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Dr. Anne Szarewski

Contraception: What’s new?. Dr. Anne Szarewski. Clinical Senior Lecturer. Wolfson Institute of Preventive Medicine. Associate Specialist,. Margaret Pyke Centre, London. COC and VTE risk. All COCs carry a similar, small risk of VTE Obesity (BMI > 30) is a significant risk factor

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Dr. Anne Szarewski

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  1. Contraception: What’s new? Dr. Anne Szarewski Clinical Senior Lecturer Wolfson Institute of Preventive Medicine Associate Specialist, Margaret Pyke Centre, London

  2. COC and VTE risk All COCs carry a similar, small risk of VTE Obesity (BMI > 30) is a significant risk factor Smoking is a risk factor for VTE Consider PO methods for those at risk

  3. Combined effect of smoking with COC use on risk of VTE in women aged 18-39 Pomp ER et al, Am J Haematol, 2008; 83, 97–102

  4. Combined effect of COC use and BMI on risk of VTE in women aged 18-39 Pomp ER et al, Br J Haematol, 2007; 139, 289–296

  5. The Danish Cohort Study Major questions about the cohort comparisons for VTE risk: • Could not assess BMI & family history of VTE • Did not account for important population-level changes in obesity • Misclassification of duration of use created a significant bias in favour of LNG • Duration of use definition incorrect • Did not adjust appropriately for duration of treatment • Short term use systematically overestimated for LNG but not for DRSP Lidegaard Ø et al. BMJ 2009; 339: b2890

  6. A diposity (BMI > 25) in Danish Women 1994 to 2005 www.si - folkesundhed.dk 70 1994 2005 60 50 40 30 40 20 37 36 21 10 18 12 0 16-24 25-44 45-66 Lidegaard 2007 % Age

  7. Studies by Jick group, BMJ 04.11 • US Claims Database study • No validation of VTE cases • No / missing info on duration of use, FH, BMI, smoking • GPRD study • 37% of VTE cases not validated • No data on FH, missing data on BMI, smoking • Selection bias • Both studies had lower VTE rates than in non-users • Jick SS, Hernandez RK. BMJ 2011;340:d2151 • Parkin L, Sharples K, Hernandez RK, Jick S. BMJ 2011;340:d2139 doi:10.1136/bmj.d2139

  8. VTE risk for non-oral contraceptivesLidegaard et al. BMJ May 2012 • Same Danish database registry • NB EVRA introduced 2001, NuvaRing 2003 • Risk of VTE of EVRA vsMicrogynon • 2.3 (95% CI 1.0-5.2) • Risk of VTE of NuvaRingvsMicrogynon • 1.9 (95% CI 1.3 – 2.7) • Risk of VTE of Mirena IUS vsMicrogynon and also vs non-users!! • 0.6 (95% CI 0.4 – 0.8)

  9. EURAS: VTE rate with Yasmin was not significantly different from other COCs 58,674 women, followed for 142,475 woman-years Dinger J et al, Contraception; 2007; 75: 344-54

  10. 12 12 DRSP DRSP LNG LNG Other OC Other OC 8 8 % % 4 4 RR 2.4 RR 2.4 RR 1.6 RR 1.6 0 0 Obesity Obesity Obesity among starters Obesity among starters EURAS: Preferential Prescribing of Yasmin to women with risk factors for VTE Dinger J et al, Contraception; 2007; 75: 344-54

  11. EURAS results: Impact of age and BMI on VTE risk during OC use VTE/10,000 WY BMI Age * Risk estimates based on 115 VTE in 116,00 WY of exposure Rabe T, Luxembourg B, Ludwig M, Dinger J, et al. J Reproduktionsmed Endokrinol 2011; 8: 126-167

  12. EURAS results: Impact of age and BMI on VTE risk in OC users without other known risk factors VTE/10,000 WY BMI Age Rabe T, Luxembourg B, Ludwig M, Dinger J, et al. J Reproduktionsmed Endokrinol 2011; 8: 126-167

  13. MHRA statement May 2011 • VTE with use of COCs is not a new issue. • The risk of a VTE in women who use any COC is very small and smaller than the risk of VTE associated with pregnancy. • When used appropriately the benefits of all combined oral contraceptives far outweigh the risk of VTE, which is rare. • All COCs, including Yasmin, should be prescribed with caution to obese women (BMI>30) http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON117560

  14. Prescribing patterns of norethisterone 5 mg for general practitioners in Oxfordshire and the rest of England Shakespeare, J. et al. BMJ 2000;320:291

  15. Yaz – a 24/4 COC • 20μg EE and 3mg drospirenone (DRSP) • Pack of 28, consisting of 24 active tablets and 4 placebo tablets.

