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Journal of Psychosomatic Research Jan 2023While implicated in causing depression, no studies have examined the impact of montelukast on antidepressant effectiveness. We examined whether existing montelukast...
OBJECTIVE
While implicated in causing depression, no studies have examined the impact of montelukast on antidepressant effectiveness. We examined whether existing montelukast therapy was associated with acute antidepressant treatment failure (objective 1), and whether montelukast initiation was associated with depression relapse during maintenance antidepressant therapy (objective 2), relative to inhaled corticosteroid (ICS).
METHODS
Patients with asthma and depression were identified using national Veterans Health Administration data from 2007 to 2019. Objective 1: 12,109 patients initiated an antidepressant after receiving montelukast or ICS for 6 months. The primary outcome was acute antidepressant treatment failure, defined as subsequent initiation of a new antidepressant or augmenting agent within 6 months. Objective 2: 14,673 patients initiated montelukast or ICS after receiving stable antidepressant monotherapy for 6 months. The primary outcome of depression relapse was defined by a subsequent change in the pre-existing maintenance antidepressant regimen within 6 months. Both objectives employed a retrospective cohort design with log-binomial regression.
RESULTS
Objective 1: Acute antidepressant failure was observed in 21.3% (628/2943) and 22.3% (2044/9166) of patients receiving montelukast versus ICS, respectively. Relative risk in adjusted analyses was 0.98 (95% CI: 0.90, 1.07). Objective 2: Depression relapse was observed in 24.4% (288/1182) and 22.4% (3027/13,491) of patients initiating montelukast versus ICS, respectively. Relative risk in adjusted analyses was 1.08 (95% CI: 0.96, 1.20) within 6 months and 1.50 (95% CI: 1.16, 1.93) within 45 days.
CONCLUSION
Discontinuation of existing montelukast therapy is unnecessary when initiating antidepressants. However, potential evidence for depression relapse following montelukast initiation warrants additional investigation.
Topics: Humans; Anti-Asthmatic Agents; Retrospective Studies; Acetates; Quinolines; Antidepressive Agents; Treatment Failure; Treatment Outcome
PubMed: 36368225
DOI: 10.1016/j.jpsychores.2022.111075 -
Medicine Dec 2020Bronchial asthma (BA) is a chronic airway inflammatory disease with reversible airflow limitation as the main clinical manifestations, such as wheezing, cough, shortness...
BACKGROUND
Bronchial asthma (BA) is a chronic airway inflammatory disease with reversible airflow limitation as the main clinical manifestations, such as wheezing, cough, shortness of breath, chest tightness, etc, mediated by a variety of inflammatory cells, which can be recurrent. Clinical can improve symptoms, but cannot be cured; glucocorticoid is the most important first-line medication. Clinical practice has shown that montelukast sodium combined with fluticasone in the treatment of adult BA can improve clinical efficacy and reduce adverse reactions. The purpose of this study is to systematically study the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA.
METHODS
The Chinese databases (CNKI, VIP, Wanfang, Chinese Biomedical Database) and English databases (PubMed, the Cochrane Library, Embase, Web of Science) were searched by computer, for the randomized controlled clinical studies of montelukast sodium combined with fluticasone in the treatment of adult BA from establishment of database to October 2020. Two researchers independently extracted the relevant data and evaluated the quality of the literatures, and used RevMan5.3 software to conduct meta-analyze of the included literatures.
RESULTS
This study assessed the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult BA through total effective rate, pulmonary function (FEV1, FVC, PEF, FEV1/FVC), and adverse reactions.
CONCLUSION
This study will provide reliable evidence-based evidence for the clinical application of montelukast sodium combined with fluticasone in the treatment of adult BA.
OSF REGISTRATION NUMBER
DOI 10.17605/OSF.IO/CKQFM.
Topics: Acetates; Adult; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Cyclopropanes; Drug Combinations; Fluticasone; Humans; Meta-Analysis as Topic; Quinolines; Research Design; Sulfides; Systematic Reviews as Topic; Treatment Outcome
PubMed: 33350727
DOI: 10.1097/MD.0000000000023453 -
American Journal of Translational... 2021The aim of this study is to explore the clinical efficacy of montelukast sodium (MKST) combined with budesonide (BUD) on children with cough variant asthma (CVA) and its...
OBJECTIVE
The aim of this study is to explore the clinical efficacy of montelukast sodium (MKST) combined with budesonide (BUD) on children with cough variant asthma (CVA) and its influence on inflammation and pulmonary function (PF).
