Add-back therapy use and its impact on LA persistence in patients with endometriosis

• Published in: Current medical research and opinion Vol. 26; no. 3; pp. 729 - 736
• Main Authors: Fuldeore, Mahesh J., Marx, Steven E., Chwalisz, Kristof, Smeeding, James E., Brook, Richard A.
• Format: Journal Article
• Language: English
• Published: England Informa UK Ltd 01-03-2010; Taylor & Francis
• Subjects: Add-back therapy; Adult; Contraceptives, Oral, Synthetic - administration & dosage; Contraceptives, Oral, Synthetic - adverse effects; Databases, Factual; Endometriosis; Endometriosis - drug therapy; Estrogens - administration & dosage; Estrogens - adverse effects; Female; Gonadotropin-Releasing Hormone - administration & dosage; Gonadotropin-Releasing Hormone - adverse effects; Hormones; Humans; Leuprolide - administration & dosage; Leuprolide - adverse effects; Leuprolide acetate; Medication adherence; Medication compliance; Middle Aged; Norethindrone - administration & dosage; Norethindrone - adverse effects; Norethindrone - analogs & derivatives; Norethindrone acetate; Patient Compliance; Progesterone Congeners - administration & dosage; Progesterone Congeners - adverse effects; Retrospective Studies
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/03007990903582985

Abstract
Objectives:
Persistence and compliance in women with endometriosis who are receiving gonadotropin-releasing hormone agonists (GnRH-a) may be limited by its hypoestrogenic side effects. Use of concomitant therapy with norethindrone acetate (NA), estrogen, estrogen/progestin combinations, or other progestin (i.e., ‘add-back therapy’ [ABT]) is recommended to alleviate these side effects. This retrospective study evaluated ABT utilization and its effect on compliance and persistence in patients with endometriosis taking the GnRH-a leuprolide acetate (LA) depot suspension.
Methods:
A retrospective analysis of a large pharmacy claims database identified patients who started LA therapy from 2002 to 2004 for the treatment of endometriosis. Patients were identified as having received ABT if they started 7 days before, or within 45 days of the last LA fill.
Results:
A total of 1285 women with endometriosis who began using LA were identified with 12 months of evaluable data: 211 (16.4%) used concomitant NA therapy, 116 (9.0%) used concomitant estrogen-based therapy, 28 (2.2%) used concomitant combination estrogen- and progestin-based therapies, 56 (4.4%) used concomitant progestin-based therapy, and 874 (68.0%) did not use any ABT. Mean ( SD) LA persistence in women receiving NA-based ABT was 5.83 2.98 months, compared with 4.25 2.62 months for those not using ABT (P < 0.0001). Average medication possession ratio was 0.43 0.20 for women receiving NA-based ABT versus 0.32 0.18 for those not receiving any ABT (P < 0.0001). Patients < 30 years of age were most likely to continue therapy longer and have greater compliance compared with the older age group cohorts (P < 0.01). Patients who used ABT continued to do so for 3.79 3.21 months.
Limitations:
Limitations of this study include those associated with the use of retrospective claims databases: It does not include any information regarding the patient&CloseCurlyQuote;s pain symptoms, disease severity, or other factors, which could correlate to compliance and persistence.
Conclusions:
Among women using LA therapy for endometriosis, only 32% used any type of ABT, and these patients had significantly higher persistence and compliance with LA therapy compared to no ABT user group.