Exploiter la richesse des banques de données

Transcription

Exploiter la richesse des banques de
données dédiées aux médicaments
Mars 2014
Agenda
• Médicaments en développement
– IMSRESEARCH, ADISINSIGHT
• Brevets
– IMSPATENTS
• Essais cliniques
– ADISCTI
• Effets secondaires, pharmacoéconomie
– ADISNEWS
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IMSRESEARCH
IMS LifeCycle R&D Focus
• Toutes les phases de développement des médicaments
de la découverte au lancement commercial
• 35000 fiches d’identification de médicaments
‒ Noms chimiques, commerciaux, codes laboratoires, Rns (30%)
‒ Classification thérapeutique (Ephmra)
‒ Pharmacologie
‒ Statut du développement pour chaque pays
• avec informations détaillées sur les licenses (offres, accords..)
‒ Résumés scientifique et commercial
• Mise à jour hebdomadaire
• IMS Health (GB)
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La référence IMSRESEARCH
ACCESSION NUMBER:
SOURCE:
DOCUMENT NUMBER:
STATUS:
GENERIC NAME:
2014:115 IMSRESEARCH
R&D Focus, (13 Feb 2014)
2505964
NEW DRUG
synthetic hepcidin, La Jolla/INSERM
CLASSIFICATION:
INDICATION:
ACTION:
B6C Other Haematological Agents
iron overload
hormone; peptide
Classification
thérapeutique
HIGHEST DEV. PHASE: Preclinical (20)
ENTRY DATE:
Entered STN: 14 Feb 2014
Last Updated on STN: 14 Feb 2014
LATEST INFORMATION: 13 February 2014 : On 10 February 2014 La Jolla announced
that it has entered into an exclusive, worldwide licensing
agreement with INSERM (France) for the development of
hepcidin agonists for the treatment chronic iron overload.
La Jolla plans to initiate a single-dose, exploratory
phase I trial of synthetically-derived hepcidin during
2014 in patients with transfusion-dependent anemia who
have severe chronic iron overload and are intolerant to or
have failed chelation therapy.
5
CURRENT DEVELOPMENT STATUS:
Type | Status
|Stage|Region| Indication
=======+===========+=====+======+=============
Highest|Preclinical|20
|
|
Phase |
|
|
|
-------+-----------+-----+------+------------Phase |Preclinical|20
|France|iron overload
COMPANY INFORMATION:
Type |Company |Nationality| Corporation
========+========+===========+================
Licensor|INSERM |France
|INSERM (France)
--------+--------+-----------+---------------Licensee|La Jolla|USA
|La Jolla (United
|
|
|States)
Stades de
développement
Sociétés
COMMERCIAL SUMMARY:
Commercial overview.
La Jolla is developing synthetic hepcidin for the treatment of chronic iron
overload in patients with transfusion-dependent anemia who are intolerant to or
have failed chelation therapy. Preclinical evaluation is ongoing. INSERM
(France) and La Jolla entered into a licensing agreement regarding hepcidin
agonists in February 2014.
6
R&D progress. **Iron overload**
Phase I, La Jolla, USA.---DESIGN:Trial planned - Feb 2014. La Jolla plans to
initiate a single-dose, exploratory phase I trial of synthetically-derived
hepcidin during 2014 in patients with transfusion-dependent anemia who have
severe chronic iron overload and are intolerant to or have failed chelation
therapy (La Jolla, FEB 2014).
Preclinical, INSERM, France.---DESIGN:Study started - 2013. Preclinical
evaluation is under way (La Jolla, FEB 2014).
Licensing/Partnering. INSERM (Licensor), La Jolla (Licensee).---Licensing
agreement signed, Preclinical - Feb 2014.La Jolla has entered into an
exclusive, worldwide license agreement with INSERM (France) for the development
of hepcidin agonists for the treatment chronic iron overload in patients who
are refractory or intolerant to chelators (La Jolla, FEB 2014).
DEVELOPMENT HISTORY:
FEB 2014
INSERM, La Jolla licensing agreement signed, .
2013
INSERM Study started (preclinical), France (iron overload)
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Exemple : Identifier les sociétés auxquelles l’Inserm a
concédé des licences
=> S (INSERM (L) LICENSOR)/CO
L1
10 (INSERM (L) LICENSOR)/CO
=> ANA L1 CO
L2
ANALYZE L1 1- CO :
27 TERMS
=> D 1L2
27 TERMS
ANALYZE L1 1- CO :
COmpany Name
TERM #
# OCC # DOC % DOC CO
------ ------- ------ ------ --------------1
12
10 100.00 INSERM
2
10
10 100.00 INSERM (FRANCE)
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2 20.00 BIOPROJET
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2 20.00 BIOPROJET (FRANCE)
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1 10.00 ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
(FRANCE)
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1 10.00 ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
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1 10.00 C2X PHARMA (FRANCE)
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1 10.00 C2X PHARMA
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DYAX
GLAXOSMITHKLINE (UK)
GLAXOSMITHKLINE
INNAVIRVAX (FRANCE)
INNAVIRVAX
INSERM : BIOPROJET
LA JOLLA (UNITED STATES)
LA JOLLA
NOVO NORDISK (DENMARK)
NOVO NORDISK
QUANTUM GENOMICS (UNITED STATES)
QUANTUM GENOMICS
TCLAND (FRANCE)
TCLAND
UNIVERSITE PARIS 5 RENE DESCARTES
(FRANCE)
1 10.00 UNIVERSITE PARIS 5 RENE DESCARTES
1 10.00 URRMA BIOPHARMA (CANADA)
1 10.00 URRMA BIOPHARMA
OF L2 ***
9
Exemple : Offres de licence ou de partenariat pour des agents
de diagnostic (classification T diagnostic agents)
=> HELP T
The following Classification Codes may be used with the Classification Code T,
e.g., S T1E/CC. For a complete listing of these codes, enter HELP CLASSCODES
at an arrow prompt (=>) in the file.
T
T1A
T1C
T1E
T1F
T1G
T1X
DIAGNOSTIC AGENTS
LOW OSMOLAR ANGIO-UROGRAPHY
GASTROENTEROGRAPHY
MRI AGENTS
ULTRASOUND AGENTS
RADIODIAGNOSTIC AGENTS
OTHER IMAGING AGENTS
=> S T1#/CC
L1
410 T1#/CC
=> S L1 AND (AVAILABLE FOR LICENSING OR AVAILABLE FOR PARTNERING)
L2
116 L1 AND (AVAILABLE FOR LICENSING OR AVAILABLE FOR PARTNERING)
=> S L2/NEW
L3
6 L2/NEW
10
=> D ALL 1L3
AN
SO
DN
STA
CN
CC
CT
HDP
ED
LI
ANSWER 1 OF 6 IMSRESEARCH
COPYRIGHT 2014 IMSWORLD on STN
R&D Focus, (14 Oct 2013)
2505641
NEW DRUG
MAb, ER-alpha 36, Shenogen; MAb, estrogen receptor-alpha 36, diagnosis,
Shenogen; MAb, estrogen receptor-alpha 36, Shenogen
T1X Other Imaging Agents
Indication: diagnosis
Pharmacology: protein; monoclonal antibody; biotechnology
Preclinical (20)
Entered STN: 18 Oct 2013
Last Updated on STN: 18 Oct 2013
14 October 2013 : Jun Bao, Senior Vice President and Chief Business
Officer of Shenogen, informed R&D Focus at BioJapan 2013, 9-11 October
2013, Yokohama, Japan, that the company is developing a monoclonal
antibody targeting estrogen receptor-alpha 36 for the diagnosis of
cancer. Preclinical evaluation is under way in China. This program is
available for partnering.
