Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment

Abstract

PurposeTo investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who had previously completed a 12-week, placebo-controlled study of dienogest, who participated in an open-label extension study for up to 53 weeks. Thereafter, a patient subgroup was evaluated in a 24-week follow-up after treatment discontinuation.MethodsA multicenter study performed in Germany, Italy and Ukraine. Women with endometriosis were enrolled at completion of the placebo-controlled study (n = 168). All women received dienogest (2 mg once daily, orally) and changes in pelvic pain (on a visual analog scale), bleeding pattern, adverse events and laboratory parameters were evaluated during and after treatment.ResultsThe completion rate among women who entered the open-label extension study was 90.5% (n = 152). A significant decrease in pelvic pain was shown during continued dienogest treatment (P < 0.001). The mean frequency and intensity of bleeding progressively decreased. Adverse events, rated generally mild or moderate, led to withdrawal in four patients (2.4%). No clinically relevant changes in laboratory parameters were observed. During treatment-free follow-up (n = 34), the reduction in pelvic pain persisted, while bleeding frequency and intensity returned to normal patterns.ConclusionsLong-term dienogest showed a favorable efficacy and safety profile, with progressive decreases in pain and bleeding irregularities during continued treatment; the decrease of pelvic pain persisted for at least 24 weeks after treatment cessation.

Oral contraceptives in the prevention of endometrioma recurrence: does the different progestins used make a difference?

“…In a recent multi-centre study, a multiphasic OC with dienogest was considered to be very active in reducing endometriosis pain over the long term; i.e., for at least 24 weeks after discontinuation of treatment [22].…”

“…For these reasons, oral contraceptives (OCs) have been widely used in many countries to treat the most common symptoms of endometriosis [22].…”

The experience of Visanne use in patients of reproductive age with external genital endometriosis

“…Даже при применении диеногеста в высокой дозе (20 мг/сут) плазменный уровень липидов оста-вался в пределах нормальных референтных значений в течение 24 нед лечения [36]. В исследованиях по препарату Визанна, включающее плацебо-контро-лируемое [46] исследование с использованием пре-парата сравнения лейпрорелина ацетата [46] и дол-госрочное продленное исследование [38], было под-тверждено отсутствие значимого влияния диеногеста на уровень липидов.…”

“…Например, средний уровень общего хо-лестерина снизился на 0,05±0,93 ммоль/л, а средний уровень триглицеридов увеличился на 0,03±0,57 ммоль/л [38].…”

“…Согласно имеющейся информации, после отме-ны терапии препаратом Визанна функция яичников и нормальные менструации быстро восстанавлива-ются; имели место случаи наступления беременно-сти вскоре после отмены лечения, в том числе у жен-щин с бесплодием в анамнезе [38,39]. Кроме того, восстановление репродуктивной функции и насту-пление беременности также наблюдалось у женщин с эндометриозом и ранее имевшимся бесплодием, которые получали диеногест в дозе 1 мг 2 раза в сутки после лапароскопии [40].…”