Atlanta, at the 55th Annual Scientific Session of the American College of Cardiology.

Blood pressure is the force with which the heart pumps blood and changes constantly due to activity, temperature, diet, emotional stress, physical state or medications. A person can be diagnosed with either high or low blood pressure, both of which carry specific risks. High blood pressure (hypertension) increases a patient's risk of stroke, heart attack, kidney failure and heart failure. Low blood pressure (hypotension) is generally considered of concern when it drops suddenly or is accompanied by symptoms, such as dizziness or fainting. In patients with heart failure, low blood pressure is also an independent risk factor for increased mortality.

The initial results from the A-HeFT trial revealed that BiDil significantly improved survival, decreased time to first hospitalization for heart failure and improved functional status in self-identified black patients. The initial results also found that BiDil was associated with a significant decrease in blood pressure across all patients treated with BiDil in the trial. As a result, BiDil was approved with precautions regarding its use in hypotensive patients. This prompted further analysis. As presented today, when patients were grouped into quartiles of baseline SBP <112 mmHg, >112<=126mmHg, >126<=140mmHg, and >140 mmHg, BiDil decreased SBP in the groups with baseline SBP >126 mmHg but not in the groups with baseline SBP <=126 mmHg. Additional analysis showed that BiDil did not decrease SBP in the group of patients with the lowest baseline SBP (<=100 mmHg). Notably, patients with lower than median SBP entered A-HeFT with features of relatively more progressive heart failure yet both groups above or below the median baseline SBP experienced similar clinical benefit of BiDil.

"BiDil is a vasodilator, which is often perceived to further reduce blood pressure in patients with existing low systolic blood pressure," said Inder S. Anand, M.D., FRCP, D. Phil. (Oxon.), the study's lead author. "In fact, this data showed that BiDil did not cause a decrease in systolic blood pressure in A-HeFT patients with low blood pressure, who are at the highest risk of death from heart failure." Dr. Anand is Professor of Medicine at University of Minnesota Medical School and Director of the Heart Failure Program at VA Medical Center, Minneapolis, Minn.

This post-approval study was conducted as a comparative analysis of patients above and below the median baseline SBP, and of four subgroups of patients; two above and two below the pretreatment median baseline SBP of 126 mmHg. Patients in these four SBP subgroups were evaluated for changes in SBP and clinical outcomes. According to the analysis:

--BiDil therapy was associated with a significant reduction in SBP of 3-4 mmHg across all BiDil-treated patients in A-HeFT. Based on the results of the comparative analysis, however, the decrease in BP was present only in the group of patients with normal to high baseline SBP (>126 mmHg) and not in the groups of patients with low (<=126 mmHg) or lowest baseline SBP (<=100 mmHg)

--The beneficial effects of BiDil on decreasing mortality and time to first hospitalization for heart failure were similar in all patients with baseline SBP above or below the median of 126 mmHg

--The benefit of BiDil on mortality and morbidity was not dependent on reducing blood pressure

"We are excited by the results of the analysis of the blood pressure data showing that heart failure patients with low blood pressure in A-HeFT benefited from BiDil without further decreasing their blood pressure," said Michael L. Sabolinski, M.D., Chief Medical Officer of NitroMed, Inc. "As we continue to analyze data from the A-HeFT trial we are encouraged to see results emerge that provide valuable information to physicians and patients regarding the use of BiDil."

About BiDil

BiDil was approved in June 2005 by the U.S. Food and Drug Administration and 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.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies (n=518) experienced a significant 43 percent decrease in the risk of mortality (P=.012) (absolute mortality rate: BiDil, 6.2 percent vs. placebo, 10.2 percent), a 39 percent reduction in the risk of first hospitalization for heart failure (P less than .001) (absolute first hospitalization rate: BiDil, 16.4 percent vs. placebo, 24.4 percent) 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 (n=532) 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)/Revatio(TM), 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. Careful clinical and hemodynamic monitoring is recommended when BiDil is administered to patients with acute myocardial infarction to avoid hypotension and tachycardia. Isosorbide dinitrate therapy may aggravate angina associated with hypertrophic cardiomyopathy.

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 percent) and dizziness (32 percent) 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, an orally administered medicine available 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 in June 2005 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 since July 2005, has been marketed by NitroMed through a nationwide, dedicated contract 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, 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: the potential impact of data derived from these studies, if any, and the statistical limitations of such data; unanticipated difficulties in obtaining regulatory approval or labeling changes with regard to new clinical data, if pursued; patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; the Company's ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil and to complete its current research activities; unanticipated difficulties in maintaining regulatory approvals to market and sell BiDil; adverse side effects experienced by patients; the Company's ability to obtain or maintain intellectual property protection and required licenses and other factors discussed in its Annual Report on Form 10-K for the year ended December 31, 2005, which has been 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.