Safety Of Propranolol Research Articles

Efficacy and safety of atenolol versus propranolol for treatment of infantile haemangioma: A narrative review.

Infantile haemangiomas (IH) remain the most common benign vascular tumours in childhood. While most IH can be managed conservatively, a proportion of these lesions can cause disfigurement, ulceration or functional impairment, requiring prompt intervention. Propranolol, a lipophilic non-selective beta blocker, has been regarded as first-line therapy, following a serendipitous discovery of its use for IH in 2008. While efficacious, it has been associated with adverse effects such as hypoglycaemia, bronchospasm, sleep disturbances and agitation in infant trials. Hence, atenolol, a hydrophilic beta-1 selective blocker, has demonstrated similar efficacy and potentially greater tolerability, being less likely to cause sleep disturbances given its inability to cross the blood brain barrier, and a decrease in bronchial reactivity. The purpose of this review is to explore and critique the current knowledge on the efficacy and safety of propranolol against atenolol in children with IH. A total of seven studies comparing the two beta-blockers were identified in our search. Atenolol appeared to be as efficacious as propranolol and was associated with fewer central nervous system and bronchial-related adverse events. Further research exploring the optimal dosing for atenolol, particularly for ulcerated or syndromic IH, as well as incidence and management of rebound growth would be beneficial.

Propranolol As a Treatment Option for Chylous Effusions and Chylous Ascites in Fetuses and Neonates: A Systematic Review.

Chylous effusion and chylous ascites are rare but serious conditions that affect both fetuses and neonates. Previous studies have documented chylous effusions or chylous ascites treatment with medications as an adjunct to respiratory support and dietary modifications, but no formal recommendations have been made. New literature suggests propranolol as an effective and safe treatment option, though no randomized clinical studies have been published to date. This review aims to assess the efficacy and safety of propranolol in the treatment of chylous effusion and chylous ascites in fetuses and newborns from case reports. A comprehensive search of 10 databases and grey literature was completed. The inclusion criteria for articles were age at diagnosis less than 40 days old and case report/series. Articles were excluded if they were animal studies or not published in English. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 4 articles were ultimately included in the study for a total of 10 reported cases. Propranolol administered to mother and neonates was effective in 100% of cases. The most common oral dose for mothers was 20 mg, 4 times daily, titrated to 40 mg, 4 times daily. The maximum dosage varied for administration orally to neonates, with the median being 3 mg/kg/day. Side effects, including bradycardia and transient hypoglycemia, were seen in 20% of the cases and resolved with dose adjustment. Propranolol is a relatively effective and safe treatment option for chylous effusion and chylous ascites that can be administered prenatally or to neonates.

Safety of propranolol in neonates with severe infantile hemangiomas: A fourteen-year experience

Background: Infantile hemangiomas (IH) are the most common vascular tumors of infancy. Nearly 4–10% of infants require systemic treatment due to uncontrolled endothelial cell proliferation. Oral propranolol has been approved for the treatment of IH. Herein, we present our experience about the safety and tolerance of this treatment. Materials and Methods: This was a fourteen-year, prospective study conducted between 2008 and 2022 by the dermatology and pediatrics departments of the Hassan II University Hospital Center, located in Fez, Morocco, involving 215 children with infantile hemangioma with an indication for treatment by oral propranolol. Results: After a median follow-up period of fourteen years, the mean age of onset was six months. We encountered a 19% rate of side effects. Therapy was interrupted due to the occurrence of bronchospasm in two cases. Four patients (2.5%) had episodes of bronchiolitis. Other side effects were digestive disorders in 3%, sleep disorders in 6 cases, and coldness of the extremities in 7 cases. Four patients (8.6%) had a volumetric rebound. However, we noted sequelae, such as residual telangiectasias (39% cases), anetodermal skin in 15%, and unsightly scars in 24%. Conclusion: Our data shows that propranolol was generally well tolerated by young infants. We found side effects to be mostly minor, transient, and manageable, except for two cases of bronchospasm, whose treatment was permanently discontinued. This may be explained by the late age of treatment onset, yet we noted sequelae, such as telangiectasias and anetodermal skin. Key words: Propranolol, Infantile hemangioma, Safety