  16. Ovarian activity / missed pill RCT:24/4 vs 21/7 (50 women each group) Ovarian activity measured by TVS and hormone profile - in the second treatment cycle • and after 3 missed tablets days 1 - 3 in cycle 3 2 women ovulated with a 7 day PFI With 10 day PFI, 5 ovulations (+ almost 6th) Klipping C et al. Contraception 2008; 78:16-25

  17. The theory behind 24/4 • 7 day PFI is too long: greater suppression of follicle development with 24/4 • Potentially increased efficacy in women with poor compliance • Reduce side effects in 7-day PFI • eg pelvic pain, headaches, bloating, breast tenderness, PMT

  18. NuvaRing • 1 ring per cycle • Regimen: • 3 weeks of ring-use • 1 ring-free week • Daily release: • 15 µg ethinyloestradiol • 120 µg etonogestrel

  19. Qlaira: (E2V/DNG) • First COC with E2V rather than EE • Four phasic; 26/2 • Indication for HMB • the only licensed COC • ?? Safer than EE • Effect of 2 mg E2V on hepatic protein synthesis is less pronounced than with EE 20 μg Mashchak et al. Am J ObstetGynecol 1982;144:511–8, Lindberg et al. ThrombHaemost 1989;61:65–9, Helgason. ActaObstetGynecol Scand Suppl 1982;107:1–29

  20. Studies by Sulak P et al. • Advocates continuous use of COC • but with breaks individually tailored for each woman • Self-selected population • Often women who have PFI problems • Requires considerable time / effort Obstet Gynecol 1997; 89: 179-83 Am J Obstet Gynaecol 2002; 186: 1142-9 Contraception 2004; 70: 281-287

  21. 1.5mg 17β oestradiol + 2.5mg nomegestrol acetate (NOMAC) 24/4 regimen Efficacy comparable to Yasmin Cycle control not quite as good as Yasmin Mansour D,, et al. Eur J Contracept Reprod Health Care 2011 ; 16: 430-43

  22. Bleeding problems on PO methods Counselling DMPA: add oestrogen (COC, HRT) shorten injection interval Mirena: Wait (6 months), can add COC POP: buy time, change brand Implanon: add COC pray

  23. Bleeding patterns with Implanon All studies Amenorrhoea Infrequent bleeding Frequent bleeding Prolonged bleeding 60 50 40 Percentage 30 20 10 0 1 2 3 4 5 6 7 8 Three-monthly assessments

  24. DMPA and fracture risk – new UK data • 312,395 women in GPRD, aged 15-50 • 53% with at least 6/12 baseline data • Average FU 5.4 – 5.9 years • Women who chose DMPA had more fractures BEFORE using DMPA than non-users • (RR 1.28 95% CI 1.07-1.53) • Long term DMPA users had lower fracture risk than short term users • Association does not appear to be causal • ‘focus more on violence prevention’ (Schwarz 2013) Lanza et al. Obstet Gynecol 2013: ;121:593–600

  25. PHARMACOLOGY EllaOne – a new PCC • Progesterone receptor modulator • Licensed up to 120 hours post UPSI • Mode of action • (1) inhibits/postpones ovulation • (2) prevents implantation • Appears more effective than Levonelle at 120 hours • (1.6 % 95% CI 0.9-2.7 vs 2.6% 95% CI 1.7-3.9) • Menstrual changes Mansour JFPRHC 2009; 35: (4): 217-8

  26. EllaOne vs Levonelle • EllaOne is more effective than Levonelle between 72 and 120 hours (actually also 0 -120 hrs) • And probably just before ovulation • EllaOne trials did not include women using hormonal contraceptives – and breastfeeding not advised for one week after use • Levonelle better following missed pills as no interference with progestogen • Levonelle can be taken more than once in a cycle – currently not advised with EllaOne • EllaOne not available OTC

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