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

Mahesh Fuldeore, Mahesh J Fuldeore, Fuldeore MJ, Steven E. Marx, Marx SE, Kristof Chwalisz, Chwalisz K, Kristof Chwalisż, Smeeding JE, James E. Smeeding, Brook RA, Richard A. Brook
Current medical research and opinion · 2010 · vol. 26(3) , pp. 729–736 · doi:10.1185/03007990903582985 · PMID:20092387 · W2079537586
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This retrospective study found that women with endometriosis using leuprolide acetate (LA) who also took add-back therapy (ABT), particularly norethindrone acetate, showed significantly higher persistence and compliance with LA compared to those not using ABT.

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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'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.

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Condition tags

endometriosis

MeSH descriptors

Contraceptives, Oral, Synthetic Databases, Factual Endometriosis Leuprolide Norethindrone Patient Compliance Adult Contraceptives, Oral, Synthetic Contraceptives, Oral, Synthetic Endometriosis Estrogens Estrogens Estrogens Female Gonadotropin-Releasing Hormone Gonadotropin-Releasing Hormone Gonadotropin-Releasing Hormone Humans Leuprolide Leuprolide

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

References (12)

Cited by (15)

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