Therapeutic superiority of combined propranolol with short steroids course over propranolol monotherapy in infantile hemangioma

Aly, Mohamed M.; Hamza, Alaa F.; Kader, Hesham M. Abdel; Saafan, Hatem A.; Ghazy, Mohamed Shaker; Ragab, Iman

doi:10.1007/s00431-015-2561-1

Cited by 31 publications

(22 citation statements)

References 21 publications

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“…There were no significant treatment responses when prednisolone was added to propranolol (Table ), unlike the study by Aly et al , which showed that combining propranolol with short steroid courses was superior to propranolol mono‐therapy. This may be explained by the small sample size of our study as well as the study design.…”

Section: Discussionmentioning

confidence: 65%

Propranolol was effective in treating cutaneous infantile haemangiomas in Thai children

et al. 2016

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Section: Discussionmentioning

confidence: 65%

Propranolol was effective in treating cutaneous infantile haemangiomas in Thai children

et al. 2016

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“…Most clinical trials use photography and measure surface area of the IH because MRI has cost and convenience issues even though it is most useful for IH evaluation. 18,[22][23][24][25][35][36][37] Moreover, the radiologist evaluated the volume independently and blindly. Third, this study had a very low dropout rate compared with other studies.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma

Kim

Choi

et al. 2017

JAMA Dermatol

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IMPORTANCE There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH). OBJECTIVE To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH. INTERVENTIONS The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d). MAIN OUTCOMES AND MEASURES The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs. RESULTS A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes. CONCLUSIONS AND RELEVANCE Our trial demonstrated that propranolol was not inferior to steroid with respect to therapeutic effects in IH. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01908972

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“…72 In a randomized controlled trial (RCT) of oral propranolol compared with observation for IHs, the overall efficacy of propranolol (defined as excellent, good, or medium response) was 98.97%, compared with 31.25% in the observation group (P < .05). 73 Last, Aly et al 74 compared oral propranolol alone versus oral propranolol combined with 2 weeks of "priming" with oral prednisolone. Those in the prednisolone-primed propranolol group showed a statistically superior reduction in IH size at weeks 2, 4, and 8 compared with the propranolol group, but the 6-month response was equivocal for both groups regarding all assessed variables.…”

Section: Management: Pharmacotherapymentioning

confidence: 99%

Clinical Practice Guideline for the Management of Infantile Hemangiomas

et al. 2019

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Infantile hemangiomas (IHs) occur in as many as 5% of infants, making them the most common benign tumor of infancy. Most IHs are small, innocuous, self-resolving, and require no treatment. However, because of their size or location, a significant minority of IHs are potentially problematic. These include IHs that may cause permanent scarring and disfigurement (eg, facial IHs), hepatic or airway IHs, and IHs with the potential for functional impairment (eg, periorbital IHs), ulceration (that may cause pain or scarring), and associated underlying abnormalities (eg, intracranial and aortic arch vascular abnormalities accompanying a large facial IH). This clinical practice guideline for the management of IHs emphasizes several key concepts. It defines those IHs that are potentially higher risk and should prompt concern, and emphasizes increased vigilance, consideration of active treatment and, when appropriate, specialty consultation. It discusses the specific growth characteristics of IHs, that is, that the most rapid and significant growth occurs between 1 and 3 months of age and that growth is completed by 5 months of age in most cases. Because many IHs leave behind permanent skin changes, there is a window of opportunity to treat higher-risk IHs and optimize outcomes. Early intervention and/or referral (ideally by 1 month of age) is recommended for infants who have potentially problematic IHs. When systemic treatment is indicated, propranolol is the drug of choice at a dose of 2 to 3 mg/kg per day. Treatment typically is continued for at least 6 months and often is maintained until 12 months of age (occasionally longer). Topical timolol may be used to treat select small, thin, superficial IHs. Surgery and/or laser treatment are most useful for the treatment of residual skin changes after involution and, less commonly, may be considered earlier to treat some IHs.

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Therapeutic superiority of combined propranolol with short steroids course over propranolol monotherapy in infantile hemangioma

Abstract: Combining propranolol with corticosteroids gives a faster response and should be considered in treating life- or function-threatening hemangiomas.

Cited by 31 publications

References 21 publications

Propranolol was effective in treating cutaneous infantile haemangiomas in Thai children

Propranolol was effective in treating cutaneous infantile haemangiomas in Thai children

Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma

Clinical Practice Guideline for the Management of Infantile Hemangiomas

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