LNG-IUS16

Report
Update intrauterine
Kontrazeption 2013
Reversible Langzeitverhütung
Hans Concin
aks Daten und Wissenschaft
Vorarlberger Krebsregister
Long-term reversible contraception.
Twelve years of experience with the TCu380A and TCu220C.
A total of 3,277 and 1,396 women, respectively, were recruited for use of each
device between 1981 and 1986 .
At the end of 12 years,
a total of 17,098 women-years of experience had been accumulated for the
TCu220C and 7,159 women-years for the TCu380A.
The cumulative 12-year intrauterine pregnancy rates were
7.0 for the TCu220C and
1.9 for the TCu380A .
No pregnancies were reported with the TCu380A after 8 years of use.
Contraception. 1997 Dec;56(6):341-52.
Copper containing, framed intra-uterine devices for
contraception.
Kulier R, O'Brien PA, Helmerhorst FM, Usher-Patel M, D'Arcangues C.
Geneva Foundation for Medical Education and Research, Route de
Florissant 3, Geneva, Switzerland, CH-1208, [email protected]
AUTHORS' CONCLUSIONS:
TCu380A or TCu380S appear to be more effective than other IUDs.
No IUD showed consistently lower removal rates for bleeding and pain in
comparison to other IUDs.
There is no evidence that any particular framed copper device is better
suited to women who have not had children.
Cochrane Database Syst Rev. 2007 Oct 17;(4)
Authors' conclusions
There is insufficient data to show that problems of early expulsions
have been overcome with the modified introducer used in GyneFix.
Apart from that, the frameless device performs similarly to TCu380,
and appears to have a lower pregnancy rate in later years, although
the absolute difference is small.
LARC methods should be offered as first-line contraceptive
methods and encouraged as options for most women. To
increase use of LARC methods, barriers such as lack of health
care provider knowledge or skills, low patient awareness, and
high upfront costs must be addressed.
Obstet Gynecol. 2009 Dec;114(6):1434-8
n engl j med 366;21 may 24, 2012
Revival of the intrauterine device: increased insertions
among US women with employer-sponsored insurance,
2002-2008.
Xu X, Macaluso M, Ouyang L, Kulczycki A, Grosse SD.
CDC, Atlanta, GA 30341, USA. [email protected]
RESULTS:
IUD insertion rates increased from 1.6/1000 women of reproductive age to 9.8/1000 over
2002-2008 and varied substantially by state. Insertion rates of the levonorgestrel-releasing
intrauterine system (LNG-IUS) increased from 0.4/1000 to 7.7/1000, whereas the insertion
rates of copper T380A IUD (copper IUD) increased from 0.6/1000 to 1.5/1000. IUD
insertions, which are most common among women aged 25-34 years, increased at roughly
the same rate across all age groups.
CONCLUSIONS:
The sixfold increase in IUD insertion rates between 2002 and 2008 was
accompanied by an
increase in the share IUD use with the LNG-IUS from 40% to 85%.
Contraception. 2012 Feb;85(2):155-9.
Reversible Langzeit-Verhütungsmethoden
Long-acting reversible Contraception
LARC
• Erster Geschlechtsverkehr
• durchschnittlich
• mit 16 Jahren
• Erstes Kind
• durchschnittlich
• mit 30 Jahren
• Längere Ausbildung
• Sicherheit & Komfort
A non-interventional study of 224 nulliparous women attending family
planning services for insertion of a LNG-IUS.
Results
There were only six unsuccessful insertions. The insertions, mostly carried out
by midwives, were regarded as easy by 72% of the inserters.
www.thelancet.com/oncology Vol 12 October 2011
www.thelancet.com/oncology Vol 12 October 2011
Women with a lower BMI were more often “very satisfied”
concerning bleeding patterns, but not concerning the general
satisfaction.
Conclusion:
Our study showed much evidence, that amenorrhea occurs more
often in women with lower BMI contrary to women with a higher
one—especially at the beginning of LNG- IUD use.
