Effects of relugolix: A Synthesis of Findings from 18 Studies

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Original Abstract of the Article

Key Research Findings

Relugolix is a new oral medication used to treat prostate cancer, uterine fibroids, and endometriosis. 13 discusses the convenience and safety of oral administration, potential side effects, and financial implications of relugolix. 15 suggests that the combined therapy of relugolix and apalutamide could be effective in preventing biochemical recurrence in patients with high-risk localized prostate cancer after radical prostatectomy. 9 reports that relugolix combination therapy is effective in reducing heavy menstrual bleeding caused by uterine fibroids, with confirmed safety. 18 discusses the effectiveness and side effects of relugolix in the treatment of endometriosis. 14 assesses the cost-effectiveness of relugolix compared to leuprolide for the treatment of advanced prostate cancer, suggesting that relugolix is more cost-effective. 12 describes the potential of oral GnRH antagonists, including relugolix, as a viable treatment option for managing symptoms related to uterine fibroids. 10 provides a comprehensive evaluation of the efficacy and safety of relugolix in treating uterine fibroids. 11 evaluates the impact of concomitant prostate cancer treatments with relugolix, suggesting no significant influence on its efficacy and safety. 6 suggests that relugolix combination therapy might minimize vasomotor symptoms and bone loss in premenopausal women. 2 indicates that the combination of relugolix and stereotactic body radiation therapy could improve initial testosterone suppression and PSA response in intermediate to high-risk prostate cancer. 3 suggests that relugolix has minimal impact on quality of life in men with advanced prostate cancer. 16 reports that the combination of relugolix with estradiol/norethisterone (or norethindrone) acetate is effective in managing heavy menstrual bleeding caused by uterine fibroids. 5 confirms the long-term efficacy and safety of relugolix combination therapy in treating heavy menstrual bleeding caused by uterine fibroids. 1 suggests that relugolix combination therapy is effective in alleviating pain associated with endometriosis. 8 reports a case where relugolix combination therapy was effective in treating a patient with multiple uterine fibroids and ovarian cysts. 7 introduces several medications, including relugolix, that incorporate a pyridazine ring in their structure. 17 provides a comprehensive evaluation of the effectiveness and safety of oral GnRH antagonists for treating endometriosis-associated pain. 4 suggests that relugolix does not significantly affect the efficacy and safety of cardiovascular therapies in men with advanced prostate cancer.

Benefits and Risks

Benefit Summary

Relugolix has demonstrated potential benefits in treating prostate cancer, uterine fibroids, and endometriosis. These benefits include:

  • Potential effectiveness in preventing biochemical recurrence in patients with high-risk localized prostate cancer after radical prostatectomy. 15
  • Confirmed effectiveness in treating heavy menstrual bleeding caused by uterine fibroids. 9
  • Long-term effectiveness and safety confirmed in treating heavy menstrual bleeding caused by uterine fibroids. 5
  • Potential effectiveness in reducing pain associated with endometriosis. 1
  • Potential for rapid and sustained testosterone suppression through oral administration. 13 , 2
  • Potential for improved cost-effectiveness compared to leuprolide. 14
  • Minimal impact on the effectiveness and safety of cardiovascular therapies. 4

Risk Summary

The main risks associated with relugolix include:

  • Potential for causing vasomotor symptoms and bone loss. 10 , 6
  • Potential for these side effects to be reduced with the combination therapy of estradiol/norethisterone (or norethindrone) acetate. 16 , 6

Comparison of Studies

Similarities between Studies

Most studies suggest that relugolix is effective in treating conditions such as prostate cancer, uterine fibroids, and endometriosis. Another shared finding is the convenience of oral administration and the rapid and sustained effects of the medication.

Differences between Studies

Studies differ in terms of the specific diseases or treatment approaches being evaluated for relugolix. For example, some studies focus on the effectiveness of relugolix alone in treating prostate cancer, while others evaluate the effectiveness of combination therapies. In the context of uterine fibroid treatment, studies have suggested that relugolix combination therapy can reduce vasomotor symptoms and bone loss. These variations in research subjects and treatment approaches can lead to differing findings regarding the effectiveness and safety of relugolix.

