DIABETES MELLITUS IN PATIENTS WITH ACROMEGALY TREATED WITH PEGVISOMANT: OBSERVATIONS FROM ACROSTUDY™

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 786-805-Diabetes & Obesity Therapeutics
Bench to Bedside
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-798
Thierry Brue*1, Anders Lindberg2, Ann-Charlotte Ĺkerblad3, Michael Droste4, Roy Gomez5, Judith Hey-Hadavi6, Maria Koltowska-Häggström3, Aart Jan Van der Lely7, Christian J. Strasburger8 and Cecilia Camacho-HĂĽbner6
1Hopital de la Timone, Marseille, France, 2Pfizer Endocrine Care, Sollentuna, Sweden, 3Pfizer Inc, Zurich, Switzerland, 4Praxis fuer Endokrinologie, Oldenburg, Germany, 5Pfizer UK, Brussels, Belgium, 6Pfizer Inc, New York, NY, 7Erasmus MC, Rotterdam, Netherlands, 8Charite Campus Mitte, Berlin, Germany
Introduction: Acromegaly is frequently associated with Diabetes Mellitus (DM). The objective of this study was to analyze effects of pegvisomant (PEG; Somavert®) on glucose metabolism in patients with acromegaly and pre-existing DM followed in ACROSTUDY1 (international non-interventional surveillance study of long-term treatment with PEG).

Patients and Methods: 1762 patients with acromegaly treated with PEG were divided into groups with (DM) or without (non-DM) diabetes. DM was defined as: DM reported in medical history or HbA1c ≥ 6.5% or glucose >200 mg/dl or anti-diabetic medication before PEG start. Both cohorts were analyzed yearly for 4 years, and longitudinally at 1 and 4 years. Main clinical characteristics, previous treatments for acromegaly, PEG administration, glucose (G), HbA1c, serum IGF-I, concomitant treatments for DM and serious adverse events (SAEs) were studied.

Results: 510 patients (28.9%) had DM before PEG start and were comparable to the non-DM group (n=1252) in terms of previous treatments, duration of acromegaly (mean ± SD, 8.7 ± 9.1 yr vs 7.1 ± 7.5 yr, respectively) and duration of PEG treatment (5.2 ± 2.7 yr vs 5.4 ± 2.7 yr, respectively). In the DM group there was more women (57.1% vs 46.3%, p<0.0001), patients had higher BMI (31.2 ± 6.0 vs 28.6 ± 5.0 kg/m2 (p<0.0001) and were older at diagnosis (median, 47.0 vs 38.7 yr, p<0.0001). The proportion of patients with IGF-I concentrations above the ULN decreased from 83% to 47% (n=150) in the DM and from 85% to 39% (n=371) in the non-DM during the 4 yrs of follow-up. Among patients with elevated IGF-I at baseline, 53.7% vs 59.4% in the DM and non-DM, respectively, had normalized IGF-I at year 1. Their mean PEG dose (18.2 vs 15.3 mg/d) was higher (p=0.015) in the DM group (n=95) than in the non-DM group (n=274), and remained higher (p=0.028) at year 4.

In the DM group, G values changed from 138.7 ± 59.0 mg/dl (n=218) at baseline to 114.9 ± 42.1 mg/dl (n=208) at year 1 and to 120.2 ± 42.9 mg/dl at year 4 (n=184) with a nadir mean HbA1c value at year 1, 6.6 ± 1.2% (n=197) vs 6.9 ± 1.4% at baseline (n=198). In this group 58.6% had HbA1c above 6.5% at baseline, 42.1% at year 1, and 51.6% at year 4.

Treatment related SAEs were reported in 12 DM and 30 non-DM patients. PEG was discontinued in 6 DM and in 12 non-DM patients due to treatment related SAEs.

Conclusion: Patients with DM on PEG showed a moderate decrease in both glucose and HbA1c values. Overall PEG treatment was well tolerated.

1. van der Lely AJ, Biller BM, Brue T, Buchfelder M, Ghigo E, Gomez R, Hey-Hadavi J, Lundgren F, Rajicic N, Strasburger CJ, Webb SM, Koltowska-Häggström M. Long-term safety of pegvisomant in patients with acromegaly: comprehensive review of 1288 subjects in ACROSTUDY. J Clin Endocrinol Metab. 2012; 97(5):1589-97.

Disclosure: TB: Advisory Group Member, Pfizer, Inc.. AL: Employee, Pfizer, Inc.. AC: Employee, Pfizer, Inc.. RG: Employee, Pfizer, Inc.. JH: Employee, Pfizer, Inc.. MK: Employee, Pfizer, Inc.. AJV: Advisory Group Member, Pfizer, Inc.. CJS: Advisory Group Member, Pfizer, Inc.. CC: Employee, Pfizer, Inc.. Nothing to Disclose: MD

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: TB, AJvdL and CJS received honoraria from Pfizer as member of the ACROSTUDY Strategic Advisory Board