Hormonal contraception and thrombosis. An update
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1 Hormonal contraception and thrombosis. An update Øjvind Lidegaard Clinical Professor in Obstetrics & Gynaecology Barcelona, Spain, Department of Gynaecology, Rigshospitalet Faculty of Health Science University of Copenhagen
2 Hormonal contraception How to get an overview? Combined products (estrogen and progestogen) Progestogen only products
3 Hormonal contraception Combined - route Combined products (estrogen and progestogen) Oral Non oral Progestogen only products Oral Non oral
4 Hormonal contraception Combined route e-dose e-type Combined products (estrogen and progestogen) Middle Low Nat e N-oral Progestogen only products Oral N-oral
5 Hormonal contraception Combined route e-dose e/p-type EE dose NETA Norethisterone LNG Levonorgestrel NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Combined products Middle Low Nat e N-oral Progestogen only products Oral N-Oral
6 Hormonal contraception - generations Combined route e-dose e/p type EE dose NETA Norethisterone LNG Levonorgestrel NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Combined products Middle 1st 2nd gen Low 3rd gen 4th gen Nat oe N-oral Progestogen only products Oral N-oral
7 Hormonal contraception Combined route e-dose e/p type EE dose NETA Norethisterone LNG Levonorgestrel NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Combined products Middle 1st 2nd gen Low 3rd gen 4th gen Nat oe E2V-DNG E2 NOMAC N-oral Patch Vaginal ring Progestogen only products Oral POP Desogestrel DRSP N-oral Depot IUS Implant
8 Hormonal contraception and venous thrombosis. Seven axes of significance Combined versus progestogen only Route of administration Progestogen type Estrogen dose Estrogen type (natural vs artificial) Duration of use (found for 2 nd generation) Age and absolute risk
9 VT: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 30% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Hormonal contraception 35% 3-7 PCOS 5-10% 2 Medical diseases 5%? 2-5 Li/15
10 VT: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 30% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Hormonal contraception 35% 3-7 PCOS 5-10% 2 Medical diseases 5%? 2-5 Li/15
11 CT, AMI and VT in DK /10 Pregnant and puerperal women excluded Incidence per 100,000 years Arterial diseases ,4 0, CT AMI 38 Venous thrombosis Lidegaard et al NEJM 2012 and BMJ 2011
12 CT, AMI and VT in DK /10 Pregnant and puerperal women excluded Incidence per 100,000 years Arterial diseases ,4 0, CT AMI 38 Venous thrombosis Lidegaard et al NEJM 2012 and BMJ 2011
13 VT: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 30% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Hormonal contraception 35% 3-7 PCOS 5-10% 2 Medical diseases 5%? 2-5 Li/14
14 Delivery Venous thrombosis in pregnant and puerperal women, DK N= Incidence of VT per 10,000 exposure years Pregnancy (n=491) Puerperium (n=218) Gestational week Weeks after delivery Virkus et al. Thromb Haemost 2011; 106: Li/12
15 1 st myth: HC vs pregnancy Age Exposure VTE/10,000 years 30 pregnancy, 1 st trim 3 30 pregnancy, 2 nd trim 4 30 pregn, birth, puerp: 8 20 low risk pill (2 nd gen) 3 20 high risk pill (3 rd, 4 th ) 6 30 low risk pill 9 30 high risk pill 18 Conclusion: The risk of VTE is higher with HC than with pregnancy.
16 VT: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 30% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Hormonal contraception 35% 3-7 PCOS 10% 2 Medical diseases 5%? 2-5 Li/15
17 Danish infrastructure National Health Registry (>1977) VT diagnoses, BMI CaVD/canc. smoking Pregnancies, surgery
18 Danish infrastructure National Health Registry (>1977) VT diagnoses, BMI CaVD/canc. smoking Pregnancies, surgery Prescription Registry (>1994): HC use Medication against hypertension, DM, hyperlipidaemia
19 Danish infrastructure National Health Registry (>1977) VT diagnoses, BMI CaVD/canc. smoking Pregnancies, surgery Prescription Registry (>1994): HC use Medication against hypertension, DM, hyperlipidaemia Cause of Deaths Registry (>1977) Lethal VT Statistics of Denmark PIN-codes, education vital status, emigration
20 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Seeger * 0.9 ( ) 4th/???
