lng-ius: heavy menstrual bleeding what is new??? dr. jyoti agarwal / dr. sharda jain / dr. jyoti...
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LNG-IUS: heavy meNStrUaL bLeedING
What IS NeW???
Dr. Sharda JainDr. Jyoti Agarwal Dr. Jyoti Bhaskar
1 Int J Women’s Health. 2011;3: 207–21; 2. J Midlife Health. 2013;4(1):8–15; 3. Open Access J
Contracep. 2013; 4:21–28; 4 NICE 2007; 5. Drug safety 2004
Major impact on a woman’s quality of life
Options AvailableOptions Available
Mirena / Endometrial Ablation
Drug therapyDrug therapy
Hysterectomy
LNG-IUS first designed in Finland – 1990
• From the concept of contraception, the spectrum of indications broadened
• In sept 2009 , the US FDA approved
mirena as a treatment for heavy menstrual bleeding
Obstet gynecol 2009;1104-1116
NatIoNaL eSSeNtIaL LISt of medIcINe (NeLm) 2011
Out of 348 drugs Govt . of India has inc luded LNG-IUS as hormonal IUD in NELM 2011
Source: Union Health Ministry of India
From Research to Practice – Long Way to Go
• Progestin releasing intrauterine system
• T shaped polyethylene frame
• Contains 52 mg levonorgestrel
• Releases 20 µg LNG daily
What is Mirena - LNG IUS
Mirena :‘Local is logical’
local mode of action • Prevents endometrial
proliferation• Thickens cervical mucus• Inhibits sperm motility
serum levels are 4 times lower than after oral ingestion
usage
4CHALLENGES
MOTIVATION INSERTION POST INSERTION COST
Motivational Facts …….• Over 60% of women diagnosed with
HMB ended up having a hysterectomy within 5 years from the diagnosis
• About 1/3 rd of hysterectomies for HMB result in removal of anatomically normal uterus
MOTIVATION
Your words can change their
world
MIRENA
Inspired by : Prof.Osama Showki
Magic Stick
International Guidelines recommend LNG-IUS as first line Rx in HMB
Data on file
Recent guidelines place more emphasis on
improvement of QoL of the patient
Data on file
Efficacy of LNG - IUSEfficacy of LNG - IUS
“The results are in line with NICE recommendations 2007, as they show that women should be offered Mirena
first to avoid more invasive treatment”
Efficacy of LNG IUS in Idiopathic Menorrhagia
97% Reduction in Menstrual Blood Loss over 1 year of therapy
Significant increase in Hemoglobin and Serum Ferritin level
Comparison of Rx Modalities Progesterone or LNG IUS
LNG IUS reduces menstrual blood loss more effectively and has a higher likelihood of treatment success than oral medroxyprogesterone acetate.
Obstet Gynecol. 2010
Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing
Intrauterine System in Primary Care against Standard Treatment for
Menorrhagia (ECLIPSE) Trial
21
Improvements in MMAS scores were significantly greater (lesser score= more severity)
Gupta J, Kai J, Middleton L, Pattison H, Gray R, Daniels J for the ECLIPSE Trial Collaborative Group N Engl J Med 2013;368:128-37
Daily routine work, social and family life, and psychological and physical well-being Menorrhagia Multi-Attribute Scale (MMAS)
COCs= Combined OC pills; LNG-IUS – Levonorgestrel Intrauterine System; GnRH – Gonadotrophin Releasing Hormone agonists
Finnish Survey:: Among 75 Obstericians/ gynaecologists
working at the Helsinki University Central Hospital (2013)
Pre congress course on heavy menstrual bleeding, 10‐ th Congress of European Society of Gynecologists, Brussels Belgium September 18-21 2013
In your opinion what is the most effective medical treatment for HMB?
Finnish trial (multicentric RCT 236 pts)
• Mirena improves the quality of life as effectively as surgical treatment at 1 year.
• Women ranked their satisfaction with a mean score of 7 / 10.
• Less than 5% of women required subsequent operative treatment
• Mirena is more cost effective than hysterectomy in the short term
LNG IUS versus Hysterectomy
24
When patients were given the option of mirena a significant percentage of women cancelled their hysterectomy
Pekka Lähteenmäki et al. 1998 316: 1122 (6)
Objective: To evaluate the efficacy, acceptability, and possible side effects of a levonorgestrelreleasingintrauterine system for menorrhagia. Method : Sixty-three women with menorrhagiabut without uterine enlargement, endometrial hyperplasia, or endometrial carcinomawere enrolled in this prospective, open, nonrandomized clinical trial and LNG-IUS was inserter in post menstrual period to these womenResult : Menstrual pattern, number of bleeding days, and subjective and objectiveestimation of menstrual blood loss using a pictorial blood loss assessment chart (PBAC) were recorded before insertion and at specific intervals for 4 years.Conclusion: Using the LNG-IUS is an effectiveand well-accepted option overall for the medical management of menorrhagia.
