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15t h Congress of the European Society of Contraception and Reproductive Health

Budapest, Hungary, 9-12 May 2018Session of the Francophone Society of Contraception

Contraception in overweight and obese women

Dr. David Serfaty, H o s p ita l S a in t-L o u is , P a r is

H o n o ra r y P re s id e n t a n d fo u n d e r o f th e E u ro p e a n S o c ie ty

o f C o n tra c e p t io n

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1D efinition and Epidem iology of O besity

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Definiting Obesity

« … Obesity is defined by the WHO by a body fat of greater than 35% in women [that can be calculated

using dual-energy X-ray absorptiometry (DEXA)].

The most commonly used tool and easiest to calculate clinically is Body Mass Index or BMI[(weight in kg/height in m²)] and inexpensive.

K.A.Shaw, A.B.EdelmanBest Practice & Research Clinical Endocrinology & Metabolism2013; 27:55-65

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BMI Categories

BMI categories are defined by the Center for Disease Control (CDC) and Prevention and the WHO as:

-class I obesity30-34.9 kg/m²-class II obesity35-39.9 kg/m²-class III obesity≥ 40kg/m²

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Epidem iology of obesity

Россия 54%

США 64%

Великобритания 51%

Китай 15%

Германия 50%

R.Norman, 2004; Y.Linne, 2004

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P e d ia tr ic

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A d o le s c e n t

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R e p ro d u c t iv e

a g e

Currently in Europe 20 to 30% of adults are clinically obese and prevalence has doubledin less than two decades

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Are obese wom en at risk for pregnancy?« … Extremes in weight can affect fertility. Obesity isassociated with ovulatory dysfunction, a decreasedrate of spontaneous pregnancy and a decreasedresponse to fertility treatment.

Despite this potential decrease in fertility, more thanone fifth of pregnancies in the United Kingdomand other developed countries are in obese women …»

K.A.Shaw et al., 2013

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« … Consequently, use of safe and effective contraceptive methods is of paramount importance. However in some social settings obese women are less likely to use contraception or to receivepreventive health care services as compared to women of normal weight…»

G.S.Merki-Field, D.Skouby, D.Serfaty et al, 2015

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Obesity and metabolic syndrome

« …As an integral part of obesitythe metabolicsyndromedescribes numerous metabolicabnormalities that togetherwithobesity increasethe cardiovascularand diabetes risk. Moreover, pregnancy in obese women oftenleads to severe morbidities…»

G S. Merki-Field et al. 2015

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2Obesity and Contraception

European Society of ContraceptionStatem ent on Contraception in O bese Wom en

G a b r i e l e S . M e r k i - F i e l d , S v e n S k o u b y, D a v i d S e r f a t y, M e d a r d

L e c h , J o h a n n e s B i t z e r, P i e r G i o r g i o C r o s i g n a n i , A n g e l o C a g n a c c i a n d R e g i n e S i t r u k -W a r e

The European Journal of Contraception and Reproductive Health Care, 2015; 20: 19-28

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3Combined Hormonal Contraceptives

and Obesity

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D o oral contraceptive pillsim pact body weight?

« …O v e r a l l t h e p u b l i s h e d l i t e r a t u r e i s v e r y r e a s s u r i n g i n r e g a r d t o w e i g h t a n d C O C e x p o s u r e

Typically, most adults gain weight over timeP r e g n a n c y i s a s s o c i a t e d w i t h w e i g h t g a i n . F o r o b e s e

w o m e n t h i s p r e g n a n c y w e i g h t i s o f t e n r e t a i n e d p o s t - p a r t u m a n d t h e y n e v e r r e t u r n t o t h e i r p r e - p r e g n a n c y w e i g h t … »

*Kate A.Shawet al.Best Practice & ResearchClinicalEndocrinology& Metabolism

2013;27:55-65

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Are combined hormonal pills, rings and patch efficace in obese women?

« S u m m a r y : T h e m a jo r it y o f q u a lif ie d o b s e r v a t io n a l a n d p r o s p e c t iv e s t u d ie s d o

n o t in d ic a te a d e c r e a s e d e ff ic a c y o f C O C in o b e s e w o m e n . D a ta a r e l im ite d fo r

u s e r s o f o b e s it y c la s s I I a n d I I I .

H o w e v e r a s m a ll in c r e a s e in fa ilu r e in w o m e n w ith B M I > 3 5 c a n n o t b e e x c lu d e d .1

T h e t r a n s d e r m a l c o m b in e d c o n t r a c e p t iv e p a tc h is le s s e ff ic ie n t in w o m e n w ith

b o d y w e ig h t ≥ 9 0 k g .

