Dienogest in long-term treatment of endometriosis

International Journal of Women's Health

Volumn 3, Issue 1, 2011, Pages 175-184

  Schindler, Adolf E ^a  

^a Institute for Medical Research and Education Essen   (Germany)

Author keywords

Dienogest; Endometriosis; Long term treatment; Pain; Progestins; Quality of life; Symptoms

Indexed keywords

BUSERELIN ACETATE; DANAZOL; DIENOGEST; ESTRADIOL; GESTAGEN; GONADORELIN AGONIST; LEUPRORELIN; MEDROXYPROGESTERONE ACETATE; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL CONTRACEPTIVE AGENT; PLACEBO; PROGESTERONE; TRIPTORELIN;

ABLATION THERAPY; ACNE; ADULT; ANTIINFLAMMATORY ACTIVITY; ANTIPROLIFERATIVE ACTIVITY; BREAST ATROPHY; BREAST DISEASE; CARDIOVASCULAR DISEASE; CONSTIPATION; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSMENORRHEA; DYSPAREUNIA; EARLY DIAGNOSIS; ECONOMIC ASPECT; EDEMA; ENDOMETRIOSIS; ESTRADIOL BLOOD LEVEL; FATIGUE; FEMALE; HEADACHE; HIRSUTISM; HOT FLUSH; HUMAN; INFERTILITY; IRRITABILITY; LAPAROSCOPY; LIVER TOXICITY; LONG TERM CARE; MAJOR CLINICAL STUDY; METRORRHAGIA; MULTICENTER STUDY; NAUSEA; OILY SKIN; PATIENT COMPLIANCE; PELVIS PAIN SYNDROME; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REVIEW; SIDE EFFECT; STOMACH ULCER; SYMPTOMATOLOGY; UTERUS BLEEDING; VAGINAL DRYNESS; WEIGHT GAIN;

EID: 84055172731     PISSN: None     EISSN: 11791411     Source Type: Journal    
DOI: 10.2147/ijwh.s5633     Document Type: Review

References (65)

