High-dose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial

Objective: In acromegaly. 25-50% of patients respond inadequately to conventional long-acting somatostatin analogue (SSA) therapy. Response may be improved by increasing SSA frequency or close. This study evaluated the biochemical efficacy and safety of high-close octreotide in patients with acromegaly. Design: A 24-week prospective, multicentre, randomised, open-label trial Conducted from 12 December 2005 to 23 October 2007 in patients with persistently Uncontrolled acromegaly despite >= 6 month conventional SSA therapy. Methods: Patients with >= 50% reduction in GH levels during previous SSA treatment were randomised to high-dose (60 mg/28 days) or high-frequency (30 mg/21 clays) octreotide i.m. injection. Primary end-points were week 12 and 24 reduction in serum IGF1 and GH front baseline. Secondary end points included IGF1 normalisation and tumour shrinkage rates. and safety/tolerability evaluations. Results: Significantly, more patients (10 out of 11) achieved week 24 IGF1 reduction in the high-dose than the high-frequency group (8 out of 15: P<0.05). In the high-dose group only, week-24 IGF1 values were significantly reduced (P=0.02) versus baseline. Normalisation of IGF1 occurred or fly with the high-dose regimen (4/11: P=0.02). Out of 14 patients experiencing adverse events, 5 reported drug-related gastrointestinal effects. No dose-response relationship was seen. Safety parameters were similar between treatment groups. apart front it slight decrease in HbA1 c in the high-close group only. Conclusion: High-close octreotide treatment is safe and effective (normalisation of IGF1 levels) in it Subset of patients with active acromegaly inadequately controlled with long-term SSA. Individualised octreotide Closes LIP to 60 mg/28 days may improve outcomes of SSA therapy