The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China

Libo Zhu, Zheng Guan, Yan Huang, Keqin Hua, Liguo Ma, Jian Zhang, Dazhen Yang, Valerie Perrot, Hongbo Li, Xinmei Zhang, Libo Zhu, Zheng Guan, Yan Huang, Keqin Hua, Liguo Ma, Jian Zhang, Dazhen Yang, Valerie Perrot, Hongbo Li, Xinmei Zhang

Abstract

Triptorelin is one of the most commonly used gonadotropin-releasing hormone agonists and has been used in the treatment of deep infiltrating endometriosis (DIE). This study aimed to evaluate the efficacy and safety of up to 24 weeks of triptorelin treatment after conservative surgery for DIE.This prospective, non-interventional study was performed in 18 tertiary hospitals in China. Premenopausal women aged ≥18 years treated with triptorelin 3.75 mg once every 28 days for up to 24 weeks after conservative surgery for DIE were included. Endometriosis symptoms were assessed, using a visual analogue scale (0-10 cm) or numerical range (0-10), at baseline (pre-surgery) and routine visits 3, 6, 9, 12, 18, and 24 months after surgery. Changes in symptom intensity over time were primary outcome measures.A total of 384 women (mean [standard deviation] age, 33.4 [6.2] years) were analyzed. Scores for all symptoms (pelvic pain, dysmenorrhea, ovulation pain, dyspareunia, menorrhagia, metrorrhagia, and gastrointestinal and urinary symptoms) assessed decreased from baseline over 24 months. Cumulative improvement rates in pelvic pain, dysmenorrhoa, ovulation pain, and dyspareunia were 74.4%, 83.6%, 55.1%, and 66.9%, respectively. The 24-month cumulative recurrence rate (≥1 symptom) was 22.2%. The risk of symptom recurrence was higher in patients with ≥2 versus 1 lesion (odds ratio [OR] 2.539; 95% CI: 1.458-4.423; P = .001) and patients with moderate (OR 5.733; 95% CI: 1.623-20.248; P = .007) or severe (OR 8.259; 95% CI: 2.449-27.851; P = .001) pain versus none/mild pain. Triptorelin was well tolerated without serious adverse events.Triptorelin after conservative surgery for DIE improved symptoms over 24 months of follow up. The recurrence rate of symptoms was low and triptorelin was generally well tolerated.Trial registration number: ClinicalTrials.gov, NCT01942369.

Conflict of interest statement

The authors have no conflicts of interests to disclose.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Figure 1
Figure 1
Flow diagram of study population.
Figure 2
Figure 2
Changes in the intensity of endometriosis symptoms over time. A visual analogue scale (VAS) or a numerical scale was used to evaluate pain or other symptoms, respectively. A score of 0 indicated that the patient was free of pain or other symptoms while 10 indicated the pain or symptoms were severe and intolerable. Mean scores and standard deviations of symptom intensities against time are presented.
Figure 3
Figure 3
Changes in the proportions of patients with different intensities of endometriosis symptoms over time. Cumulative proportion of patients with different symptom intensities are shown against time. A VAS or numerical score ≥7 was considered as severe, a score of >3 and 0 and ≤3 as mild.

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