The Efficacy and Safety of Propranolol in Treating Infantile Hemangioma: A Prospective Study

: Hemangiomas are benign vascular tumors that often develop in infants. The most common treatment option for complicated hemangiomas is propranolol. We discuss the use of oral propranolol in treating infantile hemangioma (IH) in an Iranian population at our hospital. We conducted a cross-sectional prospective descriptive study on 62 infants aged 1 to 16 months from 2017 to 2021. Propranolol was gradually administered orally at a dose of 3 mg/kg/day. The hemangioma score was examined at 6 intervals (first visit, 1, 3, 6, 9, and 12 months later). Propranolol therapies were stopped when there was no further decrease in scores for 2 successive visits. The study was completed by 62 patients. In terms of hemangiomas, 46 (74.2%) patients had 1 lesion, 12 (19.4%) had 2 lesions, and 4 (6.5%) had 3 lesions. Over time, the average size of hemangiomas steadily decreased, such that 5 patients (9.1%) were completely treated; 1 patient improved after 3 months, 3 after 6 months, 1 after 9 months, and 57 (91.9%) were partially treated. Aside from being safe and effective, propanol can also obtain a higher response rate when treatment is started early in infants aged less than 3 months.

Efficacy and safety of propranolol in infants with heart failure due to moderate-to-large ventricular septal defect (VSD-PHF study) - A prospective randomized trial.

Aims :The utility of beta-blocker therapy in infants with heart failure (HF) due to significant left-to-right shunt lesions is not known. The study aimed to assess the efficacy and safety of propranolol in infants with HF due to moderate-to-large ventricular septal defect (VSD).Methods :The prospective randomized trial included 80 infants with HF and moderate-to-large VSD, randomly allocated to receive either conventional therapy alone (n = 40) or propranolol plus conventional therapy (n = 40). The primary endpoint was a composite of all-cause mortality, hospitalization for HF and/or chest infection, and referral for surgery. The secondary clinical outcomes were the individual components of the composite endpoint. In addition, the patients were followed up to detect safety outcomes, for example, bronchospasm, bradyarrhythmia, and worsening HF symptoms.Results :The addition of propranolol therapy to the conventional medications did not result in significant improvement in the primary composite endpoint (32.50% vs. 52.50%; P = 0.07). There was a trend toward improvement, but the study is underpowered for this important question. However, propranolol therapy significantly decreased the risk of hospitalization (12.50% vs. 32.50%; P = 0.03) and worsening of Ross HF class (5.41% vs. 28.21%; P = 0.01) as compared to conventional therapy (estimated number needed to treat = 5). Propranolol did not result in any significant safety concerns in these infants except bronchospasm in an infant.Conclusions :Propranolol therapy in infants with significant left-to-right shunt may prevent worsening in HF symptoms and hospitalization and is well tolerated. However, it does not reduce mortality or need for surgery.

Propranolol for the treatment of ulcerated infantile hemangiomas: A prospective study

Propranolol for the treatment of ulcerated infantile hemangiomas: A prospective study

Efficacy and Safety of Propranolol vs Atenolol in Infants With Problematic Infantile Hemangiomas