21 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Seeger * 0.9 ( ) 4th/???
22
23 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Seeger * 0.9 ( ) 4th/??? Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd
24 Critique
25 OC and VT: Methods National Registry of Patients (>1977) VT diagnoses, BMI CaVD/canc. Smoking Pregnancies, surgery Prescription Registry (>1994): HC use Medication against hypertension, DM, hyperlipidaemia Cause of Deaths Registry (>1977) Lethal VT Statistics Denmark PIN-codes, education vital status, emigration Lidegaard et al. BMJ 2009
26 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Seeger * 0.9 ( ) 4th/??? Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd
27 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Seeger * 0.9 ( ) 4th/??? Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd
28 An Editor Grimes, Obstet Gynecol Nov 2010, 116:
29 Research using vital Definitions records should be limited to simple descriptive reports with caveats about data accuracy. Using birth certificate information for epidemiologic analyses is inappropriate because of well documented deficiencies in information quality 3. Similarly, epidemiologic research using adminstrative databases, such as the Danish National Patient Registry, must at a minimum validate each reported outcome by chart review 9 or by patient interview. In recent decades, the computer science concept of "GIGO" ("garbage in, garbage out") has somehow come to mean "garbage in, gospel out 10." When computer software tackles a large database, many accept the "computerized" output as trustworthy, regardless of the quality of the input. Sadly, no fancy statistical machinations can compensate for poor-quality data. Publications relying on unconfirmed database reports of venous thromboembolism should be ignord. Grimes. Obstet Gynecol 2010; 116:
30 An editor Financial Disclosure Dr. Grimes serves as a consultant (DSMB member) for Bayer. Grimes, Obstet Gynecol Nov 2010, 116:
31 OC and VT: Methods National Registry of Patients (>1977) VT diagnoses, Previous CaVD/canc. Pregnancies, surgery Prescription Registry (>1995): HC use Anticoagulation therapy hypertension, DM, Hyperlipidaemia million women Cause of Deaths Registry (>1977) Lethal VT Statistics Denmark PIN-codes, education vital status, emigration Lidegaard et al. BMJ 2011
32
33 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd Lidegaard 11 4, ( ) 4th/2nd IR = incidence per 10,000 women years
34 VT and drospirenone VT Risk Rate ratio no /10,000 DRSP/2nd gen Dinger ( ) 4th/2nd Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd Parkin ( ) 4th/2nd Jick ( ) 4th/2nd Lidegaard 11 4, ( ) 4th/2nd IR = incidence per 10,000 women years
35
36 Dinger & Shapiro, on the road again Dinger & Shapiro. J Fam Plan Repr Health Care2011: Nov. 14.
37 BMJ Editorial Nov 2011 Philip Hannaford. BMJ 2011; 343: d6592
38
39 HC according to relative risk of VTE No risk <1.5 Low risk High risk >4 Few data No data EE dose NETA Norethisterone LNG Levonorgestrel Combined products NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Middle 2.2* 3.0* 3.5* 6.6* 6.2* 6.4* 6.4* Low 4.8* 5.1* 6.9* Nat oe E2V-DNG 4.5* E2 NOMAC N-oral Patch7.9* Vaginal ring 6.5* Progestogen only products Oral POP 0.7 Cerazette 0.6 N-oral Depot IUS 0.6 Implant 1.4
40 .on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) biologically nonsensical results
41 ...on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) Samuel Shapiro ( )..the Danish registry is an unsuitable resource for the evaluation of VTE risk
42 .on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) Samuel Shapiro ( ) Mary E. Gaffield ( ) These new data.. may lead to a new (unfounded) scare.
