PURPOSE: Transition to intravenous treprostinil from epoprostenol typically has been accomplished by gradual titration over several days. Two European centers recently reported on the rapid transition to treprostinil from epoprostenol. A retrospective review of US PAH centers was conducted to provide best-practice insight for other US centers on the rapid transition procedure.
METHODS: Retrospective review at four US PAH centers of patients rapidly transitioned to intravenous treprostinil. Clinical assessments were preformed per each center's routine clinical practice. When available, reason for transition, transition procedure, dose titrations, pre/post 6MW and right heart catheterizations, prostacyclin side effects, and any documented comments on clinical status or quality of life were collected from patient charts. Descriptive statistics were utilized as applicable.
RESULTS: To date, data from 12 patients at 3 of the 4 centers rapidly transitioned to treprostinil between 2005 and 2006 have been collected. Mean duration on epoprostenol was 30 months. Reasons for transition included safety profile and decreased treatment complexity. Transition procedures varied slightly from center to center and evolved with center experience. Initially, rapid transitions occurred at a 1:1 epoprostenol to treprostinil dose ratio and titrated upward. More recent transitions occurred at treprostinil doses 25% higher than epoprostenol with minimal dose titrations. One patient, transitioned at 50% higher the epoprostenol dose, required dose reductions. Initial length of hospitalized monitoring for the rapid switch was 24 hrs and decreased at some centers for recent transitions. No acute or delayed decompensations occurred. Mean 6MWs pre-switch, first post-switch and at last follow-up were 349 m, 391 m and 371 m, respectively for available patients.
CONCLUSION: The rapid transition of patients to treprostinil was safe and did not require extended hospitalization for monitoring. Initiating treprostinil at a dose 25% higher than epoprostenol was associated with fewer titrations and shorter observation times.
CLINICAL IMPLICATIONS: This data supports the safety and effectiveness of rapidly transitioning patients to treprostinil from epoprostenol and provides additional information regarding the dosing strategy of such a transition.
DISCLOSURE: Shelley Shapiro, No Product/Research Disclosure Information; University grant monies S. Shapiro- NONE J. Feldman- NONE A. Waxman- HMS / MGH fund for pulmonary vascular disease; Grant monies (from sources other than industry) S. Shapiro- limited NIH subcontract J. Feldman- NONE A. Waxman- NIH RO1; Grant monies (from industry related sources) S. Shapiro industry grants- United Therapeutics, Novartis, Pfizer, Gilead, Actelion J. Feldman- NONE A. Waxman- NONE Shelly Shapiro: Grants: United Therapeutics, Gilead, Encysive, Pfizer, Novartis Robert Schilz: I receive grant support for clinical research from United Therapeutics.; Shareholder S. Shapiro- NONE J Feldman- NONE A Waxman- NONE; Employee K. Rollins is an employee of United Therapeutics. Deb Strootman is a full time employee of United Therapeutics; Fiduciary position (of any organization, association, society, etc, other than ACCP J Feldman- NONE A Waxman- NONE Shelly Shapiro: NONE; Consultant fee, speaker bureau, advisory committee, etc. J Feldman- In the past year: Encysive, United THerapeutics, Gilead/Myogen; Past 5 yrs: Actellion, Encysive, Pfizer, Cotherix, United Therpeutics, Myogen/Gilead A Waxman- Encysive, United Therapeutics, Gilead Shelly Shapiro: Speaker Fees- Gilead, United Therapeutics, Encysive Shelly Shapiro: Consultant fees- Gilead, United Therapeutics, Baxter Robert Schilz: I have served as a scientific consultant and speaker for United Therapeutics, I also serve as a speaker, scientific consultant, data safety monitor or receive grant support from: Myogen, Actelion, Glaxo-Wellcome, ICOS, Aztra-Zeneca, Intermune, Pfizer, Cotherix and Encysive, Novartis companies.; Other Robert Schilz: I am an unpaid member of the Medical Advisory Board for LifeBanc- an organ procurement organization in Northeast Ohio