Document Detail

Add-back therapy use and its impact on LA persistence in patients with endometriosis.
MedLine Citation:
PMID:  20092387     Owner:  NLM     Status:  MEDLINE    
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.
Mahesh J Fuldeore; Steven E Marx; Kristof Chwalisz; James E Smeeding; Richard A Brook
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Current medical research and opinion     Volume:  26     ISSN:  1473-4877     ISO Abbreviation:  Curr Med Res Opin     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-15     Completed Date:  2010-05-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0351014     Medline TA:  Curr Med Res Opin     Country:  England    
Other Details:
Languages:  eng     Pagination:  729-36     Citation Subset:  IM    
Abbott Laboratories, Abbott Park, IL, USA.
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MeSH Terms
Contraceptives, Oral, Synthetic / administration & dosage*,  adverse effects
Databases, Factual*
Endometriosis / drug therapy*
Estrogens / administration & dosage,  adverse effects
Gonadotropin-Releasing Hormone / administration & dosage,  adverse effects
Leuprolide / administration & dosage*,  adverse effects
Middle Aged
Norethindrone / administration & dosage,  adverse effects,  analogs & derivatives*
Patient Compliance*
Progesterone Congeners / administration & dosage,  adverse effects
Retrospective Studies
Reg. No./Substance:
0/Contraceptives, Oral, Synthetic; 0/Estrogens; 0/Progesterone Congeners; 33515-09-2/Gonadotropin-Releasing Hormone; 38673-38-0/norethindrone acetate; 53714-56-0/Leuprolide; 68-22-4/Norethindrone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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