Cargando…
Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas
In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9665945/ https://www.ncbi.nlm.nih.gov/pubmed/36357960 http://dx.doi.org/10.1097/AOG.0000000000004988 |
_version_ | 1784831392727695360 |
---|---|
author | Al-Hendy, Ayman Lukes, Andrea S. Poindexter, Alfred N. Venturella, Roberta Villarroel, Claudio McKain, Laura Li, Yulan Wagman, Rachel B. Stewart, Elizabeth A. |
author_facet | Al-Hendy, Ayman Lukes, Andrea S. Poindexter, Alfred N. Venturella, Roberta Villarroel, Claudio McKain, Laura Li, Yulan Wagman, Rachel B. Stewart, Elizabeth A. |
author_sort | Al-Hendy, Ayman |
collection | PubMed |
description | In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. Here we report the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks. METHODS: Women with uterine leiomyoma–associated heavy menstrual bleeding who completed any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial were eligible to enroll in a 28-week long-term extension study. All participants received once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) in the extension study. The primary efficacy endpoint was the proportion of women who achieved or maintained a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction in menstrual blood loss volume from LIBERTY study baseline to the last 35 days of treatment (defined as responders). Analyses were conducted for all three randomized treatment groups from pivotal studies. RESULTS: Overall, 477 women enrolled, 476 were treated, and 363 (76.1%) completed 52 weeks. Among patients treated with relugolix combination therapy through 52 weeks (n=163), sustained improvement in heavy menstrual bleeding was observed in 87.7% (responders). The least squares mean menstrual blood loss volume reduction was 89.9%, with 70.6% of patients achieving amenorrhea. At week 52, 59.0% of patients with anemia at baseline had improvements in hemoglobin concentration of greater than 2 g/dL. Distress due to uterine leiomyoma–associated symptoms measured by the BPD (Bleeding and Pelvic Discomfort) scale score was reduced by 51.3 points. Sustained reductions in uterine and uterine leiomyoma volume were observed. Bone mineral density was preserved through week 52. CONCLUSION: Improvements in heavy menstrual bleeding and anemia and reduction of uterine leiomyoma–associated symptom burden were sustained through up to 52 weeks of treatment with relugolix combination therapy in women with uterine leiomyomas. No new safety concerns were identified, and BMD was maintained. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03049735; NCT03103087; NCT03412890. FUNDING SOURCE: Myovant Sciences GmbH. |
format | Online Article Text |
id | pubmed-9665945 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-96659452022-11-21 Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas Al-Hendy, Ayman Lukes, Andrea S. Poindexter, Alfred N. Venturella, Roberta Villarroel, Claudio McKain, Laura Li, Yulan Wagman, Rachel B. Stewart, Elizabeth A. Obstet Gynecol Contents In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. Here we report the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks. METHODS: Women with uterine leiomyoma–associated heavy menstrual bleeding who completed any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial were eligible to enroll in a 28-week long-term extension study. All participants received once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) in the extension study. The primary efficacy endpoint was the proportion of women who achieved or maintained a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction in menstrual blood loss volume from LIBERTY study baseline to the last 35 days of treatment (defined as responders). Analyses were conducted for all three randomized treatment groups from pivotal studies. RESULTS: Overall, 477 women enrolled, 476 were treated, and 363 (76.1%) completed 52 weeks. Among patients treated with relugolix combination therapy through 52 weeks (n=163), sustained improvement in heavy menstrual bleeding was observed in 87.7% (responders). The least squares mean menstrual blood loss volume reduction was 89.9%, with 70.6% of patients achieving amenorrhea. At week 52, 59.0% of patients with anemia at baseline had improvements in hemoglobin concentration of greater than 2 g/dL. Distress due to uterine leiomyoma–associated symptoms measured by the BPD (Bleeding and Pelvic Discomfort) scale score was reduced by 51.3 points. Sustained reductions in uterine and uterine leiomyoma volume were observed. Bone mineral density was preserved through week 52. CONCLUSION: Improvements in heavy menstrual bleeding and anemia and reduction of uterine leiomyoma–associated symptom burden were sustained through up to 52 weeks of treatment with relugolix combination therapy in women with uterine leiomyomas. No new safety concerns were identified, and BMD was maintained. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03049735; NCT03103087; NCT03412890. FUNDING SOURCE: Myovant Sciences GmbH. Lippincott Williams & Wilkins 2022-12 2022-11-02 /pmc/articles/PMC9665945/ /pubmed/36357960 http://dx.doi.org/10.1097/AOG.0000000000004988 Text en Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. |
spellingShingle | Contents Al-Hendy, Ayman Lukes, Andrea S. Poindexter, Alfred N. Venturella, Roberta Villarroel, Claudio McKain, Laura Li, Yulan Wagman, Rachel B. Stewart, Elizabeth A. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title | Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title_full | Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title_fullStr | Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title_full_unstemmed | Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title_short | Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas |
title_sort | long-term relugolix combination therapy for symptomatic uterine leiomyomas |
topic | Contents |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9665945/ https://www.ncbi.nlm.nih.gov/pubmed/36357960 http://dx.doi.org/10.1097/AOG.0000000000004988 |
work_keys_str_mv | AT alhendyayman longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT lukesandreas longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT poindexteralfredn longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT venturellaroberta longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT villarroelclaudio longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT mckainlaura longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT liyulan longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT wagmanrachelb longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas AT stewartelizabetha longtermrelugolixcombinationtherapyforsymptomaticuterineleiomyomas |