REMODULIN (UT-15) - NEW PROSTACYCLIN DRUG TO TREAT PPH
Remodulin (treprostinil sodium) injection is a continuous subcutaneous
infusion for the treatment of pulmonary arterial hypertension (PAH) in patients
with NYHA Class II-IV symptoms. Remodulin is intended to diminish the symptoms,
such as shortness of breath, associated with physical activity in PAH patients.
Remodulin is supplied in concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL and
10.0 mg/mL. The standard infusion rate is 1.25 ng/kg/min, but can be reduced in
the event that the original dose cannot be tolerated.
Remodulin is also used to treat pulmonary
hypertension in the form of a synthetic, stable form of prostacyclin. This
pulmonary hypertension treatment is a new treatment approved under accelerated
approval regulations for advanced pulmonary hypertension. Manufactured by United
Therapeutics, Remodulin was FDA approved on May 22, 2002 based on the largest
double blind placebo-controlled study ever conducted in PAH. Pulmonary arterial
hypertension (PAH) is a disease in which blood pressure is abnormally high in
the arteries between the heart and lungs. PAH is characterized by symptoms of
shortness of breath during physical exertion. The condition can ultimately lead
to heart failure.
The approval of Remodulin was encouraging news
for many patients and doctors due to the need for expanded treatment options for
pulmonary hypertension patients. Remodulin was made immediately available
through United Therapeutics U.S. distributors. The benefit of using Remodulin
over already available Flolan is the longevity it remains within the body.
Flolan - Remodulin PPH
Opposed to Flolan therapy, Remodulin's dilation
action lasts from 4-6 hours versus the 2-3 minute action of Flolan. In addition,
Remodulin is administered under the skin called subcutaneous infusion, working
with a MiniMed microinfusion device. The use of Remodulin carries a much lower
risk of sepsis and other related hospitalizations that is associated to the use
of Flolan because the elimination of the need for a catheter.
Two 12-week, multicenter, randomized, double-blind studies were conducted to
compare Remodulin to placebo. A total of 470 subjects with NYHA Class II-IV
pulmonary arterial hypertension (PAH) we enrolled in the studies. The baseline
measures were 6-minute walking distance and level of shortness of breath during
this physical test (Borg dyspnea score). The primary endpoint was change in
6-minute walking distance over the 12-week treatment period. There was a
noteworthy change in 6-minute walking distance for those subjects treated with
Remodulin, although the effects did not achieve conventional levels of
statistical significance. There was a statistically significant change in
subjects' Borg dyspnea scores with the Remodulin treatment. There were
significant differences between Remodulin- and placebo-treated subjects in eight
out of ten hemodynamic parameters that were evaluated, including cardiac index;
mean pulmonary arterial pressure; pulmonary vascular resistance indexed; mean
right atrial pressure; systemic vascular resistance indexed; mixed venous oxygen
saturation. The two hemodynamic parameters that did not achieve statistical
significance were mean systemic arterial pressure and heart rate.
At the time of FDA approval, clinical studies of Remodulin were still ongoing
for the PAH indication to explore further effects and potential benefits of the
drug. In addition, a post-marketing, phase IV clinical trial is expected to
Remodulin Side Effects may include:
- infusion site pain
- infusion site reaction
- jaw pain
- pruritus (itching)
LAWSUITS - LEGAL & FINANCIAL HELP FOR PPH VICTIMS
you or a loved one have been diagnosed with Primary Pulmonary Hypertension (PPH),
then you may have a right to file a individual legal action against the
manufacturers of the diet pills or other products that caused your PPH. Due to
the nature of this serious and devastating disease process, PPH patients are
urged to contact an attorney immediately after he or she has been informed of
their Primary Pulmonary Hypertension diagnosis. Many important legal issues
need to be addressed early after a PPH diagnosis, that can affect the
outcome of the PPH litigation. Call us for a Free Confidential Consultation.
Talk with a Board Certified Personal Injury Trial Lawyer about your legal
rights of a PPH claim against the diet drug industry and others. No Fees or
Expenses Charged unless we make a Recovery for You.
Us Toll Free at 1-800-883-9858 or 1-800-468-4878 or E-mail
us your questions on Free
Case Evaluation Form.