1. Rogers PA, D'Hooghe TM, Fazleabas A, et al. Priorities for endo-metriosis research: Recommendations from an international consensus workshop. Reprod Sci. 2009;16(4):335-346.
2. Nasir L, Bope ET. Management of pelvic pain from dysmenor-rhea or endometriosis. J Am Board Fam Pract. 2004;17 Suppl: S43-S47.
3. Eskenazi B, Warner ML. Epidemiology of endometriosis. Obstet Gynecol Clin North Am. 1997;24(2):235-258.
4. Kennedy S, Bergqvist A, Chapron C, et al. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005; 20(10):2698-2704.
5. Sinaii N, Plumb K, Cotton L, et al. Differences in characteristics among 1,000 women with endometriosis based on extent of disease. Fertil Steril. 2008;89(3):538-545.
6. Holoch KJ, Lessey BA. Endometriosis and infertility. Clin Obstet Gynecol. 2010;53(2):429-438.
7. Fagervold B, Jenssen M, Hummelshoj L, Moen MH. Life after a diagnosis with endometriosis - a 15 years follow-up study. Acta Obstet Gynecol Scand. 2009;88(8):914-919.
8. Huntington A, Gilmour JA. A life shaped by pain: women and endo-metriosis. J Clin Nurs. 2005;14(9):1124-1132.
9. Fourquet J, Gao X, Zavala D, et al. Patients' report on how endo-metriosis affects health, work, and daily life. Fertil Steril. 2010;93(7): 2424-2428.
10. Kennedy S. What is important to the patient with endometriosis? Br J Clin Pract Suppl. 1991;72:8-10.
11. Jones G, Jenkinson C, Kennedy S. The impact of endometriosis upon quality of life: A qualitative analysis. J Psychosom Obstet Gynaecol. 2004;25(2):123-133.
12. Lemaire GS. More than just menstrual cramps: Symptoms and uncertainty among women with endometriosis. J Obstet Gynecol Neonatal Nurs. 2004;33(1):71-79.
13. Kjerulff KH, Erickson BA, Langenberg P W. Chronic gynecological conditions reported by US women: Findings from the National Health Interview Survey, 1984 to 1992. Am J Public Health. 1996;86(2): 195-199.
14. Denny E. Women's experience of endometriosis. J Adv Nurs. 2004; 46(6):641-648.
15. Nnoaham KE, Sivananthan S, Hummelshoj L, et al. Global study of women's health: A multi-centre study of the global impact of endometriosis. Human Reproduction. 2010;25 Suppl 1:i9-i11.
16. Sepulcri R P, do Amarai VF. Depressive symptoms, anxiety, and quality of life in women with pelvic endometriosis. Eur J Obstet Gynecol Reprod Biol. 2009;142(1):53-56.
17. Gao X, Outley J, Botteman M, et al. Economic burden of endometriosis. Fertil Steril. 2006;86(6):1561-1572.
18. Winkel CA, Scialli AR. Medical and surgical therapies for pain associated with endometriosis. J Womens Health Gend Based Med. 2001; 10(2):137-162.
19. Heinrichs WL, Henzl MR. Human issues and medical economics of endometriosis. Three- vs six-month GnRH-agonist therapy. J Reprod Med. 1998;43 Suppl 3:299-308.
20. Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege J F. Chronic pelvic pain: Prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996;87(3):321-327.
21. Mirkin D, Murphy-Barron C, Iwasaki K. Actuarial analysis of private payer administrative claims data for women with endometriosis. J Manag Care Pharm. 2007;13(3):262-272.
22. No authors listed. Revised American Society for Reproductive Medicine classifcation of endometriosis: 1996. Fertil Steril. 1997; 67(5):817-821.
23. The Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis. Fertil Steril. 2008;90 Suppl 5:S260-S269.
24. Guo S W. Recurrence of endometriosis and its control. Hum Reprod Update. 2009;15(4):441-461.
25. Allen C, Hopewell S, Prentice A, Gregory D. Nonsteroidal anti-infammatory drugs for pain in women with endometriosis. Cochrane Database Syst Rev. 2009;2:CD004753.
26. Schindler AE. Non-contraceptive benefts of hormonal contraceptives. Minerva Ginecol. 2010;62(4):319-329.
27. Davis L, Kennedy SS, Moore J, Prentice A. Modern combined oral contraceptives for pain associated with endometriosis. Cochrane Database Syst Rev. 2007;3:CD001019.
28. Vercellini P, Eskenazi B, Consonni D, et al. Oral contraceptives and risk of endometriosis: A systematic review and meta-analysis. Hum Reprod Update. 2011;17(2):159-170.
29. Brown J, Pan A, Hart RJ. Gonadotrophin-releasing hormone analogues for pain associated with endometriosis. Cochrane Database Syst Rev. 2010;12:CD008475.
30. Sagsveen M, Farmer JE, Prentice A, Breeze A. Gonadotrophin-releasing hormone analogues for endometriosis: Bone mineral density. Cochrane Database Syst Rev. 2003;4:CD001297.
31. Mounsey AL, Wilgus A, Slawson DC. Diagnosis and management of endometriosis. Am Fam Physician. 2006;74(4):594-600.
32. Selak V, Farquhar C, Prentice A, Singla A. Danazol for pelvic pain associated with endometriosis. Cochrane Database Syst Rev. 2007; 4:CD000068.
33. Muneyyirci-Delale O, Karacan M. Effect of norethindrone acetate in the treatment of symptomatic endometriosis. Int J Fertil Womens Med. 1998;43(1):24-27.
34. Telimaa S, Puolakka J, Ronnberg L, Kauppila A. Placebo-controlled comparison of danazol and high-dose medroxyprogesterone acetate in the treatment of endometriosis. Gynecol Endocrinol. 1987;1(1):13-23.
35. Lippert TH, Mueck AO. The clinical importance of dienogest. In: Teichmann AT, editor. Dienogest - Preclinical and Clinical Features of a New Progestogen. Berlin, Germany: Walter de Gruyter; 1995.
36. Mueck AO. What makes dienogest a unique progestogen for the treatment of endometriosis? Gynaecol Forum. 2010;15(2):18-23.
37. Oettel M, Breitbarth H, Elger W, et al. The pharmacological profle of dienogest. Eur J Contracept Reprod Health Care. 1999;4(S1):2-13.
