Estradiol valerate 2mg / Dienogest 2mg tablets

Background and objectiveEndometriosis and adenomyosis are two common diseases that impair women's health, and dienogest is one of the pharmacologic treatments which is the first-line therapeutic option for patients with pelvic pain and individuals who have no desire for immediate pregnancy. The goal of this study was to summarize the current evidence of adverse events associated with dienogest as well as the prevalence of these adverse events during treatment with dienogest.MethodsSeveral databases (PubMed, Embase, Cochrane Central and Clinicaltrials.gov, etc.) and the US FDA Adverse Event Reporting System (FAERS) Public Dashboard were searched on May 31, 2023, using the topic words alongside free words of dienogest and "adverse reaction". Studies were incorporated into this research if they reported or assessed safety issues or adverse reactions of dienogest during the period of endometriosis treatment or adenomyosis therapy. The extracted information comprised trial design, dienogest and control group demographics, as well as reported side effects.ResultsThis systematic review comprehended 39 publications in total. The mean age of patients in the included studies was 34.43 years. The follow-up duration varied from 3 to 60 months. Most adverse reactions were common and not serious, and the most common adverse reactions during dienogest medication were abnormal uterine bleeding (55%, 95% CI 37-73%), amenorrhea (17%, 95% CI 2-42%) and swelling (13%, 95% CI 3-28%). Uncommon adverse reactions included dysmenorrhea (0.2%, n = 1), dyspepsia (0.4%, n = 1), and (lower) abdominal pain (1%, 95% CI 0-3%), urticaria (1%, 95% CI 0-3%) and peritonitis (1%, n = 1). Serious adverse reactions including decreased lumbar spine Bone Mineral Density (BMD), depression, peritonitis and so on have been reported. Heterogeneity assessment revealed that patient number and study design are influencing factors to adverse reaction prevalence. Moreover, abdominal pain, diarrhea, nausea and vomiting, back pain and anemia are side effects reported both in the FAERS database and in the systematic review.ConclusionsDienogest's most frequent side effects were not severe. Dienogest is generally safe for treating endometriosis and adenomyosis. Nevertheless, people should be aware of serious adverse reactions, such as decreased lumbar spine BMD and hemorrhagic shock.

Abstract licence: CC BY-NC-ND

Background/Objectives: Adenomyosis is a benign condition characterized by the presence of endometrial tissue within the myometrium. Despite surgery being a valuable approach, medical options are considered as the first-line approach and have been investigated in the treatment of adenomyosis, although strong evidence in favor of these is still lacking. This study aims to gather all available data and determine the effectiveness of the aforementioned medical options in patients with associated pain and not currently seeking pregnancy, both in comparison to placebo and to one another. Methods: For this study, PubMed and EMBASE were used as data sources, searched up to January 2024. A systematic review and meta-analysis were performed in accordance to guidelines from the Cochrane Collaboration. The primary outcomes investigated were changes in dysmenorrhea, quantified by means of VAS scores, HMB in terms of number of bleeding days, and changes in uterine volume determined at ultrasound. Twelve eligible studies were selected. Results: The results highlighted that dienogest yields a reduction in dysmenorrhea that is significantly superior to that of the rest of the medical treatments investigated (p-value of p-value of 0.003). While it was not possible to determine which medical treatment better decreased the number of bleeding days, it was observed that COC performed significantly worse than the other treatments studied (p-value of 0.02). Conclusions: While this meta-analysis provides valuable insights in the comparative efficacy of different treatments, the paucity of relevant studies on the topic might impact the reliability of some of the conclusions drawn.

Abstract licence: CC BY

ObjectiveTo compare the short-term effects of dienogest and oral contraceptives (OCPs) on pain and quality of life in women with endometriosis.MethodThe databases including PubMed, Cochrane Library, Embase, Web of Science, CNKI, and Wanfang Database were searched, and the date ranged from the establishment of the database to November 2024. The randomized controlled trials (RCTs) compared the efficacy of dienogest and oral contraceptives in the treatment of endometriosis were included. The indicators for evaluation mainly included pain score and quality of life. The secondary indicator was safety.ResultsEight studies were included in this meta-analysis. Subgroup analysis was used to assess the endometriosis-related pain because patients received different types of OCPs. Dienogest was superior to mifepristone and Yasmin in improving VAS scores (P = 0.04, SMD=-1.19, 95%CI=-2.32 to -0.06; P = 0.03, SMD=-1.66, 95%CI=-3.16 to -0.15). However, Dienogest was not as effective as OCPs in improving pelvic pain and dyspareunia associated with endometriosis (P = 0.009, SMD = 0.42, 95%CI = 0.11 to 0.73; P = 0.006, SMD = 0.70, 95%CI = 0.20 to 1.19). For QoL score, compared to OCPs, dienogest significantly improved EHP-5, EHP-30, and SF-12 average PCS scores (P  0.05). For side effects after treatment, there is no significant difference in the risk of vaginal bleeding, headache, hot flashes, back pain, skin dryness, and nausea between dienogest and OCPs. But, OCPs increase the risk of hand numbness and weight gain.ConclusionDienogest is superior to OCPs in improving pain and QoL in patients with endometriosis, but not as effective as OCPs in pelvic pain and dyspareunia, and the safety was similar between the two types of drugs.

