Real world data in acromegaly - a retrospective chart audit

Diego Ferone; Anna Forsythe; William Ludlam; Roberta Rondena; Cherry Thomas; Monica Gadelha

doi:10.1530/endoabs.32.P867

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Endocrine Abstracts (2013) 32 P867 | DOI: 10.1530/endoabs.32.P867

ECE2013 Poster Presentations Pituitary – Clinical (<emphasis role="italic">Generously supported by IPSEN</emphasis>) (127 abstracts)

Real world data in acromegaly – a retrospective chart audit

Diego Ferone ¹ , Anna Forsythe ² , William Ludlam ² , Roberta Rondena ³ , Cherry Thomas ² & Monica Gadelha ⁴

Err

Author affiliations

¹Endocrinology Unit, DiMI and Centre of Excellence for Biomedical Research, IRCCS-AOU San Martino – IST, University of Genova, Genova, Italy, ²Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, ³Novartis Farma SpA, Orrigio, VA, Italy, ⁴Division of Endocrinology, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

Introduction: The ideal strategy and the role of the different therapeutic options in acromegaly remain unclear. This research focuses on observing treatment options, and the respective level of disease control in acromegaly.

Methods: A retrospective chart audit was conducted in US, France, Italy, and Brazil (September 2012). 97 endocrinologists completed structured case report forms for the 4 most recently-seen patients (two with somatostatin analogues (SSAs), two with pegvisomant (PegV) or PegV+SSAs), n=380; those on the last choice of medical therapy ≧6 months were included in the analysis (n=335). Patient demographics, comorbidities, treatment history, insulin-like growth factor type I (IGF-I) expressed as ULN-fold of age-related reference range, and symptoms were collected. Here we report the preliminary data related to disease management and IGF-I control.

Results: Of the 335 medically treated patients (mean age 51 yrs; 52% males), 193(58%) were treated with SSAs, 116(35%) with PegV, and 26(8%) with PegV+SSAs. 208 of 335 patients (62%) were treated with surgery prior to medical therapy (74% US, 63% Brazil, 54% France, 51% Italy), 127 (38%) received medical therapy with (n=6) or without (n=121) radiation. 63 of 208 (30%) patients treated with surgery prior to medical therapy and 66 of 127 (52%) treated with medical therapy had IGF-1>ULN. 20% of all study patients had IGF-1>1.5xULN (19% US, 28% Brazil, 21% France, 15% Italy) despite treatments. 59% of SSA treated patients had IGF-1≤ULN, vs. 67% of patients on PegV and 73% on PegV+SSAs. The rates of acromegaly symptoms and comorbidities were similar among patients treated with SSAs and PegV. Incidence of paresthesia and perspiration were significantly lower in patients with IGF-1≤ULN (P<0.05).

Conclusions: Medical therapy remains an integral component of acromegaly management. Despite the different therapeutic strategies, including different drugs, 30-52% of patients remain with elevated IGF-I and may experience signs and symptoms of active disease.