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

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CONTACT US 9650588339, 011-22414049,

WEBSITE : www.lifecarecentre.in

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