Efficacy and acceptability of long-term norethindrone acetate for the treatment of rectovaginal endometriosis

Morotti, Matteo; Venturini, Pier Luigi; Biscaldi, Ennio; Racca, A.; Calanni, Luana; Vellone, Valerio Gaetano; Stabilini, Cesare; Ferrero, Simone

doi:10.1016/j.ejogrb.2017.03.033

Cited by 31 publications

(19 citation statements)

References 31 publications

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“…It has been previously reported that hormonal therapies can decrease the size of deep endometriotic nodules [18,30]; however, it seems that there is no direct correlation between improvement of symptoms and decrease in nodule volume [30]. In our study, at the end of follow-up visits under DNG therapy, a mean nodule volume reduction of at least 10% was reported by around 30% of women.…”

Section: Discussioncontrasting

confidence: 68%

Long-Term Administration of Dienogest for the Treatment of Pain and Intestinal Symptoms in Patients with Rectosigmoid Endometriosis

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Scala

Maggiore

et al. 2020

JCM

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Background: Rectosigmoid endometriosis is a severe form of deep endometriosis, which may be responsible for pain symptoms and a wide range of intestinal complains such as diarrhea, constipation, and abdominal cramping. The primary objective of this study was to evaluate the efficacy of long-term therapy with dienogest (DNG), a fourth-generation progestin, for ameliorating quality of life, pain, and intestinal symptoms of patients affected by rectosigmoid endometriosis. Methods: A retrospective analysis of a prospectively collected database was done on patients with endometriotic nodules infiltrating at least the muscular layer of the rectosigmoid wall with an estimated colorectal stenosis <60%. The diagnosis of rectosigmoid endometriosis was based on transvaginal ultrasonography. Patients accepting to participate in the study received continuous oral treatment with DNG at the dose of 2 mg/day. Results: At the end of the first year of treatment, a significant decrease in dysmenorrhea (P < 0.001), chronic pelvic pain (P < 0.001), dyspareunia (P < 0.001), dyschezia (P < 0.001), and in intestinal symptoms (P < 0.001) was observed. A progressive increase of the Endometriosis Health Profile-30 (EHP-30) and Gastrointestinal Quality of Life Index (GIQLI) scores was observed in the first two years of therapy (P < 0.001 and P < 0.001, respectively). Improvements of patients’ symptoms and quality of life were maintained until the end of the study. The regimen was well tolerated, and the frequency and amount of irregular bleeding decreased as treatment progressed. Conclusion: The current study confirms the efficacy of long-term therapy with DNG for treating symptoms caused by rectosigmoid endometriosis.

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Section: Discussioncontrasting

confidence: 68%

Long-Term Administration of Dienogest for the Treatment of Pain and Intestinal Symptoms in Patients with Rectosigmoid Endometriosis

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Scala

Maggiore

et al. 2020

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“…Oral NETA, at the dose of 2.5 to 5 mg per day, has been repeatedly assessed in observational studies and a RCT [21,[69][70][71][72][73][74][75][76]. In particular, NETA was demonstrated effective in patients with deep dyspareunia and rectovaginal lesions [73,74].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Medical treatment of endometriosis-related pain

Vercellini

Buggio

Frattaruolo

et al. 2018

Best Practice & Research Clinical Obstetrics & Gynaecol

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Available medical treatments for symptomatic endometriosis act by inhibiting ovulation, reducing serum oestradiol levels, and suppressing uterine blood flows. For this, several drugs can be used with a similar magnitude of effect, in terms of pain relief, independently of the mechanism of action. Conversely, safety, tolerability, and cost differ. Medications for endometriosis can be categorized into low-cost drugs including oral contraceptives (OCs) and most progestogens, and high-cost drugs including dienogest and GnRH agonists. As the individual response to different drugs is variable, a stepwise approach is suggested, starting with OCs or low-cost progestogens, and stepping up to high-cost drugs only in case of inefficacy or intolerance. OCs may be used in women with dysmenorrhea as their main complaint, and when only superficial peritoneal implants or ovarian endometriomas <5 cm are present, while progestogens should be preferred in women with severe deep dyspareunia and when infiltrating lesions are identified.

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“…For these reasons, unlike most other progestins, NETA has some estrogenic activity, which may be responsible for a positive effect on BMD. NETA is efficacious in the longterm control of endometriosis-related pain [37]; however, being not able to induce a significant regression of implants, it does not represent a definitive curative treatment for this disease.…”

Section: Expert Opinionmentioning

confidence: 99%

“…ENG is initially slowly released from the subdermal implant at 60-70 mcg/day, decreasing to[35][36][37][38][39][40][41][42][43][44][45] mcg/day at the end of the first year, to 30-40 mcg/day at the end of the second year, and then to 25-30 mcg/day at the end of the third year. After 4 days from the application of the implant, ENG achieves the C max of 813 pg/ml.…”

mentioning

confidence: 99%

Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis

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Scala

Ferrero

2018

Expert Opinion on Drug Metabolism & Toxicology

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Endometriosis is a chronic estrogen and progestogen responsive inflammatory disease associated with pain symptoms and infertility. The medical therapy of endometriosis aims to induce decidualization within the hormonally dependent ectopic endometrium, and it is often administered to ameliorate women' pain symptoms or to prevent post-surgical disease recurrence. A variety of progestins have been used in monotherapy for the medical management of women with endometriosis. Areas covered: This review aims to offer the reader a complete overview of pharmacokinetic (PK) and clinical efficacy of progestins for the treatment of endometriosis. Expert opinion: Each progestin has a distinct PK parameters and pharmacodynamics affinity not only for progesterone receptor, but also for other steroid receptors, such as estrogen, androgen, and glucocorticoid. Moreover, progestins can also be delivered in different formulations. All these characteristics influence their final biological effect. Randomized, controlled, non-blinded studies support the use of oral progestin-only treatment for pelvic pain associated with endometriosis. Currently, the only two progestins approved by Food and Drug Administration (FDA) for the treatment of endometriosis are norethindrone acetate (NETA) and depot medroxyprogesterone acetate (DMPA).

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Efficacy and acceptability of long-term norethindrone acetate for the treatment of rectovaginal endometriosis

Cited by 31 publications

References 31 publications

Long-Term Administration of Dienogest for the Treatment of Pain and Intestinal Symptoms in Patients with Rectosigmoid Endometriosis

Long-Term Administration of Dienogest for the Treatment of Pain and Intestinal Symptoms in Patients with Rectosigmoid Endometriosis

Medical treatment of endometriosis-related pain

Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis

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