Safety and efficacy of pasireotide in dumping syndrome—results 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

Research output: Contribution to journalArticle

8 Scopus citations

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 <3.3 mmol/L [60 mg/dL] during an oral glucose tolerance test, OGTT) at the end of 3-month SC phase. A ≥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 (US)
Pages (from-to)1661-1672
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Volume47
Issue number12
DOIs
StatePublished - Jun 2018

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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    Tack, J., Aberle, J., Arts, J., Laville, M., Oppert, J. M., Bender, G., Bhoyrul, S., McLaughlin, T., Yoshikawa, T., Vella, A., Zhou, J., Passos, V. Q., O'Connell, P., & Van Beek, A. P. (2018). Safety and efficacy of pasireotide in dumping syndrome—results from a phase 2, multicentre study. Alimentary Pharmacology and Therapeutics, 47(12), 1661-1672. https://doi.org/10.1111/apt.14664