Mirena is an effective and well-accepted option for the medical management of menorrhagia in India : An AIIMS Study 2007
• OBJECTIVE : To evaluate the efficacy of an intrauterine system releasing levonorgestrel (LNG-IUS, Mirena) in the treatment of women with menorrhegia .
• METHOD(S) : This was a prospective, non-comparative study. Twenty patients who had Menorrhagia due to non-malignant causes were included in the study (age range 20-42 years). However patients of fibroid uterus with uterine size more than 12 weeks and those with submucous fibroid were excluded. A LNG-releasing-intrauterine system was inserted on any day during bleeding or within a week of cessation of bleeding. Menstrual blood loss was assessed, before LNG-IUS was inserted, and after 3, 6, and 12 months of use.
• RESULTS : The most common bleeding pattern at 3 months after insertion was spotting and after 6 and 12 months the majority of women presented with amenorrhea or oligomenorrhea. One woman requested removal of the LNG-IUS because of continuous spotting even after 4 months of insertion. The remaining women continued the use of LNG-IUS beyond 1 year.
• CONCLUSION: LNG-IUS is an effective treatment for Menorrhagia due to benign causes and could be an alternative to hysterectomy.
Mirena is an effective treatment for Menorrhagia and could be an alternative to hysterectomy: An Indian Study
2005
Bleeding pattern in the first 5-year period
Rönnerdag M, Odlind V. Acta Obstet Gynecol Scand 1999;78:716–21
Infrequent3.7% Regular
70.3%
Ammenorhea 26%
2nd challenge
How to insert Mirena properly???
It has been seen that properly placed Mirena rarely gets displaced
3rd challengePractical tips for
post insertion success
COUNSELLING
Is it not very costly as compared to oral medication?
Doctor, I am spotting daily? What do I do?
I have not had periods since 6 months? Am I in menopause?
Counselling !!!
• Spotting after insertion
• Amenorrhea in 25 % of women
Irregular Bleeding or spotting
May last for 3 - 4 months COC Progesterone GnRHa are used to tide over this period Sevista
Acceptance depends on good pre insertion counselling
4th
challenge
COST EFFECTIVENESS
LNG IUS
• Cost- Rs 8205/-• Insertion cost – Rs.
2000 - 5000 Covered by Insurance
ORAL PROGESTERONE
1 mnth – Rs. 3000 6 months Rs. 18000 1 Yr Rs. 36000
No insurance
Emerging new indications for use
of mirena
Endometriosis it provides long term relief of chronic pelvic pain
Obstet gynecol 2012;119:519-526
FIBROIDS
Significant reduction in both the uterine volume and blood loss
Endometrial Hyperplasia
• Beneficial effects are observed by1 year.
• Treatment should be reliably monitored through regular 6-montly outpatient follow up
Eur J Obstet Gynecol Reprod Biol. 2008
Early-stage Endometrial Carcinoma
May have a role in selected patients willing to preserve fertility
• Endometrial protection for women on tamoxifen • Women With Clotting Disorders Or Under Anti
Thrombotic Treatment
Conservative treatment of early endometrial cancer: preliminary
results of a pilot study.Gynecol Oncol. 2011; 120(1):43-6
How long ? NICE GUIDELINES : If inserted > 45 yrs of
age and has complete amenorrhea may
continue to use it until menopause. It can be removed at mid 50s as long as it controls the
bleeding
HRTChange it after 4 years “licenced”
Contraception< 45years…..5 years
> 45 years ….7 years
Are there any drugs that interact with mirena ?
• Women using mirena may be reassured that
• No drugs are known to interact with mirena
• Can be used safely with ATT
• No effect on BMD
Not to be used as Emergency Contraceptive
Health Benefits
No significant change in• Blood pressure• Lipid profile• Coagulation factors• Carbohydrate metabolism• Liver function• Bone mineral density
Sonographic Evaluation
Routine use of ultrasound is not indicated
Our Experience
with
MIRENA in
Heavy Bleeding
Used in 300 casesINCLUDING FIBROIDS AND ENDOMETRIOSIS
(July 2014)
Expulsion in 3
(UBT , hysterectomy , reinsertion )
• It can replace the need of hysterectomy in
50 % of cases.
• Especially useful when future fertility is
desired
Mirena
Positive Side
• Effective after 4 month • Major Surgery is saved – Mortality
- Morbidity
Cost Effective
To conclude …..
HYSTERECTOMY
as Treatment
Should be last resort
LNG - IUS
Its not simply a Pregnancy
Hormone.
But in true sense,a
Mother Hormone.
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 [email protected]
[email protected]@lifecareivf.com
&
Thank You