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

GIUSTINA, Andrea;BONADONNA, Stefania;MAZZIOTTI, Gherardo;
2009-01-01
2009
Ateneo di appartenenza
LS4_3 Endocrinology
LS4_5 Metabolism, biological basis of metabolism
LS7_7 Surgery
LS7_6 Gene therapy, stem cell therapy, regenerative medicine
EUROPEAN JOURNAL OF ENDOCRINOLOGY
2-s2.0-68349141978
WOS:000272934800016
Inglese
161
331
338
7
19465485
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 > or =6 month conventional SSA therapy. METHODS: Patients with > or =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.
Acromegaly; Adult; Aged; Female; Human Growth Hormone; Humans; Injections; Intramuscular; Insulin-Like Growth Factor I; Male; Middle Aged; Octreotide; Prospective Studies; Somatostatin
http://dx.doi.org/10.1530/EJE-09-0372
13
info:eu-repo/semantics/article
262
Giustina, Andrea; Bonadonna, Stefania; Bugari, G; Colao, A; Cozzi, R; Cannavo, S; DE MARINIS, L; DEGLI UBERTI, E; Bogazzi, F; Mazziotti, Gherardo; Min...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11379/31921
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