Propranolol has become the first-line therapy for problematic infantile hemangiomas (IHs) that require systemic therapy. However, different adverse events have been reported during propranolol treatment. The positive efficacy and safety of atenolol raise the question of whether it could be used as a promising therapy for IH. To compare the efficacy and safety of propranolol vs atenolol in infants (between age 5 and 20 weeks) with problematic IHs who required systemic therapy. This was a prospective, multicenter, randomized, controlled, open-label clinical trial conducted in collaboration among 6 separate investigation sites in China from February 1, 2015, to December 31, 2018. A total of 377 patients met the criteria for inclusion and were randomized to the propranolol (190 [50.4%]) and atenolol (187 [49.6%]) groups. Data were analyzed in June 2020. Participants were randomized to receive either propranolol or atenolol for at least 6 months. They completed efficacy assessments at 2 years after the initial treatment. The primary outcome was any response or nonresponse at 6 months. The key secondary outcome was changes in the hemangioma activity score. Of 377 participants, 287 (76.1%) were female, and the mean (SD) age was 10.2 (4.0) weeks in the propranolol group and 9.8 (4.1) weeks in the atenolol group. After 6 months of treatment, in the propranolol and atenolol groups, the overall response rates were 93.7% and 92.5%, respectively (difference, 1.2%; 95% CI, -4.1% to 6.6%). At 1 and 4 weeks after treatment, and thereafter, the hemangioma activity score in the atenolol group aligned with the propranolol group (odds ratio, 1.034; 95% CI, 0.886-1.206). No differences between the propranolol group and atenolol group were observed in successful initial responses, quality of life scores, complete ulceration healing times, or the rebound rate. Both groups presented a similar percentage of complete/nearly complete responses at 2 years (82.1% vs 79.7%; difference, 2.4%; 95% CI, -5.9% to 10.7%). Adverse events were more common in the propranolol group (70.0% vs 44.4%; difference, 25.6%; 95% CI, 15.7%-34.8%), but the frequency of severe adverse events did not differ meaningfully between the groups. In this randomized clinical trial, when compared with propranolol, atenolol had similar efficacy and fewer adverse events in the treatment of infants with problematic IHs. The results suggest that oral atenolol can be used as an alternative treatment option for patients with IH who require systemic therapy. ClinicalTrial.gov Identifier: NCT02342275.

Oral propranolol for the treatment of infantile haemangiomas in Singapore.

Infantile haemangiomas (IH) are the most common vascular tumours in childhood. Over the past decade, treatment of IH has been revolutionised by the discovery of the effectiveness of beta-blockers in its treatment. We review our hospital's experience with oral propranolol in the treatment of IH in an Asian population. We performed a retrospective review of the medical records and clinical photos of paediatric patients with IH treated with propranolol in a tertiary paediatric hospital in Singapore from January 2010 to February 2015. A total of 88 patients with IH treated with propranolol were identified over a five-year period, with 79 patients included in the final analysis. There was a predominance of female patients (75.9%) and preterm infants (41.8%) in our study population. The head and neck (65.8%), especially the orbital or preorbital region (45.6%), were the most common lesion sites in our cohort of patients. Mean age of onset was 2.3 ± 4.5 weeks of age, and mean age of starting propranolol treatment was 7.7 ± 10.5 weeks of age. 44.3% of patients experienced > 75% improvement, while 29.1% experienced improvement of 50%-75%. Response to treatment was influenced by the age of starting treatment. Our study provides further evidence of the efficacy and safety of propranolol in the treatment of IH in an Asian population. Early treatment is recommended for optimal results.

Clinical Significance of Screening Electrocardiograms for the Administration of Propranolol for Problematic Infantile Hemangiomas.

