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Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
Uterine leiomyomas are common in premenopausal women, and 60% experience heavy menstrual bleeding, but nonsurgical options as an alternative to hysterectomy are limited, wrote Eric Brown, MD, of Gyn-Care, Atlanta, Georgia, and colleagues.
Elagolix sodium, an oral, short-acting nonpeptide, gonadotropin-releasing hormone antagonist, has been approved by the Food and Drug Administration at a dose of 300 mg twice daily with add-back therapy for up to 24 months of use. However, this treatment protocol is contraindicated or not preferable for some patients, the researchers said.
In a study published in Obstetrics & Gynecology , the researchers randomized 54 women to 150 mg of oral elagolix once daily, and 28 to a placebo for 6 months to investigate the safety and efficacy of the lower dose. The study population included women aged 18-51 years with a history of heavy menstrual bleeding association with uterine leiomyomas. Approximately two-thirds (65.9%) were Black.
The primary endpoint was the proportion of patients who met the criteria of menstrual blood loss volume less than 80 mL during the final month of treatment and menstrual blood loss volume reduction of 50% or more from baseline to the final month of treatment.
After 6 months, nearly half (49.4%) of the elagolix group met the study endpoint compared with 23.3% of the placebo group (P = .035).
Elagolix patients showed significantly greater reductions in both mean and median menstrual blood loss volumes compared with the placebo patients over the study period, and significant differences between the groups in the mean reduction of menstrual blood loss were evident after 1 month of treatment (P < .05 for months 1, 2, 3, and 5).
Results were similar in a further sensitivity analysis in which patients with incomplete final month data were considered nonresponders; 44.4% of elagolix patients and 21.4% of patients met the primary endpoint.
Overall, 51.9% of elagolix patients and 39.3% of placebo patients reported adverse events; the most common were headache and hot flush. Three patients (5.6%) in the elagolix group discontinued the drug because of adverse events. No serious or severe adverse events were reported in the elagolix group; both cases of reported serious adverse events (COVID-19 and an enlarged uvula) occurred in placebo patients.
Patient-reported outcomes were significantly greater in the elagolix patients, based on symptom severity score, 5 of 6 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) health-related quality of life subscales, and the HRQOL total score at the end of the study.
The findings were limited by several factors including the small study population and lenient eligibility criteria that may have led to a higher placebo response rate, and the study did not monitor bone mineral density, the researchers noted.
However, the results suggest that elagolix at a 150-mg dose was well tolerated, with a safety profile similar to that seen in women who took the drug for endometriosis pain, and may be an option for women with contraindications to other therapy or for those who prefer once-daily dosing, they concluded.
The study was funded by AbbVie. Lead author Dr. Brown had no additional financial conflicts to disclose, but several coauthors disclosed relationships with AbbVie and other companies.
FROM OBSTETRICS & GYNECOLOGY