38. Herkert O, Kuhl H, Sandow J, Busse R, Schini-Kerth VB. Sex steroids used in hormonal treatment increase vascular procoagulant activity by inducing thrombin receptor (PAR-1) expression: role of the glucocor-ticoid receptor. Circulation. 2001;104(23):2826-2831.
39. Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the effcacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010; 108(1):21-25.
40. Sasagawa S, Shimizu Y, Kami H, et al. Dienogest is a selective progesterone receptor agonist in transactivation analysis with potent oral endometrial activity due to its effcient pharmacokinetic profle. Steroids. 2008;73(2):222-231.
41. Sasagawa S, Shimizu Y, Nagaoka T, Tokado H, Imada K, Mizuguchi K. Dienogest, a selective progestin, reduces plasma estradiol level through induction of apoptosis of granulosa cells in the ovarian dominant follicle without follicle-stimulating hormone suppression in monkeys. J Endocrinol Invest. 2008;31(7):636-641.
42. Klipping C, Duijkers I, Faustmann T, Klein SF, Schuett B. Pharmacodynamic study of four oral dosages of dienogest. Fertil Steril. 2010;94 Suppl 1:S181.
43. Katayama H, Katayama T, Uematsu K, et al. Effect of dienogest administration on angiogenesis and hemodynamics in a rat endometrial autograft model. Hum Reprod. 2010;25(11):2851-2858.
44. Harada T, Taniguchi F. Dienogest: A new therapeutic agent for the treatment of endometriosis. Womens Health (Lond Engl). 2010; 6(1):27-35.
45. Nakamura M, Katsuki Y, Shibutani Y, Oikawa T. Dienogest, a synthetic steroid, suppresses both embryonic and tumor-cell-induced angiogenesis. Eur J Pharmacol. 1999;386(1):33-40.
46. Okada H, Nakajima T, Yoshimura T, Yasuda K, Kanzaki H. The inhibitory effect of dienogest, a synthetic steroid, on the growth of human endometrial stromal cells in vitro. Mol Hum Reprod. 2001; 7(4):341-347.
47. Katsuki Y, Takano Y, Futamura Y, et al. Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats. Eur J Endocrinol. 1998;138(2):216-226.
48. Fu L, Osuga Y, Morimoto C, et al. Dienogest inhibits BrdU uptake with G0/G1 arrest in cultured endometriotic stromal cells. Fertil Steril. 2008;89 Suppl 5:1344-1347.
49. Shimizu Y, Mita S, Takeuchi T, Notsu T, Mizuguchi K, Kyo S. Dienogest, a synthetic progestin, inhibits prostaglandin E(2) production and aromatase expression by human endometrial epithelial cells in a spheroid culture system. Steroids. 2011;76(1-2):60-67.
50. Tatsumi H, Kitawaki J, Tanaka K, Hosoda T, Honjo H. Lack of stimulatory effect of dienogest on the expression of intercellular adhesion molecule-1 and vascular cell adhesion molecule-1 by endothelial cell as compared with other synthetic progestins. Maturitas. 2002;42(4): 287-294.
51. Horie S, Harada T, Mitsunari M, Taniguchi F, Iwabe T, Terakawa N. Progesterone and progestational compounds attenuate tumor necrosis factor alpha-induced interleukin-8 production via nuclear factor kappa B inactivation in endometriotic stromal cells. Fertil Steril. 2005;83(5):1530-1535.
52. Momoeda M, Taketani Y. Randomized double-blind, multicentre, parallel-group dose-response study of dienogest in patients with endo-metriosis. Jpn Pharmacol Ther. 2007;35:769-783. Japanese.
53. Barbieri RL. Hormone treatment of endometriosis: the estrogen threshold hypothesis. Am J Obstet Gynecol. 1992;166:740-745.
54. Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: A 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010;151(2):193-198.
55. Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001;38(6):633-638.
56. Cosson M, Querleu D, Donnez J, et al. Dienogest is as effective as triptorelin in the treatment of endometriosis after laparoscopic surgery: Results of a prospective, multicenter, randomized study. Fertil Steril. 2002;77(4):684-692.
57. Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C. Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: A 24-week, randomized, multicentre, open-label trial. Hum Reprod. 2010;25(3):633-641.
58. Harada T, Momoeda M, Taketani Y, et al. Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis - a randomized, double-blind, multicenter, controlled trial. Fertil Steril. 2009;91(3):675-681.
59. Schindler AE, Christensen B, Henkel A, Oettel M, Moore C. High-dose pilot study with the novel progestogen dienogestin patients with endometriosis. Gynecol Endocrinol. 2006;22(1):9-17.
60. Schindler AE, Henkel A, Moore C, Oettel M. Effect and safety of high-dose dienogest (20 mg/day) in the treatment of women with endometriosis. Arch Gynecol Obstet. 2010;282(5):507-514.
61. Moore C, Carol W, Graser T, Mellinger U, Walter F. Infuence of dienogest on ovulation in young fertile women. Clin Drug Invest. 1999; 18:271-278.
62. Petraglia F, Hornung D, Seitz C, et al. Reduced pelvic pain in women with endometriosis: effcacy of long-term dienogest treatment. Arch Gynecol Obstet. June 17, 2011. [Epub ahead of print.]
63. Momoeda M, Harada T, Terakawa N, et al. Long-term use of dienogest for the treatment of endometriosis. J Obstet Gynaecol Res. 2009; 35(6):1069-1076.
64. ®. Summary of Product Characteristics. 2010. Available from: http://visanne.com/en/auth/prescribing-essentials/spc/index.php. Accessed May 25, 2011.
65. Kitawaki J, Kusuki I, Yamanaka K, Suganuma I. Maintenance therapy with dienogest following gonadotropin-releasing hormone agonist treatment for endometriosis-associated pelvic pain. Eur J Obstet Gynecol Reprod Biol. April 5, 2011. [Epub ahead of print].