Ormeloxifene copy

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Ormeloxifene copy

  1. 1. Dr. Sharda Jain Dr. Jyoti Agarwal Dr. Jyoti Bhaskar
  2. 2. 2014 INTERACTIVE SESSION FEEDBACK SHARE EXPERIENCE
  3. 3. CDR INSTITUTE OF LUCKNOW -- 1991
  4. 4. SERM A NON STEROIDAL MEDICAL TREATMENT FOR DUB
  5. 5. “An optimally designed SERM with Varied Tissue Response”
  6. 6.  PILOT STUDY AT AIIMS IN 2009  A DOUBLE BLINDED RCT IN BELGAUM IN 2011  OTHER SMALLER STUDIES
  7. 7. LIARE TEAM OVER 700 PATIENTS TREATED WITH ORMELOXIFENE
  8. 8. PERSISTENT , NON RESPONDING  ANTIFIBRINOLYTICS, PROGESTERONES  NO ESTROGENS TILL AGE OF 16 YRS  ORMELOXIFENE : HB >12 gm %
  9. 9. VERY DISTRESSING TVS – NORMAL  DAFLON FOR 1 WEEK  ORMELOXIFENE – DOUBLE BENEFIT
  10. 10.  INJ DMPA IS GIVEN INITIALLY  THEN ORMELOXIFENE -- PROVIDES CONTRACEPTION AND CONTROL OF BLEEDING
  11. 11.  FIRST 3 - 6 MONTHS – THE DIFFICULT PERIOD  EXTREMELY GOOD RESPONSE
  12. 12.  TVS IN ALL PATIENTS  ENDOMETRIAL BIOPSY TO RULE OUT HYPERPLASIA
  13. 13.  Convenient dosage – twice or once weekly  60 mg tablets twice a week ( for example, Sunday & Wednesday) for 12 weeks followed by one tablet of 60 mg once a week for another 12 weeks
  14. 14. 1. Postmenopausal Bleeding 2. Endometrial Hyperplasia 3. Infertile patients 4. PCOS Special mention: 1. In PMB , after balloon therapy – once a week for 3 months 2. In hyperplasia – along with progesterone's
  15. 15.  Ovarian Cysts
  16. 16. 15 CASES -- ON BIOPSY , ATROPHIC ENDOMETRITIS
  17. 17. Progestational agents  Medroxyprogesterone acetate,  Norethisterone  Depo-medroxyprogesterone  Oral contraceptives  Levonorgestrel-releasing intrauterine device  Clomiphene citrate Other – Antiprostaglandins, antifibrinolytics, danazol, gonadotropin-releasing hormone analogs (GnRH). DUB – Medical Management Options –DUB – Medical Management Options –
  18. 18. 0 -25 -50 -75 -100 Mirena Placebo Prostaglandins Synthetase Inhibitor T A COCs Decrease % Percentage reduction in blood loss
  19. 19. QUEST GOES ON ………
  20. 20.  Medical Management remains the first line  Option has to be individualised  No medication so far is satisfactory  Let us be selective, develop our own wealth of experience and share
  21. 21. FEEDBACK !!!!
  22. 22. Dr.Jyoti Bhaskar MD MRCOG Director Lifecare IVF Consultant Lifecare Centre, Pushpanjali Crosslay Hospital
  23. 23. “Excessive menstrual blood loss which interferes with the woman’s physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms.” Nice guidelines 2007
  24. 24. Woman Centred Care  Goals  Control bleeding  Correct anemia/associated conditions  Prevent recurrence  Improve quality of life
  25. 25. MEDICAL RX MINIMAL ACCESS SURGERY HYSTERECTOMY Any interventions should aim to improve quality of life measures. [D] -- NICE guidelines
  26. 26.  Whether cycles are ovulatory or not  Age  Whether the patient requires contraception  Desires Fertility  Choice of the patient
  27. 27. First Line Levonorgestrel-releasing intrauterine system (LNG-IUS) Second Line Tranexamic acid (non-hormonal) Can be used in parallel with investigations. If no improvement, stop treatment after 3 cycles Non-steroidal anti-inflammatory drugs (NSAIDs) If no improvement, stop treatment after 3 cycles. Can be used in parallel with investigations Preferred over tranexamic acid in dysmenorrhoea Combined oral contraceptives Pharmaceutical Treatment – Nice Guidelines
  28. 28. Third Line Oral progestogen Norethisterone (15 mg) daily from days 5 to 26 of the menstrual cycle Injected progestogen Others Gonadotrophin-releasing hormone analogue (Gn-RH analogue) If used for more than 6 months add back HRT therapy is recommended
  29. 29.  Oral progestogens in the luteal phase only  Danazol  Ethamsylate  Dilatation and curettage (D and C)
  30. 30.  Medical treatment is an effective first line therapeutic option for abnormal uterine bleeding.  Tailored to the individual woman’s therapeutic goals, desire for contraception, underlying medical conditions, and tolerance of side effects
  31. 31.  Cyclic or Predictable in timing Non-hormonal options such as non- steroidal anti-inflammatory drugs and antifibrinolytics  Who desire effective contraception. COC, INJ DMPA, LNG-IUS
  32. 32.  Cyclic luteal-phase progestins do not effectively reduce blood loss and therefore should not be used as a specific treatment for heavy menstrual bleeding  Medical or Surgical treatments have failed or are contraindicated : Danazol and gonadotropin-releasing hormone agonists
  33. 33. Progestational agents  Medroxyprogesterone acetate,  Norethisterone  Depo-medroxyprogesterone  Oral contraceptives  Levonorgestrel-releasing intrauterine device  Clomiphene citrate Other – Antiprostaglandins, antifibrinolytics, danazol, gonadotropin-releasing hormone analogs (GnRH) . DUB – Medical Management Options –DUB – Medical Management Options –
  34. 34. 0 -25 -50 -75 -100 Mirena Placebo Prostaglandins Synthetase Inhibitor T A COCs Decrease % Percentage reduction in blood loss
  35. 35. QUEST GOES ON ………
