Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in
 Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to
 assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to <
 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study
 treatment.
Inclusion Criteria:

 -  Patients with medication naïve acromegaly or pituitary gigantism

 -  Patients with inadequately controlled acromegaly or pituitary gigantism

 Exclusion Criteria:

 -  Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%

 -  Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
 sustained ventricular tachycardia, ventricular fibrillation, clinically significant
 bradycardia, advanced heart block or a history of acute myocardial infarction within
 the six months preceding enrollment

 -  Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
 > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT
 syndrome, or patients receiving a concomitant medication known to prolong QT interval