Objective Low-dose nonselective β blockade is an effective treatment for problematic infantile hemangioma (PIH). Screening electrocardiograms (ECG) are performed prior to the initiation of propranolol to minimize the risk of exacerbating undiagnosed heart block. How ECG results affect subsequent propranolol usage and patient management remains unclear. We examined the value of ECG prior to propranolol therapy in a quaternary pediatric hospital. Methods A retrospective chart review was performed on all infants who received propranolol (2 mg/kg/day divided three times daily) to treat PIH at Arkansas Children's Hospital from Sept. 2008 to Sept. 2015. All available demographic, historical, and clinical data were obtained. ECGs and echocardiographic data were reviewed and summarized. A pediatric cardiologist read all ECGs. Results A total of 333 patients (75% female) received propranolol therapy. ECG information was available for 317 (95%). Abnormal findings were present on 44/317 (13.9%) of study ECGs. The most common abnormal finding was “voltage criteria for ventricular hypertrophy” (n = 35, 76.1%). Two patients had abnormal rhythms; one had first-degree atrioventricular (AV) block, and one had occasional premature atrial contractions. Of the 31 patients who underwent echocardiograms, 20 (35%) were abnormal. 2.9% of infants with PIH treated with propranolol required a follow-up with a cardiologist. No patient was precluded from taking propranolol due to the findings on screening ECG. Conclusions Screening ECGs prior to propranolol therapy are abnormal in nearly 14% of patients with PIH but are unlikely to preclude therapy. In the absence of prior cardiac history, this cohort offers further evidence suggesting that screening ECGs may be of limited value in determining the safety of propranolol in otherwise healthy infants with PIH.

Sodium Valproate versus Propranolol in Chronic Migraine Prophylaxis

Background: There is a need for effective, well tolerated and affordable drug for chronic migraine prophylaxis in low socioeconomic countries.
 Objective: To study the efficacy and safety of propranolol and sodium valproate (a food and drug administration approved and widely used treatment for prevention of migraine) as a prophylactic treatment in chronic migraine (CM) patients and to compare their efficacy and safety to each other.
 Methods: In this single center, open labeled clinical trial, 40 patients with CM were subdivided into two group: group 1 (n=20) treated with propranolol and group 2 (n=20) treated with sodium valproate. Patients maintained headache diaries over a 1-month baseline period and a 6- month active study period. The evaluation of the treatment was done after 3 and 6 months of the initiation of the treatment. The efficacy measures were evaluation of monthly attacks frequency and attacks severity using VAS of pain (visual analogue scale. Disability and impact of migraine were evaluated using Migraine assessment disability scale (MIDAS) and Headache Impact Test (HIT-6). Throughout the study, patients were monitored for any symptoms or signs of adverse effects.
 Results: Of 40 patients participated in this study (mean age, 33.48; females 72.5%). At the 6th month, the study was completed by 27 patients (propranolol; n=14 and sodium valproate; n=13). Between 55 and 62% of both groups reported more than 50% reduction in monthly attacks frequency. In both groups, there was significant reduction of VAS of pain scores. Both groups showed significant improvement of HIT-6 and MIDAS scores. Before the start of treatment, 85% to 100% of patients in both groups had severe MIDAS and HIT-6 scores. At the end of the study, only 35.7% of propranolol group and 30.8 of sodium valproate group showed severe MIDAS scores and 50% of propranolol group and 40% of sodium valproate group reported severe HIT-6 scores. 55% (n=11) of patients in propranolol reported AEs related to treatment compared to 75% (n=15) in the sodium valproate group. A higher proportion of patients discontinued the treatment because of AEs in Na valproate group compared to sodium valproate group with no statistically significant difference in between (20% vs. 5%, respectively).
 Conclusions: Propranolol and sodium valproate demonstrated similar efficacy and tolerability in the prophylactic treatment of CM.

Propranolol for infantile hepatic hemangioendothelioma: Clinical evaluation of drug efficacy and safety using a single-center patient cohort

