Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

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Detailed Description

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Currently, propranolol is the preferred treatment for problematic proliferating infantile hemangiomas (IHs). Although propranolol is clearly efficacious, rare side effects, such as hypoglycemia, may be life-threatening. The possibility of propranolol resistance and treatment failure is also important, and highlights the need for employing more established techniques in certain cases.

Nonselective β-adrenergic antagonists, such as propranolol and timolol, are competitive antagonists of catecholamines at the β1- and β2-adrenergic receptors (β-ARs). β2-AR blockade may result in hypoglycemia as a result of decreased glycogenolysis, gluconeogenesis, and lipolysis. Moreover, bronchial hyperreactivity is a direct effect of nonselective β-blockers, resulting in bronchospasms due to pulmonic β2-AR blockade. A solution to minimize many of the side effects of nonselective β-blocker therapy may be the use of more selective β1-blockers such as metoprolol or atenolol, which, at low dosages, have little β2 activity. Unfortunately, there is a paucity of clinical data comparing the efficacy of selective and non-selective β-blocker. Furthermore, because of the broad heterogeneity of IH (e.g., proliferating versus involuting), confounding with other pharmacologic exposures (e.g., corticosteroids), associated complications (e.g., ulceration) and comorbid medical anomalies (e.g., PHACE) that can influence efficiency after IH treatment, observational studies are unable to definitively establish the clinical utility of β-blockers in IH. Thus, questions regarding the efficacy of the subtypes of β-blockers must be answered in randomized controlled trials, which may provide the only way to overcome the selection and ascertainment bias.

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

Conditions

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Hemangioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Propranolol

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.

Atenolol

Group Type ACTIVE_COMPARATOR

Atenolol

Intervention Type DRUG

Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.

Interventions

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Propranolol

Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.

Intervention Type DRUG

Atenolol

Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.

Intervention Type DRUG

Other Intervention Names

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Oral propranolol Oral atenolol

Eligibility Criteria

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Inclusion Criteria

* Patients younger than 24 weeks.
* Presenting a hemangioma with the following characteristics:
* Subcutaneous and/or cutaneous
* Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
* Consent of both parents (or the person having parental authority in families)

Exclusion Criteria

* Infant presenting contraindications for the administration of propranolol or atenolol.
* Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
* Patients with an inability to participate or to follow the study treatment and assessment plan.

Maximum Eligible Age

24 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes