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  • Female Sterilization33.40%Male Sterilization0.50%Pill4.50%IUD2.50%Injectables0.10%Condoms7.30%Traditional Methods8%Not Using any Methods43.60%
  • The mechanism by which Mirena® provides contraceptive protection is not completely understood, but it probably depends on a combination of 3 different actions: Thickening of cervical mucus Inhibition of sperm motility and function inside the uterus and the ovarian tubes Suppression of endometrial growth by making the endometrium unresponsive to oestrogenA weak foreign-body reaction is also present and in some women, ovulation is inhibited.As a method of contraception, the efficacy of Mirena® compares well with that of female sterilisation, with the added benefit of reversibility [1]. Reported pregnancy rates in the first year of Mirena® use range from 0.0 to 0.2%, and the cumulative rates over 5 years range from 0.5 to 1.1%. The typical pregnancy rate for female sterilisation is 0.5% within the first year.Mirena® has the advantage over oral contraceptives in that there is no user failure (e.g. forgetting to take the Pill). Many women greatly appreciate the convenience of up to 5 years’ contraceptive protection from a single Mirena® system.Reference1. Trussell J. Contraceptive efficacy. In: Contraceptive Technology: Seventeenth Revised Edition (Hatcher RA, Trussell J, Stewart F, et al., eds.) Irvington Publishers: New York, 1998.
  • The Contraceptive CHOICE Project is a prospective cohort study of 10,000 women 14-45 years who want to avoid pregnancy for at least 1 year and are initiating a new form of reversible contraceptionOctober 5, 2012 — When adolescent and adult women were offered no-cost contraception for 3 years, abortion rates fell 62% to 78% below national levels, according to a prospective cohort study of 9256 adolescent and adult women desiring reversible contraception. Teen birth rates also fell far below national rates.Jeffrey F. Peipert, MD, PhD, the Robert J. Terry professor of obstetrics and gynecology, vice chair of clinical research, and obstetrics/gynecology residency program director at the Washington University School of Medicine in St. Louis, Missouri, and his colleagues reported their findings online October 4 in the journal Obstetrics & Gynecology .This study is important because almost half (49%) of pregnancies in the United States from 2006 to 2008 were unintended, with a cost to taxpayers of about $11 billion annually for 1 million unintended births, the authors write in the journal.Long-acting reversible contraceptive (LARC) methods (IUDs and implantable contraception) are more effective than other methods, but they also are more expensive initially, and many women cannot afford them.A total of 9256 adolescents and women enrolled in the Contraceptive CHOICE Project in the St. Louis, Missouri, metropolitan area between August 2007 and September 2011. Investigators recruited 16% of them at abortion facilities.Participants were counseled on contraceptive methods and their effectiveness, and offered the reversible contraceptive method of their choice for 3 years. They were able to switch methods during the study, if they desired.Three-Quarters Chose LARCAt enrollment, 75% of the study group selected a LARC method (46% levonorgestrel IUD, 12% copper IUD, 17% subdermal implant). Other methods were chosen by the rest of the participants: 9% oral contraceptive pills (OCPs), 7% contraceptive vaginal ring, 7% depot medroxyprogesterone acetate, and 2% contraceptive patch.Participants recruited from abortion facilities were more likely to choose a LARC compared with those recruited at other locations (84.5% compared with 72.9%, P < .001).The teenage birth rate (births per 1000 females aged 15 to 19 years) within the CHOICE cohort was 6.3 per 1000. This is far below the national level of 34.3 per 1,000 reported in 2010, note the authors. They used this rate as a proxy for unintended pregnancy, which makes up as much as 80% of teen pregnancies.Between 2008 and 2010, there was a 20.6% (P < .001) drop in the number of abortions performed at Reproductive Health Services among adolescents