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Dienogest in long-term treatment of endometriosis.

Schindler AE - Int J Womens Health (2011)

Bottom Line: Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited.These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life.Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates.

View Article: PubMed Central - PubMed

Affiliation: Institute for Medical Research and Education, Essen, Germany.

ABSTRACT
Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. The symptoms of endometriosis may cause significant impairment in quality of life and represent a substantial economic burden to patients, families, and society. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life. Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited. Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis in two clinical programs performed in Europe and Japan, including dose-ranging, placebo-controlled, active comparator-controlled, and long-term (up to 65 weeks) studies. These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life. Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates. This review article describes the clinical trial evidence that characterizes the efficacy and safety of dienogest in endometriosis, including two studies characterizing dienogest in long-term use. The relevance of these findings to the management of endometriosis in clinical practice is discussed.

No MeSH data available.


Related in: MedlinePlus

Change in visual analog scale (VAS) score during the placebo-controlled (A) and the extension (B) studies.54,62Note: Reprinted in part from Strowitzki T et al,54 with permission from Elsevier.
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f2-ijwh-3-175: Change in visual analog scale (VAS) score during the placebo-controlled (A) and the extension (B) studies.54,62Note: Reprinted in part from Strowitzki T et al,54 with permission from Elsevier.

Mentions: Women who completed the 12-week placebo-controlled study in Europe54 were offered the opportunity to enter an open-label extension study of dienogest for up to 53 additional weeks, providing an overall treatment period of up to 65 weeks.62 Notably, of the 188 women completing the placebo-controlled study, a large proportion (n = 168, 89%) consented to enter the long-term extension study. The intensity of pain showed significant, sustained improvements during the long-term study, in addition to the improvements associated with dienogest during the placebo-controlled phase. Mean visual analog scores decreased from 56.9 mm at baseline of the placebo-controlled study to 34.1 mm at baseline of the long-term study, to 11.5 mm at the end of the 53 additional weeks of treatment (Figure 2). During a 24-week treatment-free period following the long-term study, visual analog scores increased only moderately, suggesting that dienogest induces a beneficial effect that may persist after treatment cessation. Short Form 36 Health Survey scores during the treatment-free period indicated minimal changes in physical or mental indices of quality of life over six months after cessation of dienogest.


Dienogest in long-term treatment of endometriosis.

Schindler AE - Int J Womens Health (2011)

Change in visual analog scale (VAS) score during the placebo-controlled (A) and the extension (B) studies.54,62Note: Reprinted in part from Strowitzki T et al,54 with permission from Elsevier.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3140813&req=5

f2-ijwh-3-175: Change in visual analog scale (VAS) score during the placebo-controlled (A) and the extension (B) studies.54,62Note: Reprinted in part from Strowitzki T et al,54 with permission from Elsevier.
Mentions: Women who completed the 12-week placebo-controlled study in Europe54 were offered the opportunity to enter an open-label extension study of dienogest for up to 53 additional weeks, providing an overall treatment period of up to 65 weeks.62 Notably, of the 188 women completing the placebo-controlled study, a large proportion (n = 168, 89%) consented to enter the long-term extension study. The intensity of pain showed significant, sustained improvements during the long-term study, in addition to the improvements associated with dienogest during the placebo-controlled phase. Mean visual analog scores decreased from 56.9 mm at baseline of the placebo-controlled study to 34.1 mm at baseline of the long-term study, to 11.5 mm at the end of the 53 additional weeks of treatment (Figure 2). During a 24-week treatment-free period following the long-term study, visual analog scores increased only moderately, suggesting that dienogest induces a beneficial effect that may persist after treatment cessation. Short Form 36 Health Survey scores during the treatment-free period indicated minimal changes in physical or mental indices of quality of life over six months after cessation of dienogest.

Bottom Line: Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited.These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life.Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates.

View Article: PubMed Central - PubMed

Affiliation: Institute for Medical Research and Education, Essen, Germany.

ABSTRACT
Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. The symptoms of endometriosis may cause significant impairment in quality of life and represent a substantial economic burden to patients, families, and society. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life. Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited. Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis in two clinical programs performed in Europe and Japan, including dose-ranging, placebo-controlled, active comparator-controlled, and long-term (up to 65 weeks) studies. These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life. Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates. This review article describes the clinical trial evidence that characterizes the efficacy and safety of dienogest in endometriosis, including two studies characterizing dienogest in long-term use. The relevance of these findings to the management of endometriosis in clinical practice is discussed.

No MeSH data available.


Related in: MedlinePlus