Zdravniški Vestnik (Dec 2001)
FOLLOW-UP OF SAFETY AND EFFECTIVENESS OF FLUTICASONEPROPIONATE IN CHILDREN AND ADOLESCENTS WITH ASTHMA
Abstract
Background. For pediatric patients who suffer frompersistent asthma, inhalation corticosteroid therapy is of anincreasing importance. It has been known that inhalation therapylowers drug related risks in this population. The presentstudy was aimed to show that protective therapy using inhalationcorticosteroid fluticasonepropionate (ICS-FP) improvesthe health status of children with asthma and that low doses ofICS-FP have no clinically significant side effects, even in a longterm use.Methods. Sixty-five children with predominantly moderateasthma treated with protective anti-inflammatory drug ICSFPfor more than six months were monitored in an ambulatorysetting. The study included children and adolescents aged5–18 years. The efficacy of the protective treatment with ICSFPwas investigated by measurements of eosinophilic cationicprotein (ECP) in serum and spirometric parameters at thebeginning and after six months of the treatment. The safety ofprotective treatment was assessed with measurements of bodymass and height of the children and morning serum cortisollevels.Results. During the protective treatment the number of asthmaexacerbation diminished. The triggers of nonallergic exacerbationswere physical activity, changes of weather and viralinflammations and the triggers of allergic asthma exacerbationswere allergens (hous-dust mite, pollens and animaldander) and infections. ECP values similarly showed a statistically significant decreasefrom 43.1 ± 27.8 nmol/L at the beginning to 20.3 ± 13.0nmol/L after six months. Values of spirometric parameters,expressed as percentage of normal values for the populationunder study, exhibited 7–14% improvement in the six monthsobservation period. All their changes were statistically significant,e.g. in FEV1 from 82.8 ± 12.4% to 96.3 ± 16.0%. Despite regular and appropriate treatment with ICS-FP, nodecrease in morning serum cortisol levels exceeding normalvalues were observed. From 417.1 ± 138.4nmol/L at the beginningof the study, cortisol levels fell to 357.1 ± 12.3 nmol/L,a statistically significant difference. However, these changeswere small relative to the normal range of cortisol diurnalvariability. Measurements of body mass and height upon regular sixmonths periods did not show significantly lower values fromthose in healthy populations of same ages. On the contrary,the observed sample even had a significantly higher bodyheight (relative body height increase of 1.9%) and body mass(relative body mass increase of 7.3%) when compared tohealthy population.Conclusions. Present study indicates that ICS-FP protective antiinflammatorytreatment of children and adolescents is safeand effective related to the age of the patient and severity ofexacerbations.
