Table 1.
Treprostinil routea | Risks [9–11] | Benefits | Other considerations | |
---|---|---|---|---|
Placebo-corrected Hodges-Lehmann median change in 6MWD after 12 weeks [5, 7, 39] | Survival [6, 24, 38] | |||
Parenteral treprostinil (Remodulin®) | Indwelling central catheter, bloodstream infection, sepsis (IV) Injection-site pain, occasionally requiring narcotics (SC) Headache Diarrhea, nausea Rash Jaw pain Vasodilation Edema Hypotension |
+16 m (as monotherapy) | 1 year: 87 % 2 years: 78 % 3 years: 71 % 4 years: 68 % |
Device required Continuous infusion Ability to titrate dose |
Inhaled (Tyvaso®) | Cough, throat irritation, pharyngolaryngeal pain Headache, flushing Nausea, diarrhea Dizziness Jaw pain |
+20 m (with single oral background therapy) | 1 year: 97 % 2 years: 91 % 3 years: 82 % |
Device required; part replacement and cleaning qid dosing Titrate to a maximum dose (72 µg) |
Oral (Orenitram®) | Headache Diarrhea, nausea Flushing Pain in jaw Pain in extremity Hypokalemia Abdominal discomfort |
+23 m (as monotherapy) | 1 year: 92 % 2 years: 87 %b 3 years: 82 %b |
No device required bid or tid dosing Take with food Ability to titrate dose |
6MWD 6-min walk distance, bid twice daily, IV intravenous, qid four times daily, SC subcutaneous, tid three times daily
aSee Table 2 for additional details on the pivotal trials for each formulation
bStudy ongoing. Patients had an opportunity to reach 2 and 3 years of Orenitram® therapy