Evaluation of step-down therapy from an inhaled steroid to montelukast in childhood asthma

BACKGROUND: Asthma guidelines allow antileukotriene medications to be used as an alternative to inhaled corticosteroids (ICSs) in second-step intensity therapy. The aim of this study was to determine whether asthma control can be maintained after reducing treatment from low-dose ICS to montelukast. METHODS: In this prospective, real-life 12-week trial, 84 young patients with asthma (7-18 years) controlled by low-dose ICS, had treatment switched to montelukast. Symptoms and PEF were monitored daily; exhaled nitric oxide (eNO) and spirometry every four weeks; sputum eosinophil (sEo) and bronchial hyperreactivity (BHR) assessed at the beginning and at the end of the study. The primary endpoint was number of patients discontinued from the study due to asthma exacerbations. RESULTS: Eleven patients (13.1%) were discontinued due to asthma exacerbations. At the beginning, patients with elevated percentage of sEo had increased risk of exacerbations (relative risk RR, 6.6; 95% CI, 1.2-35.6), as well as those with augmented BHR (RR, 4.24; 95% CI, 1.1-16.2) as compared to patients who completed the study. An intensification of symptoms and increased use of beta-adrenergics were observed during the last visit before exclusion from the study, but not changes in spirometry, PEF, and eNO. No change in clinical parameters, inflammatory markers or BHR was observed in patients remaining in the study. CONCLUSIONS: After treatment switch from low-dose ICS to montelukast, asthma control was maintained in the majority of patients during the 12-week observation period. Sputum eosinophilia or BHR before the treatment switch was exacerbation risk factor

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Evaluation of step-down therapy from an inhaled steroid to montelukast in childhood asthma.

BACKGROUND: Asthma guidelines allow antileukotriene medications to be used as an alternative to inhaled corticosteroids (ICSs) in second-step intensity therapy. The aim of this study was to determine whether asthma control can be maintained after reducing treatment from low-dose ICS to montelukast. METHODS: In this prospective, real-life 12-week trial, 84 young patients with asthma (7-18 years) controlled by low-dose ICS, had treatment switched to montelukast. Symptoms and PEF were monitored daily; exhaled nitric oxide (eNO) and spirometry every four weeks; sputum eosinophil (sEo) and bronchial hyperreactivity (BHR) assessed at the beginning and at the end of the study. The primary endpoint was number of patients discontinued from the study due to asthma exacerbations. RESULTS: Eleven patients (13.1%) were discontinued due to asthma exacerbations. At the beginning, patients with elevated percentage of sEo had increased risk of exacerbations (relative risk RR, 6.6; 95% CI, 1.2-35.6), as well as those with augmented BHR (RR, 4.24; 95% CI, 1.1-16.2) as compared to patients who completed the study. An intensification of symptoms and increased use of beta-adrenergics were observed during the last visit before exclusion from the study, but not changes in spirometry, PEF, and eNO. No change in clinical parameters, inflammatory markers or BHR was observed in patients remaining in the study. CONCLUSIONS: After treatment switch from low-dose ICS to montelukast, asthma control was maintained in the majority of patients during the 12-week observation period. Sputum eosinophilia or BHR before the treatment switch was exacerbation risk factor.

The treatment of hypercholesterolemic children: efficacy and safety of a combination of red yeast rice extract and policosanols.

BACKGROUND AND AIMS: The prevention of cardiovascular risk, as occurs in lipoprotein disorders, is required since childhood. Aim of the study was to evaluate, in a group of children affected by primary dyslipidemia, the efficacy, tolerability and safety of a short-term treatment with a dietary supplement containing red yeast rice extract and policosanols. METHODS AND RESULTS: 40 children affected by heterozygous Familial Hypercholesterolemia (FH) (n=24) and Familial Combined Hyperlipidemia (FCH) (n=16), aged 8-16 years, were enrolled in a double-blind, randomized, placebo-controlled, cross-over trial. After a 4-week run-in period with only dietary advice, children received a dietary supplement containing 200mg red yeast rice extract, corresponding to 3mg of monacolins, and 10mg policosanols once-daily and placebo for 8 weeks, separated by a 4-week washout period. Lipid profile was assessed after each treatment period. The dietary supplement, compared with the placebo, significantly reduced total cholesterol by 18.5% (p<0.001), LDL-C levels by 25.1% (p<0.001), and apolipoprotein B by 25.3% (p<0.001) when patients were considered as a whole group. Similar results were obtained when FH and FCH were considered separately and no significant difference between groups was detected. No significant differences were observed in HDL-C and apolipoprotein A-I levels. No adverse effects were detected when liver and muscular enzymes (AST, ALT, and CK) were determined. CONCLUSIONS: The treatment with a dietary supplement containing red yeast rice extract and policosanols has been for the first time successfully employed in hypercholesterolemic children. Results indicate this strategy as an effective, safe and well tolerated in a short-term trial.

Is TW3 height prediction more accurate than TW2? Preliminary data.

