ORIGINAL ARTICLESOne-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma
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Cited by (71)
Safety of formoterol in adults and children with asthma: A meta-analysis
2011, Annals of Allergy, Asthma and ImmunologyCitation Excerpt :In children, however, the rate of asthma-related hospitalizations among patients treated with formoterol was significantly higher than the rate among patients treated with placebo (OR 8.4, 95% CI 1.1–65.3). This could be because most of the pediatric data are from a 12-month placebo-controlled study conducted by Bensch et al27 between 1996 and 1998 when the standard of care for the treatment of asthma differed from current treatment standards (LABAs were used without concomitant ICS). In that study, 8 serious asthma exacerbations were reported among patients randomized to formoterol 24 μg TDD and 12 among those randomized to 48 μg TDD, whereas no patients receiving placebo experienced a serious asthma exacerbation.
Safety of formoterol in patients with asthma: Combined analysis of data from double-blind, randomized controlled trials
2010, Journal of Allergy and Clinical ImmunologyCitation Excerpt :At the December 2008 FDA advisory committee meeting,26 data were reported for the slower-onset partial agonist salmeterol (n = 12,658), which showed no evidence of an increased risk of asthma-related hospitalization with fluticasone/salmeterol in 1 inhaler versus ICS (odds ratio, 1.01; 95% CI, 0.60-1.69).27 These results, along with results from previous studies14-17 in which the coadministration of ICS in combination with a LABA was questionable and potentially suboptimal, suggest that the most important mechanism behind the previously observed increase in asthma-related events may be the undertreatment of the inflammatory component of asthma. The increased incidence of serious exacerbations associated with a high-dose formoterol treatment reported by Mann et al16 was not confirmed by the results from the substantially larger and more robust dataset included in the current analysis, in which maintenance ICS therapy was coadministered in a large majority of the patients.
Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review
2009, Pulmonary Pharmacology and TherapeuticsCitation Excerpt :In one trial [102], we excluded one of three groups that involved 244 patients who received a dose of salmeterol (100 mcg twice daily) that exceeded the current recommendation. Forty studies [3,18–51,104–108] were selected with a total of more than 40,000 asthmatics (Table 1). Nine studies included children and adolescents [19,31,38,42–44,49–51] and 31 adolescents and adults [3,18,20–30,32–37,39–41,45–48,104–108].
Drugs acting on the respiratory tract
2009, Side Effects of Drugs Annual
This study was sponsored by Novartis. The investigators have received payments for study conduction but have not made any financial arrangement whereby the value of the compensation could be influenced by the outcome of the study. They do not have a proprietary interest in the test product and do not hold a significant equity interest in the sponsor. MH Thomson, MD Till, and G Della Cioppa hold permanent positions with Novartis Pharmaceuticals.
J Castellsague has moved to Pharmacia, Spain.