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 walking distance with the Borg dyspnea score. Treprostinil also consistently improved measures of dyspnea and fatigue and signs and symptoms of AH.
Crawford, Jr LM. Pulmonary Hypertension. JAMA. 2002;288(1):36. doi:10.1001/jama.288.1.36-JFD20007-3-1