Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly

Inclusion Criteria:

1. Patients with written informed consent prior to any study related activity

2. Patients who had inadequately controlled acromegaly as defined by a mean GH
concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and
age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)

3. Patients who had been treated with maximum indicated doses of octreotide LAR or
lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum
indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg

4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have
been previously submitted to surgery

5. Patients who completed the 24-week treatment period in core according to the
requirements of the core study protocol or corresponding amendments could enter
extension

Exclusion Criteria:

1. Patients who had received pasireotide (SOM 230) prior to enrolment

2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine
agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1
(screening)(8 weeks wash out period). Such patients must have been treated with
octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum
of 6 months prior to starting combination therapy and they should have been
inadequately controlled on monotherapy.

3. Patients who had compression of the optic chiasm causing acute clinically significant
visual field defects

4. Patients who required a surgical intervention for relief of any sign or symptom
associated with tumor compression

5. Patients who had received pituitary irradiation within 10 years prior to visit 1
(screening).

6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks
prior to visit 1 (screening).

7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid
hormone replacement therapy