Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma

Hamilos, Daniel L.; D’Urzo, Anthony; Levy, Robin J.; Marcus, Michael; Tripp, Kenneth; Parsey, Merdad V.; Baumgartner, Rudolf; McVicar, William K

doi:10.1016/s1081-1206(10)60384-5

Cited by 8 publications

(7 citation statements)

References 34 publications

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“…Additionally, a study conducted by Hamilos et al evaluated the long-term safety of levalbuterol HFA in comparison to racemic albuterol HFA administered to patients with stable asthma over 12 months. The incidence of serious adverse events was similar between the two treatment groups (3.6% for levalbuterol and 5.2% for racemic albuterol) and consistent with the current study [ 19 ].…”

Section: Discussionsupporting

confidence: 91%

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

et al. 2015

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Objective: Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma. Methods: We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged ≥12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 μg (2 inhalations × 90 μg/inhalation) as needed (PRN). Results: During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of β2-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (≤1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events: nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis. Conclusions: The safety profile of albuterol MDPI 180 μg in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.

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Section: Discussionsupporting

confidence: 91%

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

et al. 2015

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“…Long-term safety study of LS administered via metered dose inhaler in patients with asthma by Hamilos et al showed no statistical significance of beta receptormediated side-effects in 764 children who participated in this multi-center parallel group open labelled trial. 17 In contrast to long term effects, high dose continuous nebulized LS for pediatric status asthmaticus RCT by Andrews et al on 81 patients between 6-18 years of age showed similar tachycardia in both LS and RS groups. 18 482 children between 1-18 years age were given 6 doses of 2.5 mg of RS or 1.25 mg LS randomized; lower rate of hospitalization was seen in LS group but no statistically significant difference in increase in heart rate was found in between the groups.…”

Section: Studies and Resultsmentioning

confidence: 93%

Evidence behind use of levosalbutamol over salbutamol to prevent cardiac side effects

Lahiri

2017

Int J Contemp Pediatr

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Salbutamol and levosalbutamol are the two most frequently used medications for asthma in pediatrics. Levosalbutamol is more expensive than salbutamol and is usually considered safer option for patients with existing cardiac condition and, to reduce tachycardia in otherwise healthy patients. In this article, we reviewed the literature which included randomized controlled trials, retrospective studies and case reports and compared the cardiac side effects of these two medications with primary emphasis on tachycardia

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“…1999 [ 37 ] USA 213 12 weeks FP: 500 µg, BID for 12 weeks PBO (ALB prn) Mild to moderate Proportion of predicted value (standards of Crapo or Polgar): 50–80% ≥ 15% reversibility in FEV 1 within 30 min after up to four puffs of albuterol at screening or had documentation of ≥ 15% variability in FEV 1 within 6 months prior to the study Hamilos et al. 2007 [ 28 ] USA 746 12 months Levalbuterol: 90 µg: 2 actuations of 45 µg QID ALB: 180 µg: two actuations of 90 µg, QID Mild to moderate Proportion of predicted value: > 50% to < 80% 12% or higher reversibility of airflow obstruction within 15–30 min after administration of 180 µg of racemic albuterol MDI Jacobson et al. [ 38 ] USA 538 12 weeks TAC: 450, 900, and 1800 µg a PBO (ALB prn) Moderate-to-severe persistent asthma NR NR Kavuru et al.…”

Section: Resultsmentioning

confidence: 99%

Safety of SABA Monotherapy in Asthma Management: a Systematic Review and Meta-analysis

et al. 2022

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Introduction: Short-acting b 2 -agonist (SABA) reliever overuse is common in asthma, despite availability of inhaled corticosteroid (ICS)-based maintenance therapies, and may be associated with increased risk of adverse events (AEs). This systematic literature review (SLR) and meta-analysis aimed to investigate the safety and tolerability of SABA reliever monotherapy for adults and adolescents with asthma, through analysis of randomized controlled trials (RCTs) and real-world evidence. Methods: An SLR of English-language publications between January 1996 and December 2021 included RCTs and observational studies of patients aged C 12 years treated with inhaled SABA reliever monotherapy (fixed dose or as needed) for C 4 weeks. Studies of terbutaline and fenoterol were excluded. Meta-analysis feasibility was dependent on cross-trial data

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Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma

Cited by 8 publications

References 34 publications

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma

Evidence behind use of levosalbutamol over salbutamol to prevent cardiac side effects

Safety of SABA Monotherapy in Asthma Management: a Systematic Review and Meta-analysis

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