METHODS
One hundred and sixty-six children with CVA treated in the Affiliated Nanhua Hospital, University of South China from May 2017 to August 2019 were randomized into a joint group (JG, n=92) for the combination therapy of MKST and BUD, and a control group (CG, n=74) for BUD monotherapy. Their clinical symptoms, total response rates (RR), PF, and inflammatory factor expressions were evaluated before and after treatment. The adverse reactions during the treatment were statistically compared between the two groups, and the factors influencing the curative effect were analyzed using logistic regression.
RESULTS
The JG presented markedly less cough resolution times, expectoration and wheezing, and a shorter body temperature recovery time than the CG after the treatment. The post-treatment forced expiratory volume in 1 second (FEV1), the forced vital capacity (FVC), the FEV1/FVC and the peak expiratory flow (PEF) levels as well as the Asthma Control Test (ACT) scores were statistically higher in the JG than in the CG. The JG had notably lower IgE, TNF-α, and IL-8 levels than the CG after the treatment. The total RR in the JG was observably higher than it was in the CG after the treatment, but the total adverse reaction rate identified no evident difference between the two series. Children with a family history of allergies, a family medical history, low ACT scores, high IgE expressions, high TNF-α expressions, and high IL-8 expressions, as well as BUD intervention are at increased risk of reduced efficacy.
CONCLUSIONS
The reduction of efficacy in children with CVA results from multiple risk factors. MKST combined with BUD can ameliorate the PF of children with CVA, reduce their inflammatory factors, and improve the curative effect and the prognosis.
PubMed: 34306431
DOI: No ID Found -
The Journal of Allergy and Clinical... Jul 2023Recent observational studies suggest that the leukotriene receptor antagonist montelukast may have neuropsychiatric adverse effects; however, results are conflicting.
BACKGROUND
Recent observational studies suggest that the leukotriene receptor antagonist montelukast may have neuropsychiatric adverse effects; however, results are conflicting.
OBJECTIVE
To assess whether montelukast exposure in adults with asthma is associated with onset of neuropsychiatric adverse events using data from the Danish nationwide health registers.
METHODS
Individuals 18 years old or older with either 1 or more prescription redemption of inhaled corticosteroids or with at least 1 hospital contact with asthma as the main diagnosis between January 1, 2011, and December 31, 2018, were included. Montelukast exposure was assessed as a time-dependent variable. The 2 outcomes of interest were use of neuropsychiatric medicine including antidepressants, antipsychotics, anxiolytics, lithium, and medication used for attention-deficit/hyperactivity disorder (outcome 1), and hospital contacts with a neuropsychiatric diagnosis (outcome 2), within 90 days of exposure to montelukast.
RESULTS
Initiation of montelukast was significantly associated with outcome 1: use of neuropsychiatric medicine (hazard ratio [95% confidence interval]) 1.14 [1.08-1.20]; P < .0001). In the assessment of outcome 2: hospital contacts with a neuropsychiatric diagnosis, a significant risk associated with montelukast initiation was found only in the youngest age groups (hazard ratio [95% confidence interval] 1.28 [1.12-1.47], P < .001 and 1.16 [1.02-1.31]; P < .05, for age group 18-29 y and 30-44 y, respectively). Age-stratified analyses showed that the risk of both outcomes increased with decreasing age, with the highest risk seen in patients aged 18 to 29 years.
CONCLUSIONS
Among younger individuals, montelukast use was significantly associated with an increased risk of neuropsychiatric events such as use of neuropsychiatric medicine and hospital treatment. Clinicians should increase awareness of such adverse effects when prescribing montelukast.
Topics: Adult; Humans; Adolescent; Young Adult; Cohort Studies; Asthma; Leukotriene Antagonists; Acetates; Quinolines; Drug-Related Side Effects and Adverse Reactions; Anti-Asthmatic Agents
PubMed: 36948487
DOI: 10.1016/j.jaip.2023.03.010 -
Experimental and Therapeutic Medicine Jul 2019Clinical efficacy of montelukast sodium combined with budesonide or combined with loratadine in children with cough variant asthma was investigated. A retrospective...
Clinical efficacy of montelukast sodium combined with budesonide or combined with loratadine in treating children with cough variant asthma and influence on inflammatory factors in the serum.
Clinical efficacy of montelukast sodium combined with budesonide or combined with loratadine in children with cough variant asthma was investigated. A retrospective analysis of the medical records of 72 children with cough variant asthma who were treated in Xuzhou Children's Hospital, Xuzhou Medical University from April 2015 to August 2017 was performed and the 72 child patients were divided into two groups: 35 children were treated with montelukast sodium combined with budesonide in Group A, and 37 children were treated with montelukast sodium combined with loratadine in Group B. The clinical efficacy of the two groups was evaluated according to the lung function indexes [forced expiratory volume in the first second (FEV1), ratio of the forced expiratory volume in the first second to the forced vital capacity (FEV1/FVC), the peak expiratory flow (PEF)], the inflammation biomarkers [tumor necrosis factor-α (TNF-α) and interleukin-4 (IL-4)], the level of eosinophil granulocyte, and the level of IgE at three time-points: before treatment, the 4th week after treatment, and the 12th week after treatment as well as adverse reactions, recurrence of symptoms, and treatment compliance were recorded. After treatment, the levels of FEV1, FEV1/FVC, PEF, TNF-α and IL-4, eosinophil granulocyte and IgE in the two groups were significantly improved (P<0.05). The treatment compliance of Group A was significantly lower than that of Group B (P<0.05). In conclusion, the method of montelukast sodium combined with budesonide or loratadine are both worthy of clinical promotion because they have equivalent efficacy in the treatment of cough variant asthma to effectively improve the lung function and inflammatory response in patients and both bring less adverse reactions and lower recurrence rate.
PubMed: 31258680
DOI: 10.3892/etm.2019.7574 -
European Review For Medical and... 2014The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
The efficacy and safety of a single-dose of Montelukast sodium for treating virus-related infantile wheezing are investigated in this study.
PATIENTS AND METHODS
A prospective, open, randomized, controlled study was carried out on 595 cases of infants who exhibited wheezing after a respiratory syncytial virus infection. Treatment with Montelukast sodium was provided over the course of 12 weeks. The clinical efficacy of Montelukast sodium was determined based on the clinical symptom score, tidal breathing lung function, and short-acting bronchodilator usage, as well as infantile asthma diagnosis rate change at the 4th and 12th week after the administration of the treatment. The adverse reactions were also observed, and a control group was set. The mean age of the 595 patients with infantile wheezing was 10.82 months ± 4.22 months. Among these patients, 45.9% (273 out of 595) had a family history of asthma, 30.6% (182 out of 595) had allergic rhinitis, 23.9% (142 out of 595) increased peripheral blood eosinophilia, 6.1% (36 out of 595) exhibited total IgE increase, 40.0% (238 out of 595) had a recurrent history of wheezing, and 64.0% (381 out of 595) had a family history of eczema.
RESULTS
After 12 weeks of treatment, the clinical symptom scores significantly improved. Significant differences in the cough, wheezing, and motility scores were observed before and after the treatment (p < 0.05). TPTEF/TE and VPEF/VE significantly improved (p < 0.05) after the treatment. The asthma diagnosis rate was 9.6% (57 out of 595). At four weeks after treatment, various indicators correspondingly improved. Twenty-nine (4.9%) patients exhibited adverse reactions, 55.2% exhibited excitation, 20.7% suffered from insomnia, 10.3% had headaches, 3.4% had erythra, 3.4% suffered from abdominal pain, and 3.4% exhibited an increased glutamic-pyruvate transaminase level. The symptoms of eczema were relieved to some extent, and the symptoms of rhinitis became less serious. Significant differences were observed in the number of wheezing attacks, annual number of days hospitalized, annual number of days when β2AG was utilized, and lung function improvement (p < 0.05).
CONCLUSIONS
Montelukast sodium is clinically effective in treating virus-related wheezing, and clinical application for 4 weeks to 12 weeks can effectively relieve the symptoms of wheezing, improve lung function, and reduce the incidence rate of infantile asthma. Montelukast sodium also causes few adverse reactions.
