PURPOSE: Subcutaneous treprostinil (Remodulin(r); United Therapeutics) is an efficacious treatment for pulmonary arterial hypertension. Uncontrolled infusion site pain can lead to discontinuation. No standardized recommendations regarding analgesic use and timing of site changes exist in the peer-reviewed literature.
METHODS: This is a one-year, single-center, diary-based study. We recruited from a potential pool of 29 prevalent patients and provided them with a one page guideline on managing site discomfort gleaned from extensive practical experience with subcutaneous infusions; instructions about topical and oral medications (including narcotics) were included. Using a symptom diary, we collected data regarding the reason for a site change and the relationship between the new and old site. We asked patients to complete a daily symptom assessment (pain, erythema, drainage) and analgesic log for 14 days following an infusion site change. Questionnaires regarding quality of life (CAMPHOR) and burden of medication management (TQSM) were administered at enrollment. Close phone contact was maintained with the study subjects to ensure compliance with diary entries.
RESULTS: Twenty-five patients consented between January and April, 2010 and are currently completing symptom diaries. The average CAMPHOR symptom, activity and quality of life scores were 8±6, 18±6 and 16±6 respectively. As of this writing, we have received 23 diaries from 13 subjects. Eleven subjects have not changed their site since initiation of data collection (average 9 weeks without a site change since consenting). For the site changes thus far documented, subjects rated pain as “dreadful” (6/10) or worse on two consecutive days in ~50% of the diaries (11/23). In contrast, many diaries (10/23) document modest pain with all scores less than 4/10 on a visual analogue scale. Subjects used narcotics during 12/23 of reported site changes.
CONCLUSION: This infusion site management strategy with explicit instructions about analgesics and infrequent site changes allows for adequate pain management and reasonable quality of life for patients on subcutaneous treprostinil.
CLINICAL IMPLICATIONS: Our standardized practice for managing subcutaneous treprostinil infusions might allow for earlier use of parenteral prostacyclins in this disease.
DISCLOSURE: R White, Grant monies (from sources other than industry) American Heart Association; Grant monies (from industry related sources) United Therapeutics provided an investigator initiated grant to support the work described in this abstract; Dr. White also participates in multi-center trials with United Therapeutics, Gilead, and Actelion.; Consultant fee, speaker bureau, advisory committee, etc. Dr. White acts as a consultant to United Therapeutics and Gilead. His payments are fully disclosed to and supervised by the University of Rochester Conflict of Interest Advisory Group.; No Product/Research Disclosure Information