Conference: 2009 PH Resource Network Symposium
Release Date: 09.24.2009
Presentation Type: Abstracts
Joy Beckmann, RN, MSN1; Julie Lynch, RN, BSN2; Helena Purl, RN, BSN, CCRC3; Erik Emerson4; Ari Gershman, MD4; Glenna Traiger, RN, MSN5
1. Harbor UCLA Medical Center
2. Arizona Pulmonary Specialists
3. Baylor College of Medicine
4. Gilead Sciences
5. University of California, Los Angeles
PURPOSE: To assess whether LabSync provides an indirect benefit of improving persistency rates in those taking Letairis therapy for pulmonary arterial hypertension.
BACKGROUND: Letairis is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension. Like other approved ERAs, Letairis is available only through a special restricted distribution program (the LETAIRIS Education and Access Program [LEAP]) that requires patients to complete monthly liver function tests and, for female patients of childbearing potential, monthly pregnancy tests. LabSync is a voluntary, web-based service designed to assist health care providers with the monthly laboratory work associated with Letairis treatment. LabSync works with patients, physicians and laboratory facilities to: coordinate lab orders, resolve insurance issues, send patient appointment reminders, and provide lab results directly to office staff. A retrospective analysis of the LabSync database was conducted to compare Letairis persistency of patients enrolled in the program vs. patients not enrolled.
METHODOLOGY: A retrospective third-party analysis was conducted of 175 patients enrolled in LabSync and 399 control subjects only enrolled in LEAP who had at least 9 months of post enrollment data as of May 2009. The analysis matched patients for: age, gender, geographic location, total number of shipments received, days since most recent shipment (prior to LabSync enrollment), and LEAP enrollment month. The primary endpoint was a comparison of the percentage of LabSync patients remaining on therapy after 9 months vs. the matched LEAP control group. Secondary endpoints included comparing: number of missed refills, days on therapy, and age and sex differences between the two groups.
FINDINGS: LabSync patients remained on therapy at higher rates than the control group after 9 months (85% vs. 68%). LabSync patients missed fewer refills than control patients (22.2% vs. 29.1%) and averaged 35.9 more days of therapy than the control group during the post-enrollment period. LabSync patients age <60 were observed to have more days on therapy (42.7 more days on therapy than the control group) than those =60 (26.1 more days on therapy than the control group). Both female and male patients had more mean days on therapy following enrollment in LabSync (37.4 for female vs. 30.9 days for male).
IMPLICATIONS: Patients enrolled in LabSync showed greater persistency with Letairis by more days on therapy and fewer missed refills than those not enrolled. Improvements were seen regardless of age and sex; however, younger females may have experienced the greatest benefit. Future research should focus on whether the benefits seen with LabSync have a direct impact on the outcomes of this serious and progressive disease.