Double-blind randomized pilot trial evaluating the efficacy of oral propranolol on infantile haemangiomas in infants &lt; 4 months of age

Léauté‐Labrèze, Christine; Roque, Eric Dumas de la; Nacka, Fabienne; Abouelfath, Abdelilah; Grenier, N.; Rebola, M.; Ezzedine, Khaled; Moore, Nicholas

doi:10.1111/bjd.12217

Cited by 54 publications

(51 citation statements)

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“…Recurrence was not observed after termination of treatment. The median duration of propranolol treatment was 12 (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20) months. Photography of some selected cases are shown in figures 2 and 3.…”

Section: Resultsmentioning

confidence: 99%

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Propranolol as a First-Line Treatment of Infantile Hemangioma: Single Center Experience

Ince¹,

Demirağ²,

Töret³

et al. 2015

Turkiye Klinikleri J Pediatr

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A AB BS S T TR RA AC CT T OOb bj je ec ct ti iv ve e: : Infantile hemangiomas (IHs) are the most common benign vascular tumors in infancy. Spontaneous regression is expected in majority of IHs, so watchful waiting is the best management. Currently propranolol has taken the place of corticosteroids for the treatment of risky IHs. Herein we aimed to analyze our patients with IHs treated with propranolol. M Ma at te er ri ia al l a an nd d M Me et th h--o od ds s: There were 240 patients with diagnosis of IH, treatment was indicated in 11.3% (n:27) of them, and these 27 patients received propranolol as a first-line treatment between January 2012-January 2015. Medical records of these 27 patients were analized retrospectively. Clinical characteristics, physical examination findings, treatment indications, treatment details, responses and side effects of propranolol were analized retrospectively. R Re es su ul lt ts s: : The median age at diagnosis was 3 months (1-15), and M/F ratio was 0.23. The most common hemangioma localization was skin and head-neck region in 55.6% of patients. Treatment indications were local complications (haemorrhage, ulceration, infection) (44.4%), life threating organ dysfunction (33.3%) and relative indications (22.2%). The median follow-up period was 12 months (1-26 months). Pallor and partially regression in hemangiomas were observed between the fourth and sixth weeks in all patients. Complete remission occured in 15 patients, treatment is going on with partial remission in remaining 12 cases. There was no observed side effects of propranolol. C Co on nc cl lu us si io on n: : Propranolol is a well-tolerated, efficacious, and safe drug for treatment of IHs. It can be initiated and administered in the outpatient setting. Treatment indications of IHs may become more flexible taking into account of the safety profile of propranolol.K Ke ey y W Wo or rd ds s: : Hemangioma, capillary infantile; propranolol; treatment outcome Ö ÖZ ZE ET T A Am ma aç ç: : İnfantil hemanjiyomlar (İH) süt çocukluğu döneminin en sık karşılaşılan benign vasküler tümörleridir. Bu hastaların büyük bölümünde kendiliğinden gerileme beklenmektedir ve bu nedenle izleyerek beklemek en iyi yaklaşımdır. Günümüzde riskli IH tedavisinde kortikosteroidlerin yerini propranolol tedavisi almıştır. Biz burada IH tanısıyla izlediğimiz propranolol tedavisi uyguladığımız hastaları analiz ettik. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Ocak 2012-Ocak 2015 tarihleri arasında İH tanısı almış 240 hasta vardı, bunların %11,3 (n:27)'üne tedavi endikasyonu konmuştu ve ilk sıra tedavide propranolol verilmişti. Bu 27 hastanın tıbbi kayıtları retrospektif olarak incelendi. Klinik karakteristikler, fizik inceleme bulguları, tedavi endikasyonları, tedavi detayları, yanıtlar ve propranolol yan etkileri analiz edildi. B Bu ul lg gu ul la ar r: : Hastaların ortanca tanı yaşı 3 ay (1-15), E/K oranı 0,23 bulundu. Hemanjiyomun en sık lokalizasyonu deri ve baş boyun bölgesiydi (%55,6). Tedavi endikasyonları lokal komplikasyonlar (hemoraji,...