and women who lived in St. Louis City and County, compared with no appreciable change (0%, P = .39) in the number of abortions among adolescents and women living in the rest of Missouri.The researchers selected the percentage of abortions that were repeat abortions as their primary outcome of interest because providers and government statistics track this information. They also hoped to have the greatest population effect by providing the contraception to those at highest risk for unintended pregnancy.Women and adolescents who obtain abortions are at risk for unintended pregnancy and repeat abortion in the future, and may be motivated to pursue contraceptive services.According to vital statistics data from Missouri's department of health, there was a significant difference between the proportion of repeat abortions in the St. Louis and Kansas City regions in 2009 (P = .02) and 2010 (P < .01). In addition, the proportion of repeat abortions in the St. Louis region decreased steadily from 2006 to 2010 (P = .002).After adjusting for age and race, abortion rates among study participants ranged from 4.4 to 7.5 per 1000 women, far lower (62% to 78%) than the national rate of 19.6 abortions per 1000 women in 2008, the most recent year for which data are available.Abortion rates for CHOICE participants were also substantially lower than those in St. Louis City and County during the same time period (P < .001), which ranged from 13.4 to 17.0 per 1000 women.The researchers estimate that 1 abortion could be prevented for every 79 to 137 women and adolescents provided with the same intervention as the study participants.Study Simulated IOM RecommendationThe Institute of Medicine has recommended that all contraception be provided without cost under the Patient Protection and Affordable Care Act of 2010. "The Contraceptive CHOICE Project essentially simulated this recommendation in our region for reversible contraceptive methods," the authors write."[B]based on our calculations…changes in contraceptive policy simulating the Contraceptive CHOICE Project would prevent as many as 41 - 71% of abortions performed annually in the United States," the authors add.Alice Mark, MD, senior clinical advisor for Ipas, and member of the American Congress of Obstetricians and Gynecologists' Committee on Adolescent Health Care, commented on the study in a telephone interview with Medscape Medical News.Dr. Mark explained that this study provides "more support for increasing access, especially to high-risk women and young women, to the most effective methods, which include IUDs and implants." She noted that the US has a high rate of unintended pregnancy compared with other developed countries."It's a great model, especially as the Affordable Care Act comes online, [that] if the cost of the devices is taken away and women are given good choices about what they can use, if they start using these methods, I think that would be something very promising to cut the rate of unintended pregnancies," Dr. Mark said.The Contraceptive CHOICE Project is funded by the Susan Thompson Buffett Foundation.
  • Levonorgestrel- and copper-releasing IUDs: Andersson et al.Pelvic InfectionsThere was in neither the Nova T nor in the LNG-IUD group an increasedincidence of PID in relation to the IUD insertion (Figure 4). The 60-monthgross removal rates for PID were 2.2 in the Nova T and 0.8 in the LNGIUDgroup [(P < O.OS), (Table 3)]. In the LNG-IUD users, the incidence ofPID was low regardless of age whereas in the Nova T group, there was asignificantly (P < 0.01) increased PID rate compared to LNG-IUD amongthe youngest women (Table 3).The absolute risk of pelvic inflammatory disease was low (for all IUDs) : Mohllajee et al, 2006 0–5% for women with infection at the time of IUD insertion, and 0–2% for those without a sexually transmitted infection
  • Lng ius final

    1. 1. 1
    2. 2. CONTRACEPTION UPDATE Levonorgestrel Intra Uterine System: Expanding the Horizons 2
    3. 3. Current Use of Contraception in India NFHS III Survey 44% OF INDIAN WOMEN DON’T USE ANY FORM OF CONTRACEPTION Not Using any Method 43.60% Female Sterilization 37.30% Pill 3.10% Traditional Methods 7.9% Condoms 5.20% Male Sterilization 1% IUD 1.70% Injectables 0.10% Percent distribution of contraceptive method currently used NFHS III, India, 2005-06 3