Consistency and Inconsistencies in Results

While many studies suggest the effectiveness of relugolix in treating various conditions like prostate cancer, uterine fibroids, and endometriosis, some studies have reported side effects such as vasomotor symptoms and bone loss. These inconsistencies might stem from differences in study subjects, treatment approaches, or study designs.

Practical Implications and Precautions

Relugolix has shown promise in treating prostate cancer, uterine fibroids, and endometriosis. However, it's important to take this medication under the guidance of a doctor due to the potential for side effects. If you experience side effects like vasomotor symptoms or bone loss, consult your doctor.

Limitations of Current Research

Research on relugolix is still in its early stages, and there are many unknowns about its long-term safety and effectiveness. Additionally, research on the effectiveness and safety of relugolix is limited to a specific set of diseases and treatment approaches. Further research is needed to investigate the combination therapy of relugolix.

Future Research Directions

Research is needed to assess the long-term safety and effectiveness of relugolix. Expanding the range of diseases and treatment approaches evaluated for relugolix is also crucial. More research on the combination therapy of relugolix is also necessary.

Conclusion

Relugolix holds potential as an effective treatment for prostate cancer, uterine fibroids, and endometriosis. However, it's crucial to use it under medical supervision due to potential side effects. Research into its long-term safety and effectiveness, as well as its potential in a wider range of diseases and treatment approaches, is necessary. Future research holds promise for expanding the understanding and application of relugolix.

Literature analysis of 18 papers
Positive Content
18
Neutral Content
0
Negative Content
0
Article Type
3
1
1
5
17
1.

A Plain Language Summary to learn about relugolix combination therapy for the treatment of pain associated with endometriosis.

Author: GiudiceLinda C, As-SanieSawsan, Arjona FerreiraJuan C, BeckerChristian M, AbraoMauricio S, LesseyBruce A, DynowskiKrzysztof, WilkKrzysztof, LiYulan, MathurVandana, WagmanRachel B, JohnsonNeil P

Pain relief

The SPIRIT 1 and SPIRIT 2 studies showed that relugolix combination therapy was more effective in relieving pain in women with moderate to severe endometriosis compared to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

Early biochemical outcomes following neoadjuvant/adjuvant relugolix with stereotactic body radiation therapy for intermediate to high risk prostate cancer.

Author: GallagherLindsey, XiaoJerry, HsuehJessica, ShahSarthak, DannerMalika, ZwartAlan, AyoobMarilyn, YungThomas, SimpsonTiffany, FallickMark, KumarDeepak, LegerPaul, DawsonNancy A, SuySimeng, CollinsSean P

Improved prostate cancer control
Rapid testosterone suppression

This prospective study evaluated the effectiveness of relugolix, a new oral GnRH receptor antagonist, in combination with stereotactic body radiation therapy (SBRT) for intermediate to high prostate cancer. Relugolix rapidly suppressed testosterone levels and showed promising PSA response.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer.

Author: ShoreNeal D, MehlhaffBryan A, CooksonMichael S, SaltzsteinDaniel R, TutroneRonald, BrownBruce, LuSophia, FallickMark, HansonSarah, SaadFred

Reduced cardiac events

This study examined the impact of concomitant cardiovascular (CV) therapies on the efficacy and safety of relugolix, an oral GnRH receptor antagonist, compared to leuprolide in men with prostate cancer, using data from the phase 3 HERO study.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

A plain language summary of the long-term relugolix combination therapy study for uterine fibroids.

Author: Al-HendyAyman, LukesAndrea S, VenturellaRoberta, VillarroelClaudio, McKainLaura, LiYulan, WagmanRachel B, StewartElizabeth A

Improved anemia
Reduced bleeding
Stable bone mineral density
Headache
Hot flushes

The LIBERTY extension study looked at the long-term efficacy and safety of relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. The study found that most women in all three treatment groups responded well, with reduced bleeding, improved anemia symptoms, and stable bone mineral loss.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women.

Author: LukesAndrea, MigoyaElizabeth, JohnsonBrendan, LeeTien-Yi, LiYulan, Arjona FerreiraJuan Camilo

Minimized side effects
None reported

This study assessed the efficacy of a combination therapy consisting of relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for treating hormone-dependent conditions. The study aims to determine if the combination therapy provides systemic estradiol concentrations in the desired range to minimize the undesirable effects of relugolix monotherapy, such as vasomotor symptoms and bone mineral density loss.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

A plain language summary of the safety of relugolix combination therapy and improvement in symptoms in women with uterine fibroids from the LIBERTY 1 and LIBERTY 2 studies.