DSTA
Type
| Status
|Stage| Region |Indication
=========+===========+=====+=========+==========
Highest |Preclinical|20
|
|
Phase
|
|
|
|
---------+-----------+-----+---------+----------
11
---------+-----------+-----+---------+---------Phase
|Preclinical|20
|China
|diagnosis
---------+-----------+-----+---------+---------Licensing|Available |
|Worldwide|
CO
Type
|Company |Nationality| Corporation
==========+========+===========+================
Originator|Shenogen|China
|Shenogen (China)
TX
Commercial Summary: Commercial overview. OverviewShenogen is developing a
monoclonal antibody targeting estrogen receptor-alpha 36 for the
diagnosis of cancer. Preclinical evaluation is under way in China.R&D
progress. Preclinical, Shenogen, China.---DESIGN:Study started - 2013.
Preclinical evaluation is under way in China (Shenogen, OCT
2013).Licensing/Partnering. Shenogen.---Availability, Preclinical - Oct
2013.Shenogen's monoclonal antibody targeting estrogen receptor-alpha 36
for the diagnosis of cancer is available for partnering (Shenogen,
OCT 2013).
RDAT: OCT 2013
2013
RNTE: Shenogen partnering opportunity, Worldwide .
Shenogen Study started (preclinical), China
(diagnosis) .
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ADISINSIGHT
Adis R&D Insight
• Toutes les phases de développement des médicaments
de la découverte au lancement commercial
• 31000 fiches d’identification de médicaments
‒ Noms chimiques, commerciaux, codes laboratoires, Rns (30%)
‒ Classifications thérapeutiques (EphMRA, WHO)
‒ Pharmacologie, études cliniques
‒ Statut du développement pour chaque pays
• avec informations détaillées sur les licenses (offres, accords..)
• Springer Adis (US)
13
La référence ADISINSIGHT
ACCESSION NUMBER:
SOURCE:
DOCUMENT NO:
CHANGE DATE:
GENERIC NAME:
SYNONYM:
CHEMICAL NAME:
MOLECULAR FORMULA:
CAS REGISTRY NO.:
STRUCTURE:
2006:519 ADISINSIGHT
Adis R&D Insight
024329
Identification de la
Dec 4, 2013
molécule
Lobeglitazone
CKD 501; CKD-501; IDR-105; Lobeglitazone sulfate
2,4-Thiazolidinedione,
5-((4-(2-((6-(4-methoxyphenoxy)-4-pyrimidinyl)
methylamino)ethoxy)phenyl)methyl)-,sulfate (1:1)
C24 H24 N4 O5 S H2 O4 S
763108-62-9
RELATED CAS REG. NO.:
607723-33-1 (Parent drug)
EPHMRA ATC CODE:
WHO ATC CODE:
A10X Other Drugs Used in Diabetes
A10B-X Other oral blood glucose lowering drugs, excl.
insulins
HIGHEST DEV. PHASE:
Preregistration
Codes thérapeutiques
Stades de
développement
CURRENT DEVELOPMENT STATUS:
Preregistration, Korea, Democratic People's Republic of,Type-2 diabetes mellitus
Phase III, Korea, Democratic People's Republic of, Type-2 diabetes mellitus
Preclinical, United States, Type-2 diabetes mellitus
14
COMPANY INFORMATION
ORIGINATOR:
PARENT:
LICENSEE:
Chong Kun Dang (Korea, Democratic People's Republic of)
Chong Kun Dang
Sociétés
EQUIS & ZAROO
OTHER SOURCES:
WORD COUNT:
801027548; 801105485
983
TEXT
Introduction:
Lobeglitazone is an orally available, dual peroxisome proliferator-activated
receptor alpha/gamma (PPARalpha/gamma) agonist being developed by Chong Kun
Dang Pharmaceutical for the treatment of type 2 diabetes mellitus.
Lobeglitazone has been filed for approval in South Korea as a monotherapy, and
is in phase III development in combination with other anti-diabetes treatments.
EQUIS & ZAROO is developing lobeglitazone under license in the US. Development
is at the preclinical stage in the US.
Company agreements
Lobeglitazone was out-licensed to EQUIS & ZAROO in 2007, for development in
the US.
Key development milestones
Chong Kun Dang filed lobeglitazone for approval in South Korea in 2012, as a
monotherapy for type 2 diabetes mellitus.
15
Chong Kun Dang completed a randomised, double-blind phase III trial in
November 2012, to assess the efficacy and safety of lobeglitazone in
combination with metformin for 24 weeks in patients with type 2 diabetes
mellitus (NCT01106131). The control group received pioglitazone in combination
with metformin. The core trial was followed by a 28-week extension to assess
long-term safety. The trial enrolled 253 patients in South Korea.
In October 2009, Chong Kun Dang initiated a phase III trial to assess the
efficacy and safety of lobeglitazone once daily for 24 weeks as a monotherapy
for patients with type 2 diabetes (NCT01001611). Patients were randomised to
receive placebo or lobeglitazone tablet (0.5mg) once daily for 24 weeks (or 52
weeks if participating in the extension study). Enrolment of 168 patients was
completed in November 2010, and the trial was completed in South Korea in
January 2012.
A phase II study of lobeglitazone for the treatment of type 2 diabetes has
been completed in South Korea (NCT01030679). This randomised, double blind,
placebo-controlled, parallel assignment study investigated the safety and
effectiveness of lobeglitazone in lowering fasting plasma glucose levels in
patients with type 2 diabetes, as compared with placebo.
The trial enrolled 214 patients.
Chong Kun Dang is planning a randomised, crossover phase I trial to
investigate the potential pharmacokinetic drug-interaction between
lobeglitazone and warfarin in healthy male volunteers (NCT02002611). The trial
will enrol 24 subjects in South Korea.
16
The company is also planning two open-label phase I clinical trials to
evaluate the pharmacokinetics of lobeglitazone in healthy volunteers and
subjects with impaired hepatic function (19HI13018; NCT02005744, 19RI113017;
NCT02007941). Both trials will be conducted in South Korea, and one trial will
enrol 24 subjects and the other trial is intended to enrol 38 subjects.
