Efficacy and safety of propranolol as first-line treatment for infantile hemangiomas

Schiestl, Clemens; Neuhaus, Kathrin; Zoller, Silke; Subotic, Ulrike; Forster-Kuebler, Ishilde; Michels, R.; Balmer, Christian; Weibel, Lisa

doi:10.1007/s00431-010-1324-2

Cited by 114 publications

(92 citation statements)

References 18 publications

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“…15 Regardless of the mechanism of action, it is now indisputable that propranolol has an important effect on infantile hemangiomas, such that it causes their rapid regression. 16 Other groups have also reported similar results, 17,18 omas. 20 There is no recommended length of treatment, but it has been shown 20 that treating for a minimum of six months and at least until one year of age may prevent recurrences.…”

supporting

confidence: 53%

Treatment of children and adolescents with hemangioma using propranolol: preliminary results from a retrospective study

et al. 2014

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CONTEXT AND OBJECTIVE: Hemangiomas are the commonest vascular tumors during childhood. In 2008, the effect of propranolol for treating capillary hemangiomas was demonstrated. Other similar results followed, showing that it rapidly reduces lesion volume. The objective here was to evaluate children and adolescents with hemangiomas that were treated with propranolol. DESIGN AND SETTING: Retrospective study, conducted in a children's hospital. METHODS: Patients aged 0-19 years with or without previous treatment, who were treated between January 2009 and December 2010, were included. The response was assessed by comparing the lesion appearance between the start of treatment and the last consultation. We considered partial or complete responses as the response to treatment. RESULTS: Sixty-nine patients with a median follow-up of 11 months (mean age: 31 months) were included. Of these, 58 patients were recently diagnosed and 11 had had previous treatment. A response (partial or complete) was seen in 60 patients (87%). Among the capillary hemangioma cases, responses were seen in 50 out of 53 (94%), while in other lesion types, it was 10 out of 16 (63%) (P = 0.3; chi-square).Responses in patients less than one year of age were seen in 37 out of 38 (97%), whereas in those over one year of age, in 23 out of 31 (74%) (P = 0.4; chi-square). Side effects were uncommon and mild. CONCLUSIONS: Propranolol seemed to be effective for treatment of hemangiomas in children and adolescents, and not just in the proliferative stage, with responses in almost all the patients. Resposta (parcial ou completa) foi verificada em 60 pacientes (87%). Entre os hemangiomas capilares, a resposta foi de 50 em 53 (94%), enquanto em outros tipos de lesões, a resposta foi de 10 em 16 (63%) (P = 0,3; teste de qui-quadrado). A resposta em pacientes com até 1 ano de idade foi de 37 em 38 (97%), e naqueles com mais de 1 ano foi de 23 em 31 (74%) (P = 0,4; qui-quadrado). Efeitos colaterais foram incomuns e leves. CONCLUSÕES: Propranolol parece ser efetivo no tratamento de hemangiomas em crianças e adolescentes, não apenas na fase proliferativa, com resposta em quase todos os pacientes. RESUMO

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supporting

confidence: 53%

Treatment of children and adolescents with hemangioma using propranolol: preliminary results from a retrospective study

et al. 2014

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“…7,[26][27][28][29] This relatively rapid onset of action for systemic therapy most likely encourages compliance. 30 In comparison, topical timolol maleate gel has been associated with growth arrest and a slower reduction in redness and thickness within the first 2 to 4 weeks of use as seen in 2 noncontrolled studies of the use of topical timolol maleate gel for IHs.…”

Section: Discussion Efficacymentioning

confidence: 99%

RCT of Timolol Maleate Gel for Superficial Infantile Hemangiomas in 5- to 24-Week-Olds

