Strict IGF-1 Control in Acromegaly
Strict IGF-1 Control in Acromegaly
Acromegaly is a rare, chronic, and debilitating disease, usually caused by a benign tumor on
 the pituitary gland, which leads to excessive production of growth hormone (GH). GH excess in
 turn causes overproduction of another hormone called insulin-like growth factor-1 (IGF-1).
 IGF-1 levels are currently the most widely accepted measure of disease activity.

 In Canada, medical therapy with a type of medicine called "somatostatin analogues" (SSA),
 such as octreotide and lanreotide, is recommended for treatment of acromegaly. However,
 studies have shown that a significant number of patients who take SSA medications alone
 remain with elevated levels of IGF-1 in their blood.

 Another medication that is used to treat acromegaly is pegvisomant (PEGV), and the
 investigators plan to study whether strict control of IGF-1, by adding or optimizing the use
 of PEGV, results in a significant health benefits to patients who still have modestly high
 levels of IGF-1 in their blood.
Inclusion Criteria:

 -  Adult patients (at least 18 years old) with confirmed acromegaly whose IGF-I levels
 are persistently but modestly (1.0 ULN < [IGF-1 serum level] < 1.5 ULN) elevated
 following medical therapy such as SSA, PEGV, cabergoline alone or in combination.

 Exclusion Criteria:

 1. Progressive or recent visual field loss or optic chiasmal compression, or pituitary
 tumors within 2mm from the chiasm. Patients whose visual field loss, optic chiasmal
 compression or pituitary tumor has been stable for at least a year will be eligible.

 2. Cranial nerve palsies or intracranial hypertension requiring tumour decompression
 surgery

 3. Clinically significant hepatic disease and/or elevated liver enzymes (ALT, AST > 3 x
 ULN)

 4. Patients who have received pituitary surgery within one year prior to screening visit

 5. Patients who have received radiation therapy within one year prior to screening visit

 6. History of hypersensitivity to any components of Pegvisomant

 7. Inability to fully comprehend the nature of the study or cooperate with study
 procedures

 8. Pregnant / lactating women and subjects refusing to use adequate contraception to
 prevent pregnancy during the study.

 9. Subjects unwilling or unable to self-administer medication on a daily basis

 10. known or suspected alcohol / drug abuse

 11. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
 that could increase the risk associated with trial participation.