In August 2011, Chong Kun Dang completed a randomised, open-label, crossover
phase I trial to assess the pharmacokinetic interaction between lobeglitazone
and amlodipine in healthy male volunteers (NCT01341392). The trial enrolled 25
subjects in South Korea.
Chong Kun Dang conducted a randomised, open-label, crossover phase I trial to
assess the effect of ketoconazole on the pharmacokinetics of lobeglitazone in
healthy male volunteers (NCT01330563). The trial enrolled 24 subjects in South
Korea and was completed in June 2011.
Chong Kun Dang completed two phase I trials of lobeglitazone in August 2010;
both trial enrolled 24 volunteers from South Korea. One was a drug-food
interaction trial (NCT01071720) and the other was a drug interaction trial
evaluating potential interactions between lobeglitazone and glimepiride
(NCT01133431).
In February 2010, Chong Kun Dang completed a randomised, open-label, three-way
crossover phase I trial to investigate the pharmacokinetic interaction between
lobeglitazone and metformin in healthy male volunteers (NCT01005160).The trial
enrolled 24 subjects in South Korea.
17
Lobeglitazone showed favourable oral pharmacokinetics with potential for
once-daily dosing. Chong Kun Dang has conducted a phase I study of
lobeglitazone in 36 male volunteers that evaluated safety, tolerability and
pharmacokinetics/1/.
Chong Kun Dang has completed a phase I trial of lobeglitazone (2 and 4mg) in
22 healthy female volunteers in South Korea. Results have been reported from
this randomised, placebo-controlled, dose-rising, parallel group study/2/.
EQUIS & ZAROO is conducting preclinical development of lobeglitazone in the US
Patent information
Chong Kun Dang holds US patents covering lobeglitazone, and has pending patent
applications for lobeglitazone in 16 countries.
PHARMACOLOGY OVERVIEW:
Mechanism of action:
Peroxisome proliferator-activated receptor gamma agonists
Peroxisome proliferator-activated receptor agonists
Peroxisome proliferator-activated receptor gamma modulators
Transcription factor stimulants
Peroxisome proliferator-activated receptor modulators
Cytoplasmic and nuclear receptor agonists
Transcription factor modulators
Protein stimulants
Cytoplasmic and nuclear receptor modulators
Protein modulators
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Peroxisome proliferator-activated receptor alpha agonists
Peroxisome proliferator-activated receptor agonists
Transcription factor stimulants
Peroxisome proliferator-activated receptor modulators
Cytoplasmic and nuclear receptor agonists
Transcription factor modulators
Protein stimulants
Cytoplasmic and nuclear receptor modulators
-----------------------------------------tmax (h) (oral)
0.5 - 4
(unspecified)
t (1/2) beta (h) 7.8 - 9.8 (unspecified)
-----------------------------------------Activity versus parent drug:
unspecified parent
CLINICAL OVERVIEW:
Route(s) of Administration: PO
Administration Freq.(per day):
Drug Interactions:
Unknown.
Adverse Events:
In a phase I study that evaluated lobeglitazone (2 and 4mg) in 22 female
volunteers, pharmacokinetic differences were seen with lobeglitazone 4mg when
results were compared that of a previously published trial in male volunteers.
Despite the pharmacokinetic differences, the tolerability profile of
lobeglitazone 4mg was the same in both genders; there was no difference in the
number of adverse events reported between women or men.
19
PHARMACOLOGY:
Pharmacokinetics:
Lobeglitazone (2 and 4mg) did not display linear pharmacokinetics in healthy
women who participated in a placebo-controlled, phase I study (n = 22).
Statistical analysis indicated that the relationship of C sub(max) and AUC was
not dose-proportional in female volunteers; lobeglitazone (2 and 4mg) was not
associated with dose-proportional C sub(max) (214.8 and 310.0 ug/L,
respectively) and AUC (2251.3 and 6942.6 microg x h/L, respectively) in female
subjects. Results of this study were also compared with that of a previously
published trial in male volunteers. The female : male ratios of C sub(max) and
AUC (95% CI) values for lobeglitazone 2mg were 1.23 (0.89, 1.69) and 1.11
(0.73, 1.68), respectively; the corresponding values for lobeglitazone 4mg were
1.28 (1.01, 1.63) and 2.36 (1.60, 3.47), respectively/2/.
°°
REFERENCES
1. Kim JR, Cho JY, et al. Safety, tolerability and pharmacokinetics of CKD-501,
a novel peroxisome proliferator-activated receptor alpha/ gamma dual agonist
after oral administration. Clinical Pharmacology and Therapeutics. 79: 39,
No. 2, Feb 2006. Summary in 2 parts (Part A). (English). 801027548
2. Lee HE, Kim JW, et al. Pharmacokinetics and safety of CKD-501, a novel PPAR
alpha/gamma dual agonist, after oral administration in healthy female
subjects. Clinical Pharmacology and Therapeutics. 83 (Suppl. 1): 95, Mar
2008. (English). 801105485
20
Exemple : Identifier les sociétés qui développent des
antinéoplastiques en phase III en France
=> S ANTINEOPLASTIC#/CC AND (PHASE III
L1
(L)
FRANCE)/DSTA
68 ANTINEOPLASTIC#/CC AND (PHASE III (L) FRANCE)/DSTA
CC : Classification Code
=> D 1 68
DSTA : Development STAtus
L1
ANSWER 1 OF 68 ADISINSIGHT COPYRIGHT 2014 Wolters Kluwer Pharma on STN
ACCESSION NUMBER:
2013:68 ADISINSIGHT
SOURCE:
Adis R&D Insight
CHANGE DATE:
Feb 19, 2014
GENERIC NAME:
Rituximab biosimilar - Boehringer Ingelheim
SYNONYM:
BI 695500; BI-695500
CHEMICAL NAME:
Immunoglobulin G1, anti-(human CD20 (antigen)(humanmouse monoclonal IDEC-C2B8 gamma1-chain), disulfide with
humanmouse monoclonal IDEC-C2B8 kappa-chain, dimer
MOLECULAR FORMULA:
C6416 H9874 N1688 O1987 S44
CAS REGISTRY NO.:
174722-31-7
EPHMRA ATC CODE:
L1X3 Antineoplastic monoclonal antibodies; M1
Anti-Inflammatory and Anti-Rheumatic Products
WHO ATC CODE:
L01X-C02 Rituximab; M01A-X Other antiinflammatory and
antirheumatic agents, non-steroids
HIGHEST DEV. PHASE:
Phase III
COMPANY INFORMATION
ORIGINATOR:
Boehringer Ingelheim (Germany)
PARENT:
Boehringer Ingelheim
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ANSWER 68 OF 68
ACCESSION NUMBER:
SOURCE:
DOCUMENT NO:
CHANGE DATE:
GENERIC NAME:
SYNONYM:
ADISINSIGHT COPYRIGHT 2014 Wolters Kluwer Pharma on STN
Adis R&D Insight
001954
Dec 1, 2013
Tiotropium bromide
BA 679-BR; BA 679BR; BA-679-BR; BA-679BR; Tiotropium;
Tiotropium Respimat
CHEMICAL NAME:
3-Oxa-9-azoniatricyclo(3,3.1.0(2,4))nonane,
7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-,
bromide, (1alpha,2beta,4beta,5alpha,7beta)TRADE NAME:
Spiriva(R); Spiriva(R) HandiHaler(R); Spiriva(R)
Respimat(R); Tiova(R)
MOLECULAR FORMULA:
C19 H22 Br N O4 S2
CAS REGISTRY NO.:
139404-48-1
RELATED CAS REG. NO.: 186691-13-4 (Tiotropium)
EPHMRA ATC CODE:
L1 Antineoplastics; R3G3 Anticholinergics-plain,
inhalant; R7 Other Respiratory System Products
WHO ATC CODE:
L01 Antineoplastic Agents; R03B-B04 Tiotropium
bromide; R07 Other Respiratory System Products
HIGHEST DEV. PHASE:
Launched
COMPANY INFORMATION
ORIGINATOR:
Boehringer Ingelheim (Germany)
PARENT:
Boehringer Ingelheim
LICENSEE:
Pfizer
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HDP : Highest
Development Phase
=> S L1 AND PHASE III/HDP
L2
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=> ANA L2 CO
L3
ANALYZE L2 1- CO :
62 TERMS
Analyse sur les noms de
société (Company name)
=> D DOC TOP15
L3
ANALYZE L2 1- CO :
62 TERMS
Visualisation des 15
TERM #
# OCC # DOC % DOC CO
premières sociétés
------ ------- ------ ------ --------------classées par nombre de
1
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4 14.29 NOVARTIS
références associées
2
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3 10.71 AMGEN
3
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3 10.71 CARDIFF UNIVERSITY
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3 10.71 NATIONAL CANCER INSTITUTE (USA)
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7.14 CHUGAI PHARMACEUTICAL
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47 MORE TERMS WITH A DOCUMENT COUNT OF 1
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Exemple : Quels types de médicaments Allergan a-t-il sous
licence ?
=> S ALLERGAN/CO
L1
(L)
LICENSEE
35 ALLERGAN/CO (L) LICENSEE
=> D
L1
ANSWER 1 OF 35 ADISINSIGHT COPYRIGHT 2014 Wolters Kluwer Pharma on STN
ACCESSION NUMBER:
SOURCE:
Adis R&D Insight
DOCUMENT NO:
033965
CHANGE DATE:
Apr 6, 2011
GENERIC NAME:
AC 262271
SYNONYM:
AC-262271
MOLECULAR FORMULA:Unspecified
EPHMRA ATC CODE:
S1E Miotics and Antiglaucoma Preparations
WHO ATC CODE:
S01E Antiglaucoma Preparations and Miotics
HIGHEST DEV. PHASE:
Phase I
COMPANY INFORMATION
ORIGINATOR:
PARENT:
LICENSEE:
ACADIA Pharmaceuticals (United States)
ACADIA Pharmaceuticals
Allergan
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=> ANA L1 CC
L2
ANALYZE L1 1- CC :
89 TERMS
ANALYZE L1 1- CC :
89 TERMS
=> D
L2
Analyse sur les codes
thérapeutiques
(Classification Codes)
TERM #
# OCC # DOC % DOC CC
------ ------- ------ ------ --------------1
5
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2
4
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=> ANA L1 CC LEN1
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ANALYZE L1 1- CC LEN 1 :
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ANALYZE L1 1- CC LEN 1 :
11 TERMS
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(LENgth 1 uniquement le
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=> D
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CC
--------------S
N
A ALIMENTARY TRACT AND METABOLISM
D
B BLOOD AND BLOOD FORMING ORGANS
C
CARDIOVASCULAR SYSTEM
G
D
DERMATOLOGICALS
L
G
GENITO-URINARY SYSTEM AND SEX HORMONES
R
H SYSTEMIC HORMONAL PREPARATIONS
M
(EXCLUDING SEX HORMONES)
J
GENERAL ANTI-INFECTIVES, SYSTEMIC
A
L
ANTINEOPLASTIC
AND IMMUNOMODULATING
B
AGENTS
C
M
MUSCULO-SKELETAL SYSTEM
J
N
CENTRAL NERVOUS SYSTEM
P
PARASITOLOGY
R
RESPITORY SYSTEM
S
SENSORY ORGANS
T
DIAGNOSTIC AGENTS
V
VARIOUS
26
ADISINSIGHT / IMSRESEARCH
• Ces 2 banques de données sont souvent les
premières sources d’information sur les molécules
• Exemple : Tak 901
=> INDEX REGISTRY ADISBASES IMSBASES
INDEX REGISTRY, ADISCTI, ADISINSIGHT, ADISNEWS, IMSPATENTS,
IMSRESEARCH
=> S (TAK 901 OR TAK901)/CN
1
FILE ADISINSIGHT
1
FILE IMSRESEARCH
2 FILES HAVE ONE OR MORE ANSWERS, 6 FILES SEARCHED IN STNINDEX
L1
QUE (TAK 901 OR TAK901)/CN
27
=> FILE ADISINSIGHT IMSRESEARCH
=> S L1
L2
2 L1
=> D 1-2 IDE DSTA
L2
ANSWER 1 OF 2 ADISINSIGHT COPYRIGHT (C) 2014 Wolters Kluwer Pharma
Solutions on STN
ACCESSION NUMBER:
SOURCE:
Adis R&D Insight
DOCUMENT NO:
029358
CHANGE DATE:
Mar 5, 2013
GENERIC NAME:
TAK 901
CHEMICAL NAME:
5-(3-(Ethylsulfonyl)phenyl)-3,8-dimethyl-N-(1methylpiperidin-4-yl)-9H-pyrido(2,3-b)indole-7carboxamide
MOLECULAR FORMULA:
C28 H32 N4 O3 S
EPHMRA ATC CODE:
L1 Antineoplastics
WHO ATC CODE:
L01 Antineoplastic Agents
HIGHEST DEV. PHASE:
Phase I
COMPANY INFORMATION
ORIGINATOR:
Takeda (Japan)
PARENT:
Takeda
OTHER:
Millennium
DSTA Phase I, United States, Haematological malignancies
Discontinued I, United States, Lymphoma
Discontinued I, United States, Solid tumours
28
L2
ANSWER 2 OF 2
ACCESSION NUMBER:
SOURCE:
DOCUMENT NUMBER:
LABORATORY NAME:
CLASSIFICATION:
HIGHEST DEV. PHASE:
ENTRY DATE:
IMSRESEARCH
COPYRIGHT 2014 IMSWORLD on STN
R&D Focus, (15 Dec 2011)
2032928
TAK 901
L1X4 Antineoplastic Protein Kinase Inhibitors
Discontinued (2)
Entered STN: 21 Aug 2009
Last Updated on STN: 16 Dec 2011
COMPANY INFORMATION:
Type
|Company|Nationality| Corporation
==========+=======+===========+==============
Originator|Takeda |Japan
|Takeda (Japan)
DSTA
Type |
Status
|Stage|
Region
|
Indication
=======+============+=====+=============+====================
Highest|Discontinued|2
|
|
Phase |
|
|
|
-------+------------+-----+-------------+-------------------Phase |Discontinued|2
|United States|hematological cancer
|United States|lymphoma
|United States|solid tumor
|Japan
|cancer
29
=> D ALL 1
L2
ANSWER 1 OF 2 ADISINSIGHT COPYRIGHT (C) 2014 Wolters Kluwer Pharma
Solutions on STN
AN
SO
Adis R&D Insight
DN
029358
CDAT Mar 5, 2013
CN
TAK 901
°°
TX
TEXT
Introduction:
Millennium (a wholly-owned subsidiary of Takeda) is developing TAK 901,
an Aurora kinase B inhibitor for the treatment of haematological
malignancies.