    4. 4. Long Acting Reversible Contraceptives (LARCs) What are LARCs ? Methods that require administering less than once per cycle or month Options for LARCs: • Copper T • Implants • Injectables • Levonorgestrel Intra Uterine System 4
    5. 5. LARC: Levonorgestrel Intra Uterine System Contraceptive Efficacy: • Acts predominantly by preventing implantation and sometimes by preventing fertilization • Pregnancy rate: 0-0.2 % in first year of use • Duration of use : 5 years • No evidence of a delay in the return of fertility following removal or expulsion of the IUS Risk of Uterine Perforation < 1 in 1000 Risk of P.I.D <1 in 100 IUD Expulsion Rate < 1 in 20 women in 5 years Risk of Ectopic Pregnancy 1 in 1000 in 5 years National Institute for Health and Clinical Excellence 2005, WHO Handbook of Family Planning 2007 5
    6. 6. Levonorgestrel Intra Uterine System THEN… AND NOW !!! 1ST GENERATION: Non-medicated Intra uterine devices, e.g. Lippies loop and Margulies spiral 2ND GENERATION: Bioactive- “Cu” ions releasing intra uterine devices e.g. T 200, T 220, T 380. 3RD GENERATION: Bioactive- Progesterone releasing intra uterine system e.g.: LNG IUS 6
    7. 7. Levonorgestrel Intra Uterine System Pharmacokinetics • No peaks and troughs as with oral dosing • Much higher endometrial levels of progestogen as with oral therapy LNG IUS Oral Preparation (250mcg) • Detectable levels of LNG in plasma within 15 minutes Nilsson et al. 1982 7
    8. 8. Levonorgestrel Intra Uterine System Indicated for: • Contraception • In management of Idiopathic Menorrhagia • In protection of endometrium from endometrial hyperplasia during estrogen replacement therapy 8
    9. 9. Levonorgestrel Intra Uterine System Contraception LNG IUS provides Contraception through a combination of 3 actions 9
    10. 10. Levonorgestrel Intra Uterine System Contraceptive Efficacy Efficacy of LNG-IUS similar to or even better than female sterilization Failure Rate % Trussel J. Contraceptive failure in the United States. Contraception 2004;70:89–96 10
    11. 11. 46 % of study group selected LNG IUS over other contraceptive options 2% LNG IUS 7% 7% Cu T LARCs Implants 9% 46% OC Pills 17% Vaginal Rings 12% MPA Patches 75 % of study group selected LARC over other contraceptive options Reference: Contraceptive CHOICE Project Obstet Gynecol. 2012;120:1-8 11
    12. 12. 8 LNG IUS showed Continuation rate of 88%, highest amongst all the methods 49% LNG IUS 88% Cu T 57% Implants OC Pills 84% 54% Vaginal Rings 55% MPA 83% Patches LARC showed Continuation rate of 86% over non-LARC which was just 55% Reference: Contraceptive CHOICE Project Obstet Gynecol. 2012;120:1-8 12
    13. 13. LNG IUS showed Satisfaction rate of 85%, highest amongst all the methods 42% LNG IUS 85% 55% Cu T Implants 79% 55% OC Pills Vaginal Rings 55% 79% MPA Patches LARC showed highest Satisfaction rate amongst all the methods Reference: Contraceptive CHOICE Project Obstet Gynecol. 2012;120:1-8 13
    14. 14. LARCs and Depo had lowest Failure rate amongst all other methods FAILURE RATES 10.00% 9.00% 8.00% 7.00% 6.00% 5.00% LARC 4.00% 3.00% Depo MPA 2.00% Pills/Patches/Rings 1.00% 0.00% 1 year 2 year 3 year Patches/Pills/Rings had Failure rates almost 16 times higher that of LARCs in 1st year Reference: Contraceptive CHOICE Project Obstet Gynecol. 2012;120:1-8 14
    15. 15. Hormonal versus Non-Hormonal Methods (LNG IUS vs. Cu T) Patient related most frequent clinical concerns : • • • • • • • Weight gain issue Pelvic Inflammatory Disease Breast Cancer risks Ectopic pregnancy incidences Uterine perforation incidences Effect on lipid, carbohydrate metabolic profile Effect on serum Hemoglobin and Iron level in body 15
