Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Barra F

PROVIDER: S-EPMC7019573 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Barra Fabio F Scala Carolina C Leone Roberti Maggiore Umberto U Ferrero Simone S

Journal of clinical medicine 20200106 1

<h4>Background</h4>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.<h4>Methods</h4>A re ...[more]

PMID: 31935969

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Project description:PurposeInvestigation of the efficacy and safety of tapentadol prolonged release (PR) compared with morphine PR for long-term treatment of pain in children.Patients and methodsChildren aged 6 to <18 years requiring long-term treatment with opioids were studied in a 12-month, 2-part, multi-center trial: Part 1, 14-day open-label, randomized, active-controlled, parallel group non-inferiority trial comparing twice daily tapentadol PR with morphine PR; Part 2, open-label treatment with tapentadol PR for up to 12 months or no treatment "safety observation period". Pain intensity was rated with visual analogue scale or Faces Pain Scale-Revised, and non-inferiority was assessed by comparison of "treatment responders" (those completing the 14-day treatment period and showing pre-defined changes in pain rating) in each group.ResultsTwenty-three of 48 centers enrolled 73 patients. In Part 1, 45 and 24 patients received tapentadol or morphine, respectively, of which 40 and 22 completed 14-day treatment. In Part 2, thirty-six and 58 patients entered the tapentadol PR or observation periods, respectively, with 20/36 completing at least 12 weeks of treatment; 10 of the 36 had received morphine in Part 1. Forty-four of the 58 patients in the safety observation period had received tapentadol. Tapentadol PR was non-inferior to morphine PR (lower limit of confidence interval above negative non-inferiority margin of -0.2) in Part 1. Rates of adverse events were as expected with nausea (22.2%) and constipation (15.6%) in the tapentadol PR group, and with vomiting (33.3%), nausea and constipation (each 16.7%) in the morphine PR group. No new safety issues were identified; the safety profile of tapentadol over the 12 months treatment and observation periods was comparable to that established in subjects >18 years old.ConclusionTapentadol PR was well tolerated and equivalent to morphine PR for both efficacy and safety in children (6 to <18 years old) requiring long-term treatment with opioids.

Dataset Information

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

Publications

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

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