Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial

Abstract

background: Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis. The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate (LA) for treating the pain associated with endometriosis. methods:Patients with confirmed endometriosis were randomized to treatment with dienogest (2 mg/day, orally) or LA (3.75 mg, depot i.m. injection, every 4 weeks) for 24 weeks. The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment, assessed by visual analogue scale (VAS). Safety variables included adverse event profile, laboratory parameters, bone mineral density (BMD), bone markers and bleeding patterns.results: A total of 252 women were randomized to treatment with dienogest (n ¼ 124) or LA (n ¼ 128); 87.9 and 93.8% of the respective groups completed the trial. Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA, demonstrating the equivalence of dienogest relative to LA. Hypoestrogenic effects (e.g. hot flushes) were reported less frequently in the dienogest group. As expected, bleeding episodes were suppressed less with dienogest than with LA. Changes in mean lumbar BMD between screening and final visit were þ0.25% with dienogest and -4.04% with LA subgroups (P ¼ 0.0003). Markers of bone resorption increased with LA but not dienogest.conclusions: Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at standard dose in relieving the pain associated with endometriosis, although offering advantages in safety and tolerability.

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

“…Напри-мер, средний уровень общего холестерина увеличился на 0,10±0,93 ммоль/л в группе диеногеста и снизился на 0,01±0,87 ммоль/л в группе плацебо, тогда как средний уровень триглицеридов увеличился на 0,14±0,53 и на 0,07±0,48 ммоль/л соответственно [47].…”

Sequential Management with Gonadotropin-Releasing Hormone Agonist and Dienogest of Endometriosis-Associated Uterine Myoma and Adenomyosis

“…Previous trials demonstrated that dienogest provides effective reductions in endometriosis-associated pelvic pain and laparoscopic measures of pathology (Harada et al, 2009;Köhler et al, 2010;Schindler et al, 2006;Strowitzki et al, 2010b). Recently, the new progesterone 2 mg daily demonstrated equivalent efficacy to GnRHa (e.g.…”

Is endometriosis a benign disease? Modern controversial aspects of endometriosis-associated ovarian tumors

“…В исследованиях длительностью от 16 до 24 нед, сравнивающих прием диеногеста вместе с аГнРГ у пациенток с эндометри-озом, получены сопоставимые результаты по сниже-нию интенсивности боли по баллам и по классифи-кации эндометриоза Американского Общества Фер-тильности (rAFS) при повторной лапароскопии [58][59][60][61][62].…”