43 .on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) Samuel Shapiro ( ) Mary E. Gaffield ( ) Julie M Chandler ( ) Higher abortion rate in areas where.prescribing restrictions are in place
44 .on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) Samuel Shapiro ( ) Mary E. Gaffield ( ) Julie M Chandler ( ) Anne L Connolly ( ) poor studies such as this one
45 .on the road again Publication in BMJ on May 10, 2012 Anne Szarewski ( ) Samuel Shapiro ( ) Mary E. Gaffield ( ) Julie M Chandler ( ) Anne L Connolly ( ) Sven Skouby ( ) We find no reason to repeat the clear and concise arguments by Anne Szarewski
46 VT and drospirenone/lng VT IR Rate ratio Dinger ( ) 4th/2nd Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd Parkin ( ) 4th/2nd Jick ( ) 4th/2nd Lidegaard 11 4, ( ) 4th/2nd FDA Kaiser ( ) 4th/2nd IR = incidence per 10,000 women years
47
48 Shapiro, critique of FDA Shapiro S. J Fam Plan Reproduc Health Care 2013: 39: 89-96
49 VT and drospirenone/lng VT IR 4 Rate ratio Dinger ( ) 4th/2nd Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd Parkin ( ) 4th/2nd Jick ( ) 4th/2nd Lidegaard 11 4, ( ) 4th/2nd FDA Kaiser ( ) 4th/2nd Gronich ( ) 4th/2nd Bird ( ) 4th/2nd Dinger ( ) 4th/2nd
50 VT and drospirenone/lng VT IR 4 Rate ratio Dinger ( ) 4th/2nd Vlieg 09 1,524 na 1.7 ( ) 4th/2nd Lidegaard ( ) 4th/2nd Dinger na 1.0 ( ) 4th/2nd Parkin ( ) 4th/2nd Jick ( ) 4th/2nd Lidegaard 11 4, ( ) 4th/2nd FDA Kaiser ( ) 4th/2nd Gronich ( ) 4th/2nd Bird ( ) 4th/2nd Dinger ( ) 4th/2nd
51 Dinger Vlieg Lidegaard Dinger Parkin Jick Lidegaard FDA Kaiser Gronich Bird Dinger COC with DRSP vs LNG Rate ratio 3 2,7 2,8 2 1,7 1,6 2, ,0 1,0 1,5 1,7 0,8 N=118 1,524 4, , ,9
52 Blomenkamp WHO Jick Spitzer Lewis Farmer Todd Bloemenkamp Parkin Lidegaard Dinger Vlieg Lidegaard Lidegaard rd versus 2 nd generation COC 4,0 3,5 3,0 2,5 Rate ratio 15 studies, 9 significant differences 2 non-significant differences, 4 no difference 2,9 2,0 1,5 1,0 2,3 2,1 1,8 1,5 1,6 1,4 1,9 1,4 1,3 2,0 1,8 2,2 0,5 0,0 0,
53 HC and RR of VTE: Conclusion No risk <1.5 Low risk High risk >4 Few data No data EE dose NETA Norethisterone LNG Levonorgestrel NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Combined products Middle Low 2.5? Nat oe E2V-DNG 4.5 E2 NOMAC N-oral Patch 7 Vaginal ring 6 Progestogen only products Oral POP 1 Cerazette 1 N-oral Depot 1 IUS 1 Implant 1.4
54 Hormonal contraception and SHBG % increase in SHBG Nuva Ring Patch Odlin et al. Acta Obstet Gynecol Scand 2002; 81:
55 400 Hormonal contraception & SHBG 300 SHBG nmol/l Nuva Ring Patch Raps et al. Thrombosis Haemostasis 2012; doi:
56 Bitzer et al. Contraception 2013; J Fam Plann Reprod Health 2013
57 Bitzer et al. Contraception 2013; J Fam Plann Reprod Health 2013
58 Dinger versus Lidegaard Inclusion of Dinger Lidegaard potential confounders Age Yes Yes Education No Yes Length of use Yes Yes Oestrogen dose No Yes Ovarian stimulation No Yes Major surgery No Yes BMI Yes No Family disposition No No
59 2 nd myth: Confounders The Danish registry studies are not only the studies with the most detailed and most valid exposure data. The studies also include and control for more potential confounders than any other study conducted on HC and venous thrombosis.
