Transition from parenteral to oral treprostinil in pulmonary arterial hypertension

Murali M. Chakinala, Jeremy P. Feldman, Franz Rischard, Michael Mathier, Meredith Broderick, Nicole Leedom, Kevin Laliberte, R. James White

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)193-201
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume36
Issue number2
DOIs
StatePublished - Feb 1 2017

Keywords

  • hemodynamics
  • pharmacokinetics
  • pharmacology
  • prostaglandins
  • pulmonary hypertension

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine
  • Transplantation

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