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. 2016 Jun 10;55(12):1495–1505. doi: 10.1007/s40262-016-0409-0

Table 1.

Risks and benefits of the various treprostinil formulations

Treprostinil routea Risks [911] 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