Introduction and objectivesInfantile hepatic hemangioendothelioma (IHHE) is a benign liver tumor, associated with hypothyroidism and vascular malformations along the skin, brain, digestive tract and other organs. Here, we determined a single-center patient cohort by evaluating the effectiveness and safety of propranolol and sirolimus for the treatment of IHHE. Patients and methodsWe performed a monocentric and observational study, based on clinical data obtained from 20 cases of IHHE treated with oral propranolol and sirolimus at the Shanghai Children's Medical Center (SCMC), between December 2017 and April 2019. All cases were confirmed by abdominal enhanced CT examination (18/20, 90%) and sustained decrease of alpha fetoprotein (AFP) (2/20, 10%).Propranolol treatment was standardized as once a day at 1.0mg/kg for patients younger than 2 months, and twice a day at 1.0mg/kg (per dose) for patients older than 2 months. Sirolimus was used to treat refractory IHHE patients after 6 months of propranolol treatment, and initial dosing was at 0.8mg/m2 body surface per dose, administered every 12h. Upon treatment, abdominal ultrasound scanning was regularly performed to evaluate any therapeutic effects. All children were followed up for 6–22 months (mean value of 12.75 months). The clinical manifestations and therapeutic effects, including complications during drug management, were reviewed after periodic follow-up. ResultsThe effective rate of propranolol for the treatment of children with IHHE was 85% (17/20). In most cases, the AFP levels gradually decreased into the normal range. A complete response (CR) was achieved in 3 cases, partial response (PR) for 14 cases, progressive disease (PD) for 2 cases and stable disease (SD) was only detected once. Lesions decreased in two PD patients after administration of oral sirolimus. No serious adverse reactions were observed. ConclusionThis study indicates that both propranolol and sirolimus were effective drugs for the treatment of children with IHHE at SCMC.

Study of effect of propranolol, atenolol and celiprolol on exercise induced changes in heart rate, blood pressure and peak expiratory flow rate in healthy human volunteers

Background: Beta blockers are known to cause attenuation of sympathetic stimulation mediated increase in cardiovascular parameters. Very few studies are available in Indian set-up comparing these changes between different beta blockers available in market. The objective of the study was to compare efficacy and safety of propranolol, atenolol and celiprolol on heart rare, blood pressure and airway resistance, both at rest and during exercise.Methods: A prospective interventional study was carried out involving 72 healthy volunteers in the clinical pharmacology laboratory. Participants were divided in three groups of 24 each and given single oral doses of propranolol 40 mg, Atenolol 50 mg and celiprolol 40 mg was given to the participants. Exercise given in the form of step ladder test and hand grip dynamometer and effect on the different parameters like HR, SBP, DBP and PEFR were recorded before and immediately after exercise and compared.Results: All the three drugs were effective in attenuating the exercise induced cardiovascular parameters (p <0.05). Drug A cause change in HR, SBP, DBP and PEFR significantly (p <0.05). Change in SBP was more significant with drug B while significant difference was found in HR, SBP and DBP before and after exercise in drug C in both SL and HGD tests. No significant difference was found between the drug groups (p >0.05). No adverse effects were reported in the study participants.Conclusions: All the three drugs are effective in attenuating cardiovascular changes after sympathetic stimulation like exercise and there was no significant difference among them.

Comparing the Clinical, Radiologic and Biochemical Effectiveness of Atenolol and Propranolol in the Treatment of Infantile Hemangioma - A Randomized Controlled Trial

Background: In this randomized controlled study, we set out to compare effectiveness and safety of propranolol with atenolol, a non-selective lipophilic beta-blocker, in the management of infantile hemangiomas(IHs). Materials and methods: Consecutive patients with complicated and/or cosmetically significant IHs were randomized into two groups- Group A was administered oral propranolol 2mg/kg/day while Group B received oral Atenolol 1mg/kg/day for 9 months. All patients were followed up at monthly intervals for clinical response using Physician Global Assessment (PGA) and Haemangioma Activity Score (HAS). Doppler ultrasonography (USG) and measurement of serum Hypoxia Inducible factor-1 alpha (HIF-1α) was performed at baseline and end of treatment. Results: Forty patients were recruited after satisfying inclusion/exclusion criteria. Number of patients achieving PGA5 was comparable in Group A (14/20) and Group B (9/20; p=0.110). No statistically significant difference was observed in the change in HAS (p=0.941), and mean time taken to achieve PGA5 (p=0.250) between Group A and Group B. Short-term adverse-effect profile of the two drugs did not differ significantly (p=0.651). The two groups were comparable in terms of the degree of volume reduction on USG (p=0.866) and reduction in HIF-1α levels (p=0.825). Conclusions: Propranolol and atenolol are comparable in efficacy when used in the management of IHs. Trial Registration Number: The study was registered in ClinicalTrials.com (ClinicalTrials.gov Identifier: NCT03237637). Funding: ‘Special Research Grant’ for MD thesis from PGIMER, Chandigarh. Declaration of Interest: None. Ethical Approval: This study was approved by the Institutional Ethics Committee of the Postgraduate Institute of Medical Education and Research, Chandigarh.

