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Titolo:
SAFETY OF CYPROTERONE-ACETATE - REPORT OF ACTIVE SURVEILLANCE
Autore:
HEINEMANN LAJ; WILLSHAHAB L; VANKESTEREN P; GOOREN LJG; QUAST A; PIETSCH H; KONRAD N; HELGE H; GRUTERS A; KNAPPE G; VENTZ M; PRANGE G; UBELHACK R; BANASCHAK K; CAVALLARI C; MACRELLI S; HINKEL GK; JUSTUS B; SAREMBE B; ABUSCHENKO E; MOESLER T; SCHINDLER AE; REGIDUR PA; MADJIDIAN K; BRAENDLE LW; KLEINKAUFHOUCKEN A; HORN HJ; MICHEL W; MORLOT M; VEISMANN S; ZIEGLER R; KREMPIEN R; ALENFELD F; HEINRICH U; SIPPELL WG; WILLE R; LASCHET R; ALEXANDER H; GLANDER HJ; SCHWARZE I; HOEPFFNER W; DIEDRICH K; SCHILL T; HEISE HR; LEHNERT H; SCHLICHTHAAR H; WEISE W; GERLOFF C; NICKEL I; BURMANNREUTER H; KRAUSE W; FLOHR J; PLEWIG G; WOLF H; SCHWARZ HP; BECKER A; SCHMIDT C; SIEGELALMASRY E; MIX M; OTTERMANN B; RANKE MB; GRAUER ML; TELLER W; HOMOKI J; WALDHAUSER F; KAISER E; BALJER E; EIDEN R; OTT F;
Indirizzi:
ZEG,CTR EPIDEMIOL & HLTH RES,SCHONERLINDER STR 11-12 D-16341 ZEPERNICK GERMANY ASSOC PHARMACOEPIDEMIOL BERLIN GERMANY FREE UNIV AMSTERDAM HOSP,DEPT ENDOCRINOL AMSTERDAM NETHERLANDS FREE UNIV AMSTERDAM HOSP,DEPT ENDOCRINOL ANDROL AMSTERDAM NETHERLANDS LANDESNERVENKLIN ANDERNACH ANDERNACH GERMANY SACHS KRANKENHAUS PSYCHIAT & NEUROL,ABT FORENS PSYCHIAT ARNSDORF GERMANY FREE UNIV BERLIN,KLINIKUM RUDOLF VIRCHOW,KINDERKLIN & POLIKLIN D-1000BERLIN GERMANY HUMBOLDT UNIV BERLIN,KLINIKUM CHARITE,MED POLIKLIN ENDOKRINOL BERLIN GERMANY FREE UNIV BERLIN,KLINIKUM RUDOLF VIRCHOW,MED KLIN & POLIKLIN ENDOKRINOL D-1000 BERLIN GERMANY HUMBOLDT UNIV BERLIN,KLIN CHARITE,PSYCHIAT KLIN BERLIN GERMANY CATTEDRA ENDOCRINOL GINECOL,IST CLIN OSTETR & GINECOL 2 BOLOGNA ITALY TECH UNIV DRESDEN,KLINIKUM CARL GUSTAV CARUS,INST KLIN GENET D-8027 DRESDEN GERMANY GEMEINSCHAFTSPRAXIS FRAUENHEILKUNDE & GEBURTSHILF DRESDEN GERMANY PRAXIS FRAUENHEILKUNDE & GEBURTSHILFE DRESDEN GERMANY LANDESKLIN EBERSWALDE,ABT MASSREGELVOLLZUG EBERSWALDE GERMANY UNIV ERLANGEN NURNBERG,PSYCHIAT KLIN D-8520 ERLANGEN GERMANY UNIV ESSEN GESAMTHSCH KLINIKUM,FRAUENKLIN D-4300 ESSEN GERMANY AUSSENSTELLE GIESSEN,LANDESWOHLFAHRTSVERBAND,KLIN GERICHTL PSYCHIAT GIESSEN GERMANY KLIN GERICHTL PSYCHIAT HAINA KLOSTER GERMANY UNIV HAMBURG,KLIN EPPENDORF,FRAUENKLIN & POLIKLIN,ABT KLIN & EXPT ENDOKRINOL HAMBURG GERMANY UNIV HAMBURG,KRANKENHAUS EPPENDORF,PSYCHIAT KLIN,ABT FORENS & KRIMINALPSYCHIAT D-2000 HAMBURG GERMANY WEIS & PARTNER,GEMEINSCHAFTSPRAXIS LEIDENBERGER HAMBURG GERMANY UNIV HAMBURG,KLINIKUM EPPENDORF,HAUTKLIN & POLIKLIN HAMBURG GERMANY KINDERDRANKENHAUS BULT HANNOVER GERMANY ALLGEMEINES KRANKENHAUS OCHSENZOLL,PSYCHIAT ABT 7 HAMBURG GERMANY UNIV HEIDELBERG,MED KLIN ENDOKRINOL & STOFFWECHSEL HEIDELBERG GERMANY UNIV HEIDELBERG,KINDERKLIN PADIATRIE ENDOKRINOL HEIDELBERG GERMANY CHRISTIAN ALBRECHTS UNIV KIEL,KINDERKLIN PAEDIAT ENDOKRINOL KIEL GERMANY CHRISTIAN ALBRECHTS UNIV KIEL KLINIKUM,ZENTRUM KLIN THEORET MED 2 KIEL GERMANY PFALZKLIN LANDECK PSYCHIAT KLINGENMUNSTER GERMANY UNIV LEIPZIG,KLIN GYNAKOL & GEBURTSHILFE D-7010 LEIPZIG GERMANY UNIV LEIPZIG,KLIN & POLIKLIN HAUTKRANKHEITEN D-7010 LEIPZIG GERMANY UNIV KLINIKUM LEIPZIG,KINDERKLIN ENDOKRINOL LEIPZIG GERMANY UNIV LUBECK,KLIN FRAUENHEILKUNDE & GEBURTSHILFE