Issue: February 2013
January 07, 2013
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‘Provisional’ guidelines available for propranolol in infantile hemangioma

Issue: February 2013
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A recently published consensus paper provides a “provisional set” of best practices relating to the use of oral propranolol for treatment of infantile hemangiomas, a review of existing evidence supplemented by expert opinion based on the existing data and clinical experience.

Beth A. Drolet, MD, professor and vice chair of dermatology, Medical College of Wisconsin, and medical director of the Birthmarks and Vascular Anomalies Center, Children’s Hospital of Wisconsin, Milwaukee, and colleagues offered a framework for considering this medication’s use in the treatment of complicated infantile hemangiomas and also for the hemangiomas associated with PHACE Syndrome (posterior fossa abnormalities, hemangiomas, arterial lesions, cardiac and eye abnormalities). The framework was designed by a multidisciplinary team that reviewed existing data on the pharmacologic properties of propranolol and all published reports pertaining to the use of propranolol in pediatric patients.

Beth A. Drolet, MD 

Beth A. Drolet

“There has been a dramatic and rapid shift in the way we care for babies with complicated infantile hemangiomas,” Drolet told Infectious Diseases in Children. “Currently, treatment protocols vary significantly, and this is the first attempt to gain consensus around the pretreatment evaluation and toxicity monitoring. We hope these guidelines can be the platform for more traditional clinical trials.”

Propranolol is used to treat hemangiomas, which is only part of the syndrome, according to Drolet. Although there is uncertainty regarding optimum dosage of propranolol’s use, it is generally recommended that 20 mg/5 mL preparation be used. Propranolol should always be escalated from a low starting dose of 1 mg/kg/day divided into three times daily and be titrated up for a dose response.

The expert panel also provided relative contraindications, recommendations for pretreatment evaluation and guidelines for cardiovascular monitoring. Drolet and colleagues also said bradycardia may be the best measure for obtaining whether toxicity has occurred because measurement of blood pressure is complicated in infants. Bronchospasm and hypoglycemia appear to the most frequent serious adverse events in infants prescribed oral propranolol for the treatment of hemangiomas.

“These recommendations will provide the platform for large-scale phase 2/3 clinical trials to determine optimal dosing regimens and long-term safety profiles,” the researchers wrote. “We anticipate that these guidelines will be modified as more data are made available from these future studies.”

In a related paper, TinaS. Chen, MD, along with Infectious Diseases in Children Editorial Board Members Lawrence F. Eichenfield, MD, and Sheila Fallon Friedlander, MD, discussed the pathogenesis and therapy options for infantile hemangiomas, including propranolol. Like the study by Drolet and colleagues, the panel agreed that the dose be titrated up.

Chen and colleagues noted that propranolol’s “side effect profile and risk-benefit ratio of such interventions must always be evaluated before instituting therapy.”

In addition, they also stressed that there are “important detrimental associations,” including “structural anomalies associated with segmental infantile hemangiomas,” and said that evaluating newer treatment options is important.

Disclosure: Friedlander and Eichenfield have served as investigators for Pierre-Fabre, without compensation. Drolet reports no relevant financial disclosures.

Beth A. Drolet, MD,can be reached at bdrolet@mcw.edu..

Tina S. Chen, MD, can be reached at 7862 El Cajon Blvd., La Mesa, CA 91941.