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according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.
In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.
Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.
After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).
“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.
Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.
The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.
The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”
Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.
SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.
In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.
“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”
Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.
Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.
She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).
In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.
“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”
Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.
Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.
She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).
In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.
“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”
Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.
Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.
She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”
Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).
according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.
In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.
Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.
After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).
“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.
Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.
The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.
The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”
Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.
SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.
according to a study of the intention-to-treat populations of the randomized, double-blind, phase III VENUS I and VENUS II trials.
In these pivotal studies, ulipristal (Ella) at either 5 mg or 10 mg significantly improved both rate of and time to amenorrhea, noted Andrea S. Lukes, MD, of Carolina Women’s Research and Wellness Center in Durham, N.C. To assess effects on quality of life, she and her associates analyzed baseline and 12-week responses to the widely validated Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QOL) questionnaire, which examined factors such as symptom severity, energy and mood, physical and social activities, self-consciousness, and sexual functioning.
Among 589 patients in the analysis, 169 received placebo, 215 received 5 mg ulipristal, and 205 received 10 mg ulipristal. At baseline, average total quality of life scores on UFS-QOL were 33 (standard deviation, 220), 32 (SD, 21), and 36 (SD, 23), respectively, the researchers wrote in Obstetrics & Gynecology.
After 12 weeks of treatment, both doses of ulipristal were associated with significantly greater improvements on all UFS-QOL scales, compared with placebo (P less than .001). For example, on a scale of 0-100, symptom severity improved by a mean of 23 with ulipristal 5 mg and by a mean of 30 with ulipristal 10 mg (both P less than .001 versus placebo).
“Although a small proportion of patients experienced no change or some worsening in these outcomes, the majority of women reported clear improvements; for example, more than 70% of patients in the ulipristal treatment arms achieved a meaningful improvement of 30 or more points on the Revised Activities subscale,” the researchers wrote.
Additionally, significantly greater improvements in physical and social activities were seen for both ulipristal doses, compared with placebo, from baseline to the end of treatment.
The VENUS II trial included two 12-week treatment courses. In this trial, women who switched from ulipristal to placebo experienced some worsening in quality of life, while those who switched from placebo to ulipristal improved their UFS-QOL scores, the investigators said. Patients who stayed on ulipristal throughout continued to benefit from one treatment course to the next.
The researchers concluded that the findings, “taken together with the significant improvements in amenorrhea, suggest that ulipristal is a promising, noninvasive treatment option for women suffering from symptomatic uterine leiomyomas.”
Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.
SOURCE: Lukes AS et al. Obstet Gynecol 2019;133 (5):869-78.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: For women with symptomatic uterine leiomyomas, ulipristal at either 5 mg or 10 mg significantly improved both the rate of and time to amenorrhea, compared with placebo.
Major finding: Patients who received 5 or 10 mg ulipristal showed significant improvements in Uterine Fibroid Symptom Health-Related Quality of Life scales, compared with those who received placebo (P less than .001).
Study details: VENUS I and II, 12-week randomized controlled trials of ulipristal acetate or placebo in 589 women with symptomatic uterine leiomyomas and abnormal uterine bleeding.
Disclosures: Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.
Source: Lukes AS et al. Obstet Gynecol. 2019 May;133(5):869-78.