60 Bitzer et al. Contraception 2013; J Fam Plann Reprod Health 2013
61 900 First ever VTE, women Number National Health Registry, Denmark
62 900 First ever VTE, women Number National Health Registry, Denmark
63 900 First ever VTE, women Number National intervention National Health Registry, Denmark
64 400 Sale of COC in DK acc to progestogen DDD per 1000 per day COC CPA 300 COC DRSP COC GSD COC DGS COC NGM COC LNG COC NETA National Prescription Registry, Denmark
65 3 rd myth: Pill scares An appropriate information about thrombotic risks with different product types is mandatory in order to Ensure the lowest possible risk of VTE Ensure immediate action in case of an event Such sober information does not cause a new pill scar, but contrary keeps people s confidence in advices from experts Hiding or manipulating scientific evidence has been responsible for all serious pill scares in the past.
66 900 First ever VTE, women Number National intervention National Health Registry, Denmark
67 900 First ever VTE, women Number National intervention National Health Registry, Denmark
68 First ever VTE, women Number ~ in Denmark per year ~ in EU per year National intervention National Health Registry, Denmark
69 An appropriate practice Scientists have to reach consensus Health authorities should update their recommendations The press should inform the public without overdramatizing the scientific evidence The general practitioners should follow the updated recommendations. Women should be informed about the symptoms of VT to ensure immediate action Lidegaard, Expert Opinion Drug Safety 2014: 13:
70 IMAP= International Medical Advisory Panel
71
72
73 HC and thrombotic stroke Reference: Non-users All women in Denmark years old during the period January 1995 through December 2009 (15 years) Data from four National registries Included: 1,626,158 women 14,251,063 women years 4,914,401 current use 3,311 thrombotic strokes Lidegaard et al. N Engl J Med 2012; 366:
74 HC and thrombotic stroke No risk: <1.5 Low risk: High risk: >2 No data EE dose NETA Norethisterone LNG Levonorgestrel NGM Norgestimate DGS Desogestrel GSD Gestodene DRSP Drospirenone CPA Cyproteroneacetate Combined products Middle 2.2* 1.7* 1.5* 2.2* 1.8* 1.6* 1.4 Low 1.5* 1.7* 0.9 Nat oe E2V-DNG E2 NOMAC N-oral Patch3.2 Vaginal ring 2.5* Progestogen only products Oral POP 1.4 Cerazette 1.4 N-oral Depot IUS 0.7 Implant 0.9
75 Hormonal contraception age Clinical recommendations Young women (<35 years) 1 st choice Low risk (2 nd gen) COC 2 nd choice No risk LNG-IUS (e.g Jaydess) 3 rd choice High risk 3 rd or 4 th gen COC Women from 35 years or women at risk 1 st choice No risk LNG-IUS 2 nd choice Low risk 2 nd gen. COC 3 rd choice Non hormonal contraception Lidegaard, Expert Opinion Drug Safety 2014: 13:
76 VT: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 30% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Hormonal contraception 35% 3-6 PCOS 5-10% 2 Medical diseases 5%? 2-5 Li/15
77 PCOS and thrombotic stroke 9,640 women with PCOS were included (0.7% of all included women) 3,994 (41%) of these had a recorded BMI 2,029 women experienced a thrombotic stroke, of these 25 in women with PCOS The Incidence rate of thrombotic stroke increased more than 100% through the study period, and 20 times with increasing age
78 2 Adj. relative risk of cerebral infarction according to different exposures 2,15 1,62 1,58 1,47 1 0,88 1,10 1,00 1,11 0,63 0,63 0 PCOS 1 (low) (high) HC < >30 Education Body mass index *) Adjusted for year, education, hormonal contraception, and BMI
79 Conclusion Fertile women with PCOS have a doubled risk of thrombotic stroke which is not explained by a higher BMI or use of hormonal contraception. Other studies have demonstrated also a doubled risk of venous thrombosis in women with PCOS. Therefore, also women with PCOS should have low risk 2nd generation hormonal contraception as first choice
80 George Monbiot One of the most widespread human weaknesses is our readiness to accept claims that fit our beliefs and reject those that clash with them. We demand impossible standards of proof when confronted with something we don't want to hear, but will believe any old cobblers if it confirms our prejudices: Guardian, November 22, 2011
81 Hormonal contraception That s where we are now. Thanks for your attention Conflicts of interest: The primary investigator has been an expert witness in legal processes in USA in 2011 and 2012.
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