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Pulmonary Hypertension
JAMA. 2002;288:36.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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The FDA has approved treprostinil sodium injection (Remodulin, United
Therapeutics Corp, Research Triangle Park, NC) as a continuous subcutaneous
infusion for the treatment of pulmonary arterial hypertension (PAH) in patients
with New York Heart Association (NYHA) Class II-IV symptoms to diminish symptoms
associated with exercise.
The product was approved on the basis of two 12-week, multicenter, randomized,
double-blind studies that compared treprostinil with placebo in 470 patients
with NYHA Class II-IV PAH. Treprostinil was administered as a subcutaneous
infusion using a portable pump, and the dose averaged 9.3 ng/kg per minute
at week 12. The effect of the drug on the 6-minute walking distance, the primary
end point of the studies, did not achieve statistical significance. Compared
with placebo, however, treprostinil improved associated subjective measurements
of shortness of breath during the 6-minute walk test called the Borg dyspnea
score, and had a significant effect on a symptom assessment that combined
. . . [Full Text of this Article]
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