Author: Al-HendyAyman, LukesAndrea S, PoindexterAlfred N, VenturellaRoberta, VillarroelClaudio, CritchleyHilary Od, LiYulan, McKainLaura, Arjona FerreiraJuan C, LangenbergAndria Gm, WagmanRachel B, StewartElizabeth A

Reduced menstrual bleeding

The LIBERTY 1 and LIBERTY 2 clinical trials evaluated the efficacy and safety of relugolix combination therapy for reducing heavy menstrual bleeding in women with uterine fibroids.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Uterine Leiomyomas.

Author: NeblettMichael F, StewartElizabeth A

Amenorrhea
Anemia improvement
Leiomyoma bleeding reduction
Leiomyoma pain reduction
Reduced hypogonadal side effects
Uterine volume reduction
Hypogonadal side effects

This overview reviews the efficacy and safety of oral gonadotropin-releasing hormone (GnRH) antagonists for the management of uterine leiomyomas. Oral GnRH antagonists provide rapid suppression of sex steroids and can reduce leiomyoma-associated heavy menstrual bleeding, pain, and anemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

11.

Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer.

Author: GeorgeDaniel J, SaadFred, CooksonMichael S, SaltzsteinDaniel R, TutroneRonald, BossiAlberto, BrownBruce, SelbyBryan, LuSophia, BuckleyDavid, TombalBertrand, ShoreNeal D

Effective testosterone suppression

This subgroup and pharmacokinetic/pharmacodynamic analysis of the HERO study assessed the impact of concomitant prostate cancer treatments on relugolix, an oral GnRH receptor antagonist. The study found that concomitant use of enzalutamide or docetaxel did not significantly impact the efficacy or safety of relugolix, supporting its use in combination with these agents.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

A Practical Guide to Relugolix: Early Experience With Oral Androgen Deprivation Therapy.

Author: KasparianSaro, WeiOren, TsaiNi-Chun, PalmerJoycelynne, PalSumanta, LyouYung, DorffTanya

Relugolix compliance
Relugolix safety
Relugolix cost

Relugolix, a new oral androgen deprivation therapy (ADT) for prostate cancer, showed acceptable compliance, no new major safety signals, and improved PSA levels. The cost of treatment was a major reason for patients not initiating or discontinuing therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

15.

Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases.

Author: BrownGordon, BelkoffLaurence, HafronJason M, SaltzsteinDaniel R, PotdarRushikesh, BhaumikAmitabha, PhillipsJennifer, McGowanTracy, ShoreNeal D

Prostate cancer treatment
Unknown

This substudy of the Apa-RP study evaluates the use of relugolix, an oral gonadotropin-releasing hormone antagonist, in combination with apalutamide for patients with high-risk localized prostate cancer after radical prostatectomy.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids.

Author: SyedYahiya Y

Improved fibroid symptoms
Reduced bleeding
Reduced bone loss
Reduced hot flashes
Vasomotor symptoms

Relugolix/estradiol/norethisterone acetate, a fixed-dose combination, is approved for managing heavy menstrual bleeding associated with uterine fibroids. It effectively reduces bleeding and improves other symptoms, with a favorable safety profile and minimal bone loss.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Oral gonadotropin-releasing hormone antagonists for treating endometriosis-associated pain: a systematic review and network meta-analysis.

Author: YanHailan, ShiJinghua, LiXiaoyan, DaiYi, WuYushi, ZhangJing, GuZhiyue, ZhangChenyu, LengJinhua

Improved QoL
Pain relief
Ovarian hypoestrogenic effects

Oral GnRH antagonists were effective for endometriosis-associated pain and dysmenorrhea, with a dose-response relationship. High-dose treatments were associated with a significantly increased incidence of adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Combination GnRH antagonists for endometriosis: Balancing efficacy with side effects.

Author: WhitakerL H R, SaraswatL, HorneA W

Endometriosis pain relief

This article highlights clinical trials of Relugolix, a combined HRT-GnRH antagonist, for endometriosis-associated pain. The trials suggest that Relugolix may be an effective treatment option for women with endometriosis, offering potential relief from pain and a favorable side effect profile.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

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