N o d a ta a r e a v a ila b le o n th e e ff ic a c y o f th e m o n th lly c o m b in e d c o n t r a c e p t iv e

v a g in a l r in g in o b e s e w o m e n … »

1= Dinger J et al. Obstet Gynecol 2011; 117:33-40

• EuropeanSociety of Contraception Statementon Contraception

in Obese Women:

G.S.Merki-Field, S.Skouby, D.Serfatyet al.EJCRH2015; 20: 19-28

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Pharmacokineticsof combinedhormonal pills, ring and patch in obese women

«…Summary: Pharmacokinetics studies withCOC and CVR foundreducedethinylestradiol levels, but no decreasedprogestinlevels in obese women. This didnot result in decreasedovariansuppression, probablybecausethe progestinis the most relevant for contraceptive efficacy. However, becausesteadystate of the progestinlevels is delayed, it has to beconsideredwhether additional protection wouldbeuseful for 14 days in obese new starters…»

E u r o p e a n S o c ie t y o f C o n t r a c e p t io n S ta te m e n t o n C o n t r a c e p t io n in

O b e s e W o m e n :G .S .M e rk i-F ie ld , S .S k o u b y, D .S e r fa t y e t a l.E JC R H 2 0 15 ; 2 0 : 19 -2 8

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Are oral contraceptive com bined pillssafe in obese wom en?

«… One of the greatestconcernswiththe use of an oestrogencontainingcontraception isthe increasedriskfor venousthromboembolism(VTE).

Obesityalonedoubles the riskof VTE and whencombinedwithCOCs, thisriskincreasesfurther.However, the combinedriskof obesityand pregnancyfar exceedsthe riskof an obesityand COC use.

K.A. Shaw et al. 2013

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a = formulations containing<50mcg EEComparisonof riskfactorsfor veinousthromboembolismwithcombinedhormonal oral contraceptive pills.

K.A. Shaw et al. 2013

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Risks of Venous Thromboembolism on COCs

Incidenceof VTE per 100,000

Incidence VTE on COCaper 100,000

General population 4-5 12-20

Obesity(BMI>30kg/m²) 1 0 - 3 0 6 0 - 1 0 0

BMI 25-29 47

BMI 30-34 60

BMI >35 105

AGE

30-39 50

40-44 100

45-49 175

Pregnancy 48-60 n/a

Obesity& Pregancy 1 0 0 - 2 0 0 n/a

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COCs, obesity and stroke and myocardialinfarction

Despitethe knownincreased riskof VTE withobesityand COCs, there is no clearevidencewhetherobese womenhave an increased riskof embolicevents likestroke or myocardial infarction(MI).

U S-M EC, M M W R 2010

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CHC, Obesityand comorbidities

« … Obese women are more likely to have comorbidities such as HTA, hyperlipidemia, diabetes or high risk of CV diseases that also

increase risk of MI and stroke.

But, currently, the WHO-MEC does not have a

separate recommendation for obesity withcomorbid conditions… »

K .A. Shaw et al, 2013

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Benefitsof COCs in Obese Women(1)

« …Obesity is associated withpoorer pregnancy outcomes bothfor the woman and her child.

K.A. SHAW et al, 2013

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Benefitsof COCs in Obese Women(2)

« …An obese mother increases the risk of an obese child…Obese women have a higher risk of endometrial cancer and may benefit from the decreased risk of endometrial hyperplasia and endometrial cancer associated with COC use.

K .A. SH AW et al, 2013

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R isk for V TE and arterial events in CH C obese wom en users

«…Summary: CHC do furtherincreasethe riskfor VTE and ATE in obese women. Thereforetheyshouldonlybeusedif no otheracceptable contraceptive methodslikeprogestin-onlycontraceptives or intrauterine devicesare availableor acceptable –or if benefitsstill outweightthe risks. Obese womenshouldbeinformedof theirriskof thrombosis* and shouldbecounselledon the addedriskof takingcombinedhormonal contraceptives…»

* P a r t ic u la r ly o b e s e o ld e r w o m e n

ESC Statementon contraception in obese women; EJCRH, 2015

W H O -M E C 2 0 15 : B M I ≥ 3 0 =2; U K M E C 2 0 16 : B M I ≥ 3 5 =323

4Progestin-only contraceptive methods

in obese women24

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POC in obese womenP r o g e s t i n - o n l y c o n t r a c e p t i v e s ( P O C ) i n c l u d e p r o g e s t o g e n - o n l y

p i l l s ( P O P ) w i t h n o r e t h i s t e r o n e , l e v o n o r g e s t r e l o r d e s o g e s t r e l ;l e v o n o r g e s t r e l r e l e a s i n g i n t r a u t e r i n e s y s t e m s ( L N G - I U S ) ;

i n j e c t i o n s w i t h d e p o - m e d r o x y - p r o g e s t e r o n e a c e t a t e a n d s u b c u t a n e o u s i m p l a n t s r e l e a s i n g e t o n o g e s t r e l o r

l e v o n o r g e s t r e l .T h e m o d e o f a c t i o n o f P O P s r a n g e s f r o m f u l l o v u l a t i o n

s u p p r e s s i o n t o a l o c a l b a r r i e r t o s p e r m t r a n s p o r t b y i n c r e a s i n gv i s c o s i t y o f c e r v i c a l m u c u s

From the standpoint of venous and arterialthrombosis, progestin-only agents are the safesthormonal methods.

