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Current Opinion in Allergy and Clinical... Apr 2021Inhaled corticosteroids (ICS) are widely used as the first-line treatment of asthma. When the disease is not controlled by standard doses of ICS, other anti-inflammatory... (Review)
Review
PURPOSE OF REVIEW
Inhaled corticosteroids (ICS) are widely used as the first-line treatment of asthma. When the disease is not controlled by standard doses of ICS, other anti-inflammatory drugs should be considered. The aim of this report is to review the main adverse events induced by anti-inflammatory drugs in children with asthma and discuss possible actions to prevent or mitigate these effects.
RECENT FINDINGS
Proper interpretation of ICS safety studies requires knowledge of the pharmaceutical properties and delivery device systems of the different ICS available. Genetic variants affecting susceptibility to corticosteroid-induced adrenal suppression were found in children and adults who use ICS to treat their asthma. There is evidence of the association between montelukast use and neuropsychiatric events.
SUMMARY
Benefits of ICS, properly prescribed and used, outweigh their potential adverse effects. There is substantial evidence that the combination of ICS with long-acting beta2 agonists is safe for asthmatic children. Awareness of the potential risks of neuropsychiatric events in children taking montelukast should inform the clinicians' prescribing practices. Omalizumab is generally well-tolerated, but the evidence on the safety of other biologic agents in children is scanty. The risk of systemic adverse events with anti-inflammatory drugs must be balanced against the risks of uncontrolled asthma and/or frequent oral steroid use.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Child; Drug Therapy, Combination; Humans; Pharmaceutical Preparations
PubMed: 33470588
DOI: 10.1097/ACI.0000000000000730 -
Heliyon Nov 2023Use of montelukast, as a cause of neuropsychiatric events, in patients with asthma or allergic rhinitis is controversial, and comprehensive statistical analyses...
Use of montelukast, as a cause of neuropsychiatric events, in patients with asthma or allergic rhinitis is controversial, and comprehensive statistical analyses verifying this relationship remain lacking. To better understand the relationship between montelukast and neuropsychiatric events, it is vital to guide patients in the effective use of the drug, especially in children whose mothers are concerned about its side effects. In this study, randomized controlled trials (RCTs) investigating montelukast and neuropsychiatric events were retrieved from a literature search of the Medline (1966 to February 2023), Embase (1974 to February 2023), Web of Science, and other related databases. After screening, 18 RCTs were ultimately included in a meta-analysis to merge statistics, which demonstrated no significant increase in neuropsychiatric events compared with placebo. A similar pattern of adverse neuropsychiatric events was observed in patients grouped according to age, with headache being the most common adverse neuropsychiatric event. Overall, montelukast did not significantly increase neuropsychiatric events in patients with allergic rhinitis and/or asthma compared with placebo. Large-sample RCTs are needed to verify the association between neuropsychiatric events and montelukast use in children, and attention is also devoted to FDA warnings.
PubMed: 38034763
DOI: 10.1016/j.heliyon.2023.e21842 -
Journal of Family Medicine and Primary... Sep 2022Churg-Strauss syndrome is a rare disease with systemic vasculitis and hypereosinophilia. It is accompanied by allergic rhinitis and asthma. Herein, we present a case of...
Churg-Strauss syndrome is a rare disease with systemic vasculitis and hypereosinophilia. It is accompanied by allergic rhinitis and asthma. Herein, we present a case of Churg-Strauss syndrome in a family medicine outpatient clinic. This report aimed to emphasize that if patients diagnosed with asthma have cough and/or hemoptysis that cannot be controlled despite interventions such as inhalation, corticosteroid therapy, montelukast treatment, and anti-histamine therapy, vasculitic diseases involving the lung may be considered.
PubMed: 36505587
DOI: 10.4103/jfmpc.jfmpc_547_21 -
The Journal of Allergy and Clinical... Dec 2023Montelukast, a selective leukotriene receptor antagonist, is a commonly prescribed allergy medication but its potential association with neuropsychiatric adverse events...
The Risk of Neuropsychiatric Adverse Events With Use of Leukotriene Receptor Antagonists in Patients With Asthma: Analysis of Korea's National Health Insurance Sharing Service Database.
BACKGROUND
Montelukast, a selective leukotriene receptor antagonist, is a commonly prescribed allergy medication but its potential association with neuropsychiatric adverse events is concerning.
OBJECTIVE
To analyze Korea's National Health Insurance System claims records to identify the risk of neuropsychiatric adverse events in patients with asthma treated with montelukast.