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Section: Resultsmentioning

confidence: 99%

“…Currently propranolol has taken the place of corticosteroids and it is recommended as first-line treatment of infantile hemangiomas. [11][12][13][14][15][16][17] In this study we present our successful treatment experience with oral propranolol in patients with hemangioma.…”

mentioning

confidence: 99%

Propranolol as a First-Line Treatment of Infantile Hemangioma: Single Center Experience

Ince¹,

Demirağ²,

Töret³

et al. 2015

Turkiye Klinikleri J Pediatr

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“…31,32 Studies included a total of 1265 children with IH (ages ranging from 2 weeks to 9 years), and most were fair quality. [16][17][18][20][21][22]25,28,30 Studies compared pre-and posttreatment photographs to assess improvement in IH and reported change using varied metrics. Three studies used a visual analog scale.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…21 The additional studies reported percent reduction, 27 change in total surface area, 19 or mean percentage decrease in size. 17 Fourteen studies explicitly reported using masked assessors to rate changes in IH. [15][16][17][19][20][21][22]24,25,27,[29][30][31][32] All studies included IH in multiple anatomic locations, and lesion types (when reported) also varied, with the exception of most studies of topical timolol, which generally included only superficial lesions.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…After dual screening, 18 met all criteria for quantitative synthesis and were included in the meta-analysis (Table 2). Studies included 2 RCTs and 1 cohort study evaluating oral propranolol (doses ranging from 1-4 mg/kg/day) and placebo or observation [15][16][17] ; 1 RCT compared different forms of propranolol (oral 2 mg/kg/day, intralesional 1 mg, topical 1%). 18 Two RCTs and 2 cohort studies compared oral propranolol (2.0-2.7 mg/kg/day) and oral prednisolone or oral prednisone (2-4 mg/kg/day).…”

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confidence: 99%

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Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis

Chinnadurai¹,

Fonnesbeck

Snyder

et al. 2016

Pediatrics

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STUDY SELECTION: Two reviewers assessed studies using predetermined inclusion criteria. DATA EXTRACTION:One reviewer extracted data with review by a second. RESULTS:We included 18 studies in a network meta-analysis assessing relative expected rates of IH clearance associated with β-blockers and steroids. Oral propranolol had the largest mean estimate of expected clearance (95%; 95% Bayesian credible interval [BCI]: 88%-99%) relative to oral corticosteroids (43%, 95% BCI: 21%-66%) and control (6%, 95% BCI: 1%-11%). Strength of evidence (SOE) was high for propranolol's effects on reducing lesion size compared with observation/placebo. Corticosteroids demonstrated moderate effectiveness at reducing size/volume (moderate SOE for improvement in IH). SOE was low for effects of topical timolol versus placebo. LIMITATIONS:Methodologic limitations of available evidence may compromise SOE. Validity of meta-analytic estimates relies on the assumption of exchangeability among studies, conditional on effects of the intervention. Results rely on assumed lack of reporting bias. CONCLUSIONS:Propranolol is effective at reducing IH size compared with placebo, observation, and other treatments including steroids in most studies. Corticosteroids demonstrate moderate effectiveness at reducing IH size/volume. The meta-analysis estimates provide a relative ranking of anticipated rates of lesion clearance among treatments. Families and clinicians making treatment decisions should also factor in elements such as lesion size, location, number, and type, and patient and family preferences. Dr Chinnadurai contributed to the conceptualization and design of the original review and meta-analysis and helped assess studies, verify data, develop the analysis, and draft the initial manuscript; Dr Fonnesbeck contributed to the conceptualization and design of the original review and meta-analysis, conducted the metaanalysis, and helped verify data and draft the initial manuscript; Drs Likis and McPheeters contributed to the conceptualization and design of the original review and meta-analysis and helped assess studies, develop the analysis, and draft the initial manuscript; Drs Morad and Snyder contributed to the conceptualization and design of the original review and meta-analysis and helped assess studies, verify data, develop the analysis, and draft the initial manuscript; Ms Sathe contributed to the conceptualization and design of the original review and meta-analysis and helped evaluate studies, extract and verify data, develop the analysis, and draft the initial manuscript; and all authors approved the fi nal manuscript as submitted. Infantile hemangiomas (IH) are the most common tumors of childhood. IH are benign but possess potential for permanent local tissue damage, ulceration, infection, bleeding, functional impact, and pain. Because of historical inconsistencies in naming conventions, the true prevalence of IH is unclear, but it is estimated that they affect ∼4% to 5% of children, 1 with higher prevalence in females and Caucasians. 2,3 ...

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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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Double-blind randomized pilot trial evaluating the efficacy of oral propranolol on infantile haemangiomas in infants < 4 months of age

Cited by 54 publications

References 10 publications

Propranolol as a First-Line Treatment of Infantile Hemangioma: Single Center Experience

Propranolol as a First-Line Treatment of Infantile Hemangioma: Single Center Experience

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis

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

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