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

¹ , Department of Medical and Surgical Sciences² Biomedical Sciences and Biotechnology, University of Brescia, 25123 Brescia, Italy³ Endocrinology, University of Naples, Naples, Italy⁴ Endocrinology, Niguarda Hospital, Milan, Italy⁵ Endocrinology, University of Messina, Messina, Italy⁶ Endocrinology, Catholic University, Rome, Italy⁷ Endocrinology, University of Ferrara, Ferrara, Italy⁸ Endocrinology, University of Pisa, Pisa, Italy⁹ Endocrinology, University of Genoa, Genoa, Italy¹⁰ Endocrinology, Bergamo Hospital, Bergamo, Italy¹¹ Endocrinology, University of Turin, Turin, Italy

(Correspondence should be addressed to A Giustina who is now at Endocrine Service, Montichiari Hospital, Via Ciotti 154, 25018 Montichiari, Italy; Email: a.giustina{at}libero.it)

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 dose. This study evaluated the biochemical efficacy and safety of high-dose 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 days) octreotide i.m. injection. Primary end-points were week 12 and 24 reduction in serum IGF1 and GH from 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 only 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 from a slight decrease in HbA1c in the high-dose group only.

Conclusion: High-dose octreotide treatment is safe and effective (normalisation of IGF1 levels) in a subset of patients with active acromegaly inadequately controlled with long-term SSA. Individualised octreotide doses up to 60 mg/28 days may improve outcomes of SSA therapy.