Introduction

Propranolol (trade name: Hemangiol) has been approved in Germany since April of 2014 for the treatment of growing hemangiomas in infants aged 5 weeks and older. A hemangioma is a nodule formed by blood vessels. Hemangiomas occur most commonly in the first days or weeks after birth, and are usually not dangerous. They are often found on the head or the neck, but they may also develop on the internal organs, most commonly the liver.

If a hemangioma continues to grow during the first weeks after birth, it is referred to as "growing" or "proliferative." However, they usually stop growing after a couple of weeks. Most hemangiomas then gradually disappear on their own. Only few hemangiomas cause complications such as ulcers, scars or bleeding.

Propranolol is an option for children between five weeks and five months of age, if the hemangioma:

  • Poses a risk to the child's life or vital body functions
  • Causes ulcers that are painful or do not heal
  • May cause permanent scarring or severely affect the child's physical appearance.

Propranolol is believed to restrict blood flow to the hemangioma and inhibit its growth.

Application

Propranolol is taken as a solution twice a day during or shortly after a meal. There should be at least nine hours between doses.

The dose is determined by the infant's weight. When starting treatment, 1 mg of propranolol is given daily per kilogram of body weight. This amount is increased to 3 mg of propranolol daily per kilogram of body weight over the course of two weeks.

Propranolol is used for six months.

Other treatments

Treatment options for a growing hemangioma depend mainly on its size and position and how likely complications are. Regular observation is often the first step. That allows for changes to be monitored and determines whether treatment is really needed.

If so, drugs such as cortisone are an option, and surgery may also be considered.

Assessment

In 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) compared the advantages and disadvantages of propranolol for treating a growing hemangioma with other standard therapies.

The manufacturer provided one suitable study to answer this question. 157 infants with growing hemangiomas that posed a risk of causing permanent scarring or severely affecting physical appearance took part in this study. Two thirds of the children were given propranolol and one third a placebo. Children whose hemangioma was life-threatening or endangered an important body function, and children whose hemangioma caused a painful ulcer that did not respond to simple wound care, were not allowed to participate in this study.

What are the advantages of propranolol?

  • Physical appearance of infants: The study suggests that propranolol can improve physical appearance: In 60 out of 100 babies who were given propranolol, the hemangiomas shrunk enough to be completely or almost invisible from the outside. The number of improvements in those infants who were given a placebo (combined with an individual therapy) can only be roughly estimated. Many of these children left the study upon their parents' or doctors' request or because the therapy was ineffective. Even if it is assumed that the hemangioma had shrunk in those children, the number of infants with an improvement would be a maximum of 30 out of 100.

Where was there no difference?

  • Deaths: No babies died during the study.
  • Impairment of important body functions, ulcers, bleeding: Hemangiomas can cause complications such as bleeding or ulcers, or impair important body functions. The study showed no difference between treatment with propranolol or a placebo.
  • Termination of treatment due to side effects: The study did not find any difference between treatments here either.
  • Severe side effects: Side effects like high fever or severe bronchitis were very rare in both groups. The study found no difference.

Which questions remain unanswered?

  • Other side effects: The study did not provide any conclusive evidence that infants who were given propranolol had more side effects like infections or diarrhea than babies who were given a placebo.
  • Quality of life: The study contained no suitable data concerning the influence of propranolol on quality of life.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of propranolol (Hemangiol).

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