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Prevention of asthma by ketotifen in infants with atopic dermatitis
Y Iikura1, C K Naspitz, H Mikawa
1Department of Allergology, National Pediatric Hospital, Tokyo, Japan.
Insights
Ketotifen significantly reduced asthma onset in infants with atopic dermatitis. This prophylactic drug prevented asthma in 13.1% of children, compared to 41.6% in the placebo group.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Pharmacology
Background:
- Atopic dermatitis is a common condition in infants.
- Asthma frequently co-occurs with atopic dermatitis.
- Preventive strategies for asthma in high-risk infants are needed.
Purpose of the Study:
- To assess the prophylactic efficacy of ketotifen in preventing asthma onset.
- To evaluate ketotifen's safety profile in infants with atopic dermatitis.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- 121 infants with atopic dermatitis but no prior asthma symptoms were enrolled.
- Participants received either ketotifen or placebo for one year, with bimonthly follow-ups.
Main Results:
- Asthma developed in 13.1% of the ketotifen group versus 41.6% in the placebo group (P < .001).
- The study criteria for asthma onset included two distinct episodes of wheezing requiring bronchodilator treatment.
- Reported side effects were minimal, and laboratory tests showed no significant abnormalities.
Conclusions:
- Ketotifen demonstrates significant prophylactic effects against asthma development in infants with atopic dermatitis and elevated IgE levels.
- Ketotifen is a safe and effective option for preventing asthma in this pediatric population.
Abstract:
To evaluate the prophylactic effect of ketotifen against the onset of asthma we selected 121 infants with atopic dermatitis, without any history suggestive of asthma (cough and/or wheezing). Sixty-one children received ketotifen twice daily. Those who weighed less than 14 kg received 0.8 mg; 14 kg or more, 1.2 mg. Sixty children, a placebo syrup indistinguishable from the active syrup. Both groups were followed for 1 year, with bimonthly evaluations. The criteria for onset of asthma were two different episodes of wheezing treated with bronchodilator drugs. Both groups were comparable regarding age, sex, weight, onset, and duration of atopic dermatitis and age at the onset of asthma. During the 1 year study, asthma was observed in eight children of the ketotifen group (13.1%) and in 25 children of the placebo group (41.6%) (P less than .001). Side effects were negligible and routine laboratory tests disclosed no significant alterations. Ketotifen is a very useful drug for prevention of asthma in children with atopic dermatitis and total IgE more than 50 IU/mL.