Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
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|ClinicalTrials.gov Identifier: NCT02342275|
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemangioma||Drug: Propranolol Drug: Atenolol||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Active Comparator: 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.
Other Name: Oral propranolol
Active Comparator: 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.
Other Name: Oral atenolol
- The color (redness or blueness) and size of IH [ Time Frame: 24 weeks ]Response to therapy was measured by blinded volume estimation at weeks 0, 4, 8, 12, 16, 20, and 24 by using serial hemispheric measurements of tumor volume. Photographs of the IHs were taken at weeks 0, 1, 4, 12, and 24 by a medical photographer.
- Frequency of adverse events (e.g. hypotension, hypoglycemia, sleep disturbance, cool or mottled extremities, diarrhea, etc.) collected by investigator and reported by parents. [ Time Frame: 24 weeks ]
- Cardiovascular examinations, including blood pressure, heart rate and electrocardiogram were performed at weeks 0, 1, 4, 12, and 24. [ Time Frame: 24 weeks ]
- Blood glucose was measured at weeks 0, 1, 4, 12, and 24. [ Time Frame: 24 weeks ]
- Neurodevelopment [ Time Frame: 12 months ]At one year of age, children were tested using the Gesell Developmental Schedules (GDS)
- Quality of life (QOL) [ Time Frame: 24 weeks ]The QOL instrument for IH (IH-QOL), Pediatric Quality of Life Inventory (PedsQLTM) 4.0 Genetic Core Infant Scales (GCIS), PedsQLTM 4.0 Family Impact Module (FIM) and PedsQLTM Family Information Form (FIF) were used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342275
|West China Hospital of Sichuan University|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Yi Ji, MD, PhD||West China Hospital|