Conditions: Acromegaly
Keywords: Sandostatin LAR High Dose GH-receptor antagonist combination with dopamine-agonist acromegalic patients octreotide acetate Somavert Dostinex pegvisomant cabergoline not adequately controlled active acromegaly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I \[IGF I\]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

Detailed description:

Arms:
arm 1: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months. arm 2: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months arm 3: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows:

1. st week: 0.25 mg twice a week (0.50 mg/week)
2. nd week: 0.50 mg/week twice a week (1 mg/week)
3. rd week: 0.50 mg four times a week (2 mg/week)
4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Interventions: intervention 1: Sandostatin LAR intervention 2: pegvisomant intervention 3: cabergoline
Intervention descriptions: intervention 1: 40 mg intramuscular (i.m.) every 28 days for 3 months intervention 2: Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months intervention 3: Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows:

1. st week: 0.25 mg twice a week (0.50 mg/week)
2. nd week: 0.50 mg/week twice a week (1 mg/week)
3. rd week: 0.50 mg four times a week (2 mg/week)
4. th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Protocol document: