German acromegaly patients interim results from the international Observational Acromegaly Study on Impact of Sandostatin LAR OASIS

The Observational Acromegaly Study on Impact of Sandostatin LAR (OASIS) is an international, observational study in recently diagnosed acromegalic patients. Observations include biochemical parameters, acromegaly symptoms, tumor volume, safety and tolerability. Patient data are collected under normal practice conditions over 12 months. It is planned to enroll more than 700 patients from approximately 160 centers worldwide. In Germany 30 centers are involved in the study. Until May 2007, 53 patients out of 330 patients worldwide have been enrolled in the study, representing one of the largest international prospective acromegaly registries to date. Baseline characteristics of the first 53 German patients with available data are reported here. Around half of the patients are female (52.8%), the majority (94%) are Caucasian, mean age is 49.62 years. Most patients (62.3%) have a diagnosed macroadenoma. Available baseline mean levels were GH 23.7ng/mL in 43 patients and IGF-1 814.13ng/mL in 46 patients. At three months, follow-up data were available for 25 patients with mean GH 6.65ng/mL and for 25 patients with mean IGF-1 654.8ng/mL. From the first 53 patients enrolled, 20 have received initially medical treatment with Octreotide LAR alone (17 patients) or combined with a dopamine agonist (3 patients) and 23 have undergone surgery alone (19 patients) or combined with medical treatment (4 patients). At baseline, symptoms of acromegaly were evaluated and recorded throughout the study. On the whole, most patients experienced 2 to 3 symptoms (37% of patients who received medical treatment at baseline and 52% of patients who underwent surgery). For the patients receiving a medical treatment at baseline, most patients had hyperhidrosis (62.5%), fatigue (43.8%) and headache (25%). For the patients who have undergone surgery, the most recorded symptoms were hyperhidrosis (64.7%), headache (41.2%), osteoarthralgia (35.3%) and fatigue (35.3%). At three months follow up, symptoms were recorded for 8 patients under medical treatment and 6 patients who underwent surgery. Hyperhidrosis was observed in 6 and 3 patients respectively, headache in 2 and 3 patients, respectively and fatigue in 5 and 4 patients, respectively. Follow up data will clarify which treatment regimen best controls symptoms over the course of the therapy.