Exp Clin Endocrinol Diabetes 2006; 114 - P3
DOI: 10.1055/s-2006-954696

Preliminary results from the OASIS study: world-wide medical treatment practice in recently diagnosed acromegalic patients

C Sievers 1, B Allolio 2, H Bouterfa 3, F Callies 4, U Deuss 5, M Droste 6, M Engelbach 7, M Faust 8, R Finke 9, A Fuchs 10, B Hanspach 11, J Jacobeit 12, D Kaulen 5, HJ Kroehne 13, T Wiesner 14, A Koschker 2, C Kriesche 11, R Moericke 15, U Schroeder 4, AP Silva 3, H Wallaschofski 16 C Wuester 17, on behalf of the German OASIS study group
  • 1Neuroendocrinology Group, Max Planck Institute of Psychiatry, Munich, Germany
  • 2Universitaet Wuerzburg, Germany
  • 3Novartis Pharma AG, Basel, Switzerland
  • 4Hannover, Germany
  • 5Koeln, Germany
  • 6Oldenburg, Germany
  • 7Frankfurt, Germany
  • 8Universitaetsklinikum Koeln, Germany
  • 9Berlin, Germany
  • 10Novartis Pharma GmbH, Nuernberg, Germany
  • 11Chemnitz, Germany
  • 12Hamburg, Germany
  • 13Jena, Germany
  • 14Universitaetsklinikum Leipzig, Germany
  • 15Magdeburg, Germany
  • 16Universitaetsklinikum Greifswald, Germany
  • 17Mainz, Germany

Background: Somatostatin analogues are the standard medical therapy for acromegaly. There is significant interest in how the use of different treatment regimens (e.g. surgery, medical therapy) impacts the clinical course of disease. This study has been designed to better understand clinical decision making in the context of various treatment options.

Methods: The Observational Acromegaly Study on Impact of Sandostatin LAR (OASIS) is an international, observational study in recently diagnosed acromegalic patients. Observations include biochemical control (GH and/or IGF-1), control of acromegaly symptoms, effect on tumor volume, safety and tolerability. Patient data are collected under normal practice conditions over a 12 months period. It is planned to enroll >1000 patients from approximately 200 centers worldwide. Results: As of July 2006, 214 patients are enrolled from 74 centers in 16 countries. In Germany, 53 patients have been enrolled from 21 centers. Baseline characteristics of the first 24 German patients with available data are reported here. About half of the patients are female (54.2%), the majority (91.7%) are Caucasian, and the mean age is 51 years. Most patients (70.8%) have a diagnosis of macroadenoma. Available baseline mean levels were GH 9.56 ng/mL in 21 patients and IGF-1 642.8 ng/mL in 19 patients. At first quarter follow-up data were available for 16 patients with GH and for 15 patients with IGF-1 levels and the mean values were 7.76 ng/mL and 467.0 ng/mL, respectively. The majority of the patients (n=22, 91.6%) is treated with Sandostatin LAR while 8.4% are taking other drugs or are not medically treated. 6 (27.3%) underwent surgical treatment. The most common starting dose for Sandostatin LAR was 20mg (63.6% of patients) followed by 10mg (22.7%) and 30mg (4.5%). Conclusions: Enrollment into this international study is rapidly increasing. Additional data from this first interim analysis will be reported including a description of symptoms leading to acromegaly diagnosis and presence/severity of acromegaly-related symptoms, as well as safety data.