Oral contraceptives Epidemiological aspects Øjvind Lidegaard
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1 Oral contraceptives Epidemiological aspects Øjvind Lidegaard Professor Gynaecological Clinic 4232 Rigshospitalet Copenhagen University
2 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis - AMI OC and cancer OC and women at risk Li/05
3 OC use in Denmark Per cent Calculated from total sale in DDD/fem pop years. Li/05
4 OC generations according to estrogen dose and progestagen type Progestagen generation Estrans Levonor- Norges- Deso- Gesto- Dros- NETA gestrel timate gestrel dene pirenon 50-1st+ EVRA nd th Nuvaring3rd + + POP Low dose = 20-40ug EE Li/07
5 OC types in DK according to estrogen dose during the period % 80% 50ug EE 60% 40% 30-40ug EE 20% 0% POP 20ug EE Sale statistics. Dansk Lægemiddelstatistik Li/02
6 Progestagen types in combined OC in Denmark (%) 100% Gest. 20ug 80% 60% Gestodene 30ug 40% 20% Levonorgestrel Desogestrel 20ug Desogestrel 30ug Norgestimate 0% Norethisterone Sale statistics. Li/05
7 Use of oral contraceptives in DK 2003 DDD/100 women/day at different ages Li/05
8 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis - AMI OC and cancer OC and women at risk Li/05
9 CTA, AMI and VTE in DK Pregnant and puerperal women excluded Incidence per 100,000 per year Arterial diseases CTA+ AMI CTA AMI Venous diseases Lidegaard Ø. Am J Obstet Gynecol 1998; 179: S62-7. VTE DVT PE Li/04
10 Thrombotic diseases in young women Quantitative and qualitative impact Incidence rate of disease Mortality/case-fatality rate Disability among survivors Long-term survival Age differentiation Li/05
11 Thrombotic diseases in young women Per 1 million per year CTA AMI VTE Incidence Non pregnant Mortality Non pregnant Case-fatality rate 2.3% 25% 1.3% Significant disability 30% 30% 5% Long-term survival Lidegaard. Am J Obstet Gynecol 1998; 179: s62-7 Li/04
12 Risk factors for cardiovascular diseases in women of reproductive age CTA AMI VTE High age Smoking Hypertension Diabetes Family VTE - + Family AMI Family CTA BMI > Migraine + - Varicose veins - + Leiden fact V - + Lidegaard, Nordisk Medicin 1998; 113:
13 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis - AMI OC and cancer OC and women at risk Li/05
14 VTE: Genetic risk factors Risk factor Prevalence RR Leiden fact V hetero 5% 8 Leiden fact V homoz 0.2% 64 Protein C insufficiency 0.2% 15 Protein S insufficiency <0.1% >10 Antithrombin III insuff. 0.02% 50 Prothrombin 20210A 2% 3 Hyperhomocysteinaemia 3% 3 Høibraaten E. HRT and risk of VTE. Diss. Oslo 2001 Li/04
15 VTE: Acquired risk factors Prevalence RR Age 30 vs <30 50% 2.5 Pregnancy 4% 8 Adiposity (BMI>25) 36% 2 Varicose veins 8% 2 Immobilisation/trauma? 2-10 Oral contraceptives 33% 3-4 Medical diseases 5%? 2-5 Li/04
16 Incidence rate of VTE among pregnant and puerperal women, DK N= Incidence of VTE per 10,000 exposure years Pregnancy (n=162) 80 Puerperium (n=103) Nonpreg 4 4 Week 1-12 Week Week Week >36 Delivery Week Week Week Week 7-8 Week Li/04
17 Adiposity in Danish women and men in 1994 and women 2005 women 94 men 2005 men Adiposity: BMI > Li/07
18 Severe adiposity in Danish women in 1994, 2000 and Adiposity: BMI Li/07
19 OCs and VTE studies PDS cas/con 2nd 3rd Blomenkamp / WHO, Eur / Jick, UK /cohort ref 1.8 Spitzer / Lewis / Farmer /cohort Todd /cohort ref 1.4 Blomenkamp / Lidegaard / Dinger /cohort 4.gen: 4 Seeger /cohort 4th vs ot: 0.9
20 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis - AMI OC and cancer OC and women at risk Li/05
21 OCs and AMI studies Study PDS cas/con 2nd 3rd WHO, Eur / % CI: Lewis (97) / % CI: MICA (99) / % CI: Lidegaard / % CI: Dunn et al. BMJ 1999; 318: Li/03
22 OCs and thrombotic stroke Study PDS Cases/ controls OR 2nd/3rd WHO Schwartz Heinemann Lidegaard / / / / / / /1.4 Lidegaard et al. Contraception 2002; 65:
23 OCs and thrombosis Current status November 2007 CTA AMI VTE 2nd gen: rd gen: th gen:?? 4.0 Li/07
24 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis -AMI OC and cancer OC and women at risk Li/05
25 OCs and cancer risk Relative risk Breast cancer: 1,0 Endometrial cancer: 0,5 Ovarian cancer: 0,5 Cervical cancer: 1,2 All cancers: No change All cause mortality: No change Conclusion: No change in risk of cancer in general in ever-users of OCs Hannaford et al. BMJ 2007; online
26 Clinical guidelines When OCs are prescribed Careful clinical history including risk factors and family disposition Previous VTE: No OCs Genetic predisposition VTE risk factor 5: No OCs VTE risk factor <5: Careful inf, 2 nd gen No risk factors: Any low dose pill Arterial risk factors: 3 rd gen. pill Li/04
27 OC: Epidemiological aspects OC use OC and thrombosis - venous thromboembolism - cerebral thrombosis -AMI OC and cancer OC and women at risk Li/05
28 Migraine and OCs Risk of cerebral thrombosis: RR Migraine in general 3 Migraine with aura 6 Migraine without aura 2 2. Gen. OCs 2,5 3. Gen. OCs 1,5 Migraine + 2. Gen OCs 7,5 Migraine + 3. Gen OCs 4,5 Conclusion: No OCs to women with migraine with aura. Otherwise 3. gen.
29 Smoking and OCs Risk of thrombosis: Brain Heart Smoking <10/day Smoking 10-20/day Smoking >20/day Gen. OCs Gen. OCs Conclusion: No OCs to women smoking 20 cigarettes/day and who are >35 yrs.
30 History when OCs are prescribed Previous thrombosis? Smoking, diabetes, hypertension Migraine, with or without aura Family thrombosis? Previous compliance with OCs Menstrual bleedings Actual liver disease Sexual practice
31 Clinical examination when OCs are prescribed Women >25 years: BP Women with risk factors: BP BMI (=weight / height 2 ) Varicose veins Time for a control after three months where BP is measured on all women.
32 Presentation on Routine information when OCs are prescribed How to manage a forgotten pill. Warning signs: New migraine, dizziness, visual disturbances Adaptation take few months Increased risk of venous thrombosis, the absolute risk however low Common not serious side effects Common non-contraceptive benefits
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