Topics: Acetates; Anti-Asthmatic Agents; Asthma; Bronchodilator Agents; Case-Control Studies; Cyclopropanes; Female; Humans; Infant; Male; Prospective Studies; Quinolines; Respiratory Sounds; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses; Sulfides; Treatment Outcome
PubMed: 24706299
DOI: No ID Found -
European Journal of Pediatrics Jul 2017There is conflicting evidence of the effectiveness of montelukast in preschool wheeze. A recent Cochrane review focused on its use in viral-induced wheeze; however, such... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
There is conflicting evidence of the effectiveness of montelukast in preschool wheeze. A recent Cochrane review focused on its use in viral-induced wheeze; however, such subgroups are unlikely to exist in real life and change with time, recently highlighted in an international consensus report. We have therefore sought to investigate the effectiveness of montelukast in all children with preschool wheeze (viral-induced and multiple-trigger wheeze). The PubMed, Cochrane Library, Ovid Medline and Ovid EMBASE were screened for randomised controlled trials (RCTs), examining the efficacy of montelukast compared with placebo in children with the recurrent preschool wheeze. The primary endpoint examined was frequency of wheezing episodes. Five trials containing 3960 patients with a preschool wheezing disorder were analysed. Meta-analyses of studies of intermittent montelukast showed no benefit in preventing episodes of wheeze (mean difference (MD) 0.07, 95% confidence interval (CI) -0.14 to 0.29; mean for montelukast 2.68 vs placebo 2.54 (p = 0.5)), reducing unscheduled medical attendances (MD -0.13, 95% CI -0.33 to 0.07; mean for montelukast 1.62 vs placebo 1.78 (p = 0.21)) and reducing oral corticosteroids (MD -0.06, 95% CI -0.16 to 0.02; mean for montelukast 0.35 vs placebo 0.36 (p = 0.25)). The pooled results of the continuous regimen showed no significant difference in the number of wheezing episodes between the montelukast and placebo groups (MD -0.40, 95% CI -1.00 to 0.19; mean for montelukast 2.05 vs placebo 2.37 (p = 0.18)).
CONCLUSIONS
This review highlights that the currently available evidence does not support the use of montelukast in preschool children with recurrent wheeze. We recommend further studies to investigate if a 'montelukast responder' phenotype exists, and how these can be easily identified in the clinical setting. What is Known: • Current guidelines recommend montelukast use in preschool children with recurrent wheeze. • A recent Cochrane review has found montelukast to be ineffective at reducing courses of oral corticosteroids for viral-induced wheeze. What is New: • This meta-analysis has examined all children with preschool wheeze and found that montelukast was not effective at preventing wheezing episodes or reducing unscheduled medical attendances. • A specific montelukast responder phenotype may exist, but such patients should be sought in larger multicentre RCTs.
Topics: Acetates; Anti-Asthmatic Agents; Child; Child, Preschool; Cyclopropanes; Humans; Infant; Models, Statistical; Quinolines; Recurrence; Respiratory Sounds; Respiratory Tract Diseases; Sulfides; Treatment Outcome
PubMed: 28567533
DOI: 10.1007/s00431-017-2936-6 -
Irish Journal of Medical Science Aug 2020Asthma in elderly patients causes excessive suffering and inconvenience. Regimens with better efficacy and less adverse events are still in need of researches.
BACKGROUND
Asthma in elderly patients causes excessive suffering and inconvenience. Regimens with better efficacy and less adverse events are still in need of researches.
AIMS
To investigate the effect of montelukast sodium plus budesonide on lung function, inflammatory factors, and immune levels in elderly asthma patients.
METHODS
A total of 180 patients with asthma were assigned into the control group and the observation group. The control group was given aerosol inhalation of budesonide suspension, while the observation group was given budesonide inhalation and oral montelukast sodium. The treatment effect, lung function (forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF)%), inflammatory factors (interleukin (IL)-4, IL-6, and tumor necrosis factor-α (TNF-α)), and immune level (immunoglobulin (Ig) A, and IgE) were analyzed and compared between the two groups.
RESULTS
After treatment, the effective rate was significantly higher in the observation group. The lung function and serum inflammatory factors were improved in both groups. The FEV1, FVC, and PEF% in the observation group were better, and the inflammatory factors IL-4, IL-6, and TNF-α were lower. Patients in both groups showed elevated IgA level and reduced IgE level, and the improvements were more significant in the observation group. There was no significant difference between the two groups in terms of adverse reaction.
CONCLUSIONS
Montelukast sodium plus budesonide has a promising clinical effect on asthma in elderly patients, effectively improves lung function and immunocompetence, and controls inflammatory response, without increasing the adverse reaction.
Topics: Acetates; Aged; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Budesonide; Cyclopropanes; Female; Humans; Inflammation; Male; Middle Aged; Quinolines; Respiratory Function Tests; Sulfides
PubMed: 31900843
DOI: 10.1007/s11845-019-02167-5 -
Brazilian Journal of Medical and... 2020Montelukast sodium is an effective and well-tolerated anti-asthmatic drug. Long non-coding RNAs (lncRNAs) are involved in the treatment of asthma. Therefore, this study...