°
°
An open-label, single group assignment phase I trial determined the
safety, tolerability and maximum tolerated dose of TAK 901 in patients
with haematological malignancies in the US (NCT00807677). The trial
enrolled 31 patients and was completed in March 2013.
A phase I trial assessing TAK 901 for the treatment of advanced solid
tumours or lymphoma was completed in December 2011 (NCT00935844). The
trial enrolled 20 patients in the US.
Results from studies of TAK 901 in preclinical models of acute myeloid
leukaemia were reported in June 2011.
°°°
30
IMSPATENTS
IMS LifeCycle Patent Focus
• Brevets de médicaments commercialement importants
• Une référence par médicament et par brevet
‒ pour EP et PCT, une référence par état désigné
‒ 262000 références depuis 1995
• Une référence IMSPATENTS mentionne :
‒
‒
‒
‒
‒
‒
‒
Noms commerciaux, noms chimiques
CAS Registry Number
Classifications thérapeutiques (Ephrma)
Phase de développement
Numéros, dates de publication et de dépôt
Dates d’expiration (mention des ccp, des extensions pédiatriques)
Commentaires commerciaux
• Mise à jour mensuelle
31
La référence IMSPATENTS
ACCESSION NUMBER:
DOCUMENT NUMBER:
FAMILY NUMBER:
SOURCE:
ENTRY DATE:
CAS REGISTRY NUMBER:
GENERIC NAME:
LABORATORY CODE:
TRADE NAME:
CHEMICAL NAME:
DERIVATIVE(S):
2013:15908
IMSPATENTS
406848
10855
Patents International, (4 Jun 2013)
Entered STN: 26 Jun 2013
Last updated on STN: 9 Jan 2014
51333-22-3
budesonide propionate; budesonide (INN)
S 1320
BETACTIN; ENTOCORT; ENTOCORT EC; HORACORT;
INFLAMMIDE; NARICORT; PREFERID; PULMICORT;
RHINOCORT; PULMICORT
(11beta,16alpha)-16,17-[butylidenebis(oxy)]11,21-dihydroxypregna-1,4-diene-3,20-dione
51333-22-3 budesonide
126168-43-2 cmpd with gamma-cyclodextrin 2:3)
150693-37-1 mixt with formoterol
150693-38-2 mixt with formoterol fumarate
68707-09-5 replaced by 51372-29-3
32
STRUCTURE:
CLASSIFICATION:
PHARMACOLOGY:
A7E Intestinal Anti-inflammatory Agents;
D7A Topical Corticosteroids; R3D Corticoids
allergic rhinitis; asthma; Crohn disease;
skin disease; ulcerative colitis
corticosteroid
HIGHEST DEV. PHASE:
Marketed (80)
CORPORATION:
PATENT ASSIGNEE:
SUPPLEMENTARY TERM:
INDEX TERM:
AstraZeneca (United Kingdom)
Astra (Sweden)
Composition
Dry powder budesonide compositions - 1997
INDICATION:
33
PATENT INFORMATION:
Publication
Number
----------------EP 1019033
EP 1019033
DESIGNATED STATES:
PRIORITY INFORMATION:
Patent
Type
----------application
grant
United Kingdom
SE 1997-133
Publication
Date
----------20000719
20080319
Filing
Date
-------19980113
19980113
Expiration
Date
---------20180113
20180113
19970120
TEXT:
Expiry Comments: Granted (2008)
Country Comments: EP1019033 B is based on WO9831350 and claims
a dry powder composition comprising budesonide and a carrier,
both of which comprise particles having a mass median diameter
of less than 10 mcm and are uniformly distributed. The
composition has a poured bulk density of from 0.28 to 0.38 g/ml
ABSTRACT:
The patent family listed here claims a dry powder composition
comprising budesonide and a carrier and relates to the
PULMICORT FLEXHALER formulations of budesonide.
34
Exemple : Identifier les sociétés qui détiennent des brevets
sur le traitement de la maladie de Crohn (couvrant la France
et expirant après 2014)
=> S CROHN DISEASE AND FR/PCS AND XPY>2014
L1
72 CROHN DISEASE AND FR/PCS AND XPY>2014
=> D COTAB 1L8
PCS : pays de publication ou état désigné
XPY : année d’expiration
IMSPATENTS COPYRIGHT 2014 IMSWORLD on STN.
ANS|
Patent Assignee
|
Compound
|Publication
|
|
|Number(s)
===+========================+=====================+============
1|Aptalis (Canada)
|5-aminosalicylic acid|EP 2512443
---+------------------------+---------------------+-----------2|Abbott (United States) |ustekinumab
|EP 2319870
|EP 2301970
|EP 2099414
|EP 1175446
---+------------------------+---------------------+------------
35
---+------------------------+---------------------+-----------6|BioMarin (United States)|BH4
|EP 1845952
---+------------------------+---------------------+-----------7|Zeria (Japan)
|acotiamide
|EP 870765
|
|
|EP 870765
---+------------------------+---------------------+-----------8|Pfizer (United States) |sildenafil
|EP 941075
|
|
|EP 941075
|EP 941075
|
|
|EP 941075
|EP 1097711
|
|
|EP 1097711
°°°
36
Exemple : Le Veramyst est-il couvert par des ccp ?
=> S VERAMYST/CN AND (EXTENSION OR SPC OR CCP)
L1
30 VERAMYST/CN AND (EXTENSION OR SPC OR CCP)
=> D CYTAB 1-10
L1
IMSPATENTS COPYRIGHT 2014 IMSWORLD on STN.