  36. 36. “The ideal therapy should be a designer drug which can block the action of estrogen on the endometrium but not its beneficial actions on other tissues”
  37. 37. J Clin Oncol 2000 18:3172-3186. Estrogens Antiestrogens SERMs TamoxifineTamoxifine DroloxifineDroloxifine ToremifineToremifine RaloxifineRaloxifine OrmeloxifineOrmeloxifine
  38. 38. “An optimally designed SERM with Varied Tissue Response”
  39. 39.  It blocks the cytosol receptors by its competitive binding affinity over Estradiol  It’s action lasts long after the drug is withdrawn  The long elimination of the half-life of ormeloxifene provides a basis for a weekly dosing schedule1  It is estrogen antagonist in Uterus & Breast and has mild estrogenic action on vagina, Bone mineral density, CNS and Serum Lipids2  No action on Hypothalamic Pituitary Ovarian function, Thyroid or Adrenal  No Progestational, Androgenic or Antiandrogenic properties2
  40. 40.  Dysfunctional uterine bleeding at any age  Relief of PMS in perimenopausal women  For women desiring contraceptive property  Has an excellent safety profile, very well-tolerated & practically without any undesirable side-effects
  41. 41.  Convenient dosage – twice or once weekly  60 mg tablets twice a week ( for example, Sunday & Wednesday) for 12 weeks followed by one tablet of 60 mg once a week for another 12 weeks
  42. 42.  CDR Institute Lucknow 1991  Once a week Non Hormonal Contraceptive  Marketed in India in 1992 as Saheli and Choice-7 and Centron  Included in the National Family Welfare Programme in 1995
  43. 43.  Study Population: Forty-two women with menorrhagia were recruited for the study  Dosage: Ormeloxifene was given to each patient 60 mg twice a week for 3 months and then once a week for 1 month. Patients were followed up at 2 and 4 months of therapy, then at 3 and 6 months after treatment was stopped  Assessments:  Menstrual blood loss (MBL) was measured objectively by a pictorial blood loss assessment chart (PBAC) score and subjectively by a visual analog scale (VAS) J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009
  44. 44.  The pretreatment median PBAC score was 388 (range 169–835)  Median PBAC reduced to 80 (range 0–730) and 5 (range 0– 310) at 2 and 4 months, respectively (p-value <0.001)  The percentage reduction in PBAC score - 97.7% at 4 months J. Obstet. Gynaecol. Res. vol. 35, No. 4: 746–752, August 2009 Reduction in PBAC Score
  45. 45.  Amenorrhea with the therapy – 18 patients (42.9%)  Adverse effects included ovarian cyst (7.1%), cervical erosion and discharge (7.1%), gastric dyspepsia (4.8%), vague abdominal pain (4.8%) and headache (4.8%) J. Obstet. Gynaecol. Res. Vol. 35, No. 4: 746–752, August 2009 Percentage Reduction in PBAC ScorePercentage Reduction in PBAC Score 97.7%97.7% 2.3%2.3%
  46. 46. Journal of South Asian Federation of obstetrics and Gynaecology Jan –April 2011 .Study Population: 84 women attending gynae OPD in Belgaum India were enrolled , 42 in each arm. Dosage: Group A – 60 mg ormeloxifene twice a week for 3 consecutive cycles and Group B – 10 mg MPA from day 5-25 for 3 cycles. All were made to use same type of sanitary napkins and TVS done for ET before and after treatment Data Analysis : Mean PBAC score and endometrial thickness were compared Result: Mean PBAC score reduction of 85.7 % and 54% in group A and B resp ET reduction was more in Ormeloxifene group but not statistically sign. Conclusion: oremloxifene is more effective in reducing bleeding than MPA
  47. 47. 49 PBAC Score (p = 0.0205)
  48. 48.  Indications 1. Puberty Mennorhagia 2. Postnatal Bleeding 3. DUB- after TVS r/o Ovarian Cyst 4. Mirena Users – immediate 3 months  Dose- 60mg twice weekly for 3months.  Effective upto 1 year after stopping it.
  49. 49. 1. Postmenopausal Bleeding 2. Endometrial Hyperplasia 3. Infertile patients 4. PCOS Special mention: 1. In PMB , after balloon therapy – once a week for 3 months 2. In hyperplasia – along with progesterone's
  50. 50.  Ovarian Cysts
  51. 51.  FIBROADENOMA  BREAST MASTALGIA
  52. 52. Role of Ormeloxifene in benign Mastalgia of diverse origin Paper No 779 presented by Dr. Subrat kumar Mohakul and Dr. Sujatha Guttala. on 18th Jan 2013 at 56th AICOG 2013,
  53. 53. Ormeloxifene (Sevista) Product Monograph. Data on file.
  54. 54.  First Line of management of DUB should be pharmaceutical  Available medical modalities are far from satisfactory  Important to individualize the treatment  Mirena is the first line of treatment – Nice Guidelines  Ormeloxifene is safe, efficacious, cheap and easy to administer.
  55. 55. ADDRESS 11 Gagan Vihar, Near Karkari Morh Flyover, Delhi - 51 CONTACT US 9650588339, 011-22414049, WEBSITE : www.lifecarecentre.in www.drshardajain.com www.lifecareivf.com E-MAIL ID Sharda.lifecare@gmail.com Lifecarecentre21@gmail.com info@lifecareivf.com & Thank You
  56. 56. Thank YouThank You THANK YOU Making one person smile can change the world. May be not the whole world but their world..

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