Chan¹,

McKay²,

Adams

et al. 2013

Pediatrics

133

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WHAT'S KNOWN ON THIS SUBJECT:The systemic nonselective b-blocker propranolol hydrochloride is increasingly used as firstline management for infantile hemangiomas. Superficial nonulcerating lesions do not require systemic medications. Case series have suggested the efficacy of timolol; however, its safety has been questioned. WHAT THIS STUDY ADDS:This randomized controlled trial indicates that timolol maleate 0.5% gel is a well-tolerated, safe, and effective treatment of superficial infantile hemangiomas. abstract OBJECTIVE: Timolol maleate 0.5% gel is a safe and effective medication for treating superficial infantile hemangiomas (IHs) in infants with a median age of 9 weeks.METHODS: Forty-one infants who had superficial IHs without ulceration and not near mucosal surfaces were recruited and randomly assigned to placebo and treatment (timolol maleate 0.5% gel) groups. Efficacy was assessed by performing blinded volume measurements at weeks 0, 1, 2, 3,4,8,12,16,20, and 24 and blinded investigator photograph scoring at weeks 0, 12, and 24. Safety was assessed by measuring heart rate and systolic and diastolic blood pressure at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24. RESULTS: Fifteen of the 19 infants receiving treatment and 17 of the 22 infants receiving placebo completed the study. Significant color change on the blinded photographic scores was noted at week 24 of the study (P = .003). There was a significantly higher proportion of treated IHs that reduced in size by .5% at weeks 20 and 24 (P , .02). The predicted proportion of IH volume change was also significantly less for treated IHs from week 16 onward when compared with placebo (P , .05). There was no significant variation in blood pressure and heart rate between the groups. CONCLUSIONS: Topical timolol maleate 0.5% gel with a maximum dose of 0.5 mg per day is a safe and effective option for small superficial IHs that have not ulcerated and are not on mucosal surfaces. Pediatrics

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“…Propranolol, a well-tolerated, nonselective, β-AR blocker, has been recently reported to induce the involution of IHs (5), the most common tumor of infancy, efficiently and with good tolerance (15). Even though its mechanism of action has not been fully elucidated, recent research demonstrated that the expression of proangiogenic growth factors such as VEGF is downregulated by propranolol in a dose-dependent manner (6).…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics and local safety profile of propranolol eye drops in rabbits

et al. 2014

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Background: Oral propranolol, a nonselective β-blocker, is able to reduce the progression of retinopathy of prematurity in newborns, but it appeared unsafe. This study aimed to find, in rabbits, a propranolol eye drop concentration able to induce lower plasma but higher retinal concentrations than those obtained after oral administration. Methods: Male New Zealand white rabbits were treated with oral propranolol (0.25 mg/kg/6 h) for 5 d, and propranolol concentrations were measured after 1, 2, 3, and 6 h in plasma, aqueous humor, vitreous humor, and retina. These concentrations were compared with those obtained after the administration of one drop of 25 μl of propranolol 0.1% prepared in saline, applied every 6 h to both eyes for 5 d. A Draize eye test and histological analyses were performed to assess eye drop tolerability. results: The administration of eye drops produced retinal concentrations similar to, but plasma concentrations significantly lower than, those measured after oral administration. The local tolerability profile was excellent. conclusion: Propranolol eye drops are able to ensure high retinal and low plasma concentrations of propranolol, and this finding opens the perspective of possible topical treatment with propranolol in newborns with retinopathy of prematurity.

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Efficacy and safety of propranolol as first-line treatment for infantile hemangiomas

Abstract: Our report supports the excellent effect and good tolerance of this novel therapy, and we propose the use of propranolol as first-line treatment for IH.

Cited by 114 publications

References 18 publications

Treatment of children and adolescents with hemangioma using propranolol: preliminary results from a retrospective study

Treatment of children and adolescents with hemangioma using propranolol: preliminary results from a retrospective study

RCT of Timolol Maleate Gel for Superficial Infantile Hemangiomas in 5- to 24-Week-Olds

Pharmacokinetics and local safety profile of propranolol eye drops in rabbits

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