ANS|Country
|Publication |Expiry
|Expiry Comments| NOTE
|
|Number(s)
|Date
|
|
===+=========================+=============+==========+===============+======
1|Czech Republic
|CZ 20030352 |20210803 |Granted (2013);|1, 2
|Czech Republic
|CZ 304043
|
|SPC Filed for |
|
|
|
|AVAMYS
|
---+-------------------------+-------------+----------+---------------+-----2|Taiwan, Province of China|TW 244486
|20231127 |Granted (2005);|3, 4
|
|
|
|Extension
|
|
|
|
|Granted
|
---+-------------------------+-------------+----------+---------------+-----3|Spain
|EP 1305329
|20210803 |Granted (2007);|5, 6, 7,
|
|EP 1305329
|
|Legal Action; |8
|
|
|
|SPC Granted for|
|
|
|
|AVAMYS
|
---+-------------------------+-------------+----------+---------------+--------
37
---+-------------------------+-------------+----------+---------------+-------4|Liechtenstein
|EP 1305329
|20210803 |Granted (2007);|5, 6, 9
|
|EP 1305329
|
|Legal Action; |
|
|
|
|SPC Granted for|
|
|
|
|AVAMYS
|
---+-------------------------+-------------+----------+---------------+-------5|Korea, Republic of
|KR 2003028806|20210819 |Granted (2008);|10, 11
|Korea, Republic of
|KR 827379
|
|Extension
|
|
|
|
|Granted
|
---+-------------------------+-------------+----------+---------------+-------6|United Kingdom
|EP 1305329
|20210803 |Granted (2007);|5, 6, 12
|
|EP 1305329
|
|Legal Action; |
|
|
|
|SPC Granted for|
|
|
|
|AVAMYS
°°°°
5. EP1305329 B is based on WO0212265 and claims fluticasone furoate
specifically, along with its solvates and unsolvated form I, II and III
polymorphs.
6. Opposition was filed against EP1305329 B at the European patent office by
Norton Healthcare in September 2008, subsequently an appeal was filed in
April 2011.
°°°
12. A supplementary protection certificate (SPC) for the AVAMYS formulations of
fluticasone furoate has been granted in the UK citing EP1305329 B.
The SPC expires on 10 January 2023.
38
IMSPATENTS
Les formats tabulaires
CYTAB
COTAB
CCTAB
Country
Patent Assignee
Classification code
Publication N°
Compound
Compound
Expiry date
Publication N°
Patent Assignee
Expiry comments
Note
39
ADISCTI
Adis Clinical Trials Insight
• Information axée sur les essais cliniques
• 1700 journaux depuis 1998
• 600000 références bibliographiques
‒ dont 50% CITATION ONLY (BIB + CT)
• Springer Adis (Us)
40
La référence ADISCTI
ACCESSION NUMBER:
DOCUMENT NUMBER:
TITLE:
2014:2557 ADISCTI
809159798
InterMune Reports Phase 3 ASCEND Trial Results of
Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF).
ADIS TITLE: InterMune Reports Phase 3 ASCEND Trial
Results of Pirfenidone in Idiopathic Pulmonary
Fibrosis (IPF).
AUTHOR:
InterMune
SOURCE:
Media Release (Feb 25, 2014), Vol. in 2 parts (Part A)
| , URL: http://www.intermune.com
DOCUMENT TYPE:
Best Evidence
ADIS REC. CREATED:
4 Mar 2014
REFERENCE:
Respiratory Tract Disorders
Fiches d’identification
LANGUAGE:
English
AdisInsight
WORD COUNT:
364
OTHER SOURCE:
ADISINSIGHT 1998006975; ADISINSIGHT 2012001136
ENTRY DATE:
Entered STN: 7 Mar 2014
Last Updated on STN: 7 Mar 2014
TEXT - Results Highlights:
Efficacy:
Pirfenidone was significantly superior to placebo in the treatment of
idiopathic pulmonary fibrosis, according to top-line results. Specifically,
pirfenidone significantly improved forced vital capacity over 1 year vs placebo
(p<0.000001; primary endpoint). It was also significantly superior to
placebo in the 6-minute walking test and progression-free survival, key
secondary endpoints.
41
Tolerability:
Pirfenidone was generally tolerated well and had a favourable safety profile in
patients with idiopathic pulmonary fibrosis, according to top-line results.
TEXT - Author Comments:
"We are pleased to report these top-line ASCEND Phase 3 results. Based on
the strength of the ASCEND results, InterMune is preparing a resubmission of
our New Drug Application for pirfenidone to the U.S. Food and Drug
Administration (FDA), which we expect to submit by early third quarter of this
year."
Informations détaillées
TEXT - Subject Details:
sur l’essai clinique
Type: patients
Age: 40-80 Years
Sex: not stated
Location: Australia, Brazil, Croatia, Israel, Mexico, Multinational, New
Zealand, Peru, Singapore, USA
Disease: Idiopathic-pulmonary-fibrosis
Patient Inclusion: 1. Diagnosis of definite or probable Idiopathic Pulmonary
Fibrosis (IPF) per the ATS 2011 Guidelines up to 48 months before randomization
2. Age 40 to 80 at randomization 3. Percent Forced Vital Capacity (%FVC)
≥50% and ≤90% at screening 4. Percent Carbon Monoxide Diffusing
Capacity (%DLCO) ≥30% and ≤90% at screening Select
Patient Exclusion: 1. Forced expiratory volume in one second (FEV1)/FVC ratio
0.8 after administration of bronchodilator at Screening
2. Expected to receive a lung transplant within 1 year from randomization or,
for patients at sites in the United States, on a lung transplant waiting list
at randomization
3. Known explanation for interstitial lung disease
42
4. History of asthma or chronic obstructive pulmonary disease
5. Active infection
6. Ongoing IPF treatments including investigational therapy, immunosuppressants,
and cytokine modulating agents
7. History of unstable or deteriorating cardiac or pulmonary disease (other than
IPF)
within the previous 6 months
Pirfenidone
-------------------------------------------------------------------Drug/Treatment
Dose
Route
Frequency
Duration
-------------------------------------------------------------------Pirfenidone
2403 mg/day
PO
tid
1 year
-------------------------------------------------------------------Placebo
TEXT - Study Details:
Design: double-blind, multicentre, parallel, prospective, randomised
Control: baseline comparison, placebo comparison
Phase: III
Endpoints: Forced-vital-capacity
Name: Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF (ASCEND)
Companies: InterMune
ID: 700241613 (Clinical Trials Insight)
NCT01366209 (ClinicalTrials.gov: US National Institutes of Health)
PIPF016 (InterMune)
CONTROLLED TERM:
CONTROLLED TERM:
Drug Descriptors: Pirfenidone, therapeutic use
Disease Descriptors: Idiopathic pulmonary fibrosis,
treatment
43
ADISCTI
• Evaluation, aspects positifs, négatifs des essais
cliniques (20% des références)
• Clinical relevance (/CL)
A
B
C
Study provides new evidence of clinical benefit
Study provides supporting evidence to existing data
Study adds no new or important information
• Pour plus de détails , consulter HELP EVAL
44
Exemple : Cediranib
=> FILE ADISCTI
=> E CEDIRANIB/CT
E1
2
E2
3
E3
157 -->
E4
70
E5
1
E6
3
E7
17
E8
107
E9
360
°°
CEDELIZUMAB, PHARMACOKINETICS/CT
CEDELIZUMAB, THERAPEUTIC USE/CT
CEDIRANIB/CT
CEDIRANIB, ADVERSE REACTIONS/CT
CEDIRANIB, DRUG INTERACTIONS/CT
CEDIRANIB, PHARMACODYNAMICS/CT
CEDIRANIB, PHARMACOKINETICS/CT
CEDIRANIB, THERAPEUTIC USE/CT
CEFACLOR/CT
=> S CEDIRANIB/CT,TI
L1
167 CEDIRANIB/CT
=> S L1 NOT CITATION-ONLY/DT
L2
149 L1 NOT CITATION-ONLY/DT
=> S L2 AND CL/FA
L3
14 L2 AND CL/FA
Elimination des références
uniquement bibliographiques
Limitation aux références avec
évaluation clinique
45
=> D ALL
L3
AN
DN
TI
AU
SO
DT
DED
RE
LA
WC
OS
ED
ANSWER 1 OF 14 ADISCTI COPYRIGHT 2014 Wolters Kluwer Pharma on STN
2014:1953 ADISCTI
803099848
LATE BREAKING ABSTRACT: Randomised double-blind phase III trial of
cediranib (AZD 2171) in relapsed platinum sensitive ovarian cancer:
Results of the ICON6 trial.