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POP containingdesogestrel 75m c g: Efficacyandsafetyin obese women

«…There islimiteddata on the efficacyof desogestrel75mcg in obese women*. This POP isnot associatedwithan increasedriskfor thromboemboliceventsor arterialembolicevents. The impact of desogestrel 75m c g on plasma lipidsand glucose metabolismisminimal.The WHO-MEC 2015 do not includeanyrestriction for the use of POP in obese women. But the impredictiblebleedingpattern of POP maylimitthe acceptabilityof the methodin somewomen…»______________________________________________________*T h e r e i s i n s u f f i c i e n t e v i d e n c e t o s u p p o r t a d o s e o f m o r e t h a n o n e p i l l ( P O P ) p e r d a y i n w o m e n w h o a r e h e a v y o r o v e r w e i g h t ( F S R H ,

2 0 1 5 )

G.S.MERKI-FIELD et al.,2015

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PO P in obese wom en

« …Summary: At present no data indicate a decreased efficacy of desogestrel 75m c g in obese women. Considering in addition that thisprogestogen-only pill does not increasedVTE and ATE risk in the risk group of obese women, it can behighly recommended for use. It seems to be an important and safe option…»

E S C S t a t e m e n t o n C o n t r a c e p t i o n i n O b e s e w o m e n , E J C R H , 2 0 1 5

WHO MEC 2015: BMI≥30=1; BMI≥35=127

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Nexplanon® in obese wom en

« …even if epidemiologic and clinical data at presentdo not indicate a decreased efficacy in obese women, caution is recommended. As etonogestrel plasma levels decline over time, an earlier replacement of the implant after 24 monthsinstead of 36 months may be considered in someobese women, in particular those whith concomitant use of hepatic enzyme inducers…»

ESC Statem ent on Contraception in O bese wom en, EJCRH , 2015

POC implants (Nexplanon, Sino-ImplantII) in obese women: WHO-MEC 2015=1; UK MEC =1

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Depo-medroxyprogesterone acetate (DMPA) in obese women

Riskof venous thromboticeventsamong injectable MPA userscomparedwithnon-users

M PA= m edroxyprogesterone acetate

G.Plu-Bureau et al.Best Practice & Research Clinical Endocrinology&Metabolism

2013;27:25-3429

A u th o rs , y e a r o f p u b lic a t io n Ye a r o f re c ru itm e n t O R (9 5 % C 1 ) M PA

V e rs u s n o n -u s e rsWHO 1998 (case control)Van Hylkama Vlieg 2010 (case control)

1989-19931999-2004

Pooled OR

2.2(0.7-7.3)3.6(1.8-7.1)

3.2(1.8-5.7)

«…Summary: DMPA is effective contraceptive in overweight women and obese women. Data in regard to the associated VTE risk are limited. Copper-IUD or lower dose progestin-only methods might be the better choice, if available and accepted by the woman…»

• Statementon Contraception in Obese women, EJCRH, 2015

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Em ergency contraception in obese wom en

- Three options are available for EC in the majority ofEuropeancountries: LNG1.5mg; UPA30mg; Cu-IUD

Women who are obese can use LNG or UPA asemergencycontraceptivepillswithout restriction(=WHOMECCategory 1, 2015)

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Intrauterinedevicesand intrauterinesystems in obese women

«…Summary: Copper-IUDsare highlyrecommendedin obese women, aftercontraindicationshave been takenintoconsideration.The LNG-IUS isa safeand effective contraceptive methodfor obese womenwithoutcontraindicationfor use of a device. In womenwithheavymenstrualbleeding, thisdeviceismore beneficial thanthe copper-IUD. An advantagemightbethe protection of the endometriumin obese women.

E S C S ta te m e n t o n C o n tra ce p tio n in o b e se w o m e n , E JC R H , 20 15

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Are therespecial considerationsfor COC use in womenundergoingbariatricsurgery? (1)

« … Withthe expandingobesityepidemic, more womenare undergoingbariatricsurgeryfor weight loss. Rapidimprovement in comorbidities and resolutionof ovulatorydysfunction → increasedfecundity. Patients undergoingbariatricsurgeryshouldbecounselledpre-operativelyto avoidpregnancyfor 1-2 years after surgery. However, manyof thesewomenare not usingeffective contraception or are not usinganycontraception…»

K.A. Shaw, AB. Edelman, 2013

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W e m u s t n o t s t i g m a t i z e o b e s e w o m e n

W e m u s t h e l p t h e m t o c h o o s e t h e i r i d e a l m e t h o d o f c o n t r a c e p t i o n

T h e y p a r t i c u l a r l y n e e d o u r e m p a t h y .

Thank you 38