D-2400 LUBECK GERMANY UNIV MAGDEBURG,OTTO VON GUERICKE KLINIKUM,ZENTRUM KINDERHEILKUNDE D-39106 MAGDEBURG GERMANY UNIV MAGDEBURG,OTTO VON GUERICKE KLINIKUM,KLIN ENDOKRINOL D-39106 MAGDEBURG GERMANY UNIV MAGDEBURG,FRAUENKLIN D-39106 MAGDEBURG GERMANY UNIV MARBURG,ABT DERMATOL,MED ZENTRUM HAUTKRANKHEITEN MARBURG GERMANY LANDESKRANKENHAUS MERZIG,ABT FORENS PSYCHIAT MERZIG SAARLAND GERMANY NIEDERSACHS LANDESKRANKENHAUS,ABT FORENS PSYCHIAT MORINGEN GERMANY UNIV MUNICH,DERMATOL KLIN & POLIKLIN,KLIN INNENSTADT D-8000 MUNICH GERMANY UNIV MUNICH,DR VON HAUNERSCHEN KINDERSPITAL D-80337 MUNICH GERMANY FACHKLIN PSYCHIAT NEUROL & REHABIL,FORENS PSYCHIAT ABT NEUSTADT GERMANY UNIV KLINIKUM ROSTOCK,KINDERKLIN ENDOKRINOL ROSTOCK GERMANY BEZIRKSKRANKENHAUS STRAUBING,FORENS PSYCHIAT KLIN STRAUBING GERMANY UNIV TUBINGEN,KINDERKLIN,ZENTRUM WACHSTUMSFORSCH D-7400 TUBINGEN GERMANY UNIV ULM,KINDERKLIN ULM GERMANY UNIV VIENNA,KINDERKLIN,ALLGEMEINES KRANKENHAUS WIEN A-1090 VIENNA AUSTRIA DEUTSCH KLIN DIAGNOST GYNAKOL WIESBADEN GERMANY RFMH DERMATOL ZURICH SWITZERLAND PSYCHIAT LANDESKRANKENHAUS WIESLOCH GERMANY
Titolo Testata:
Pharmacoepidemiology and drug safety
fascicolo: 3, volume: 6, anno: 1997,
pagine: 169 - 178
SICI:
1053-8569(1997)6:3<169:SOC-RO>2.0.ZU;2-W
Fonte:
ISI
Lingua:
ENG
Soggetto:
HEPATOCELLULAR-CARCINOMA; EXOGENOUS HORMONES; CANCER; LIVER;
Keywords:
CYPROTERONE ACETATE; LIVER CANCER; LIVER TOXICITY; ACTIVE SURVEILLANCE; FOLLOW-UP STUDY; PHARMACOEPIDEMIOLOGY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
19
Recensione:
Indirizzi per estratti:
Citazione:
L.A.J. Heinemann et al., "SAFETY OF CYPROTERONE-ACETATE - REPORT OF ACTIVE SURVEILLANCE", Pharmacoepidemiology and drug safety, 6(3), 1997, pp. 169-178

Abstract

Concern about a potentially increased risk of liver cancer associatedto cyproterone acetate (CPA) treatment led to a postmarketing long-term surveillance study with historic accural of four groups of patientswith sexual-hormonal disorders under treatment with CPA. The aim of the study was to provide a description of potential ADRs under CPA treatment with special emphasis on liver cancer. A long-term follow-up of 2506 patients was conducted. Six hundred and two persons were followedup retrospectively for longer than 10 years. In 16,721 patient-years of observation after the first CPA dose no malignant liver tumour was observed, whereas six would have been expected in this cohort. Seven incident, non-fatal benign liver tumours were found. Altogether 9.6% ofa subset of 1685 patients with reported liver tests had, at some time, elevated liver enzymes, No cases were reported where CPA therapy hadbeen discontinued due to severe liver disorder. We concluded from this active surveillance project, that CPA treatment is probably safe in the groups of patients followed up. Even though there was not a singlecase of liver cancer detected, the hypothesis of an elevated risk is being tested in an ongoing collaborative European case-control study which is examining the association of CPA use and primary hepatocellular cancer. (C) 1997 by John Wiley & Sons, Ltd.

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Documento generato il 03/12/20 alle ore 16:05:12