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Safety and efficacy of pasireotide in dumping syndrome—results from a phase 2, multicentre study
Author(s) -
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.
Publication year - 2018
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.14664
Subject(s) - medicine , nausea , clinical endpoint , pasireotide , adverse effect , dumping syndrome , gastroenterology , postprandial , surgery , constipation , acromegaly , randomized controlled trial , cancer , insulin , gastrectomy , growth hormone , hormone
Summary 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.