Exp Clin Endocrinol Diabetes 2015; 123 - P04_15
DOI: 10.1055/s-0035-1547673

Somatuline autogel treatment in acromegaly – 1 year data from SOPRANo study

S Störmann 1, J Schopohl 2, C Bullmann 3, C Terkamp 4, J Flitsch 5, G Stalla 6, R Finke 7, M Christ-Crain 8, A Luger 9, M Droste 10, I Kreitschmann-Andermahr 11, P Hoffmanns 12, S Petersenn 13
  • 1Medizinische Klinik und Poliklinik IV; Klinikum der Universität München
  • 2Medizinische Klinik IV; Klinikum der Universität München
  • 3Amedes Experts Hamburg
  • 4Hannover Medical School
  • 5University Hospital Hamburg-Eppendorf; Neurosurgery
  • 6Max-Planck-Institut für Psychiatrie
  • 7Praxisgemeinschaft An der Kaisereiche
  • 8Klinik für Endokrinologie, Diabetologie und Metabolismus; Universitätsspital Basel
  • 9Universitätsklinik für Innere Medizin III; Abteilung für Endokrinologie & Stoffwechsel
  • 10Praxis für Endokrinologie und Diabetologie – Oldenburg
  • 11Neurochirurgische Klinik, Universitätsklinikum Essen
  • 12Ipsen Pharma GmbH
  • 13Endoc; Zentrum für Endokrine Tumoren

Introduction:

Somatuline Autogel (ATG) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide, used for the treatment of acromegaly and NET. Predictive markers for the use of SSA in these indications are important to optimize treatment.

Methods:

SOPRANo is a non-interventional, multi-center trial, recruiting patients in Germany, Austria and Switzerland. The aim is to evaluate the efficacy and safety of ATG with special focus on predictive markers for long-term treatment success (including early response, somatostatin receptor expression, and lanreotide plasma levels). Patients are eligible for the trial if they have diagnosis of acromegaly, indication for ATG treatment and signed written informed consent. We report here the data of an interim analysis of a 6 months observation period of 45 patients with acromegaly enrolled since June 2012.

Results:

45 patients with acromegaly at an age average of 52.0 (± 13.1), 22 of these were male. Mean duration of acromegaly was 6 years (± 10), 86% presented a macroadenoma. Most common co-morbidities were hypertension (76%), diabetes (40%) and pituitary dysfunction (62%). 93% had been pre-treated by surgery, 48% received prior medical treatment. After 6 months of ATG treatment GH values decreased from (median; 25%/75%) 2.4 ng/ml (0.9/16.7) to 0.8 ng/ml (0.3/2.6) and IGF-I level from 251% ULN (129/372) to 124% ULN (78/149). Somatostatin receptor expression was analysed in a subset of 7 patients with a mean expression of g2. Epworth Sleepiness Scale did not change from baseline to 6 months. Ring size decreased by 4 sizes. HbA1c and glucose levels remained stable.

Conclusion:

SOPRANo represents the first database evaluating the use Lanreotide ATG treatment of acromegalic (and NET) patients from Germany, Austria and Switzerland. Baseline data are in line with the commonly known profile of acromegalic patients. Future analyses will present patients' outcomes in relation to predictive markers.