Octreotide Efficacy and Safety in First-line Acromegalic Patients

Inclusion criteria

• Males and females 18 and < 80 years old.
• Recently diagnosed not previously treated patients with acromegaly.
• Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
• Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
• IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
• Tolerance shown with a test of a subcutaneous injection of octreotide
• Written Informed Consent before any procedure specific to the study. Inclus

Exclusion criteria

• Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
• Compression of optic chiasm that produces any impairment of field of vision.
• Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
• Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
• Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
• Pregnant women
• History of alcohol or drug abuse in the six months prior to the inclusion visit.
• Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
• Intake of an investigational drug during the study and 30 days before patient inclusion in this study

Other protocol-defined inclusion / exclusion criteria may apply.