title: 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.
authors.affiliation: a Health Economics and Outcomes Research, Abbvie , North Chicago , IL , USA ;
authors.forename: Ahmed M
authors.initials: AM
authors.lastname: Soliman
authors.affiliation: b Truven Health Analytics , Ann Arbor , MI , USA ;
authors.forename: Machaon
authors.initials: M
authors.lastname: Bonafede
authors.affiliation: b Truven Health Analytics , Ann Arbor , MI , USA ;
authors.forename: Amanda M
authors.initials: AM
authors.lastname: Farr
authors.affiliation: a Health Economics and Outcomes Research, Abbvie , North Chicago , IL , USA ;
authors.forename: Jane
authors.initials: J
authors.lastname: Castelli-Haley
authors.affiliation: c Georgetown University School of Medicine , Washington , DC , USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Winkel
mesh_terms: D000293:Adolescent; D000328:Adult; D004715:Endometriosis / Q000188:drug therapy / Q000601:surgery*; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods; D010535:Laparoscopy / Q000379:methods*; D007813:Laparotomy / Q000379:methods*; D016729:Leuprolide / Q000008:administration & dosage*; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016729:Leuprolide
keywords: Adherence; Endometriosis; Laparoscopy; Leuprolide acetate; Recurrence; Surgery