Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT (R) validation study
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Identificadores
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Visualización o descarga de ficheros
Fecha de publicación
2019Título de revista
Pituitary
Tipo de contenido
Artigo
DeCS
factor I de crecimiento insulinoide | anciano | proyectos piloto | mediana edad | humanos | acromegalia | adulto | hormona del crecimiento humanaMeSH
Adult | Middle Aged | Insulin-Like Growth Factor I | Humans | Pilot Projects | Human Growth Hormone | Aged | AcromegalyResumen
PURPOSE: The SAGIT(R) instrument, designed to assist clinicians to stage acromegaly, assess treatment response and adapt patient management, was well received by endocrinologists in a pilot study. We report an interim analysis of baseline data from the validation phase. METHODS: The SAGIT(R) validation study (ClinicalTrials.gov NCT02539927) is an international, non-interventional study. Data collection included: demographic/disease characteristics; medical/surgical histories; concomitant acromegaly treatments; investigators' subjective evaluation of disease-control status (clinical global evaluation of disease control [CGE-DC]; controlled/not controlled/yet to be clarified) and clinical disease activity (active/not active); growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels; investigators' therapeutic decision. RESULTS: Of 228 patients enrolled, investigators considered disease to be controlled in 110 (48.2%), not controlled in 105 (46.1%), and yet to be clarified in 13 (5.7%) according to CGE-DC. Thirty-three patients were treatment-naive (not controlled, n = 31; yet to be clarified, n = 2). Investigators considered 48.2% patients in the controlled and 95.2% in the not-controlled groups to have clinically active disease. In the controlled group, 29.7% of patients did not exhibit hormonal control (GH </= 2.5 microg/L; normalized IGF-1) and 47.3% did not have rigorous hormonal control (GH < 1.0 microg/L; normalized IGF-1) by contemporary consensus. Current acromegaly treatment was continued with no change for 91.8% of patients in the controlled and 40.0% in the not-controlled groups. CONCLUSIONS: These data highlight discrepancies between investigator-evaluated disease-control status, disease activity, hormonal control, and treatment decisions in acromegaly. Once validated, the SAGIT(R) instrument may assist clinicians in making active management decisions for patients with acromegaly.