Oral Propranolol in Infantile Hemangiomas: Analysis of Factors that Affect the Outcome.

Aim:The primary treatment for the subset of infantile hemangiomas (IHs) which develops complication is pharmacological intervention, and propranolol has become a popular choice. Here, we evaluated the efficacy and safety of propranolol in a clinical cohort of IHs and analyzed clinical characteristics associated with a good outcome.Materials and Methods:We retrospectively reviewed a total of 52 IHs patients, between ages 1 and 48 months (median age: 7.5 months), who were treated with oral propranolol, with dose ranging from 2 to 3 mg/kg/day. Efficacy was evaluated using mean percentage reduction, visual analog scale (VAS), and parental satisfaction levels at week 2 and months 1, 2, 6, and 12. The adverse effects were noted and responses after 6 months were graded. Statistical analyses of the outcome were also performed for the responses with regard to age at propranolol initiation, site of lesion, and mean duration of treatment.Results:A therapeutic response with at least 50% mean percentage reduction in size was noted in 84.6% at the end of 6 months. VAS score and parental satisfaction levels correlated well with mean percentage reduction (63.7 ± 15.6) at 6 months. Patients aged <6 months and those with cephalic lesions exhibited a greater therapeutic response rate with shorter overall mean duration of the treatment.Conclusions:Oral propranolol at 2–3 mg/kg/day dosing has shown to be effective and safe for IHs in pediatric age group. Intervention in the early proliferative phase, with especially, the cephalic lesions result in better resolution rates with shorter duration of overall treatment.

Efficacy and safety of propranolol on the proliferative phase of infantile hemangioma: A hospital-based prospective study

Background: Propranolol may be more effective and safer than previously established therapies, and it may be used as a first-line therapy for infantile hemangioma (IH). Propranolol is thought to inhibit the growth of blood vessels by decreasing vascular endothelial growth factor. Aims and Objectives: The aim of this study is to study the efficacy and safety of propranolol in IH and for standardization of dose in tablet form. Materials and Methods: A total of 23 patients with 30 IH s were recruited in the study prospectively, after ruling out any contraindications for oral propranolol and obtaining consent from parents. Patients with 7 kg weight were given 5 mg thrice daily. Patients were evaluated according to visual analog scale and ultrasonographically on day 0, day 30, day 60, and day 90. Results: Out of a total of 30, 25 (83.33%) were superficial, 3 (10%) were deep, and 2 (6.66%) were mixed hemangioma. All patients with superficial hemangiomas showed a change in the color of the lesion and arrest of growth within the 1st month of therapy and a gradual decrease in size was noticed in 23 (92%, n = 25) patients during the study period except in 2 (8%). Complete clearance was noticed in 68% of patients of superficial hemangioma at the end of the study period. Out of 25 patients, a total of 5 (20%) patients had ulceration at the time of presentation which started to heal within 15 days of therapy. Five (16.66%, n = 30) patients with deep and mixed variety showed arrest of growth but no decrease in size. No side effects were seen except temporary coldness of extremity in 1 (3.33%) patient. Conclusion: Propranolol is safe and effective for treatment of proliferative phase of superficial hemangiomas with very less side effects compared to oral steroids and other recommended therapies, and unavailability of syrup can be overcome by giving tablet in fixed dosage.

