Analysis of subsequent surgery rates among endometriosis patients who underwent surgery with and without concomitant leuprolide acetate therapy

Abstract

Objective To compare subsequent endometriosis-related surgery following initial laparoscopy among women treated with leuprolide acetate (LA) or other endometriosis therapies versus women who received no pharmacotherapy.

Research design and methods This retrospective cohort analysis utilized MarketScan Commercial claims data. Women with endometriosis aged 18–49 who underwent laparoscopy between 1 January 2005 and 31 December 2011 were identified using diagnosis and procedures codes and were categorized into four cohorts based on claims within 90 days of laparoscopy: surgery plus adherent LA, surgery plus non-adherent LA, surgery plus other therapy, and surgery alone. Patients with proportion of days covered ≥0.80 in the 6 months after laparoscopy were considered adherent to LA.

Main outcome measures Subsequent endometriosis-related surgery (laparoscopy, laparotomy or other excision/ablation/fulguration of endometriosis lesions, oophorectomy, or hysterectomy) was measured in the 6 and 12 months following initial laparoscopy. Risk of subsequent surgery was compared using multivariable Cox proportional hazards modeling.

Results Most women were treated with surgery only (n = 9865); fewer were treated with LA (adherent: n = 202; non-adherent: n = 490) or other therapies (n = 230). The proportion of patients with subsequent surgery ranged from 2.0% to 10.0% during the 6 month follow-up (12 month: 9.7% to 13.5%). Adherent LA use was associated with significantly lower risk of surgery compared to surgery alone (hazard ratio [HR] = 0.31, p = 0.020) while use of other therapies was associated with significantly higher risk (HR = 1.51, p = 0.045) over the 6 month follow-up. There was no significant difference between the surgery plus non-adherent LA and surgery only cohort over 6 months (p = 0.247). The association between adherent LA and subsequent surgery was not significant over the 12 month follow-up.

Conclusion Therapy with LA after laparoscopy for endometriosis was associated with lower risk of subsequent surgery at 6 months among women who were adherent to LA. Key limitations include lack of ability to capture disease severity which may have resulted in uncontrolled confounding.

Keywords:

• Adherence
• Endometriosis
• Laparoscopy
• Leuprolide acetate
• Recurrence
• Surgery

Declaration of funding

This study was funded by AbbVie which also markets the endometriosis drugs Lupron® and Lupaneta Pack™. The design and financial support for the study was provided by AbbVie. AbbVie participated in data analysis, interpretation of data, review, and approval of the manuscript. AbbVie funded medical writing services provided by Truven Health Analytics.

Declaration of financial/other relationships

A.M.S. and J.C.-H. have disclosed that they are employees of AbbVie and may own AbbVie stock or stock options. M.B. and A.M.F. have disclosed that they are employees of Truven Health Analytics which has received consultancy fees from AbbVie. C.W. has disclosed that he is a Clinical Professor at the Department Obstetrics and Gynecology at Georgetown University in Washington DC and has served in a consulting role on research to AbbVie for this project.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing and editorial services for this manuscript was provided by Santosh Tiwari, an employee of Truven Health Analytics.

Previous presentation: Portions of this work will be presented as a poster at the Society for Reproductive Investigation 63rd Annual Scientific Meeting to be held on 16–19 March 2016 in Montreal, Canada.

Notes

*Eligard is a registered trade name of Tolmar Pharmaceuticals

†Viadur is a registered trade name of Bayer Pharmaceuticals Corporation