Abstract

Abstract Study question Are there differences in patient’s social demographic, clinical and treatment characteristics among patients diagnosed with HMB and/or UF? Summary answer Baseline characteristics were similar across all UF-status defined-groups. Differences were observed in education, net-worth and 12-monthfollow-up characteristics. Nearly 60% were prescribed pain meds pre-diagnosis. What is known already Uterine leiomyomas (or fibroids) are benign neoplasm that affect women of reproductive age1. In the US, treatment for UF is individualized, dependent on size and location of the fibroids, patient profile, symptom severity and type of diagnosis. Patients may be diagnosed with HMB before UF (HMB-UF), diagnosed with UF first and then HMB (UF-HMB), diagnosed with only HMB (HMB-Only) or UF only (UF-Only). Previous studies indicated that the majority (70%) of women received no prescription medications regardless of surgery status and 40% had pain at time of diagnosis.2,3 Study design, size, duration Our retrospective real-world observational study included 295,400 women across four cohorts between 10/1/2012 -12/31/2020. The majority (96,961; 44%) had HMB-Only, 46,763 (21%) UF-Only, 35,421 (16%) HMB-UF, and 40,806 (19%) UF-HMB. Patients required 12 months continuous enrollment before index date (earlier of HMB or UF diagnosis date based on cohorts) and 12-months of follow-up unless hysterectomy was observed before 12 months. Surgical and pharmacologic agents explored were based on ACOG guidelines for UF. Participants/materials, setting, methods Optum® Socio-Economic Status claims database was used to identify newly diagnosed women 18-55 years old with UF and/or HMB claims, without history of conservative/radical surgery or non-dermatological cancers. Descriptive analyses were performed for patients’ social demographics and treatment characteristics during pre- and post-index period. Main results and the role of chance Across all cohorts, During the 12-month follow-up, nearly 80% of patients used at least 1 prescribed pain medication compared to nearly 60% at baseline. The increase in pain medication use was mainly driven by increase in NSAIDs, opioids, analgesics, and anti-migraine in all cohorts except HMB-O (Opioids: baseline 24-30% to follow up 41-55%; NSAIDs: 20-21% to 44-53%; analgesics: 6-8% to 19%-33%; anti-migraine: 8-11% to 16-29%). Limitations, reasons for caution True incidence of index claims are difficult to estimate. Over-the-counters medications or claims made outside the study period are not captured. Pain medication may be unrelated to UF-associated pain. Findings only reflect the commercially insured population and may not be generalizable. Claims data provide limited clinical profile and prescribing rationales. Wider implications of the findings The majority of the patients in these cohorts experienced pain and were prescribed opioids. Determining the link between the use of pain medication and symptoms of UF and HMB is important, as pain medications do not address HMB. Trial registration number Not applicable

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