EP- Patients Objectives Design Methods Introduction Results • • • • • • • • • • • • • • • • • • 17 ECE 17 the at Presented Hormonal values before values Hormonal (%) n adenoma, Typeof (range) member/relative family by Injection self to able Patient Median time since diagnosis, months months diagnosis, since time Median (range) yearsdiagnosis, ageat Median staff healthcare byInjection Male, n (%) n Male, Prior treatment, Prior treatment, n (%) Table 1. Patient demographics and disease characteristics Microadenoma 789-EP the GH patients prescribing included: 90 mg/6 weeks(n=4), 90 mg/8 weeks(n=3), 60mg/8 weeks(n=2) and120 mg/12 weeks(n=1) Five different subgroups were considered for the analysis according to starting dosage pattern. Other dosages Lanreotide with 22 characteristics The 62 The The All Descriptive Patients months, Study into The This Experience Initial Somatostatin requires Control Persistently and Acromegaly with analysis interval with and for,
(95% CI) %ULN IGF of (95% CI) mean ng/mL, GH, Surgery Radiotherapy – – – – Microadenoma Macroadenoma
.
789 8 patients
patients
first
or
levels the
elevated dosage % following decision
administration Lanreotide PAS
To To To To similar . . was
recommended primary refusing
included
of
assess evaluate assess determine
Information Direct (6 of
hormonal study
with
with set whose a
,
the
population GH
<10 mm, mm, <10
reduction <
a
8
Autogel
recommendations provided
statistics
in were 2
elevated - (PAS) intervals
is question question
1, mean and efficacy
active
GH
. to insulin
multicentre,
th were
analogues patients patients’ the and 5 - Spanish
and
inject, n (%) n inject,
are surgery,
a
patients’ objective
European Congress of Endocrinology,EuropeanCongressof Dublin, Ireland,16 Autogel clinical prescribe 18 9 5 1 Azpiroz Escolá Álvarez Cristina practice clinical routine in acromegalypatients initial with control hormonal achieve to ACROSTART: Spanish retrospective study determine to the timeframe Virgen de las Nieves,Virgende las Granada; Rabinovich Elena María Torres Vela
ng/mL
adults
use
on dose omission and on whether the patient was continuing continuing was patient the on whether and omission on dose Hospital Universitario Hospital UniversitarioPrincesa,La Madrid;de Hospital Universitario La Paz, Madrid; efficacy rare levels
12 macroadenoma screened IPSEN
response
it
because
shown
treatment IGF by secondary 120
about about acromegaly
- of was
.
in weeks) Cristina Álvarez Escolá Pituitary clinical
like
doses written summarized 5 , GH of adherence
consisted
healthcare close
chronic
general -1 Starting managed GH
hospitals
and/or records
with
< after mg Lanreotide of
and
satisfactionpossible 3 answers with satisfied(verysatisfied, all satisfied, at not
growth
prescribed
2 Pharma
(SSAs)
and secretion
Lanreotide Lanreotide in was .
non 5 levels
of was
from
available
they 5
relatives informed reported active Table achieving ng/mL failure
, MaríaÁngeles Gálvez Moreno satisfaction
IGF >10 mm. PAS, Primary Analysis Set. Analysis PAS,Primary mm. >10
objectives -interventional, normalised
endocrine to the
resources lacked
conducted dose
factor to
the
indicated of
Lanreotide underwent , injections have 08
to -I
quantitative 15
L’Hospitalet
(8.1; 325.5) (13.0; 77.0) SSA
1
Autogel
acromegaly is Autogel 57 and/or
levels of (1.6; 2.1) 22 (38.6) (2.6; 7.4) 35 (61.4) 44 (77.2) 21 (36.8) 39 (68.4) 14 (24.6) 1.9xULN
