Effect of propranolol vs prednisolone vs propranolol with prednisolone in the management of infantile hemangioma: A randomized controlled study

Malik, Muneer Abas; Menon, Prema; Rao, K. L. N.; Samujh, Ram

doi:10.1016/j.jpedsurg.2013.08.020

Cited by 70 publications

(81 citation statements)

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“…Unfortunately, none of these therapeutic modalities are ideal due to restrictions or potential serious side effects [4][5][6][7]. β-blockers have recently been introduced as a safe and effective treatment for IH [8][9][10][11]. However, their use is not without risk, and not all tumors respond to these drugs [12,13].…”

Section: Introductionmentioning

confidence: 99%

Wnt3a Expression is Associated with MMP-9 Expression in Primary Tumor and Metastatic Site in Recurrent or Stage IV Colorectal Cancer

2014

Cancer Cell Signaling

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Infantile hemangioma (IH), which is the most common tumor in infants, is a benign vascular neoplasm resulting from the abnormal proliferation of endothelial cells and pericytes. For nearly a century, researchers have noted that IH exhibits diverse and often dramatic clinical behaviors. On the one hand, most lesions pose no threat or potential for complication and resolve spontaneously without concern in most children with IH. On the other hand, approximately 10% of IHs are destructive, disfiguring and even vision-or life-threatening. Recent studies have provided some insight into the pathogenesis of these vascular tumors, leading to a better understanding of the biological features of IH and, in particular, indicating that during hemangioma neovascularization, two main pathogenic mechanisms prevail, angiogenesis and vasculogenesis. Both mechanisms have been linked to alterations in several important cellular signaling pathways. These pathways are of interest from a therapeutic perspective because targeting them may help to reverse, delay or prevent hemangioma neovascularization. In this review, we explore some of the major pathways implicated in IH, including the VEGF/VEGFR, Notch, β-adrenergic, Tie2/angiopoietins, PI3K/AKT/mTOR, HIF-α-mediated and PDGF/PDGF-R-β pathways. We focus on the role of these pathways in the pathogenesis of IH, how they are altered and the consequences of these abnormalities. In addition, we review the latest preclinical and clinical data on the rationally designed targeted agents that are now being directed against some of these pathways.

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Section: Introductionmentioning

confidence: 99%

Wnt3a Expression is Associated with MMP-9 Expression in Primary Tumor and Metastatic Site in Recurrent or Stage IV Colorectal Cancer

2014

Cancer Cell Signaling

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“…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). [19][20][21][22] One cohort study compared oral propranolol (2 mg/kg/day) and intralesional bleomycin (0.5 mg/kg) 23 ; and 1 RCT and 1 cohort study evaluated oral propranolol (2-3 mg/kg/day) and other β-blockers (1-4 mg/kg/ day). 24,25 Three cohort studies and 2 RCTs assessed topical timolol (0.5%) compared with placebo or observation or another agent, [26][27][28][29][30] and 1 RCT and 1 cohort study evaluated different steroids, including oral prednisone and intralesional triamcinolone.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…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%

“…Three studies used a visual analog scale. 22,24,28 Ten studies used a subjective rating of response (eg, good, fair, poor; complete, partial, no response), typically with a percentage improvement related 3 to each grade (eg, good ≥75% size reduction). 15,16,18,20,23,25,26,[29][30][31] Two studies rated improvement as greater or less than either 50% 32 or 75%.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…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. Supplemental Table 5 outlines key study characteristics.…”

Section: Study Selection and Study Characteristicsmentioning

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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Effect of propranolol vs prednisolone vs propranolol with prednisolone in the management of infantile hemangioma: A randomized controlled study

Cited by 70 publications

References 23 publications

Wnt3a Expression is Associated with MMP-9 Expression in Primary Tumor and Metastatic Site in Recurrent or Stage IV Colorectal Cancer

Wnt3a Expression is Associated with MMP-9 Expression in Primary Tumor and Metastatic Site in Recurrent or Stage IV Colorectal Cancer

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis

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

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