Table 2.
Oral treprostinil transition and evaluation of outcomes
| Patient | Prostacyclin dose/route prior to transition | Oral treprostinil dose | Clinical worsening | Adverse events | Conversion failure | ||
|---|---|---|---|---|---|---|---|
| Initiation, mg | Discharge, mg | Last clinic visit, mg (w after transition) | |||||
| 1 | 40 ng/kg/min; SQ | 1, TID | 10, TID | 10.25, QID (44) | Yes; mild increase in symptoms, decline in 6MWD, increase in BNP level; required increase in treprostinil dose | Yes; flushing | No |
| 2 | 12 breaths QID; INH | 0.5, TID | 2.5, TID | 7, QID (52) | No | Yes; headache, jaw pain, loose stool, flushing | No |
| 3 | 24 ng/kg/min; SQ | 0.5, TID | 3.5, TID | 2, BID (44) | No | Yes; nausea, vomiting, diarrhea, dyspnea, edema; required lowering of dose | No |
| 4 | 50 ng/kg/min; IV | 1, TID | 10, TID | 10, QID (55) | No | Yes; headache, nausea, diarrhea, flushing, jaw pain, dizziness | No |
| 5 | 40 ng/kg/min; SQ | 1, TID | 8, TID | 7, TID (50) | No | Yes; nausea, vomiting, edema; required lowering of dose | No |
| 6 | 70 ng/kg/min; SQ | 1, TID | 13, TID | NA; discont. at 12 | Yes; syncopal episode, decreased energy and exercise tolerance | Yes; headache, nausea, vomiting, flushing, syncope, dyspnea, dizziness | Yes; resumed SQ treprostinil but at higher dose (75 ng/kg/min vs. 70 ng/kg/min at baseline) |
| 7 | 39 ng/kg/min; IV | 1, TID | 8.5, TID | NA; discont. at 2 | No | Yes; headache, nausea, vomiting, edema, chest pain, shortness of breath, numbness/tingling | Yes; resumed SQ treprostinil at 40 ng/kg/min (same as baseline) |
| 8 | 36 ng/kg/min; SQ | 0.5, TID | 5, TID | 8, TID (27) | No | No | No |
| 9 | 12 breaths QID; INH | 1, TID | 4, TID | NA; discont. at 2 due to plan for hospice care | No | Yes; headache, nausea, flushing | No |
| Median SQ/IV dose (range) | Median (range), mg | Median (range), mg | Median total daily, mg (median [range] w after transition) | Total clinical worsening, n | Total adverse events, n | Total conversion failures, n | |
| Total | 42 (24–70) ng/kg/min | 1 (0.5–1), TID | 8 (2.5–13), TID | 28; range: 4–41a (47 [27–55]) | 2 | 8 | 2 |
Note
Conversion failure defined as the need to discontinue oral treprostinil and transition back to the original prostacyclin therapy based on the presence of clinical worsening and/or adverse events. BID = twice daily dosing; BNP = brain-type natriuretic peptide; discont. = discontinued; INH = inhaled; IV = intravenous; NA = not applicable; 6MWD: 6-minute walk distance; SQ = subcutaneous; TID = 3 times daily dosing; QID = 4 times daily dosing; w = weeks.
a
One patient received BID dosing; 2 patients received TID dosing; 3 patients received QID dosing.