TY - JOUR
T1 - Safety and efficacy of pasireotide in dumping syndrome—results from a phase 2, multicentre study
AU - Tack, J.
AU - Aberle, J.
AU - Arts, J.
AU - Laville, M.
AU - Oppert, J. M.
AU - Bender, G.
AU - Bhoyrul, S.
AU - McLaughlin, T.
AU - Yoshikawa, T.
AU - Vella, A.
AU - Zhou, J.
AU - Passos, V. Q.
AU - O'Connell, P.
AU - Van Beek, A. P.
N1 - Funding Information:
Declaration of funding interests: Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. We thank Swetha Sirimalla (Novartis Healthcare Pvt Ltd) for medical editorial assistance with this manuscript. This study was funded by Novartis Pharma AG.
Funding Information:
Declaration of personal interests: Jan Tack, Jens Aberle, Joris Arts, Gwendolyn Bender, Sunil Bhoyrul has nothing to disclose. Martine Laville reports grants and other (medical writing) from NOVARTIS, during the conduct of the study. Jean-Michel Oppert reports grants from NOVARTIS, during the conduct of the study. Tracey McLaughlin, reports grants to Stanford University, during the conduct of the study. Takaki Yoshikawa reports personal fees from Novartis, during the conduct of the study; grants and personal fees from Chugai, grants and personal fees from Taiho, grants and personal fees from Yakult, personal fees from Lilly, personal fees from Ono, personal fees from Bristol-Myers, grants from Novartis, personal fees from Abbott, personal fees from Daiichi-Sankyo, personal fees from Takeda, personal fees from Olympus, personal fees from Covidien, personal fees from Johnson and Johnson, outside the submitted work. Adrian Vella reports personal fees from Novartis, during the conduct of the study; personal fees from Sanofi Aventis, grants from XOMA, grants from Novartis, grants from VTV Therapeutics, personal fees from VTV therapeutics, outside the submitted work. Jocelyn Zhou, Vanessa Q. Passos and Paul O'Connell reports personal fees (employment) from Novartis, outside the submitted work. Andr? P. Van Beek reports other (advisory board) from Novartis, during the conduct of the study; grants from Novartis, outside the submitted work. Declaration of funding interests: Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. We thank Swetha Sirimalla (Novartis Healthcare Pvt Ltd) for medical editorial assistance with this manuscript. This study was funded by Novartis Pharma AG.
Publisher Copyright:
© 2018 John Wiley & Sons Ltd
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
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U2 - 10.1111/apt.14664
DO - 10.1111/apt.14664
M3 - Article
C2 - 29696671
AN - SCOPUS:85045902814
SN - 0269-2813
VL - 47
SP - 1661
EP - 1672
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 12
ER -