Safety and efficacy of pasireotide in dumping syndromeresults from a phase 2, multicentre study

J. Tack*, J. Aberle, J. Arts, M. Laville, J. M. Oppert, G. Bender, S. Bhoyrul, T. McLaughlin, T. Yoshikawa, A. Vella, J. Zhou, V. Q. Passos, P. O'Connell, A. P. Van Beek

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: Dumping syndrome is a prevalent complication of oesophageal and gastric surgery characterised by early (postprandial tachycardia) and late (hypoglycaemia) postprandial symptoms.

Aim: To evaluate efficacy and safety of the somatostatin analogue, pasireotide in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.

Methods: A single-arm, open-label, multicentre, intrapatient dose-escalation, phase 2 study with 4 phases: screening, 3-month SC (subcutaneous), 3-month IM (intramuscular) and 6-month optional extension IM phase. Primary endpoint was the proportion of patients without hypoglycaemia (plasma glucose = 50% response rate was considered clinically relevant.

Results: Forty-three patients with late dumping were enrolled; 33 completed the 3-month SC phase and 23 completed the 12-month study. The proportion of patients without hypoglycaemia at month 3 (primary endpoint) was 60.5% (26 of 43; 95% confidence interval, 44.4%-75.0%). Improvement in quality of life was observed during SC phase, which was maintained in the IM phase. The proportion of patients with a rise in pulse rate of >= 10 beats/min during OGTT reduced from baseline (60.5%) to month 3 (18.6%) and month 12 (27.3%). Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34.9%); diarrhoea, hypoglycaemia (27.9% each); fatigue, nausea (23.3% each); and abdominal pain (20.9%).

Conclusion: These results suggest that pasireotide is a promising option in patients with dumping syndrome after bariatric or upper gastrointestinal cancer surgery.

Original languageEnglish
Pages (from-to)1661-1672
Number of pages12
JournalAlimentary Pharmacology & Therapeutics
Volume47
Issue number12
DOIs
Publication statusPublished - Jun-2018

Keywords

  • SOMATOSTATIN RECEPTOR SUBTYPE-5
  • RAT INTESTINAL CULTURES
  • GASTRIC BYPASS
  • OCTREOTIDE ACETATE
  • GLUCOSE-TOLERANCE
  • BARIATRIC SURGERY
  • CUSHINGS-DISEASE
  • SMS 201-995
  • HYPERGLYCEMIA
  • HYPOGLYCEMIA

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