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Transition from parenteral to oral treprostinil in pulmonary arterial hypertension.

Transition from parenteral to oral treprostinil in pulmonary arterial hypertension.
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Chakinala MM, Feldman JP, Rischard F, Mathier M, Broderick M, Leedom N, Laliberte K, White RJ,


Chakinala MM, Feldman JP, Rischard F, Mathier M, Broderick M, Leedom N, Laliberte K, White RJ, (click to view)

Chakinala MM, Feldman JP, Rischard F, Mathier M, Broderick M, Leedom N, Laliberte K, White RJ,

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The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 2016 06 2436(2) 193-201 pii S1053-2498(16)30197-8
Abstract
BACKGROUND
Parenteral prostanoids are effective treatment for pulmonary arterial hypertension, but long-term pump infusion systems have significant delivery-related safety and convenience limitations.

METHODS
Subjects with a favorable risk profile transitioned from parenteral to oral treprostinil using a protocol-driven titration during 5 days of inpatient observation. Baseline and Week 24 assessments included 6-minute walk distance, echocardiogram, right heart catheterization, pharmacokinetics, treatment satisfaction and quality of life. Thirty-three subjects (76% female, mean age 50 years) enrolled; 85% were using subcutaneous treprostinil with a median dose of 57 (range 25 to 111) ng/kg/min. Participants were using background, approved non-prostanoid therapy, including 9 on 2 oral therapies; baseline right atrial pressure and cardiac output were in the normal range. All 33 subjects transitioned to oral treprostinil therapy within 4 weeks, but 2 transitioned back to parenteral drug before Week 24. At Week 24, subjects were taking a median total daily dose of 44 (15 to 75) mg, with 25 of 31 using a 3-times-daily regimen at 7- to 9-hour intervals.

RESULTS
The 6-minute walk distance was preserved (median +17 m [-98 to 95 m]) at its baseline of 446 m. Hemodynamic variables, including pulmonary vascular resistance, were similar at Week 24 except for mixed venous saturation, which dropped from a median of 71% to 68% (p < 0.001). Overall quality of life and treatment satisfaction measures did not change; however, mood-related symptom and treatment convenience subscores improved. Common adverse effects included headache, nausea, flushing and diarrhea. CONCLUSIONS
Lower risk patients managed on parenteral treprostinil may be candidates for transition to a more convenient, oral form of the drug.

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