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Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study
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  • Floriane Socchi,
  • Michele Bigorre,
  • Marion Normandin,
  • Guillaume Captier,
  • Didier Bessis,
  • Michel Mondain,
  • Catherine Blanchet,
  • Mohamed Akkari,
  • Pascal Amedro,
  • GAVOTTO Arthur
Floriane Socchi
University Hospital Centre Montpellier
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Michele Bigorre
University Hospital Centre Montpellier
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Marion Normandin
University Hospital Centre Montpellier
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Guillaume Captier
University Hospital Centre Montpellier
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Didier Bessis
University Hospital Centre Montpellier
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Michel Mondain
University Hospital Centre Montpellier
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Catherine Blanchet
University Hospital Centre Montpellier
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Mohamed Akkari
University Hospital Centre Montpellier
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Pascal Amedro
University Hospital Centre Montpellier
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GAVOTTO Arthur
University Hospital Centre Montpellier
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Abstract

Aim: Infantile haemangioma (IH) is the most common benign tumour in children. Since 2014, propranolol has become the first-choice therapy and currently Hemangiol® is the only approved drug for complicated haemangioma. This post-marketing study reported the use of Hemangiol® for IH in paediatric practice. Method and Results: From January 2014 to November 2018, 94 children (median age 4 [0;21] months; 75% female) treated with Hemangiol® for proliferative IH were enrolled in the study. The systematic paediatric cardiology consultation never contraindicated beta-blockers. Two Hemangiol® initiation protocols were used: a conventional ambulatory 3-week titration phase protocol (N=76, 80.9%), and a rapid initiation protocol with a 48-hour dose escalation in conventional hospitalization for severe proliferative IH (N=18, 19.1%). In both protocols, the haemodynamic tolerance was good. The mean maintenance dose of Hemangiol® was 2.7±0.8 mg/kg/day, with a median treatment duration of 7 [1.5;19] months. Adverse events (AEs) have been found in 25 (26,6%) patients including 8 (8.5%) patients with serious AEs (uncontrolled bronchial hyperreactivity, N=5; serious hypoglycaemia, N=3). Some patients had one or more AEs, a total of 24 non-serious AEs was reported in 19 patients (sleep disturbances, N=9; respiratory disorders, N=5; digestive disorders, N=6). No cardiac adverse event was reported. Conclusion: This post-marketing surveillance drug study supports the good tolerance of Hemangiol® in children with IH. A rapid initiation protocol is of interest when treatment is urgent. The pre-therapeutic paediatric cardiology consultation should not be systematic but only indicated on specific patients. ClinicalTrials.gov: NCT 04105517.

Peer review status:ACCEPTED

25 Apr 2020Submitted to British Journal of Clinical Pharmacology
27 Apr 2020Submission Checks Completed
27 Apr 2020Assigned to Editor
30 May 2020Reviewer(s) Assigned
18 Jun 2020Review(s) Completed, Editorial Evaluation Pending
20 Jul 2020Editorial Decision: Revise Minor
31 Jul 20201st Revision Received
03 Aug 2020Submission Checks Completed
03 Aug 2020Assigned to Editor
03 Aug 2020Review(s) Completed, Editorial Evaluation Pending
07 Aug 2020Reviewer(s) Assigned
08 Sep 2020Editorial Decision: Revise Minor
09 Sep 20202nd Revision Received
10 Sep 2020Submission Checks Completed
10 Sep 2020Assigned to Editor
10 Sep 2020Review(s) Completed, Editorial Evaluation Pending
11 Sep 2020Editorial Decision: Revise Minor
13 Sep 20203rd Revision Received
14 Sep 2020Submission Checks Completed
14 Sep 2020Assigned to Editor
14 Sep 2020Review(s) Completed, Editorial Evaluation Pending
21 Sep 2020Editorial Decision: Revise Minor
21 Sep 20204th Revision Received
22 Sep 2020Submission Checks Completed
22 Sep 2020Assigned to Editor
22 Sep 2020Review(s) Completed, Editorial Evaluation Pending
24 Sep 2020Editorial Decision: Accept