Expanding the therapeutic repertoire of infantile haemangiomas: cohort-blinded study of oral nadolol compared with propranolol

Pope, Elena; Chakkittakandiyil, Ajith; Lara‐Corrales, Irene; Maki, Erik D.; Weinstein, Miriam

doi:10.1111/j.1365-2133.2012.11131.x

Cited by 68 publications

(59 citation statements)

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“…[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. 31,32 Studies included a total of 1265 children with IH (ages ranging from 2 weeks to 9 years), and most were fair quality.…”

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.…”

mentioning

confidence: 99%

“…We considered 4 studies as good quality 15,19,27,31 and 5 as poor quality. 23,24,26,29,32 Two investigators also graded the strength of the body of evidence (confidence in the estimate of effect) by using methods based on the Methods Guide for Effectiveness and Comparative Effectiveness Reviews. 36 The full team reviewed the final strength of evidence (SOE) designation with discussion to reach consensus as needed.…”

mentioning

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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Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

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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“…19,[21][22][23][24][25][26] 65% of infants were girl and 35 % were boy which was similar to other studies. [26][27][28] In this study most of patients (70%) have significant damage decreasing and a few of them (30%) have week response to propranolol. After compare the result of this study with other studies seen that most of patients in all studies have very good or good response to propranolol and there was significant relation between damages size and propranolol use.…”

mentioning

confidence: 99%

Assessment of propranolol efficacy on pediatric haemangioma: an experimental study

Fathi

Mirzarahimi

2015

Int J Res Med Sci

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Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma

et al. 2022

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IMPORTANCE Propranolol for infantile hemangiomas (IH) has been shown to be effective and relatively safe. However, other less lipophilic β-blockers, such as nadolol, may be preferable in individuals who experience propranolol unresponsiveness or adverse events. OBJECTIVE To document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH.DESIGN, SETTING, AND PARTICIPANTS This double-blind noninferiority prospective study with a noninferiority margin of 10% compared propranolol with nadolol in infants aged 1 to 6 months with problematic IH. The study was conducted in 2 academic pediatric dermatology centers in Canada between 2016 and 2020. Infants aged 1 to 6 months with a hemangioma greater than 1.5 cm on the face or 3 cm or greater on another body part causing or with potential to cause functional impairment or cosmetic disfigurement.INTERVENTIONS Oral propranolol and nadolol in escalating doses up to 2 mg/kg/d. MAIN OUTCOMES AND MEASUREBetween-group differences comparing changes in the bulk (size and extent) and color of the IH at week 24 with baseline using a 100-mm visual analog scale. RESULTSThe study included 71 patients. Of these, 36 were treated with propranolol. The mean (SD) age in this group was 3.1 (1.4) months, and 31 individuals (86%) were female. Thirty-five infants were treated with nadolol. The mean (SD) age in this group was 3.2 (1.6) months, and 26 individuals (74%) were female. The difference in IH between groups by t test was 8.8 (95% CI, 2.7-14.9) for size and 17.1 (95% CI, 7.2-30.0) for color in favor of the nadolol group, demonstrating that nadolol was noninferior to propranolol. Similar differences were noted at 52 weeks: 6.0 (95% CI, 1.9-10.1) and 10.1 (95% CI, 2.9-17.4) for size and color improvement, respectively. For each doubling of time unit (week), the coefficient of involution was 2.4 (95% CI, 0.5-4.4) higher with nadolol compared with propranolol. Safety data were similar between the 2 interventions.CONCLUSIONS AND RELEVANCE Oral nadolol was noninferior to oral propranolol, indicating it may be an efficacious and safe alternative in cases of propranolol unresponsiveness or adverse events, or when faster involution is required.

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Expanding the therapeutic repertoire of infantile haemangiomas: cohort-blinded study of oral nadolol compared with propranolol

Cited by 68 publications

References 10 publications

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis

Assessment of propranolol efficacy on pediatric haemangioma: an experimental study

Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangioma

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