Evaluation of propranolol, flunarizine and divalproex sodium in prophylaxis of migraine

Background: Preventive treatment has an important role in the management of migraine. Propranolol and flunarizine have been used for more than two decades while, open-label, controlled studies suggest divalproex sodium may also be efficacious for migraine prevention. The objective of the study to compare efficacy and safety of propranolol, flunarizine and divalproex sodium in patients for migraine prophylaxis.Methods: Following approval from IEC a 12-week randomized, open, comparative study was carried out at the outpatient department of Medicine. Patients between 18 to 65 years, with history of 3 to 12 migraines a month (IHS) for six months were included. Patients were divided into three groups of 30 patients to receive - propranolol 20 to 160mg/day; flunarizine 5 to 10mg/day or divalproex sodium 250 to 750mg/day, for three months.Results: Total 90/116 patients completed the study. No significant differences were found between the groups with regards to mean age or other baseline migraine features. All the drugs significantly decreased the frequency, duration and severity of migraine (P&lt;0.001). There is no statistically significant difference between propranolol, flunarizine and divalproex sodium for any of the efficacy parameters. All the three treatments were well-tolerated and safe.Conclusions: All the three study drugs were equally effective with an acceptable tolerability profile, Divalproex sodium group showed more side effects, none of which were serious. However, further studies with larger number of patients and longer duration of treatment are recommended.

Repurposing propranolol as a drug for the treatment of retinal haemangioblastomas in von Hippel-Lindau disease

BackgroundVon Hippel-Lindau (VHL) disease is a rare oncological disease with an incidence of 1:36,000, and is characterized by the growth of different types of tumours. Haemangioblastomas in the central nervous system (CNS) and retina, renal carcinoma and pheochromocytomas are the most common tumours. The absence of treatment for VHL leads to the need of repeated surgeries as the only option for these patients. Targeting VHL-derived tumours with drugs with reduced side effects is urgent to avoid repeated CNS surgeries. Recent reports have demonstrated that propranolol, a β-blocker used for the treatment of hypertension and other cardiac and neurological diseases, is the best option for infantile hemangioma (IH). Propranolol could be an efficient treatment to control haemangioblastoma growth in VHL disease given its antiangiogenic effects that were recently demonstrated by us. The main objective of the present study was the assessment of the efficacy and safety of propranolol on retinal haemangioblastoma in von Hippel-Lindau disease (VHL).Methods7 VHL patients, from different regions of Spain, affected from juxtapapillary or peripheral haemangioblastomas were administered 120 mg propranolol daily. Patients were evaluated every 3 months for 12 months, at Virgen de la Salud Hospital (Toledo). The patients had juxtapapillary or peripheral haemangioblastomas but had refused standard treatments.ResultsPropranolol was initiated with a progressive increase up to a final dose of 120 mg daily. All tumours remained stable, and no new tumours appeared. The reabsorption of retinal exudation was noted in the two patients having exudates. No adverse effects were recorded. VEGF and miRNA 210 levels were monitored in the plasma of patients as possible biomarkers of VHL. These levels decreased in all cases from the first month of treatment.ConclusionsAlthough more studies are necessary, the results of this work suggest that propranolol is a drug to be considered in the treatment of VHL patients with retinal haemangioblastomas. VEGF and miRNA 210 could be used as biomarkers of the VHL disease activity.Trial registrationThe study has a clinical trial design and was registered at EU Clinical Trials Register and Spanish Clinical Studies Registry, EudraCT Number: 2014–003671-30. Registered 2 September 2014.

Propranolol for infantile hemangioma: An evaluation of its efficacy and safety in Iranian infants

Background: Propranolol has been recently indicated to inhibit the rapid growth and involution of infantile hemangioma. In the present study, we investigated the efficacy and safety of propranolol in Iranian infants. Methods: A total of 30 infants with indications for medical intervention, such as large hemangiomas, wounds with or without secondary infection, or active trauma-induced bleeding, were selected. First, a total concentration of 1 mg/kg/day was orally administered to the infants; the dosage further increased (2-3 mg/kg/day) in case the infants experienced no adverse effects. Following weekly (one month after treatment) and monthly (up to six months) follow-ups, hemangioma activity score (HAS) was calculated to evaluate swelling, color of the lesion, and ulcer size. Results: In the present study, infants with the mean age of 5.33±3.50 years received therapy. Improvement was observed in the lesions of all patients, characterized by a significant decline in size, change in color, and reduction in ulcer size (P<0.001). No serious adverse effects were recorded, except agitation which was overcome by reducing the drug concentration. Conclusion: It seems that propranolol can be considered as an efficacious and safe alternative to other pharmaceutical and surgical interventions for infantile hemangiomas in Iranian infants.

