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

Laura De Marinis Grasso, A Giustina, S Bonadonna, G Bugari, A Colao, R Cozzi, S Cannavo, E Degli Uberti, F Bogazzi, G Mazziotti, F Minuto, M Montini, E. Ghigo

Risultato della ricerca: Contributo in rivistaArticolo in rivista

84 Citazioni (Scopus)

Abstract

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. © 2009 European Society of Endocrinology.
Lingua originaleEnglish
pagine (da-a)331-338
Numero di pagine8
RivistaEuropean Journal of Endocrinology
Volume161
DOI
Stato di pubblicazionePubblicato - 2009

Keywords

  • Adult
  • Aged
  • Female
  • Human Growth Hormone
  • Humans
  • Injections, Intramuscular
  • Insulin-Like Growth Factor I
  • Male
  • Middle Aged
  • Octreotide
  • Prospective Studies
  • Somatostatin
  • acromegaly
  • adult
  • aged
  • angiopeptin
  • article
  • blood
  • cholelithiasis
  • clinical article
  • clinical trial
  • controlled clinical trial
  • controlled study
  • diarrhea
  • drug derivative
  • drug dose comparison
  • drug efficacy
  • drug megadose
  • drug safety
  • drug tolerability
  • female
  • flatulence
  • gastrointestinal toxicity
  • growth hormone
  • growth hormone blood level
  • hormonal therapy
  • human
  • human growth hormone, abdominal pain
  • intramuscular drug administration
  • male
  • metabolism
  • middle aged, Acromegaly
  • multicenter study
  • octreotide
  • outcome assessment
  • priority journal
  • prospective study
  • randomized controlled trial
  • side effect
  • somatomedin C
  • somatostatin
  • treatment duration
  • treatment response

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