Safety of Propranolol Therapy for Severe Infantile Hemangioma

Prey, S.; Voisard, Jean-Jacques; Delarue, Alain; Lebbé, Geneviève; Taı̈eb, Alain; Léauté‐Labrèze, Christine; Ezzedine, Khaled

doi:10.1001/jama.2015.13969

Cited by 65 publications

(68 citation statements)

References 8 publications

(8 reference statements)

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“…Recent data indicate that in complicated infantile hemangioma, severe cardiovascular events associated with the use of propranolol are very rare and occur exclusively after multiple dosing [9] , confirming the assumption that the single-dose and the multiple-dose cardiovascular effect of propranolol are different [4,10] . The present experience demonstrates the excellent cardiovascular tolerance of propranolol 2 mg/kg of body weight daily for ≈ 8 weeks in infantile hemangioma.…”

Section: Discussionmentioning

confidence: 91%

Cardiovascular Profile of Propranolol after Multiple Dosing in Infantile Hemangioma

et al. 2016

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Propranolol is becoming the treatment of choice for complicated infantile hemangioma. We report here data on peripheral blood flow, O₂-saturation, electrocardiographic PR-interval, left ventricular function, blood pressure and heart rate that were assessed before and during treatment for ≥4 weeks with propranolol 2 mg/kg of body weight daily in 67 infants <12 months of age in normal sinus rhythm and with structurally normal hearts. Management with propranolol was well tolerated in all and did not modify peripheral blood flow, O₂-saturation, electrocardiographic PR-interval and left ventricular fractional shortening or ejection fraction. Absolute blood pressure levels were similar without and with propranolol. However, age-adjusted centile levels for both systolic and diastolic levels were significantly lower while on propranolol. The heart rate was significantly lower both when expressed as absolute value and when expressed as age-adjusted centile on treatment with propranolol. In conclusion, propranolol 2 mg/kg of body weight daily causes a statistically though not clinically relevant decrease in blood pressure and heart rate in cardially healthy infants affected by infantile hemangioma. Temporary discontinuation during acute febrile illnesses and during diarrheal diseases should be considered to prevent excessive hypotension.

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Section: Discussionmentioning

confidence: 91%

Cardiovascular Profile of Propranolol after Multiple Dosing in Infantile Hemangioma

et al. 2016

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“…11 The dosage is 2-3 mg/kg/day in two separate doses for 6 months, 4,12 although some children need longer treatment. 4 The most common adverse events (AE) are respiratory disorders as well as sleep disturbances, acrocyanosis, asymptomatic hypotension and diarrhoea; 4,13,14 rare but severe AE (SAE) are bradycardia, hypoglycaemia and hyperkalaemia. 15 Moreover, recent studies have raised concerns about potential neurodevelopmental or cognitive side-effects.…”

Section: Introductionmentioning

confidence: 99%

Nd:YAG and pulsed dye laser therapy in infantile haemangiomas: a retrospective analysis of 271 treated haemangiomas in 149 children

Hartmann

Lockmann

Grönemeyer

et al. 2017

Acad Dermatol Venereol

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“…Known side effects of propranolol include hypotension, bradycardia, bronchospasm and hypoglycemia 14, 15 . Many clinicians remain cautious about the administration of oral propranolol for IHs, especially in young infants, because these drugs act systemically and affect the cardiovascular system.…”

Section: Introductionmentioning

confidence: 99%

Safety and tolerance of propranolol in neonates with severe infantile hemangiomas: a prospective study

Chen

Xiang

et al. 2017

Sci Rep

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Although the efficacy of propranolol for the treatment of infantile hemangiomas (IHs) has been well documented, there is a paucity of clinical data regarding the safety and tolerance of propranolol in neonates. A prospective study of 51 patients less than 30 days of age with severe IH was conducted. All patients were admitted to the hospital for monitoring during initial propranolol treatment at day 0 with dose adjustments at days 7 and 28. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), blood glucose (BG) levels and potential side effects were evaluated during treatment. There were significant decreases in mean heart rate and SBP after the initiation of propranolol therapy (P < 0.05). In contrast, no significant differences in mean DBP and BG levels were observed after each dose during hospitalization (P > 0.05). Bradycardia and hypotension were noted in at least 1 recorded instance in 11.8% and 5.9% of patients, respectively. These hemodynamic changes were not persistent and were asymptomatic. Two patients who had a history of neonatal pneumonia reported severe bronchial hyperreactivity during treatment. This study demonstrated that propranolol administered to properly selected young infants was safe and well tolerated. However, close monitoring should be considered in high-risk young patients.Infantile hemangiomas are the most common vascular tumor in children. If left untreated, the typical characteristic evolution of these tumors is rapid postnatal proliferation, stabilization and slow, spontaneous involution. IHs may be located on any region of the body but are mostly located on the skin of the head, face and neck. Although IHs are usually harmless, approximately 12-24% of IHs have complications. The most commonly occurring complication is ulceration, followed by visual compromise, airway obstruction, auditory canal obstruction and cardiac failure 1 . In many such cases, early intervention may be justified to potentially arrest the growth of the lesion, reduce associated complications, and avoid years of psychosocial concerns.Previously, the standard treatment options for IH included laser, surgical excision or medical therapies such as corticosteroids. The options in life-threatening cases include treatment with vincristine, interferon-α or cyclophosphamide 1 . Unfortunately, none of these therapeutic modalities is ideal due to their restrictions or potentially serious side effects, such as temporary growth retardation, increased risk of infection and behavioral changes 2, 3 . In June 2008, Leaute-Labreze et al. 4 reported their serendipitous discovery that oral propranolol was effective in the management of severe IHs. Subsequently, a growing number of studies further demonstrated that propranolol stops growth and induces an IH regression that is much better and safer than other treatments, including corticosteroids [5][6][7][8][9] . Currently, propranolol has been adopted as a first-line therapy for problematic IHs. Regardless of subtype or depth, the largest increase in ...

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Safety of Propranolol Therapy for Severe Infantile Hemangioma

Abstract: Infantile hemangioma is a vascular tumor characterized by rapid growth during the first weeks of life and spontaneous involution over a few years. 1 Severe forms require systemic therapy. Propranolol induces regression, but safety data are lacking in children. 2,3

Cited by 65 publications

References 8 publications

Cardiovascular Profile of Propranolol after Multiple Dosing in Infantile Hemangioma

Cardiovascular Profile of Propranolol after Multiple Dosing in Infantile Hemangioma

Nd:YAG and pulsed dye laser therapy in infantile haemangiomas: a retrospective analysis of 271 treated haemangiomas in 149 children

Safety and tolerance of propranolol in neonates with severe infantile hemangiomas: a prospective study

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