Clinical Outcomes of Infants With Periorbital Hemangiomas Treated With Oral Propranolol

Periorbital infantile hemangiomas (IHs) require early intervention because they have the potential risk of causing visual disturbances. In recent years, propranolol has shown promise in the effective management of periocular and periorbital IHs. The objective of our study was to assess the clinical outcomes, efficacy, and safety of propranolol in the management of infants with high-risk periorbital IHs. This retrospective study was conducted at the Stomatological Hospital affiliated with China Medical University. The medical records of infants with periorbital hemangiomas who were treated with systemic propranolol at a dose of 1.0 to 1.5mg/kg per day between January 2014 and June 2015 were reviewed. We excluded infants who did not qualify for propranolol treatment and infants who received previous therapy or other treatments. The records were reviewed for treatment response, adverse events during treatment, length of treatment, and recurrences. Treatment response was classified using a 4-point scale system based on reduction in volume as poor (<25%), moderate (25 to 50%), good (50to 75%), or excellent (>75 to 100%) and change in color, as well as surface texture, by a panel of 3 plastic surgeons using 2-dimensional photographs, clinical examination, and Doppler ultrasonography measurements taken before and after treatment. Of 38 infants with periorbital hemangiomas, 26 were treated with systemic propranolol at a dose of 1.0 to 1.5mg/kg administered once daily. A total of 11 male and 15 female infants with a mean age of 5.2months (range, 2 to 12months) were treated. The mean length of treatment was 22weeks (range, 4 to 41weeks). Adverse events of diarrhea (n= 3) and sleep changes (n= 1) were encountered during treatment in 4 patients. The overall treatment response was scored as excellent in 17 patients, good in 7, moderate in 2, and poor in 0. No patients required discontinuation of treatment because of adverse events, and there were no cases of recurrence or tumor regrowth noted during the mean follow-up period of 6.5months (range, 3 to 10months). Oral propranolol at a dose of 1.0 to 1.5mg/kg per day (age ≤3months, 1.0mg/kg; age>3months, 1.5mg/kg) was effective and well tolerated for the management of 26 Chinese infants with high-risk periorbital IHs. Early intervention should be considered to reduce risk of visual impairment and improve esthetic outcomes.

Propranolol was effective in treating cutaneous infantile haemangiomas in Thai children.

The aim of this study was to explore the efficacy and safety of propranolol in treating infantile haemangiomas, the most common benign vascular tumours in children. We carried out a retrospective chart review of infantile haemangioma patients admitted to the Faculty of Medicine, Khon Kaen University, Thailand, from January 2009 to January 2015. There were 53 infantile haemangioma cases treated with oral propranolol. Treatment responses occurred as early as two weeks after propranolol administration in 91.5% of the follow-up patients, with all 53 cases achieving the desired treatment responses two months after propranolol was initiated. No significant differences in treatment responses were found between propranolol as a mono-therapy or as a combination therapy with prednisolone at the two-week (p value 0.13) and one-month follow-ups (p value 0.98). Complications were documented in three cases (5.6%) when the propranolol dose was increased, and these were asymptomatic hypoglycaemia in two cases and one case of hypotension. Propranolol was effective in treating infantile haemangiomas, and combining it with prednisolone achieved no significant differences in treatment outcome. Cases should be monitored for hypoglycaemia and hypotension. More data on using propranolol for infantile haemangiomas are needed, including long-term follow-up studies.