< according determine
8 (14.0) most
March
, Concepción, Páramo Fernández 5 (8.8)
103.5
N=57 2 Autogel
in were PAS – consent decisive
surgical 5.0
for
51 . hormonal information I Germans become patients 5
with
Lanreotide 44
until (IGF
:
ng/mL
disease,
common
lead Lanreotide
Autogel that
in % IGF
normalised
excluded at
Lanreotide commonly
without to
obtaining surgery controlling
-I)
of
17 was
variables
-1 to 31 treatment, in de Llobregat, retrospective,
a
to
(14.6; 285.0) the levels, and the (26.0; 74.0)
the who 14
with
longer centres
control Trias routine
10 (76.9) (1.4; 2.2) (0.7; 7.6 improving 4 weeks 1.8xULN therapy on substantial 2 (15.4) 8 5 4 ( 8 ( 2 (
Hospital ClínicoCarlos, San Madrid; October 60 mg/
1 (7.7) made 100.7
n=13 regarding
characterized 55.0
dose ( (
A patients 4.2
61.5) 38.5) 30.8) 61.5) assistance
15.4) pillar
normalisation
hormonal or utogel ≥ Autogel
1
timeframe a had tumour
2
Autogel
11 IGF , MaríaVenegas Eva Moreno i Pujol, Badalona;i used
the
received
2
median dosage
consecutive
)
Hospital Universitario Virgen Rocío,del Sevilla;
clinical
prior
to
in , María, Ángeles Gonzalo Redondo
or
of
- been
most
2013 1
Spain
start
are therapy survival, size in in
acromegaly
Spain levels control the morbidity (−11.3; 37.5)
(8.1; 128.4) (21.0; 76.0) post
to clinical selected
(1.7; 5.0) 4 weeks 3.3xULN treatmentat the end of the study
2 (33.3) 4 (66.7) 1 ( 5 ( 2 ( prescribed
90 mg/
2 4 of
60 6
interval
in
. 103.7 20 May 2015 May -20 practice frequent
age treatment treated radiotherapy Hospital Universitario Reina Sofía,Córdoba; 13.1 and
45.0
n=6 date ( (
16.7) 83.3) 33.3)
to
Five by 33.3) 66.7)
0 daily
- , healthcare of
authorisation
on 90
3
enhanced
independently
IGF evaluations of
achieve
and
practice
and
clinical patients at and
and
cases
could
64
with -
10 cause least medical 1
optimum initial (19.3; 284.2) Hospital de la SantaHospital de
(51
(20.0; 77.0) in 120 mortality levels (0.2; 13.4
years 10 (76.9) (1.2; 2.1) 4 weeks 1.6xULN
120 mg/
practice 2 (15.4) 6 ( 7 ( 6 (
6 7
1 (7.7)
129.9 n=13
Lanreotide
between be staff, 49.0 % as clinical ( ( two
6.8
46.2) 53.8) 46.2)
46.2) 53.8) hormonal were growth
mg of
6
dose
)
patients), used
3 primary
study , Edelmiro MenéndezEdelmiro, Torre
therapy
considering
which (range
consecutive
administered )
either management from ) 2
excluded
of
practice
in
the 15 hormone
(17.9; 325.5)
performed
Lanreotide
(13.0; 72.0)
is Hospital
the well
treatment
(0.8; 1.8) 16 (0.6; 3.2 Autogel 6 weeks 1.3xULN 120 mg/
5 (83.3) 1 (16.7) 3 ( 4 ( 1 ( 23
in 6 with
control with initiation 170.1 a 51.0 n=6 ( 1.9
, Antonio Miguel Picó AlfonsoPicó Miguel, Antonio
50.0) 66.7) 16.7)
100) -90 0 patient's pituitary patients 0 controlled
the
from
self evaluations extended Creu may
)
)
.
(GH)
every
Clínic of
for Demographic
starting -injections 4
(defined
in
Autogel of the the
i 2 differ
(41.6; 218.6) adenoma unsuitable
(34.0; 72.0) enrolment
at Sant treatment , Juan Antonio García Arnés
secretion (1.0; 2.2) (1.3; 5.3 8 weeks 1.6xULN 62 120 mg/
28
2 3 ( 7 (
1 (11.1) 9 (100) 7
Provincial, Barcelona; disease patients 120.8 primary 3
47.0 least n=9 ( dosing Hospital Regional Universitario Carlos Haya, Málaga; ( 3.3 22.2) 33.3) 77.8)
77.8) 0 0
days
dose adult
Pau, Barcelona; from
and DOI: 10.3252/pso.eu.17ece.2015
as
7
)
or
Hospital UniversitarioHospitalde Asturias, Oviedo; Central
4 1 .
