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Assessing the Efficacy of an Established Method for Successful Subcutaneous Treprostinil: A Formal Study of Aggressive Pain Management and Infrequent Site Changes

Y. Levin

Karen Frutiger

Antonia Heininger

K. Wessman


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Conference: 2010 International PHA Conference and Scientific Sessions

Release Date: 06.24.2010

Presentation Type: Abstracts

Levin Y, Frutiger K, Heininger A, Wessman, K, White RJ. 
Division of Pulmonary and Critical Care Medicine, University of Rochester, NY, Rochester, NY, USA

BACKGROUNDSubcutaneous treprostinil is an efficacious therapy for pulmonary arterial hypertension. Uncontrolled site pain often leads to discontinuation in otherwise excellent treatment candidates. No standardized recommendations regarding infusion site management (e.g., analgesic use and timing of site changes) exist in the peer-reviewed literature.

METHODSThis is a one-year, single-center, diary-based study. We recruited from a potential pool of 29 prevalent subcutaneous treprostinil patients. We provided patients with a one page guideline on managing site discomfort gleaned from extensive practical experience with subcutaneous infusions; instructions about topical medications, NSAIDS, antihistamines, and narcotic agents were all 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 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 the initiation of the 12 month study period. Close phone contact was maintained with the study subjects to ensure compliance with diary entries.

RESULTSTwenty-five patients (duration of therapy 1 month to 6 years) are currently enrolled in the study and completing symptom diaries. The average baseline CAMPHOR symptom, activity and quality of life scores were 8 ±6, 18± 6 and 16±6 respectively. All patients have been enrolled for at least four weeks and one as long as nine weeks. As of March 31, we have received twelve diaries indicating a low frequency of infusion site changes. Ten patients have not changed their site since initiation of data collection (e.g., more than four weeks); one patient has had her current site for six months. We will present baseline subject data including time on subcutaneous treprostinil as well as complete three month data from the symptom diaries (average lifespan of a given infusion site, daily pain intensity measured on a visual analogue scale, and utilization of narcotics including dose, frequency, and duration of use.)

CONCLUSIONA cohesive 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. Infusion sites can be maintained for extended periods without an apparent increase in adverse events.

This study is supported in part by an investigator initiated grant from United Therapeutics, Inc.