is the registered trademark of Biopeutics for
a new bridging drug in heart transplantation.
An estimated 4.8 million Americans
have congestive heart failure (CHF). Its increasing prevalence, with resulting
hospitalizations and deaths have made CHF a major
chronic condition in the United
year, there are an estimated 400,000 new
cases. The primary cardiac
abnormality in heart failure is a loss of functioning myocardium that leads to
reduced left-ventricular function. Despite
substantial benefits from currently available inotropic, diuretic and
vasodilator medications, end-stage congestive heart failure is characterized
a very high death rate, often in excess of 50% within a year, usually due to
progressive cardiac dysfunction.
Heart transplantation has become a successful therapy for patients with
end-stage congestive heart failure. Itimproves quality of life and longevity; however, not enoughdonor
hearts are available for the estimated 2,486 candidates who are awaiting
transplantation in the United States
as of April 2007. Roughly 70% of these
people can expect to wait more than 6 months to undergo transplant. Based
on 2005 statistics, an estimated 15% of
waiting candidates will die each year.
Patients awaiting cardiac transplantation often
suffer from severe dyspnea and extreme fatigue at rest despite optimized treatment
oral medications, making the use of continuous intravenous drug therapy
necessary for circulatory support and to prolong survival to transplant (also
referred to as bridging to transplantation).
While most of the experience with continuous inotropic support has been
with hospitalized patients, outpatient treatment using continuous infusions has
the potential to improve patient comfort and decrease hospitalization and costs. It
is notable that the re-admission rate due to worsening of CHF in transplant candidates
inotropic support with dobutamine or milrinone is high at 66%.
a naturally occurring compound and it
has potent pulmonary and systemic vasodilator actions and is an important
endogenous regulator, which may serve to maintain blood flow to vital organs
such as the kidney. It also has various ancillary properties such as inhibition
of platelet adhesion and induction of cell proliferation. Specifically,
by virtue of its capillary
neoangiogenic effect, exogenously-administered Papeilin® is
postulated to prolong survival to cardiac