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Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study.

ABSTRACT: PURPOSE:The SAGIT® 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® 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-naïve (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 µg/L; normalized IGF-1) and 47.3% did not have rigorous hormonal control (GH?

SUBMITTER: Giustina A

PROVIDER: S-EPMC6728296 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study.

Giustina Andrea A Bronstein Marcello D MD Chanson Philippe P Petersenn Stephan S Casanueva Felipe F FF Sert Caroline C Houchard Aude A Melmed Shlomo S

Pituitary 20191001 5

<h4>Purpose</h4>The SAGIT® 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.<h4>Methods</h4>The SAGIT® validation study (ClinicalTrials.gov NCT02539927) is an international, non-interventional study. Data collection included: demographic/disease characteristics; medical/surgical histories; concomitan ...[more]

PMID: 31338660

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Dataset Information

Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study.

Publications

Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study.

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