    16. 16. LNG IUS versus Copper T IUD Clinical concerns: • Weight gain1 – Studies have shown that women do not gain more weight while using the IUS more than those using a non-hormonal method of contraception -Cu-IUD. (5-year study) • Pelvic Inflammatory Disease1 – the rate of pelvic inflammatory disease is lower with use of LNG IUS, compared to the Cu-IUD at 3 and 5 years – LNG-IUS may actually protect against upper genital tract infection by thickening of cervical mucus Therapy Removal Rate due to Pelvic Inflammatory Disease (5years) Cu T 2.2 LNG IUS 0.8 1 Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Andersson K, Odlind V, Rybo G. 16
    17. 17. LNG IUS versus Copper T IUD Clinical concerns: • Breast Cancer 1 – Use of LNG IUS is not associated with an increased risk of development of breast cancer as compared with Cu T • Ectopic Pregnancy 2 – Their is a low incidence of ectopic pregnancy with LNG IUS use – An analysis of 42 randomized trials estimated ectopic rates per 1000 womanyears to be: LNG IUS 0.1 Cu T 3 0.5 Not using any Contraception 0.3 - 0.5% per year 1Dinger J,. Bardenheuer K, & Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception 83 (2011) 211–217. 2Mirena Extended CCDS 2011 Bayer HealthCare Pharmaceuticals, 22nd March 2011 3 Paula Bednarek International Journal of Women’s Health 2009:1 45–58 17
    18. 18. LNG IUS versus Copper T IUD Clinical concerns: • Uterine Perforation 1 – The incidence of uterine perforation is less than 1 per 1000 placements – Appears to be similar to that observed with Cu- IUDs 2 – If perforation or penetration occurs, it may decrease the effectiveness of LNG IUS, which must then be removed – A history of uterine perforation is not a contraindication for later use of an IUD 1 Mirena Product Information based on Extended CCDS 2011 Bayer HealthCare Pharmaceuticals, 22nd March 2011 2 Harrison-WoolrychM, Zhou L, & Coulter D. (2003). Insertion of intrauterine devices: a comparison of experience with Mirena and Multiload Cu 375 during 18 post-marketing monitoring in New Zealand. N Z Med J 116, U538
    19. 19. LNG IUS versus Copper T IUD Clinical concerns: • Effect on other body parameters and in special cases – In long-term studies comparing LNG IUS and Cu-IUDs, the use of LNG IUS results in significantly higher levels of hemoglobin, serum ferritin and serum protein than in the use of Cu-IUDs1 – LNG IUS has no clinically significant effects on serum lipids, carbohydrate metabolism, liver enzymes or the coagulation system1 – LNG-IUS provides a good alternative to systemic hormonal methods, particularly in diabetics with vascular disease, smokers, and women with a history of thrombosis2 – Women with coagulopathies, including those on warfarin, experience a reduction in bleeding with the LNG-IUS2 1 LuukkainenT. (1991). Levonorgestrel-releasing intrauterine device. Ann N Y AcadSci 626, 43-49. 2 Bednarek and Jensen International Journal of Women’s Health 2009:1 45–58 19
    20. 20. LNG IUS versus Copper T IUD LNG IUS showed higher (45% & 88%) patient Preference and Continuation rate as compared to Cu T IUD (10% & 84%) PATIENT PREFERENCE &CONTINUATION RATES 20 Peipert et al Reversible Contraception Continuation and Satisfaction ObstetGynecol 2011;117:1105–13)
    21. 21. Levonorgestrel Intra Uterine System in Idiopathic Menorrhagia • Idiopathic menorrhagia is defined as when menstrual blood loss is >80 ml (>7 days) in the absence of organic pathology • Options in management of Menorrhagia: Medical Therapy: • • • • • Progestogens (oral or injectable) LNG IUS Tranexamic acid Non-steroidal antiinflammatory agents Combined oral contraceptives GnRH analogues Surgical Therapy: • Hysterectomy • Thermal Balloon ablation • Trans Cervical Resection of the Endometrium • Cryotherapy 21
    22. 22. Efficacy of LNG IUS in Idiopathic Menorrhagia LNG IUS leads to significant reduction of MBL to 23.4 mL (78.7% decrease), 26.4 mL (83.8% decrease), 2.7 mL (97.7% decrease) and 13.7 mL (85.0% decrease) at 6, 12, 24, and 36 months 22
    23. 23. Efficacy of LNG IUS in Idiopathic Menorrhagia A meta-analysis done with LNG IUS and published in 2011 concluded: • MBL declined sharply during the first 3 months • The median decline after 3 months was -84.5% and after 6 months was -92.9% • This significant effect of reduced menstrual bleeding remained stable till the 5year period of use 23 Endrikat J, et al. Arch Gynecol Obstet. 2011
