Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

Harada, Tasuku; Momoeda, Mikio; Taketani, Yuji; Asô, Takeshi; Fukunaga, Masao; Hagino, Hiroshi; Terakawa, Naoki

doi:10.1016/j.fertnstert.2007.12.080

Cited by 213 publications

(196 citation statements)

References 16 publications

(32 reference statements)

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“…The outcomes from this study support previous studies which investigated the efficacy of dienogest in relieving symptoms of endometriosis (Cosson et al, 2002;Schindler et al, 2006;Momoeda and Taketani, 2007;Seitz et al, 2008;Harada et al, 2009;Kö hler et al, 2010). In a phase II dose-finding study, dienogest 2 mg daily offered improvements in patient-reported symptoms and in second-look laparoscopic assessments of pathology after 24 weeks.…”

Section: Discussionsupporting

confidence: 85%

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

et al. 2010

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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.

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Section: Discussionsupporting

confidence: 85%

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

et al. 2010

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“…Эффективность и безопасность диеногеста в сравнении с лейпрорелином, бусерелином и трипто-релином изучались в трех рандомизированных кли-нических испытаниях (РКИ) [8,11,12]. Во всех трех исследованиях диеногест в дозе 2 мг/сут обладал сходной эффективностью с аГнРГ по снижению вы-раженности симптомов.…”

Section: анализ сведений об эффективности диеногеста в сравнении с агunclassified

“…Диеногест -пероральный прогестаген, который исследовался в различных дозировках в длительных клинических исследованиях в сравнении с плацебо и активными препаратами в Европе и Японии [8][9][10][11][12]. Препарат показал высокую эффективность и без-опасность, был одобрен в качестве монотерапии для лечения эндометриоза в странах Европы, Японии, Австралии, Сингапуре и др., рекомендован россий-скими клиническими рекомендациями по лечению эндометриоза [5,13].…”

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Comparative pharmacoeconomic evaluation of the use of specific drug treatment for endometriosis

Avxentyeva¹,

Андреева²

2016

Probl. reprod.

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Цель исследования -сравнительная фармакоэкономическая оценка применения диеногеста в сравнении с агонистами гонадотропин-рилизинг-гормона (аГнРГ) для специфического медикаментозного лечения эндометриоза. Материал и методы. Фармакоэкономическое обоснование применения диеногеста в настоящем исследовании было выполнено методом минимизации затрат. Рассчитана разница в затратах на лечение эндометриоза у одного пациента в течение 6 мес с применением диеногеста в сравнении с дидрогестероном и аГнРГ (лейпрорелин, трипторелин, бусерелин, гозерелин) с терапией прикрытия (комбинация дроспиренона и эстрадиола). источником информации о ценах на лекарственные препараты послужили средние отпускные цены из аптек в России за июль 2015 г. из базы данных ims Health. Проведен анализ чувствительности результатов расчетов к колебаниям значений цен на препараты. результаты. Затраты на лечение одной пациентки с эндометриозом в течение 6 мес составили 54 864 руб. для лейпрорелина, 55 398 руб. для трипторелина, 28 794 руб. для бусерелина, 58 926 руб. для гозерелина, 18 540 руб. для дидрогестерона и 14 201 руб. для диеногеста. По результатам расчетов диеногест оказался наиболее экономичным препаратом для лечения эндометриоза. Анализ чувствительности показал, что полученные результаты являются устойчивыми к изменению цен на исследованные препараты. Заключение. использование диеногеста для лечения эндометриоза так же эффективно, как использование аГнРГ, и может привести к значительному снижению издержек. В сравнении с дидрогестероном диеногест не только более эффективен, но и приводит к экономии. Таким образом, более широкое использование диеногеста для лечения эндометриоза в России может привести к значительной экономии бюджета здравоохранения. Ключевые слова: эндометриоз, агонисты гонадотропин-рилизинг-гормона (аГнРГ), диеногест, анализ минимизации затрат. Comparative pharmacoeconomic evaluation of the use of specific drug treatment for endometriosisProf. m.V. AVxentYeVA 1 , Prof. e.n. AnDReeVA Objective. to evaluate the use of dienogest for specific therapeutic treatment of endometriosis in comparison with dydrogesterone and gonadotropin-releasing hormone (GnRH) agonists. Material and methods. this pharmacoeconomic evaluation of dienogest use was performed by using cost-minimization analysis. six-month treatment costs were calculated for treatment of endometriosis with dienogest, dydrogesterone and GnRH agonists (leuprorelin, triptorelin, buserelin and goserelin) with add-back therapy (drospirenone and estradiol). Costs were calculated for a period of 6 months. Average prices for evaluated alternatives were taken from ims Health retail report (july 2015). one way sensitivity analysis was conducted for assessment of how fluctuations in drug prices can influence on final calculations. Results. the costs of endometriosis treatment per patient for six months were 54 864 rub for leuprorelin, 55 398 rub for triptorelin, 28 794 rub for buserelin, 58 926 rub for goserelin, 18 540 rub for dydrogesterone and 14 201 rub for dienogest. Dienogest is ...

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“…Thus, dienogest suppresses growth and inflammation of lesions. Dienogest is therefore expected to reduce pain and induce diminishment and atrophy of lesions in patients with endometriosis through suppression of ovarian function and direct suppression of endometriosis cell proliferation, with its effect in inducing atrophy of lesions having been reported to be comparable to that of GnRHa and danazol (9,10). Dienogest is superior to GnRHa and danazol in terms of lack of restrictions on dosing period, milder adverse reactions and lower risk for thrombosis, thus providing a valid means of treating endometriosis which required long-term control of menstruation.…”

Section: Dienogest a New Progestinmentioning

confidence: 99%

Progestin therapy for endometrial cancer: The potential of fourth-generation progestin (Review)

et al. 2012

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Abstract. Progestin preparations are made of synthetic progesterone and have often been used for hormone therapy in gynecological patients with endometriosis or endometrial cancer. Hormone therapy using progestin is considered to be one of the effective means of treatment particularly when dealing with endometrial cancer (an estrogen-dependent tumor). Numerous reports have been published concerning its efficacy in advanced or recurrent cases of atypical endometrial hyperplasia or endometrial cancer. Dienogest has been developed as a fourth-generation progestin for hormone therapy for endometriosis that can be used with high safety for long periods of time. In Japan, dienogest has been recommended as a first-line drug for endometriosis-associated pain. However, its antitumor activity has also been attracting close attention following a report that this drug suppressed the proliferation in vitro of endometrial cancer-derived cell lines which failed to respond to other progestins such as medroxyprogesterine acetate (MPA). The mechanism for antitumor activity of dienogest is considered to differ from the mechanism for antitumor activity of conventional progestin preparations used for treatment of endometrial cancer. This drug is expected to be clinically applicable as a new drug for the treatment of endometrial cancer. Contents

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Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis—a randomized, double-blind, multicenter, controlled trial

Cited by 213 publications

References 16 publications

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

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

Comparative pharmacoeconomic evaluation of the use of specific drug treatment for endometriosis

Progestin therapy for endometrial cancer: The potential of fourth-generation progestin (Review)

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