Published Study: Use of BiDil(R) Individual Components Are Not Bioequivalent to the Fixed Dose Combination BiDil- Used in A-HeFT
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A study published in the current edition of Clinical Pharmacokinetics,
a peer-reviewed scientific journal, reports that
two different combinations of individual isosorbide dinitrate (ISDN) and
hydralazine hydrochloride (HYD), used in the Vasodilator-Heart Failure
Trials (V-HeFT) I and II are not bioequivalent to BiDil®,
the fixed-dose combination of ISDN and HYD, used in the African American
Heart Failure Trial (A-HeFT). The study compared identical amounts of
the formulations of ISDN and HYD used in V-HeFT I and II, and BiDil, the
proprietary fixed dose combination, used in A-HeFT and demonstrated that
the formulations used in V-HeFT I and V-HeFT II are neither
bioequivalent to each other, nor to BiDil.
Generic formulations of ISDN and HYD have not been shown to be
bioequivalent to BiDil and there is no basis to conclude that the
clinical efficacy of generic ISDN and hydralazine will be the same as
BiDil. Only BiDil was studied and proven effective in A-HeFT and it is
unknown whether other formulations provide the same clinical benefits.
The non-bioequivalence in the formulations used may explain why V-HeFT
I, V-HeFT II, and A-HeFT had very different results in reducing
mortality and morbidity. BiDil is an orally administered medicine
approved in the United States for the treatment of heart failure in
self-identified black patients.
"Decreasing mortality is really important and
BiDil does that. Currently available formulations of ISDN and HYD have
not been shown to have the same mortality and morbidity benefit as BiDil
or to be therapeutically equivalent to or substitutable for BiDil. Heart
failure in blacks carries a mortality rate higher than many forms of
cancer, as well as impairing quality of life and requiring acute
hospital admissions. In treating this life- threatening disease, it’s
now clear that the use of BiDil represents standard of care for these
patients,” said Dr. Milton Packer, a heart
failure specialist and co-author of the study from the University of
Texas, Southwestern Medical Center in Dallas.
Earlier today, NitroMed reported that approximately 80% of African
Americans who have commercial and Medicare Part D and Medicaid
prescription drug insurance coverage in the United States, have
affordable access to BiDil.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical
company and the maker of BiDil®
(isosorbide dinitrate/hydralazine hydrochloride), 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 for the treatment of heart failure as an adjunct to current
standard therapy, 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 contraindicated in patients who are allergic to organic
nitrates. Augmentation of the vasodilatory effects of isosorbide
dinitrate by phosphodiesterase inhibitors (e.g., Viagra®/Revatio™,
Levitra®, Cialis®)
could result in severe hypotension. Adverse events reported in A-HeFT
and seen more frequently in the group given BiDil included headache (50%
in BiDil patients vs. 21% in placebo patients) and dizziness (32% in
BiDil patients vs. 14% in placebo patients).
BiDil is marketed by NitroMed through a specialty medicines sales
organization.
For full prescribing information, visit: www.BiDil.com.
BiDil is a registered trademark of NitroMed, Inc.
Forward Looking Statements
Statements in this press release about future expectations, plans and
prospects for the Company, including the Company’s
positioning to achieve the Company’s goals
and objectives, 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
discussed in the Section titled "Risk Factors”
in the Company’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2007, which has been filed with the
SEC, and in the other filings that the Company makes with the SEC from
time to time. 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.