Abstract licence: CC BY-NC-ND

BackgroundRelugolix, an oral GnRH receptor antagonist, is effective in treating uterine myomas and endometriosis. However, concerns persist regarding the venous thromboembolism (VTE) risk associated with its combination with oral estradiol (E2) and norethisterone acetate (NETA).ObjectiveThis expert opinion evaluates the thrombotic risk of relugolix combined therapy (relugolix-CT) based on pharmacological data, clinical trials, and regulatory assessments.MethodsA review of pivotal trials (LIBERTY 1, LIBERTY 2, SPIRIT 1, SPIRIT 2), regulatory reports (European Medicines Agency, Food and Drug Administration), and real-world safety data was conducted, focusing on hemostatic effects and VTE risk.ResultsRelugolix monotherapy reduces estrogen levels, leading to minor decreases in coagulation factors. While E2 and NETA mitigate hypoestrogenic effects, concerns about their prothrombotic potential remain. However, clinical trials and postmarketing surveillance have not shown a significant increase in VTE risk. A meta-analysis suggests that E2-based regimens have a lower thrombotic risk than ethinylestradiol-based therapies.ConclusionThe VTE risk of relugolix-CT appears lower than that of traditional combined oral contraceptives. Nonetheless, patient selection is essential, particularly for those with thrombotic risk factors. Continued real-world surveillance is crucial to refining its safety profile in clinical practice.

Abstract licence: CC BY-NC-ND

BackgroundEndometriosis (EMs) is a common chronic inflammatory gynecological disease that belongs to the classification of Traditional Chinese Medicine Syndromes "Zheng Jia," and the classic Chinese formula Guizhi Fuling (GZFL) demonstrates significant clinical efficacy in the treatment of this condition. This study aims to investigate GZFL's effect and potential mechanism in EMs.MethodsThe search reviewed randomized controlled trials in 7 databases from inception to 2024, assessed quality with the Cochrane tool, and analyzed data with STATA 15 by 2 reviewers. In the network pharmacology study, we searched and screened the components and targets of GZFL, subsequently compared these targets to EMs targets, and used bioinformatics techniques to analyze and explore their potential interactions.ResultsNine randomized controlled trials involving 897 participants were analyzed. Meta-analysis showed that GZFL combined with dienogest significantly enhanced the clinical effectiveness rate (odds ratio = 2.404, 95% confidence intervals [CI], 1.868 to 3.093; P ConclusionIn conclusion, GZFL combination treatment could increase the clinical effectiveness rate of EMs patients, and reduce the serum level of carbohydrate antigen 125, estradiol, matrix metalloproteinases, pain scores, and the diameter of the ectopic cyst. The potential mechanism might be linked to the modulation of hormone receptors and inflammation.

Abstract licence: CC BY

Purpose of reviewWhile laparoscopic surgery plays a key role in the management of endometriosis, symptoms commonly recur, and repeat surgery comes with increased risk. Medical management, including hormonal and nonhormonal treatment, is vital in managing painful symptoms. This review summarizes recent evidence regarding various medical management options available to treat pelvic pain associated with endometriosis.Recent findingsEfficacy of dienogest vs. combined oral contraceptive on pain associated with endometriosis: randomized clinical trial.Once daily oral relugolix combination therapy vs. placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2).A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.Two-year efficacy and safety of relugolix combination therapy in women with endometriosis-associated pain: SPIRIT open-label extension study.SummaryAll symptomatic women with suspected endometriosis who are not desiring immediate fertility can be offered suppressive treatment to control symptoms and slow the progression of disease. First-line treatments include the combined oral contraceptive pill and progestogens. Second-line treatments include gonadotropin-releasing hormone agonists and antagonists but current guidelines recommend that these should be reserved for people whose symptoms fail to be controlled by first-line agents. The use of complementary and alternative medicines is also increasing in both volume and number of agents used.

Abstract licence: CC BY