12
, Ricardo, VílchezJoya endpoints Secondary Primary endpoint • • • • • • mean(95% CI) 2. Figure Set. Analysis Primary PAS, 1. Figure *Informationnot wasavailable 2patients.for Autogel 3. Figure Set. Analysis Primary PAS, References for The Globally, Mean There treatment Globally, At patients 2. 3. 1. Mean number (95% CI)
• • •
10 Patients (%) 100 Months the the 11 10 12 14 16 18 20 7 0 1 2 3 4 5 6 7 8 9 10 20 30 40 50 60 70 80 90 Conclusions
Manjila Reddy Reddy Holdaway 0 2 4 6 8 use 0 , Javier Aller Pardo AllerJavier , Lanreotide responder Real One In being despite Hospital Universitario Cecilio,San Granada;
16
length
was beginning 24
Complejo Hospitalario Endocrinologist visits Endocrinologist therapy
a
with of Use of healthcare resources until hormonal control in the PAS population (N=57), number, (N=57), PAS population in the control hormonal until resources healthcare of Use months control, to time hormonal Median Patient satisfaction with with satisfaction Patient the
R, et al. et R,
51
Not at all
S, et al. et S, (1.2, 117.0) patients at -
fifth a real life healthcare
IM, et al. et IM, PAS
the the
N=57 L 4.9 median very 7.3 of out available
disparity
treatment
BMJ BMJ (4.2, 9.9) -
Neurosurg
end of
(n=55)* treatment
anreotide anreotide life
most 17 of of 7.1
good
with
patients,
Eur
Autogel
2010; 341:c4189. the treatment, , Sara ArroyoSara ,
55 of
time
setting, J presented
resources
information, available the Endocrinol
adherence
(92 common
patients Satisfied Focus
with Poster to 3
of 41.8 (1.2, 57.6) study 60 mg/ 60 , Concepción, Carrera Blanco .
4 wks 7 reach
5.0 n=13 at:
13 %
starting 2010;29:E14. Xeral
and with Lanreotide the with
)
2008;159(2):89 , MaríaPaz deMiguel Novoa
the information
until (Figure patients
mean Laboratory tests
hormonal
to 8
managed Lanreotide Lanreotide -Cies
and achieving starting
,Salinas IsabelVert
Lanreotide
therapy a reaching median 4
satisfied
Hospital Universitario Príncipe deAsturias,Henares; Alcalá de
(3.1, 5.4) doses high
it 8
18
Very maximum de Vigo, Vigo;
Hospital Universitario Hierro,Puertade Majadahonda; 50.9 3 Autogel
4.2 rated was ) (2.6, 28.3) Starting dosage of Lanreotide Lanreotide of dosage Starting
90 mg/ 90 – , Francesc Pérez Francesc ,
4 wks
95 control
3.4 (Figure
n=6 A .
dose
treatment
hormonal 1139
injections
time and to
hormonal 12 was utogel
Fundación Jiménez Díaz,Madrid;
be tumour
was 5. 4. Autogel
mm
4
(range) interval
68 Lucas Giustina ) elapsed satisfied 17
P AS, Primary Analysis Set. Analysis Primary PAS, (N=57 PAS population 4. Figure
3 4
control Hospital General
months . (95 9
(2.2, 106.8) 120 mg/
volume T, al. et
adherence 4 wks without Imaging tests Imaging months
Patients (%) 100
A. et al. et A.
% n=13 10 20 30 40 50 60 70 80 90 8.1
control 0
led
dosing CI (1.3, 2.3) is or
(95 Clin
1.8 between Patient adherence to treatment
shown No doses missed 0
was Nat. Rev. Rev. Nat. 9 very
(range ,
% , Eugenia, Resmini Endocrinol to
3185 18 assistance treatment in treatment
CI
was 2010
satisfied a
, Pineda Eva
4
in 86.0 55 and , Mónica
Universitari Endocrinol
) (2.8, 117.0) 120 mg/ 1
Autogel fast Figure
6 wks at
-80 .
( 2 8.2 mm initiating Oxf 4 14 n=6
,
last
. ) 117 ) 9 treatment ) , Irene
2006;65(3):
3 Absenteeism days Funding byFunding with hormonal
months
(95 2014;10:243 evaluation
. 2
0 of
13 )
% d'Alacant (Figure Hospital General
the healthcare (9.2, 27.1)
Marazuela
CI 18.1 treatment 320
Halperín 120 mg/ Lanreotide (1.8, 22.0) Continuing
0 Ipsen 8 wks treatment – with – 18 satisfaction, , 248.
326.
4.2
n=9 during 5774 1 82.5
, Alacant;
control )
10 Pharma, Spain.
120
in the in the
) ,
for treatment staff
with Autogel
mg the
in
19