ADIS TITLE: LATE BREAKING ABSTRACT: Randomised double-blind phase III
trial of cediranib (AZD 2171) in relapsed platinum sensitive ovarian
cancer: Results of the ICON6 trial.
Ledermann J A; Perren T J; Raja F A; Embleton A; Rustin GJS; Jayson G;
Kaye S B; Swart A M; Vaughan M
2013 European Cancer Congress (Sep 27, 2013), pp. abstr. 10, URL:
http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/SearchableProgramme.aspx
Meeting Info: European Cancer Congress (2013 : September 2013 :
Amstderdam, Netherlands)
Best Evidence
ADIS Rec Created: 18 Feb 2014
Oncology; Women's Health; Genitourinary Disorders
English
1224
ADISINSIGHT 1998000730; ADISINSIGHT 1998000759; ADISINSIGHT 1998007957;
46
EVAL Adis Comment:
Results data from this trial are expected to support regulatory
submissions for cediranib to be administered in combination with
platinum-based chemotherapy in women with platinum-sensitive relapsed
ovarian, fallopian tube or peritoneal cancer in first relapse.
CL
A
TX
Results Highlights:
Efficacy:
Cediranib + platinum-based chemotherapy resulted in a significantly longer
median progression-free survival interval, compared with platinum-based
chemotherapy alone (11.4 vs 9.4 months; p<0.01; co-primary endpoint),
as well as a significantly longer median overall survival duration (20.3
vs 17.6 months; p<0.05; co-primary endpoint) in women with
platinum-sensitive relapsed ovarian, fallopian tube or peritoneal cancer
in first relapse.
Tolerability:
°°°
CT
Drug Descriptors: Carboplatin, adverse reactions; Carboplatin, therapeutic
use; Cediranib, therapeutic use; Cediranib, adverse reactions;
Gemcitabine, adverse reactions; Gemcitabine, therapeutic use; Paclitaxel,
therapeutic use; Paclitaxel, adverse reactions; Platinum complexes,
adverse reactions; Platinum complexes, therapeutic use
CT
Disease Descriptors: Fallopian tube cancer, treatment; Ovarian cancer,
treatment; Peritoneal cancer, treatment
CT
Pharmacoecononic Descriptors: Cost analysis
47
ADISNEWS
3 Newsletters :
• Reactions (alerts to adverse drug reactions from all adverse
drug events reported in the world's biomedical literature –
78000 réf.)
• Inpharma (alerts to drugs and drug therapy – 40000 réf.)
• Pharmacoeconomics & Outcomes News (health economics
news – 20000 réf.)
• Limitation à la newsletter “Reactions” pour les alertes de
pharmacovigilance
=> S SIMVASTATIN
L1
1357 SIMVASTATIN
FS : File Segment
=> S L1 AND REACTIONS/FS
L2
712 L1 AND REACTIONS/FS
48
La référence ADISNEWS
=> D IALL
ACCESSION NUMBER:
ENTRY DATE:
DOCUMENT NUMBER:
TITLE:
2014:1494 ADISNEWS
Entered STN: 13 Mar 2014
Last Updated on STN: 13 Mar 2014
01149954-803100534
ADR news: Lisinopril/lithium. Azotaemia and transcortical
motor aphasia in an elderly patient: case report. Serious.
REACTIONS 12 Mar 2014 ISSN: 0114-9954
SOURCE:
TEXT:
A 65-year-old man developed transient transcortical motor aphasia due to
lithium toxicity during treatment for bipolar affective disorder type 1 [time
to reaction onset not stated]; the toxicity was attributed to a combination of
factors including high lithium dosing after recent weight loss and dehydration
with prerenal azotaemia whilst receiving lisinopril [therapeutic indication and
time to reaction onset not stated].
The man's history included hypertension, chronic obstructive pulmonary disease,
coronary artery disease, remote myocardial infarction with coronary stenting
and implantable defibrillator placement, ischaemic cardiomyopathy (ejection
fraction 20-25%), and a left ventricular thrombus; he had undergone left
below-knee amputation and was unsteady on his feet. His medications were oral
lithium 300mg three times daily, oral lisinopril 10 mg/day, metoprolol,
aspirin, warfarin, spironolactone, simvastatin, gabapentin, sildenafil and a
prostate health supplement. He presented with worsening confusion, word-finding
difficulty and a tremor, following a fall in which he hit his head. His wife
reported he had progressive mild memory impairment and difficulty finishing his
)
49
sentences and finding words for the previous few days. His family also reported
a weight loss of 20 pounds over the previous 6 months. He reported polydypsia
and polyuria of several days' duration. His wife had noted increased exertion
over the past week with inadequate hydration. Examination revealed a moderate
bilateral tremor in his upper limbs at rest and with purposeful movement; he
had no paresis. He was oriented to place and person but not to time or season.
He had slow speech with delayed initiation and he had difficulty with word
finding but his thought process did not appear illogical or tangential.
