Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma
 causing overproduction of growth hormone which leads to acromegaly. The objective of this
 study is to assess the safety and efficacy of long-acting repeatable formulation of
 octreotide and to compare it to the safety and efficacy of surgery in patients with
 acromegaly who have not had any previous treatment for acromegaly.
Inclusion Criteria:

 -  Newly diagnosed or previously untreated acromegalic patients

 -  Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of
 glucose (OGTT)

 -  IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age
 and gender)

 Exclusion Criteria:

 -  Requires surgery for recent significant deterioration in visual fields or other
 neurological signs, which are related to the pituitary tumor mass

 -  No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)

 -  Symptomatic cholelithiasis

 Other protocol-defined exclusion criteria may apply.