METHODS
This retrospective population-based study analyzed the National Health Insurance claims records of the entire Korean population between 2008 and 2015. We compared the risk of neuropsychiatric adverse events among patients with asthma using inhaled corticosteroids and/or long-acting β2-agonists with montelukast or pranlukast and those not using leukotriene receptor antagonists (control group).
RESULTS
There was no increased risk of the composite outcome of all measured neuropsychiatric adverse events in patients with asthma who were prescribed montelukast or pranlukast compared with those who were not. However, montelukast use was associated with an increased risk of hallucinations (inverse probability treatment weighting hazard ratio, 1.45; 95% CI, 1.07-1.96) and attention problems (inverse probability treatment weighting hazard ratio, 1.24; 95% CI, 1.01-1.52). Significant negative hazards for disorientation, anxiety, stress reactions, and somatic symptoms were observed in the montelukast group. When grouped by sex, the risk of hallucinations and attention problems was higher in men prescribed montelukast compared with the controls.
CONCLUSIONS
We did not observe an increase in all neuropsychiatric adverse events in the leukotriene receptor antagonist-treated group; however, an increased risk of hallucinations and attention problems was observed in those taking montelukast, regardless of the medication administration period.
Topics: Male; Humans; Leukotriene Antagonists; Retrospective Studies; Asthma; Quinolines; Acetates; National Health Programs; Hallucinations; Republic of Korea; Anti-Asthmatic Agents
PubMed: 37660732
DOI: 10.1016/j.jaip.2023.08.037 -
Heliyon Aug 2022Knowing the level of active ingredients in an expired drug is a matter of concern irrespective of its final disposition. This is also a matter of national security and...
BACKGROUND
Knowing the level of active ingredients in an expired drug is a matter of concern irrespective of its final disposition. This is also a matter of national security and defense as it has important implications on the nation's stockpile of prescription medications. Current literature has limited information about the strength of expired medications and any relevant trends.
OBJECTIVE
To utilize high performance liquid chromatography (HPLC) to determine the strength of selected drugs for asthma and chronic obstructive pulmonary disease (COPD) as a class of therapeutic agents commonly used in free clinics.
METHODS
Samples from expired lots of montelukast and albuterol pharmaceutical products were analyzed for their levels of their respective active ingredients. Two HPLC methods were developed, validated, and applied to achieve this goal. Quantitative analysis of each drug was performed using two different reversed phase C18 columns with a linear gradient of acetonitrile in 0.1% aqueous formic acid at a flow rate of 1 mL/min for both methods. Detection wavelength for montelukast and albuterol was 280 and 277 nm, respectively.
RESULTS
Expiry dates of analyzed batches ranged from 2003 to 2019. Despite the extended time range beyond expiry dates, levels of both drugs were relatively consistent and exceeded 90% of the listed strength in most analyzed lots.
CONCLUSIONS
Our results introduce a new perspective towards reducing the financial burden resulting from disposal of expired medications with retained strength. They also offer supporting evidence to extend the use of out-of-date montelukast and albuterol preparations at home and in free clinics.
PubMed: 36016533
DOI: 10.1016/j.heliyon.2022.e10104 -
International Immunopharmacology Dec 2023Montelukast, a cysteinyl leukotriene receptor (CysLTR)1 antagonist, is emerging as an attractive strategy to curtail diabetic complications; however, its role in aortic...
AIMS
Montelukast, a cysteinyl leukotriene receptor (CysLTR)1 antagonist, is emerging as an attractive strategy to curtail diabetic complications; however, its role in aortic and testicular tissues is unknown. This study investigated the effect of CysLTR1 antagonism by montelukast on toll-like receptor (TLR)4 and nuclear factor kappa B (NF-κB) pathways in diabetes-induced aortic and testicular injury.
METHODS
Adult male Sprague-Dawley rats were made diabetic with Streptozotocin (STZ, 55 mg/kg). Following this, Streptozotocin-induced diabetic (SD) rats were administered montelukast (10 and 20 mg/kg, orally) for 8 weeks. Blood glucose, serum malondialdehyde (MDA), inflammatory markers, and histopathology were evaluated.
RESULTS
Montelukast showed protection against diabetic complications, as evidenced by the ameliorative effect against STZ-induced alterations in oxidative stress as indicated by serum MDA levels. Moreover, montelukast conferred a significant decrease in the aortic and testicular levels of CysLTR1, TLR4, and NF-κB with a subsequent decrease in the levels of NOD-like receptor family pyrin domain containing (NLRP)3, caspase 1, interleukin (IL)-1β, IL-6, monocyte chemoattractant protein (MCP)-1, and tumor necrosis factor (TNF)-α. Additionally, administration of montelukast resulted in autophagy stimulation, as shown by decreased p62/Sequestosome (SQSTM)1 levels. Finally, montelukast protection resulted in normal thickness of whole aortic wall, regular tunica (t.) intima, mild vacuolation of smooth muscle fibers in aorta, increased size of seminiferous tubules, and increased spermatogenesis in testis as demonstrated by histopathology.
CONCLUSIONS
The protective effect of montelukast against diabetes-induced aortic and testicular injury is due to its antioxidant, anti-inflammatory, and autophagy stimulation characteristics.
Topics: Rats; Male; Animals; NF-kappa B; Rats, Sprague-Dawley; Streptozocin; Diabetes Mellitus; Tumor Necrosis Factor-alpha; Inflammation; Diabetes Complications; Aorta
PubMed: 37907048
DOI: 10.1016/j.intimp.2023.111127 -
The Journal of Asthma : Official... Nov 2023Histamine and cysteinyl leukotrienes (CysLTs) are potent inflammatory mediators in allergic rhinitis (AR). Studies involving other combinations of antihistaminics...
Efficacy and safety of fixed-dose combination of Bilastine-Montelukast in adult patients with allergic rhinitis: a phase III, randomized, multi-center, double-blind, active controlled clinical study.
BACKGROUND
Histamine and cysteinyl leukotrienes (CysLTs) are potent inflammatory mediators in allergic rhinitis (AR). Studies involving other combinations of antihistaminics (Levocetirizine) and highly selective leukotriene receptor antagonist (LTA) (Montelukast) combination have shown additive benefits and are widely prescribed for AR.
OBJECTIVE
Evaluate the efficacy and safety of Bilastine 20 mg and Montelukast 10 mg fixed-dose combination (FDC) therapy in patients with AR.
METHODS
A randomized, double-blind, comparative, parallel, phase III study was conducted to evaluate efficacy and safety of Bilastine 20 mg and Montelukast 10 mg FDC at 16 tertiary care otolaryngology centres in India. Adult patients with AR for one year with IgE antibody positive and 12-h NSS score >36 in 3 days were randomized to receive either Bilastine 20 mg and Montelukast 10 mg or Montelukast 10 mg & Levocetirizine 5 mg tablets for 4 weeks. The change in total symptom score (nasal symptom scores (NSS) & non-nasal symptom scores (NNSS)) from baseline to week 4 was assessed as primary endpoint. Secondary endpoints included changes in TSS, NSS, NNSS, individual symptom scores (ISS), Rhinoconjunctivitis Quality of Life (RQLQ), discomfort due to rhinitis (VAS), and clinical global impression (CGI) scores.
RESULTS
The change in mean TSS from baseline to week 4 in Test group (16.6 units) was comparable to reference group (17 units) (= 0.8876). The difference in change in mean NSS, NNSS and ISS from baseline to day 7, 14, 28 were comparable. RQLQ improved from baseline to Day 28. Significant improvements were observed in discomfort due to AR measured by VAS and CGI scores from baseline to day 14 and 28. The safety and tolerability of patients were comparable between the groups. All adverse events (AEs) were mild to moderate in severity. No patient discontinued due to AEs.
CONCLUSIONS
The FDC of Bilastine 20 mg and Montelukast 10 mg was efficacious and well tolerated in Indian patients with AR.
PubMed: 37140964
DOI: 10.1080/02770903.2023.2209175 -
Medicina (Kaunas, Lithuania) Apr 2024: The influence of montelukast (MK), an antagonist of cysLT1 leukotriene receptors, on lung lesions caused by experimental diabetes was studied. : The study was...
: The influence of montelukast (MK), an antagonist of cysLT1 leukotriene receptors, on lung lesions caused by experimental diabetes was studied. : The study was conducted on four groups of six adult male Wistar rats. Diabetes was produced by administration of streptozotocin 65 mg/kg ip. in a single dose. Before the administration of streptozotocin, after 72 h, and after 8 weeks, the serum values of glucose, SOD, MDA, and total antioxidant capacity (TAS) were determined. After 8 weeks, the animals were anesthetized and sacrificed, and the lungs were harvested and examined by optical microscopy. Pulmonary fibrosis, the extent of lung lesions, and the lung wet-weight/dry-weight ratio were evaluated. : The obtained results showed that MK significantly reduced pulmonary fibrosis (3.34 ± 0.41 in the STZ group vs. 1.73 ± 0.24 in the STZ+MK group < 0.01) and lung lesion scores and also decreased the lung wet-weight/dry-weight (W/D) ratio. SOD and TAS values increased significantly when MK was administered to animals with diabetes (77.2 ± 11 U/mL in the STZ group vs. 95.7 ± 13.3 U/mL in the STZ+MK group, < 0.05, and 25.52 ± 2.09 Trolox units in the STZ group vs. 33.29 ± 1.64 Trolox units in the STZ+MK group, respectively, < 0.01), and MDA values decreased. MK administered alone did not significantly alter any of these parameters in normal animals. : The obtained data showed that by blocking the action of peptide leukotrienes on cysLT1 receptors, montelukast significantly reduced the lung lesions caused by diabetes. The involvement of these leukotrienes in the pathogenesis of fibrosis and other lung diabetic lesions was also demonstrated.
Topics: Sulfides; Cyclopropanes; Animals; Quinolines; Acetates; Rats, Wistar; Diabetes Mellitus, Experimental; Male; Rats; Lung; Pulmonary Fibrosis; Leukotriene Antagonists; Streptozocin; Blood Glucose
PubMed: 38792932
DOI: 10.3390/medicina60050749 -
Journal of Human Reproductive Sciences 2022Puberty is a critical process for the development of sexual organs and reproductive ability. It is triggered and regulated by the hormones. Rosuvastatin can delay the...
BACKGROUND
Puberty is a critical process for the development of sexual organs and reproductive ability. It is triggered and regulated by the hormones. Rosuvastatin can delay the onset of puberty through the inhibition of cholesterol and androgen biosynthesis. On the other hand, montelukast has protective effects against various diseases and against reproductive toxicity induced by other medications, but its effects on puberty have not been studied.
AIMS
Assessment of the protective effect of montelukast against rosuvastatin-induced delayed puberty.
SETTINGS AND DESIGN
At the university.
MATERIALS AND METHODS
Eighteen male Wistar rats aged 30 days and weighted 50-60 g were distributed to three groups (six rats per group) and intraperitoneally administered every day for 5 days with 0.2 ml of distilled water as control, 10 mg/kg of rosuvastatin and with rosuvastatin + montelukast (10 mg/kg for each drug). These animals' groups were euthanised on day 50 of age to assess the effect of rosuvastatin alone and with montelukast on the serum levels of the reproductive hormones and histological manifestations and morphometric measurements of the testes.
STATISTICAL ANALYSIS USED
One-way analysis of variance and Bonferroni multiple tests were performed to analyse the findings using the GraphPad Prism software.
RESULTS
Treatment of rats with rosuvastatin showed a significantly decreased level of testosterone and luteinising hormone as well as histopathological and morphometric alterations in the testicular tissues in comparison with the control. Interestingly, co-treatment of rosuvastatin with montelukast could not reverse or mitigate these changes induced late puberty.
CONCLUSION
There is no protective effect of montelukast against rosuvastatin-induced delayed puberty.
PubMed: 36341010
DOI: 10.4103/jhrs.jhrs_56_22 -
Wiener Klinische Wochenschrift Jan 2022Montelukast, a leukotriene receptor antagonist (LTRA) has been approved for use in Europe since 1998. Indications for use (from the age of 6 months) include mild to...
Montelukast, a leukotriene receptor antagonist (LTRA) has been approved for use in Europe since 1998. Indications for use (from the age of 6 months) include mild to moderate asthma, seasonal allergic rhinitis with asthma, and the prevention of exercise-induced asthma episodes. The psychiatric side effects of montelukast have been known for the last 10 years; in the case of such symptoms benefits and risks should be considered. Due to potential life-threatening psychiatric adverse events, particularly suicide, a black box warning was issued. In this statement the Austrian working group of pediatric pulmonology and allergology advises that treatment with montelukast should be started only after critical evaluation. Treatment should be stopped on the occurrence of any neuropsychiatric side effects.
Topics: Acetates; Anti-Asthmatic Agents; Austria; Child; Cyclopropanes; Humans; Infant; Pulmonary Medicine; Quinolines; Sulfides
PubMed: 34904177
DOI: 10.1007/s00508-021-01981-1