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Abstract: Poster Presentations |

SAFETY AND TOLERANCE OF A RAPID 3-5 DAY IN-HOSPITAL UP-TITRATION PROTOCOL OF SUBCUTANEOUS (SQ) TREPROSTINIL IN PATIENTS WITH SEVERE PULMONARY ARTERIAL HYPERTENSION (PAH) FREE TO VIEW

Francisco J. Soto, MD, MS*
Author and Funding Information

Medical College of Wisconsin, Milwaukee, WI


Chest


Chest. 2007;132(4_MeetingAbstracts):634a. doi:10.1378/chest.132.4_MeetingAbstracts.634a
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Abstract

PURPOSE: In its pivotal study, clinical benefit with the use of SQ treprostinil in PAH was mainly seen with a dose >14 ng/kg/min. However, only a small group of patients reached this dose by 3 months. We believe that such slow uptitration leads to an imbalance in most patients’ and clinicians perception of benefit: 3 or more months of potential substantial site pain while enjoying only a limited clinical benefit. Our experience suggests that a faster uptitration can be safely accomplished.

METHODS: We reviewed the data of patients with severe PAH seen at the Medical College of Wisconsin's PH Center and who underwent rapid inhospital uptitration.

RESULTS: We identified five consecutive patients between 5/06-4/07. Average age was 52. Sixty percent were male. Sixty-percent had idiopathic PAH and 40% were scleroderma-related. All patients were monitored in the intensive care unit. Dose was started at 2 ng/kg/min and was increased by 2 ng every 8-12 hours as tolerated by side effects and hemodynamics. Dose achieved during inpatient uptitration (ng/kg/min) and time to reach such dose: Patient One: 10 (4 days); Two: 14 (3 days); Three: 16 (4 days); Four: 16 (4 days); Five: 12 (4 days). Two patients developed severe headache which resolved with analgesics. Two patients required dose decrease of anti-hypertensive agents. There were no significant adverse hemodynamic effects. After discharge, dose continued to be increased by at least 2 ng/kg/min × week.

CONCLUSION: Our protocol appeared to be safe and was well tolerated. In <5 days, our patients achieved treatment doses that were reached by only a small number of patients in the pivotal study after at least 3 months of therapy.

CLINICAL IMPLICATIONS: Current data suggest that the strongest clinical benefit of SQ Treprostinil is seen with doses >40ng/kg/min. Given the time it takes to reach such dose with a “standard” uptitration protocol, a high rate of early discontinuation of therapy is likely to occur. Our rapid uptitration protocol could improve therapy adherence by reaching a more rapid clinical benefit.

DISCLOSURE: Francisco Soto, Consultant fee, speaker bureau, advisory committee, etc. Consultant fee, speaker bureau and/or advisory committee for Actelion Pharmaceuticals, Encysive Pharmaceuticals, Pfizer, Gilead and United Therapeutics; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. The rapid uptitration protocol discussed in this abstract has not been prospectively studied yet.

Wednesday, October 24, 2007

12:30 PM - 2:00 PM


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