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Improving Nausea and Vomiting Post-Elipse Balloon: a Novel Single-Dose Regimen of 300 mg Netupitant/0.5 mg Palonosetron Hydrochloride

  • R. IencaEmail author
  • C. Giardiello
  • A. Scozzarro
  • R. Schiano di Cola
  • N. Di Lorenzo
  • Girish Juneja
  • G. Lopez
  • F. Badiuddin
Original Contributions

Abstract

Background

Post intragastric balloon placement symptoms like nausea and vomiting have been the major cause of a high rate of early removal. Common therapy with ondansetron alone, or in combination, with prokinetic agents have been shown to have very little or no effect. Recently, an improved therapy based on aprepitant and ondansetron combination showed a significant improvement in symptoms management. Lack of aprepitant availability in several countries and patients difficulties to follow the right prescription convinced us to explore other pharmacological options.

Objective

Evaluate safety and efficacy of a netupitant and palonosetron-combined drug and to reduce and control post Elipse® placement symptoms

Methods

Between January and March 2018, 30 patients (9 male, 21 female), (mean weight 97.8 and mean BMI 34.7), underwent Elispe® placements, at 550 ml volume, in an outpatient fashion. All patients received a single pill 300 mg netupitant/0.5 mg palonosetron 6 h prior to placement. All patients received ondansetron 4 mg prescription to be taken as needed. A daily VAS score to report intensity of nausea, vomit, cramps, gastric pain, satiety for the first week post-placement was completed.

Results

4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3.

Conclusion

In our experience, the use of a single-pill netupitant/palonosetron resulted to be very easy to administer and effective in reducing vomit, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Elipse™ placements symptoms safely.

Keywords

Weight loss Obesity Intra-gastric balloon Intra-gastric balloon drug therapy Overweight Elispe balloon Anti-emetic drug Balloon side effects Nausea Vomiting 

Notes

Compliance with Ethical Standards

Conflict of Interest

Roberta Ienca and Cristiano Giardiello are consultants for Allurion; Faruq Badiuddin is an advisor for Allurion. The authors declare that there are no other conflicts of interest for this study.

Ethical Approval

All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Elipse Weight Management CenterNuova Villa Claudia ClinicRomeItalia
  2. 2.Emergency and Metabolic Surgery DeptPineta Grande HospitalCasertaItaly
  3. 3.Department of Surgical ScienceTorvergata UniversityRomeItaly
  4. 4.Bariatric CenterAl Zahra HospitalDubaiUAE
  5. 5.Center for Strategic Healthcare DevelopmentDubai Science ParkDubaiUAE
  6. 6.Surgical DivisionBR Medical SuitesHealthcare City, DubaiUAE

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