BACKGROUND/AIMS: Skeletal maturation is considered a reliable variable in evaluating the 'tempo' of growth. It is important in the diagnosis of endocrinological diseases, in chronic diseases, in hormonal therapy follow-up and in computing height prediction for prognostic and therapeutic purposes. It is also used when chronological age is not available for minors without known birth dates. There are different methods to evaluate skeletal maturation and height prediction. The Tanner-Whitehouse (TW) method 2 (TW2) has been considered to be the most useful method so far, and has recently been updated with modified height prediction equations (TW2-Mark II). TW3 is the newest method. The aim of this study is to evaluate whether TW3 is more accurate in the assessment of height prediction than TW2-Mark II in a sample of healthy north Italian subjects. METHODS: Anthropometrical data were collected as part of a survey in 1977-1978 in Turin. The sample involved 1,384 healthy children. The children, now adults, have been traced and recalled to measure their final height in order to test height prediction reliability. At present, we have collected 118 adult heights. RESULTS: According to the TW2 method 40% of the males had a height prediction error larger than +/- residual SD (4.1 cm), and with TW3 this was 32.9%. The female height prediction error with TW2 was larger than +/- residual SD (3.6 cm) in 29.2% of girls, and the same value was found with TW3. CONCLUSION: According to our preliminary data, TW3 does not represent any real progress.

Is the persistence of isolated GH deficiency in adulthood predicted by anatomical hypothalamic-pituitary alterations?

The aim of this study was to verify the persistence in adulthood of GH deficiency diagnosed in childhood and treated with hGH in childhood and to study whether anatomical hypothalamic-pituitary alterations evaluated by magnetic resonance (MR) imaging could predict it. To this goal, in six GHD adults (3 males and 3 females aged 17.2-24.5 yr, BMI 21.8 +/- 1.3), we studied anterior pituitary hormone response to GHRH (1 microgram/kg iv)+pyridostigmine (120 mg po)+ GnRH (100 micrograms iv) +TRH (400 micrograms iv)+hCRH (100 micrograms iv) as well as brain MR imaging. In childhood, the diagnosis of severe isolated GHD had been done based on auxological findings as well as on GH response < 7 micrograms/L after two classical provocative stimuli. In the present study, hormonal responses showed the persistence of severe isolated GHD in 4 out of 6 patients (peak, mean +/- SEM: 3.8 +/- 0.6, range 2.6-4.8 micrograms/L). In these patients, IGF-I levels were found low or low-normal. In other 2 patients, a clear GH response to stimulation (peak: 51.3 and 43.0 micrograms/L, respectively) together with normal IGF-I levels were found. No other anterior pituitary hormone deficiency was present in all subjects. MR imaging showed pituitary hypoplasia in all patients with persistent GHD; in 2 out of them, pituitary stalk interruption and ectopic neurohypophysis was also present. On the other hand, MR imaging showed normal hypothalamo-pituitary morphology in the 2 subjects with normal somatotrope response. In conclusion, our present data indicate that testing with a potent stimulus such as GHRH+pyridostigmine is a reliable method to assess the persistence of GH deficiency which associates with anatomical hypothalamic-pituitary alterations at the MR imaging. Patients with transient GH deficiency in childhood and normal pituitary GH reserve in adulthood have normal hypothalamic-pituitary MR imaging.

Final height in sexually precocious girls after therapy with an intranasal analogue of gonadotrophin-releasing hormone (buserelin).

Twenty-two girls affected by sexual precocity with impaired final height prognosis were followed until they achieved final height. Twelve of them were treated with an intranasal (D-Ser6)-gonadotrophin-releasing hormone (GnRH) analogue (buserelin) administered at a mean dose of 25 micrograms/kg/day (range 20-32) for a mean period of 14 months (range 8-18). Ten girls refused treatment. Mean final height of the treated girls was 157.3 +/- 8.2 cm, significantly (p = 0.03) higher than the 149.7 +/- 5.5 cm of untreated patients. Treated girls surpassed midparental height (+1.7 cm) while untreated girls reached the lower part of target zone (-3.5 cm). Our data suggest that intranasal buserelin treatment preserves final height in girls with sexual precocity and initially impaired height prognosis.

[Surveillance of congenital malformations. Experiences in 1986-1987]. / Sorveglianza delle malformazioni congenite. Esperienza relativa al biennio 1986-1987.

Epidemiological data on the congenital malformations detected in 8,723 newborns over a two year period are presented.

[Newborn infants from epileptic mothers: malformation and auxonologic risk]. / Il neonato da madre epilettica: rischio malformativo ed auxologico.

A case-control study was performed to determine if newborns of epileptic mothers have a higher probability of having congenital malformations. Forty seven newborns of epileptic mothers and an equivalent number of controls with no history of epileptic disease and paired for mother's age, parity, type of education were examined. Thirty one mothers had been treated during the first term of pregnancy and 16 had not. A large number of anthropometric parameters were measured in each newborn to minimize the subjective component in diagnosing even minimal malformations and fetal growth abnormalities. To evaluate weight, length and head circumference the neonatal standards of Largo et al. were used. For all other measures the standards of Merlob et al. were used. Single absolute values of the parameters measured were converted into standard points to eliminate the effect of the sex and gestational age variables. The incidence of malformations was not seen to be significantly different in the newborns of epileptic mothers as a whole and divided into the two subgroups (treated and untreated) versus controls. The fetal syndromes described in literature were not observed. Of all the anthropometric measures examined only length was significantly reduced in newborns of epileptic mothers. Maternal epilepsy and its treatment do not appear to be a considerable risk factor for the newborn.

[Surveillance of congenital malformations. Monitoring of polydactyly using the Chen method]. / La sorveglianza delle malformazioni congenite. Monitoraggio della polidattilia con il metodo Chen.

The Chen method was adopted to monitor the principal congenital malformations in a large peripheric center. In 1982 two consecutive alarms showed an evident increase in the prevalence at birth of polydactylia. A retrospective analysis of the main risk factors failed to satisfactorily explain this increase.