The online version of this article (https://doi.org/10.1007/s11102-019-00977-5) contains supplementary material, which is available to authorized users.
The data in this manuscript were presented as abstracts at the Endocrine Society Congress 2019 and the 21st European Congress of Endocrinology 2019.
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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.
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.
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 < 1.0 µg/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.
These data highlight discrepancies between investigator-evaluated disease-control status, disease activity, hormonal control, and treatment decisions in acromegaly. Once validated, the SAGIT® instrument may assist clinicians in making active management decisions for patients with acromegaly.
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Lugo G, Pena L, Cordido F (2012) Clinical manifestations and diagnosis of acromegaly. Int J Endocrinol 2012:540398–540398 CrossRef
Katznelson L, Laws ER Jr, Melmed S, Molitch ME, Murad MH, Utz A, Wass JA (2014) Acromegaly: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 99:3933–3951 CrossRef
Melmed S, Bronstein MD, Chanson P, Klibanski A, Casanueva FF, Wass JAH, Strasburger CJ, Luger A, Clemmons DR, Giustina A (2018) A consensus statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol 14:552–561 CrossRef
Caron P, Brue T, Raverot G, Tabarin A, Cailleux A, Delemer B, Renoult PP, Houchard A, Elaraki F, Chanson P (2018) Signs and symptoms of acromegaly at diagnosis: the physician’s and the patient’s perspectives in the ACRO-POLIS study. Endocrine 63:120–129 CrossRef
Carmichael JD, Bonert VS, Mirocha JM, Melmed S (2009) The utility of oral glucose tolerance testing for diagnosis and assessment of treatment outcomes in 166 patients with acromegaly. J Clin Endocrinol Metab 94:523–527 CrossRef
Alexopoulou O, Bex M, Abs R, T’Sjoen G, Velkeniers B, Maiter D (2008) Divergence between growth hormone and insulin-like growth factor-i concentrations in the follow-up of acromegaly. J Clin Endocrinol Metab 93:1324–1330 CrossRef
Melmed S, Casanueva FF, Klibanski A, Bronstein MD, Chanson P, Lamberts SW, Strasburger CJ, Wass JA, Giustina A (2013) A consensus on the diagnosis and treatment of acromegaly complications. Pituitary 16:294–302 CrossRef
Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S, Group, S.I.: SAGIT(R) (2016) Clinician-reported outcome instrument for managing acromegaly in clinical practice–development and results from a pilot study. Pituitary 19:39–49 CrossRef
Webb SM, Badia X, Surinach NL (2006) Validity and clinical applicability of the acromegaly quality of life questionnaire, AcroQoL: a 6-month prospective study. Eur J Endocrinol 155:269–277 CrossRef
Rowles SV, Prieto L, Badia X, Shalet SM, Webb SM, Trainer PJ (2005) Quality of life (QOL) in patients with acromegaly is severely impaired: use of a novel measure of QOL: acromegaly quality of life questionnaire. J Clin Endocrinol Metab 90:3337–3341 CrossRef
Bianchi A, Giustina A, Cimino V, Pola R, Angelini F, Pontecorvi A, De Marinis L (2009) Influence of growth hormone receptor d3 and full-length isoforms on biochemical treatment outcomes in acromegaly. J Clin Endocrinol Metab 94:2015–2022 CrossRef
Giustina A, Barkan A, Casanueva FF, Cavagnini F, Frohman L, Ho K, Veldhuis J, Wass J, Von Werder K, Melmed S (2000) Criteria for cure of acromegaly: a consensus statement. J Clin Endocrinol Metab 85:526–529
Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S, Acromegaly Consensus G (2010) A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab 95:3141–3148 CrossRef
Schofl C, Grussendorf M, Honegger J, Tonjes A, Thyroke-Gronostay D, Mayr B, Schopohl J, Participants of German Acromegaly, R (2015) Failure to achieve disease control in acromegaly: cause analysis by a registry-based survey. Eur J Endocrinol 172:351–356 CrossRef
Giustina A, Bronstein MD, Casanueva FF, Chanson P, Ghigo E, Ho KK, Klibanski A, Lamberts S, Trainer P, Melmed S (2011) Current management practices for acromegaly: an international survey. Pituitary 14:125–133 CrossRef
Ahmad MM, Buhary BM, Al Mousawi F, Alshahrani F, Brema I, Al Dahmani KM, Beshyah SA, AlMalki MH (2018) Management of acromegaly: an exploratory survey of physicians from the Middle East and North Africa. Hormones (Athens). 17:373–381 CrossRef
Casanueva FF, Barkan AL, Buchfelder M, Klibanski A, Laws ER, Loeffler JS, Melmed S, Mortini P, Wass J, Giustina A, Pituitary Society, E.G.o.P.T. (2017) Criteria for the definition of pituitary tumor centers of excellence (PTCOE): A Pituitary Society Statement. Pituitary 20:489–498 CrossRef
van der Lely AJ, Gomez R, Pleil A, Badia X, Brue T, Buchfelder M, Burman P, Clemmons D, Ghigo E, Jorgensen JOL, Luger A, van der Lans-Bussemaker J, Webb SM, Strasburger CJ (2017) Development of ACRODAT((R)), a new software medical device to assess disease activity in patients with acromegaly. Pituitary 20:692–701 CrossRef
Colao A, Grasso LFS, Giustina A, Melmed S, Chanson P, Pereira AM, Pivonello R (2019) Acromegaly. Nat Rev Dis Primers 5:20 CrossRef
Cuevas-Ramos D, Carmichael JD, Cooper O, Bonert VS, Gertych A, Mamelak AN, Melmed S (2015) A structural and functional acromegaly classification. J Clin Endocrinol Metab 100:122–131 CrossRef
- Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT® validation study
Marcello D. Bronstein
Felipe F. Casanueva
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