Mirena
Liegedauer
1. -2. Monat
LNG – pg/ml
Ibk/Brg Brazil
253
1. Jahr
191
20
2. Jahr
157
30
3. Jahr
134
40
6. Jahr
133
50
7. Jahr
133
8. Jahr
117
8,5 Jahre
AmenorrhoeRate
137
41,8
119
31,5
Fertility and Sterility® Vol. -, No. -, - 2012
Study design
Multicentre, open-label, randomised, Phase III study
Healthy nulliparous and
parous women aged
18−35 years requesting
contraception*
*Subjects were recruited from
investigators’ practices and
through advertising and referrals
R
A
N
D
O
M
I
S
E
Jaydess (LNGIUS12)
3 years
LNG-IUS16
LNG-IUS16
3 years
2 years
Core study
Extension
study†
(optional)
† LCS16 is currently being studied for up to 5 years of use. Subjects in the LNG-IUS16 group who completed the 3-year core study were
given the option to continue using the system in an extension study for up to 2 more years (5 years in total).
The data reported later in this slide deck are for the 3-year core study only
Disposition of subjects
Randomised
(n = 2,885)
*Full
Allocated to Jaydess
(n = 1,432)
Placement attempted (n = 1,432)
Placement not attempted (n = 0)
Allocated to LNG-IUS16
(n = 1,453)
Placement attempted (n = 1,452)
Placement not attempted (n = 1)
(unsure of uterine depth)
Discontinued in year 1 (n = 266)
Failed placements: n = 6
Adverse events: n = 175
Discontinued in year 1 (n = 246)
Failed placements: n = 7
Adverse events: n = 168
Discontinued in year 2 (n = 203)
Adverse events: n = 85
Discontinued in year 2 (n = 194)
Adverse events: n = 66
Discontinued in year 3 (n = 144)
Adverse events: n = 53
Discontinued in year 3 (n = 142)
Adverse events: n = 44
Study completion (n = 819)
Study completion (n = 870)
Analysed for efficacy
and safety
(n = 1,432)*
Analysed for efficacy
and safety
(n = 1,452)*
analysis set: all subjects who had an LNG-IUS placement attempted
Baseline characteristics
Jaydess
(N = 1,432)
LNG-IUS16
(N = 1,452)
Total
(N = 2,884)
27.2 [18–35]
27.1 [18–35]
27.1 [18–35]
Mean weight, kg
68.7
68.7
68.7
Body mass index, kg/m2
25.32
25.32
25.32
Current smokers, n (%)
334 (23.3%)
360 (24.8%)
694 (24.1%)
Mean number of births
1.1
1.1
1.1
556 (38.8%)
574 (39.5%)
1,130 (39.2%)
Variable
Mean age, years [range]
Nulliparous, n (%)
•
Both treatment groups were well balanced
•
Compared with the Phase II study, the mean age was lower and a higher proportion of nulliparous subjects were enrolled
Full analysis set: all subjects who had an LNG-IUS placement attempted
Unadjusted 3-year Pearl Indices
Treatment
Relevant
exposure
[WY]
Jaydess
3,058.62
Total number of
pregnancies
10
(3 ectopic)
Number of
pregnancies by
year
3-year
Pearl
Index
Year 1: 5
0.33
Year 2: 3
Year 3: 2
LNG-IUS16
3,211.36
10
(7 ectopic)
Year 1: 2
0.31
Year 2: 4
Year 3: 4
•
•
•
Adjusted and unadjusted 3-year Pearl Indices were nearly identical
Kaplan–Meier estimates for the cumulative failure rate over 3 years: 0.009
(Jaydess) and 0.010 (LNG-IUS16)
Pregnancies in both Jaydess and LNG-IUS16 treatment groups were distributed
evenly over the course of the 3 year study
Reporting of adverse events over time
Percentage of subjects
Percentage of subjects reporting ≥1 AE by year of treatment
Clear trend in both treatment groups for fewer subjects reporting
adverse events over time
Most frequently reported
treatment-related adverse events (1)
Adverse event
(MedDRA preferred term)
Jaydess
(N = 1,432)
LNG-IUS16
(N = 1,452)
Acne
144 (10.1%)
144 (9.9%)
Headache
47 (3.3%)
48 (3.3%)
Increased weight
34 (2.4%)
