Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial.
ABSTRACT Studies evaluating newer antihistamines in children are few. Levocetirizine is a potent and highly selective H1-antihistamine with a proven efficacy in adults. Primary objective was to assess the efficacy of levocetirizine 5 mg once-daily in reducing seasonal allergic rhinitis (SAR) symptoms, as measured by Total Four Symptom Score (T4SS = sum of sneezing, rhinorrhea, nasal and ocular pruritus), over the first 2 wk of treatment. Efficacy over 4 and 6 wk of treatment, effect on nasal congestion and on health-related quality of life as measured by PRQLQ (Paediatric Rhinoconjunctivitis Quality of Life Questionnaire) were among the major secondary objectives. A double-blind, randomized, placebo-controlled study including 177 children with a documented SAR (to grass and/or weed) for at least a year and having a mean baseline T4SS > or = 6 (out of 12). Children evaluated daily the severity of T4SS and nasal congestion on a scale from 0 (absent) to 3 (severe). PRQLQ responses were assessed on a scale from 0 (not bothered) to 6 (extremely bothered) and analysed descriptively. Global evaluation of disease evolution judged by investigators, parents and children was made on a scale from 1 (marked worsening) to 7 (marked improvement). For the primary objective, levocetirizine was statistically highly superior to placebo with a difference in adjusted means of 1.29 (95% CI: 0.66-1.92) in favour of levocetirizine (p < 0.001). The effect of levocetirizine was almost twice that of placebo (94.1% relative improvement over placebo). Nasal congestion was improved with levocetirizine reaching maximum difference to placebo of 0.31 (p < 0.05), a relative improvement over placebo of 77.5%. PRQLQ scores at week 2 improved with levocetirizine more than with placebo (0.85 vs. 0.51, respectively) remaining larger after 4 and 6 wk of treatment. In the study, 84.3%, 80.9%, 80.9% of children had their disease evolution rated as slightly-to-markedly improved by, respectively, the investigators, the parents and children themselves. Incidence of treatment-emergent adverse events was similar in both groups (33.7% with levocetirizine; 30.7% with placebo). No child in the levocetirizine group discontinued treatment because of adverse events. The 6-wk duration of this study was longer than the usual 2-4-wk duration for similar studies and shows that levocetirizine controls SAR symptoms in children over the entire pollen season.
Article: Allergic rhinitis in children.BMJ Clinical Research 07/2014; 349:g4153. DOI:10.1136/bmj.g4153 · 14.09 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Allergic rhinitis (AR) affects a large percentage of paediatric patients. With the wide array of available agents, it has become a challenge to choose the most appropriate treatment for patients. Second-generation anti-histamines have become increasingly popular because of their comparable efficacy and lower incidence of adverse effects relative to their first-generation counterparts, and the safety and efficacy of this drug class are established in the adult population. Data on the use of the second-generation anti-histamines oral cetirizine, levocetirizine, loratadine, desloratadine and fexofenadine, and the leukotriene receptor antagonist montelukast as well as azelastine nasal spray in infants and children are evaluated in this review. These agents have been found to be relatively safe and effective in reducing symptoms associated with AR in children. Alternative dosage forms such as liquids or oral disintegrating tablets are available for most agents, allowing ease of administration to most young children and infants; however, limited data are available regarding use in infants for most agents, except desloratadine, cetirizine and montelukast. Unlike their predecessors, such as astemizole and terfenadine, the newer second-generation antihistamines and montelukast appear to be well tolerated, with absence of cardiotoxicities. Comparative studies are limited to cetirizine versus ketotifen, oxatomide and/or montelukast. Although second-generation antihistamines and montelukast are deemed relatively safe for use in paediatric patients, there are some noteworthy drug interactions to consider when selecting an agent. Given the wide variety of available agents for treatment of AR in paediatric patients, the safety and efficacy data available for specific age groups, type of AR, dosage form availability and cost should be considered when selecting treatment for AR in infants and children.Drugs 12/2009; 69(18). DOI:10.2165/9884960-000000000-00000 · 4.13 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: The occurrence of stabbing headaches in children requires a thorough diagnostic approach that excludes secondary headaches. The organic background should be taken into consideration when alarming symptoms occur, such as a purely 1-sided location, a change in the character of the headache, or possibly a link to physical activity. The current study describes the case of an 8-year-old girl who suffered short-lasting stabbing headache attacks. The headaches with increasing intensity and frequency started 1 month before her hospitalization and were usually preceded by physical activity (dancing, running). The pain, which was located in the right supraorbital region, lasted 1 second and occurred several times during the day. No associated symptoms were observed. In addition, the girl suffered from allergic rhinitis and was on antiallergic treatment (levocetirizine, fluticasone nasal spray). On admission she was in good general condition, and a pediatric and neurologic examination revealed no abnormalities. Her brain MRI was normal. The initial diagnosis was that the patient was suffering from primary stabbing headaches. However, during a follow-up visit 4 months later, a relationship was observed between the cessation of the headache attacks and the discontinuation of an antihistaminic drug. Six months later, the girl remained headache free. In cases involving differential diagnoses of stabbing headaches, it is important to consider the adverse reactions of the drugs used.PEDIATRICS 03/2014; 133(4). DOI:10.1542/peds.2013-0655 · 5.30 Impact Factor