Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix
| Autor: | David F. Archer, Sanjay K. Agarwal, Keith Gordon, Eric S. Surrey, Yabing Mai, Sukhbir S. Singh, Kristof Chwalisz |
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| Rok vydání: | 2020 |
| Předmět: |
endometriosis
medicine.medical_specialty Clinical Trials and Supportive Activities Clinical Sciences Endometriosis Reproductive health and childbirth Placebo dysmenorrhea Placebo group Electronic diary 03 medical and health sciences 0302 clinical medicine 030202 anesthesiology Clinical Research Internal medicine Post-hoc analysis medicine Journal of Pain Research Original Research business.industry Pelvic pain Contraception/Reproduction Pain Research Evaluation of treatments and therapeutic interventions Pharmacology and Pharmaceutical Sciences medicine.disease bleeding elagolix Clinical trial Anesthesiology and Pain Medicine Pain reduction 6.1 Pharmaceuticals medicine.symptom Chronic Pain business 030217 neurology & neurosurgery nonmenstrual pelvic pain |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| Popis: | Sanjay K Agarwal,1 Sukhbir S Singh,2 David F Archer,3 Yabing Mai,4 Kristof Chwalisz,5 Keith Gordon,6 Eric Surrey7 1Department of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, La Jolla, CA, USA; 2Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; 3Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, USA; 4 Statistics, AbbVie Inc, North Chicago, IL, USA; 5Clinical Development, AbbVie Inc, North Chicago, IL, USA; 6Medical Affairs, AbbVie Inc, North Chicago, IL, USA; 7Colorado Center for Reproductive Medicine, Lone Tree, CO, USACorrespondence: Sanjay K AgarwalDepartment of Obstetrics and Gynecology and Reproductive Sciences, Center for Endometriosis Research and Treatment, UC San Diego, 9500 Gilman Drive, #0633, La Jolla, CA, USATel +1 (858) 534-8930Email skagarwal@ucsd.eduObjective: In this post hoc analysis, we evaluated the impact of elagolix on dysmenorrhea and nonmenstrual pelvic pain across menstrual period (bleeding days) and nonmenstrual (nonbleeding) days.Methods: Data from two randomized, 6-month, placebo-controlled trials (Elaris Endometriosis (EM)-I and EM-II) of elagolix (150 mg once daily (QD) and 200 mg twice daily (BID)) in premenopausal women with moderate to severe endometriosis-associated pain (N = 1686) were pooled. Women recorded the presence of menstrual period and severity of dysmenorrhea or nonmenstrual pelvic pain in a daily electronic diary.Results: At baseline, women in the placebo group and both elagolix treatment groups reported moderate or severe dysmenorrhea, on average, 81% of their menstrual period days and moderate/severe nonmenstrual pelvic pain, on average, 56% of their nonmenstrual (nonbleeding) days. Compared with placebo at month 6, elagolix-treated women had a significantly lower mean (standard deviation (SD)) percentage of menstrual period days with moderate or severe dysmenorrhea (elagolix 150 mg QD = 52.4 (38.9), p = 0.002; elagolix 200 mg BID = 38.5 (43.6), p < 0.001, placebo = 61.3 (33.7)) and a significantly lower mean (SD) percentage of nonmenstrual (nonbleeding) days with moderate or severe nonmenstrual pelvic pain (elagolix 150 mg QD = 31.1 (35.8), p < 0.001; elagolix 200 mg BID = 19.7 (29.9), p < 0.001; placebo = 35.6 (33.9)).Conclusion: Following 6 months of elagolix treatment, women who still menstruated had a lower proportion of menstrual period days with moderate or severe dysmenorrhea compared with placebo, demonstrating pain reduction despite continued menses. Additionally, pain did not shift from dysmenorrhea to nonmenstrual pelvic pain, as the percentage of days with moderate or severe nonmenstrual pelvic pain was also reduced for elagolix-treated women compared with placebo.Trial Registration: The Elaris EM-I study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01620528. The Elaris EM-II study is registered with the US National Library of Medicine, www.ClinicalTrials.gov, NCT01931670. Both studies are registered with the EU Clinical Trial Register, www.clinicaltrialsregister.ed, 2011-004295-11.Keywords: bleeding, dysmenorrhea, elagolix, endometriosis, nonmenstrual pelvic pain |
| Databáze: | OpenAIRE |
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