Oral propranolol for infantile hemangiomas: a prospective study on the role of 48-hour Holter monitoring in additional safety assessment

Petrović, Jelena; Trifunovic, Branislav; Vukomanović, Goran; Topalović, Mirko; Trajković, Goran; Parezanović, Vojislav

doi:10.1080/09546634.2016.1277177

Cited by 12 publications

(10 citation statements)

References 25 publications

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“…There were only 2 (2.9%) respiratory problems in our study, which may occur because children with a history of neonatal pneumonia are more likely to have respiratory disorder [27]; however, all patients included in our study did not have such a history. There was no asymptomatic hypotension or bradycardia observed; because we did not measure blood pressure in the routine follow-up [28, 29], hand-held pulse oximeter was used by parents for self-test and out-patient care. Pathoglycaemia was not found in the outpatient follow-up, but as mentioned above, the 2 cases of cold and sweaty hands and feet might have occurred owing to hypoglycaemia.…”

Section: Discussionmentioning

confidence: 99%

Propranolol Treatment for Infantile Hemangiomas: Short-Term Adverse Effects and Follow-Up to Age Two

Yang

et al. 2019

BioMed Research International

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Objective To analyse the short-term adverse effects (AEs) of propranolol in the treatment of infantile hemangiomas (IHs) and their relevant factors, as well as the relationship between child growth and propranolol. Methods A total of 506 patients with confirmed or suspected IHs were enrolled, and a total of 439 cases were included in the study. Short-term AEs were analysed using single-factor analysis and binary logistic regression. Out of 439 patients, 292 were enrolled to examine the effect of propranolol on 2-year-olds' height and body weight (BW), by comparison with reference range and among groups. Spearman rank correlation analysis was used to determine the relationship between BW, height, and duration of propranolol treatment. Results Among 439 patients, 70 (16.0%) experienced AEs. Among them, 48 had gastrointestinal (GI) symptoms, 23 had central nervous system (CNS) symptoms, 8 had both symptoms above, and 7 had other symptoms. Most of the AEs occurred on the starting day (day 0), and 6 children's AEs were transient. Starting age of no older than 3 months led to more CNS symptoms, and starting age of older than 3 months was a protective factor against CNS symptoms, with an OR value of 0.303 (0.117–0.783). Height and BW of 292 two-year-old children were no less than the reference levels, although those of 3 females and 1 male were less than the average −2 standard deviation (−2SD). The height and BW of the children at the age of two was not related to the length of time of propranolol treatment. Conclusion Oral propranolol has a good tolerance in the treatment of IHs. Oral propranolol exerts more adverse effects on the CNS of lower age children, and it has exhibited no effect on the growth of two-year-old children.

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Section: Discussionmentioning

confidence: 99%

Propranolol Treatment for Infantile Hemangiomas: Short-Term Adverse Effects and Follow-Up to Age Two

Yang

et al. 2019

BioMed Research International

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“…No AE, serious or not, was reported during drug initiation at the hospital, whatever the protocol used, as well as during the follow-up. No significant decrease in systolic blood pressure was observed, and the initial decrease in heart rate and diastolic blood pressure was moderate and not clinically relevant, as in the literature [38][39][40] . Similarly, previous studies have reported the safety of oral propranolol for the treatment of IH 41 and suggested not to extend cardiac monitoring beyond initiation period except for heart rate during following consultations 42 .…”

Section: Discussionmentioning

confidence: 56%

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

et al.

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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.

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“…No AE, serious or not, was reported during drug initiation at the hospital, whatever the protocol used, as well as during the follow‐up. No significant decrease in systolic blood pressure was observed, and the initial decrease in heart rate and diastolic blood pressure was moderate and not clinically relevant, as in the literature 40–42 . Similarly, previous studies have reported the safety of oral propranolol for the treatment of IH 43 and suggested not extending cardiac monitoring beyond the initiation period except for heart rate during following consultations 44 .…”

Section: Discussionmentioning

confidence: 72%

“…No significant decrease in systolic blood pressure was observed, and the initial decrease in heart rate and diastolic blood pressure was moderate and not clinically relevant, as in the literature. [40][41][42] Similarly, previous studies have reported the safety of oral propranolol for the treatment of IH 43 and suggested not extending cardiac monitoring beyond the initiation period except for heart rate during following consultations. 44 In light of these results, an outpatient Hemangiol initiation protocol could be considered in selected and not at-risk patients, as suggested by Puttgen et al 45 This study supports the absence of relevance for a systematic pretherapeutic paediatric cardiology consultation.…”

Section: T a B L E 3 Serious Adverse Eventsmentioning

confidence: 92%

Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

Socchi

Bigorre

Normandin

et al. 2020

Brit J Clinical Pharma

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Oral propranolol for infantile hemangiomas: a prospective study on the role of 48-hour Holter monitoring in additional safety assessment

Abstract: Oral propranolol for IHs does not remarkably affect heart rhythm including circadian variations throughout hospital initiation. Therefore, there is no necessity for Holter monitoring in additional safety assessment.

Cited by 12 publications

References 25 publications

Propranolol Treatment for Infantile Hemangiomas: Short-Term Adverse Effects and Follow-Up to Age Two

Propranolol Treatment for Infantile Hemangiomas: Short-Term Adverse Effects and Follow-Up to Age Two

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

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