48 (3.3%)
Breast pain
21 (1.5%)
30 (2.1%)
Dysmenorrhoea
98 (6.8%)
76 (5.2%)
Vaginal haemorrhage*
65 (4.5%)
69 (4.8%)
Bleeding-related
Most frequently reported
treatment-related adverse events (2)
Jaydess
(N = 1,432)
LNG-IUS16
(N = 1,452)
Ovarian cyst*
110 (7.7%)
201(13.8%)
Pelvic pain
68 (4.7%)
87 (6.0%)
Abdominal pain
48 (3.4%)
37 (2.5%)
Uterine spasm
28 (2.0%)
37 (2.5%)
Abdominal pain lower
30 (2.1%)
31 (2.1%)
Vaginal discharge
28 (2.0%)
28 (1.9%)
Procedural pain
28 (2.0%)
24 (1.7%)
Adverse event
(MeDRA preferred term)
Other
*Ovarian cysts were only to be reported as adverse events if they were abnormal non-functional
cysts and/or had a diameter >3 cm
Adverse events: ovarian cysts
•
Ovarian cysts were to be reported as adverse
events if they were abnormal non-functional
cysts and/or had a diameter >3 cm
•
The only treatment-related adverse event that
occurred significantly more frequently in one
treatment group than the other was ovarian
cyst
Percentage of subjects
Subjects who developed ovarian cysts
–
More subjects developed ovarian cysts
while using LNG-IUS16 than while using
Jaydess
–
This may reflect the lower systemic
exposure to LNG with Jaydess, which may
have had less of an effect on the
hypothalamic–pituitary axis
Ectopic pregnancy
Time
Treatment
Relevant
exposure
[WY]
Year 1
Jaydess
LNG-IUS16
1,217.78
1,252.78
2
2
0.16
0.16
Year 2
Jaydess
LNG-IUS16
1,015.67
1,067.49
1
3
0.10
0.28
Year 3
Jaydess
LNG-IUS16
825.17
891.09
0
2
0.00
0.22
2 years*
Jaydess
LNG-IUS16
2,233.45
2,320.27
3
5
0.13
0.22
3 years
Jaydess
LNG-IUS16
3,058.62
3,211.36
3
7
0.10
0.22
•
•
*First
Number of
ectopic
pregnancies
Rate per 100
woman-years
Jaydess and LNG-IUS16 were associated with very low absolute rates of ectopic
pregnancy
Ectopic pregnancies observed were evenly distributed among the subgroups (age,
parity and BMI)
2 years of treatment
CI, confidence interval; PI, Pearl Index; WY, woman-years (1 WY = 365 days)
User satisfaction
Subjects’ overall satisfaction with treatment at the end of 3 years
Percentage of subjects
100
80
75.6 79.2
60
40
20
19.1 16.7
2.9
0
•
2.1
2.2
1.7
<0.1
0.3
<0.1
0.1
User satisfaction was assessed in 2116 out of 2884 women in the FAS following
implementation of Study Protocol Amendment 3 on 16 Jan 2009. Therefore, data for
were not captured for subjects who discontinued the study before this date
LNG-IUDs im Vergleich
Jaydess
Mirena
Liegedauer
3 Jahre
5 Jahre
Größe
28*30 mm
32*32 mm
Durchmesser des Insertionsröhrchens
3,8 mm
4,8 mm (EvoInserter™ 4,45mm)
Indikation
Kontrazeption
Kontrazeption, Hypermenorrhoe,
Endometriumprotektion bei HRT
Pearl Index
0,41 (0,33 nach 3 Jahren)
0,2 Mirena
Hormongehalt gesamt
13,5mg
52mg
Tägliche Hormonabgabe
Beginn/Ende der Anwendung
14µg/d  5µg/d
20µg/d  10µg/d
LNG-Serumspiegel
Beginn/Ende der Anwendung
162pg/ml  59pg/ml
206pg/ml  131pg/ml
Ovulationshemmung
Praktisch nicht; kein Einfluss auf Ovarialfunktion
& Östrogenspiegel
Bei einigen Frauen
Amenorrhoerate
11,6 %
20%
Detektion
Röntgendicht durch Bariumsulfat & bessere
Sichtbarkeit im Ultraschall durch Silberring
Röntgendicht durch Bariumsulfat
Besonderheiten
Signifikant weniger Ovarialzysten unter der
Anwendung
Quelle: Fachinformationen Jaydess® & Mirena®
Mirena
Liegedauer
1. -2. Monat
LNG – pg/ml
Ibk/Brg Brazil
253
1. Jahr
191
2. Jahr
157
3. Jahr
134
6. Jahr
133
7. Jahr
133
8. Jahr
117
8,5 Jahre
Jaydess
162
59
137
119

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