    24. 24. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial Improvements in MMAS scores were significantly greater among women assigned to LNG- IUS than among those assigned to usual treatment (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 24
    25. 25. Effectiveness and Cost-Effectiveness of Levonorgestrel- Containing Intrauterine System in Primary Care against Standard Treatment for Menorrhagia (ECLIPSE) Trial Scores for women in the LNG- IUS group were better than for those in the usual-treatment group LNG-IUS lead to greater improvement in women’s assessments of the effect of heavy menstrual bleeding on their daily routine, including work, social and family life, and psychological and physical well-being 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 25
    26. 26. LNG IUS versus Surgical therapies for management of Menorrhagia • LNG IUS represents a well-tolerated, effective and less invasive alternative to endometrial ablation, endometrial resection and Hysterectomy • Allows women to preserve their fertility • LNG IUS has similar efficacy to endometrial ablation in the treatment of menorrhagia • More medication for urinary incontinence, more urinary tract infections, incomplete emptying, stress urinary incontinence with hysterectomy than with LNG-IUS • The quality-of-life scores, general and psychological health parameters and hemoglobin and ferritin levels improved to a similar extent for both Hysterectomy and LNG IUS Kristina Gemzell, Pirjo Inki , Recent developments in the clinical use of the LNG IUS,. 2011 26
    27. 27. Levonorgestrel Intra Uterine System Suitability • Women who need effective long-term contraception. • Women who have just had a baby: Spacing method • Women who need a reversible alternative to sterilization or surgeries • Women who are dissatisfied with other methods of contraception • Continuation Rates high – 1 year post insertion 94% – 2 years post insertion 87% – 3 years post insertion 82% – 4 years post insertion 76% – 5 years post insertion 65% 27
    28. 28. Levonorgestrel Intra Uterine System Taming the “Cost factor” • Menorrhagia causes significant health system costs including expensive, invasive surgical treatment such as hysterectomy • The cost of menorrhagia is driven by treatment costs, management of complications and lost work days • The cost of hysterectomy per patient in India totals to more than Rs. 20,000 1 • Financial cost of lost work days to a patient due to hysterectomy totals to Rs.30,0002 • Beyond the economic burden of heavy menstrual bleeding there are psycho-social implications of invasive treatments, primarily permanent infertility Sources: Hidlebaugh 2000; Cote 2002; 1 Assuming average hysterectomy cost per patient in government hospital is Rs.15,000 and medical treatment pre- and post- surgery is Rs 5000. 2 Assuming the earning of a patient undergoing hysterectomy is Rs 10,000 per month and 3 months bed rest is required post-surgery 28
    29. 29. Levonorgestrel Intra Uterine System Counselling Women undergoing LNG IUS insertion should receive detailed information on: • • • • • • Contraceptive efficacy Duration of use Risks and possible side effects Non-contraceptive benefits Procedure for initiation and removal/discontinuation When to seek help while using the method. 29
    30. 30. Levonorgestrel Intra Uterine System Counselling • Pre Insertion Counselling related to – – – – – Contraceptive efficacy Possible side effects Patient information leaflet Placement procedure Menstrual irregularities • Post Insertion Counselling related to – – – – Threads in position Any pain or discomfort Menstrual irregularities Possible side effects 30
    31. 31. • Highly effective long-term reversible contraception • Good patient tolerability and compliance • Bleeding pattern change towards lighter, shorter and less painful periods • Rapid return of fertility after removal 31
    32. 32. !! TAKE HOME MESSAGES !! • LNG IUS shown to be more efficacious and preferred option amongst various LARCs • LNG IUS should be considered as the first line of therapyfor management of idiopathic menorrhagia • Counselling very crucial to enhance patient acceptability of this highly innovative system 32