Comprehension was intact, but he was unable to recite his daughters' or wife's
names and could not say where he lived. His handwriting was illegible. Serum
lithium level was supratherapeutic (1.9 mEq/L) and INR was subtherapeutic
(1.42). The man was hospitalised for lithium toxicity and assessment for
possible stroke; lithium was withdrawn. °°°°
La référence originale
REFERENCE(S):
(1) Katz, R. B.; Packer, C. D. Lithium toxicity presenting as transient
transcortical motor aphasia: A case report. Psychosomatics 2014, V55,
P87-91 (English, Case report (USA))
CONTROLLED TERM:
Aphasia, drug-induced; Elderly; Lisinopril, serious
adverse-reactions; Lithium, serious adverse-reactions;
Uraemia, drug-induced
CAS REGISTRY NO.:
50-78-2 (ASPIRIN)
52-01-7 (SPIRONOLACTONE)
81-81-2 (WARFARIN)
7439-93-2 (LITHIUM)
79902-63-9 (SIMVASTATIN)
139755-83-2 (SILDENAFIL)
50
Vocabulaire contrôlé
=> E SIMVASTATIN/CT
E1
E2
E3
E4
E5
E6
E7
E8
E9
E10
E11
E12
Controlled Term
1
SIMETHICONE, SERIOUS DRUG-INTERACTIONS/CT
7
SIMETHICONE, THERAPEUTIC-USE/CT
0 --> SIMVASTATIN/CT
146
SIMVASTATIN, ADVERSE-REACTIONS/CT
32
SIMVASTATIN, DRUG-INTERACTIONS/CT
1
SIMVASTATIN, GENERAL/CT
62
SIMVASTATIN, PHARMACODYNAMICS/CT
7
SIMVASTATIN, PHARMACOKINETICS/CT
123
SIMVASTATIN, SERIOUS ADVERSE-REACTIONS/CT
98
SIMVASTATIN, SERIOUS DRUG-INTERACTIONS/CT
2
SIMVASTATIN, SERIOUS OVERDOSE/CT
329
SIMVASTATIN, THERAPEUTIC-USE/CT
=> S E4-E5 OR E9-E11
L3
=> D ALL
395 ("SIMVASTATIN, ADVERSE-REACTIONS"/CT OR "SIMVASTATIN, DRUG-INTER
ACTIONS"/CT) OR ("SIMVASTATIN, SERIOUS ADVERSE-REACTIONS"/CT OR
"SIMVASTATIN, SERIOUS DRUG-INTERACTIONS"/CT OR "SIMVASTATIN,
SERIOUS OVERDOSE"/CT)
51
L1
AN
ED
DN
TI
SO
TX
ANSWER 1 OF 395 ADISNEWS COPYRIGHT 2014 Adis Data Information BV on STN
2014:987 ADISNEWS
01149954-803099718
ADR news: Simvastatin. Recurrent colonic dilatation and volvulus in an
elderly patient: case report. Serious.
REACTIONS 19 Feb 2014 ISSN: 0114-9954
A 70-year-old man man developed recurrent colonic dilatation and volvulus
while receiving simvastatin.
About 6 months after starting simvastatin 40mg [route, frequency and
indication not stated] the man developed symptoms of abdominal discomfort
and a persistent sensation of being unable to fully open his bowels.
The man was admitted to hospital a total of 14 times in 6 years with these
symptoms. At each visit, abdominal x-rays demonstrated a sigmoid volvulus,
with no mechanical cause apparent on colonoscopy and CT scans. He
initially underwent a laparoscopic sigmoid colectomy, with a good
postoperative recovery. However, he returned with the same symptoms after
2 years. Simvastatin was held, and his symptoms markedly improved. He was
able to open his bowels daily with no discomfort.
However, following the man's admission to hospital for investigation of
weakness, simvastatin was inadvertently recommenced. His symptoms
reappeared, and abdominal x-rays showed dilated loops of large bowel.
Simvastatin was stopped, and he was initiated on ezetimibe. At review
several months later, he confirmed the continued ease and frequency at
which he could open his bowels.
52
Author Comment: "Implementation of [the Naranjo] probability scale yielded
a score of 6, which correlates to a probable adverse drug reaction
association [for simvastatin]".
RE
(1) Fernandes, R.; Shaikh, I.; Wegstapel, H. Possible association
between statin use and bowel dysmotility. BMJ Case Reports 2012,
V2012, P[3 pages] (English, Case report (United Kingdom))
CT
Elderly; Intestinal-disorders, drug-induced; Intestinal-obstruction,
drug-induced; Simvastatin, serious adverse-reactions
RN
=> S SIMVASTATIN
L1
1357 SIMVASTATIN
=> S L1 AND REACTIONS/FS
L2
712 L1 AND REACTIONS/FS
=> S E4-E5 OR E9-E11
L3
395 ("SIMVASTATIN, ADVERSE-REACTIONS"/CT OR "SIMVASTATIN, DRUGINTERACTIONS"/CT) OR ("SIMVASTATIN, SERIOUS ADVERSE-REACTIONS"/CT OR
"SIMVASTATIN, SERIOUS DRUG-INTERACTIONS"/CT OR "SIMVASTATIN, SERIOUS
OVERDOSE"/CT)
53
AN
ED
DN
TI
SO
TX
RE
CT
RN
2014:1120 ADISNEWS
Une référence de
pharmaéconomie
11735503-803100085
Statin intensification rates low in US hospitals.
PHARMACOECONOMICS AND OUTCOMES NEWS 25 Feb 2014 ISSN: 1173-5503
Rates of statin initiation in patients hospitalised with an acute
myocardial infarction (AMI) are high in US hospitals, but rates of statin
intensification and maximisation are low.
These are the main findings of a large prospective study that used data
from 4271 patients from 24 US hospitals to examine statin prescription
patterns on admission and discharge.*
The data analysis showed that 87% of patients who were statin naive on
presentation for their AMI and had no contraindication for statin therapy
were started on a statin during hospitalisation, most commonly
atorvastatin (47%) or simvastatin (39%)°°°°°.
(1) Arnold, S. V.; Kosiborod, M.; Tang, F.; Zhao, Z.; Maddox, T. M.;
McCollam, P. L.; Birt, J.; Spertus, J. A. Patterns of Statin
Initiation, Intensification, and Maximization Among Patients
Hospitalized with an Acute Myocardial Infarction. Circulation 2014,
P4 Feb 2014. Available from (English, Study (USA))
Drug-utilisation; HMG-CoA-reductase-inhibitors, therapeutic-use;
Myocardial-infarction, treatment; Prescribing
134523-00-5 (ATORVASTATIN)
147098-20-2 (ROSUVASTATIN)
Les banques de données ADIS ou IMS sont des sources d’
information incontournables sur les sociétés pharmaceutiques
et les molécules qu’elles développent .
Elles permettent de retrouver des informations détaillées sur
- les stades de développement, les licences (Adisinsight,
Imsresearch)
- les brevets, les certificats complémentaires de protection
(Imspatents)
- les essais cliniques (Adiscti)
- les effets secondaires (Adisnews)
54
Pour plus d’information
Martine MICHEL
[email protected]
www.capadoc.com
www.stn-international.com
www.cas.org
55

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