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Abstract
Discussion Forum (0)
Introduction: Linzagolix is an oral GnRH antagonist being developed to treat uterine fibroid (UF)-associated heavy menstrual bleeding (HMB). We present pooled 24-week safety data from two Phase 3 trials of linzagolix in women with UF-related HMB.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Introduction: Linzagolix is an oral GnRH antagonist being developed to treat uterine fibroid (UF)-associated heavy menstrual bleeding (HMB). We present pooled 24-week safety data from two Phase 3 trials of linzagolix in women with UF-related HMB.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Safety of linzagolix in the treatment of women with uterine fibroids: Results from two Phase 3 clinical trials
Prof. Hugh Taylor
Affiliations:
Yale University
Yale University
Abstract
Discussion Forum (0)
Introduction: Linzagolix is an oral GnRH antagonist being developed to treat uterine fibroid (UF)-associated heavy menstrual bleeding (HMB). We present pooled 24-week safety data from two Phase 3 trials of linzagolix in women with UF-related HMB.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Introduction: Linzagolix is an oral GnRH antagonist being developed to treat uterine fibroid (UF)-associated heavy menstrual bleeding (HMB). We present pooled 24-week safety data from two Phase 3 trials of linzagolix in women with UF-related HMB.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
Methods: PRIMROSE 1 and 2 (total n=1037) are randomized, double-blind, placebo-controlled Phase 3 trials investigating efficacy and safety of linzagolix 100 mg and 200 mg once daily, with and without E2-1mg/NETA-0.5mg add-back therapy (ABT). Safety endpoints included adverse events (AEs) and lumbar spine bone mineral density (BMD) by DXA.
Results: Overall AE rates in linzagolix-treated subjects (50 to 63%) were similar to placebo (49%); 8.6% of subjects on LGX discontinued due to AEs, versus 8.1% on placebo. The most common AEs (>5% in any arm) were hot flush, headache, and nausea. Rates of hot flush and headache were 10.1% and 6.0% in the 100 mg, 5.2% and 5.2% in the 100 mg+ABT, 33.3% and 11.9% in the 200 mg, and 9.6% and 7.2% in the 200 mg+ABT groups, respectively, versus placebo rates of 5.3% and 5.7%. Nausea rates were 1.5%, 3.3%, 5.2%, and 1.9%, versus 1.0% in placebo. Mean % (LB 95% CI) BMD changes were -2.06 (-2.65), -1.09 (-1.67), -3.63 (-4.13), and -1.13 (-1.6) in 100 mg, 100 mg+ABT, 200 mg, and 200 mg+ABT, and 0.46 (0.06) in placebo.
Conclusion/Implications: AE rates and BMD at 24 weeks support the potential for long term use of linzagolix 100 mg and 200 mg+ABT in UF without high risk of AEs or clinically unacceptable BMD loss.
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