Montelukast sodium is an effective and well-tolerated anti-asthmatic drug. Long non-coding RNAs (lncRNAs) are involved in the treatment of asthma. Therefore, this study aimed to investigate the effect of montelukast sodium on children with cough-variant asthma (CVA) and the role of lncRNA prostate cancer gene expression marker 1 (PCGEM1) in drug efficacy. The efficacy of montelukast sodium was evaluated by assessing the release of inflammatory factors and pulmonary function in CVA children after a 3-month treatment. An ovalbumin (OVA)-sensitized mouse model was developed to simulate asthmatic conditions. PCGEM1 expression in clinical peripheral blood samples and lung tissues of asthmatic mice was determined. Asthmatic mice experienced nasal inhalation of PCGEM1 overexpression with simultaneous montelukast sodium to investigate the roles of PCGEM1 in asthma treatment. The NF-κB axis after PCGEM1 overexpression was detected to explore the underling mechanisms. Consequently, montelukast sodium contributed to reduced levels of pro-inflammatory factors and improved pulmonary function in CVA children. PCGEM1 was poorly expressed in OVA-sensitized asthmatic mice and highly expressed in CVA children with response to the treatment. PCGEM1 overexpression enhanced the anti-inflammatory effects and promoted effects on pulmonary function of montelukast sodium in CVA children and OVA-sensitized asthmatic mice. Furthermore, PCGEM1 inhibited the activation of the NF-κB axis. This study demonstrated the anti-inflammatory and lung-protective effects of montelukast sodium on CVA, which was strengthened by overexpression of PCGEM1. Findings in this study highlighted a potential anti-asthmatic target of montelukast sodium.
Topics: Acetates; Animals; Anti-Asthmatic Agents; Asthma; Child; Child, Preschool; Cough; Cyclopropanes; Disease Models, Animal; Female; Humans; Male; Mice; Mice, Inbred BALB C; Protective Agents; Quinolines; RNA, Long Noncoding; Sulfides
PubMed: 32520202
DOI: 10.1590/1414-431X20209271 -
Recent Patents on Drug Delivery &... 2018The rationale of this study is that, treatment of asthmatic Guinea pig with combined administration of Montelukast sodium and Green Tea Extract (GTE) as a single capsule...
AIM AND BACKGROUND
The rationale of this study is that, treatment of asthmatic Guinea pig with combined administration of Montelukast sodium and Green Tea Extract (GTE) as a single capsule will mitigate the inflammatory injury in the airways and weaken the asthmatic response. Recent patents for the treatment of asthma researched a polyphenolic alternatives for antiasthmatic combination therapy, especially for those patients who remains unresponsive or poorly responsive for current asthma therapy (US7232585B2). Synergistic activity of green tea polyphenols and therapeutic, prophylatic agents are also reported in some recent patents (US20120172423A1, US20150320696A1). The present work is therefore aimed, to study the effect of Montelukast Sodium capsules coformulated with GTE on oxidative stress markers including Malondialdehyde (MDA), Glutathione (GSH) in different organs and Oxygen Radical Absorbance Capacity (ORAC) assay in plasma.
MATERIALS AND METHODS
Guinea pigs were placed in histamine chamber and exposed to an aerosol challenge of 0.2% w/v histamine dihydrochloride in distilled water using pressurized air driven nebulizer at a pressure of 0.05 MPa-0.106 MPa for one week. After that, they were divided in to four groups of three each; control, asthmatic control, asthmatic treated with marketed preparation and asthmatic received developed capsules. After oral administration of formulations for three days, pigs were scarificed and oxidative stress markers level including cytoarchitectural manifestation in tissues was studied.
RESULTS
In comparison with the healthy control group, MDA level of the asthmatic animal liver and lung was found to be elevated as 0.059 ± 0.031(p < 0.002) and 0.802 ± 0.310 (p < 0.005) respectively, whereas GSH level was declined as 13.223 ± 1.485 (p < 0.0001) in liver and 3.037 ± 0.282 (p < 0.0004) in lung tissues. TAC of asthmatic animal plasma was low as 2.132 ± 0.986 mM Trolox Eq/L (p < 0.009). The level of these biomarkers reverts back towards normal after treatment with marketed and developed formulation, although treatment with developed formulation was more efficacious since it was coformulated with GTE, which acts as an adjuvant for the management of inflammatory disease like asthma.
CONCLUSION
It is contemplated that, use of GTE as an adjuvant to anti leukotriene drug played a significant role in asthma management by reducing oxidant injury. Since, studies in animals do not directly translate to human biology, further multi-control studies with better sampled patient population and more number of patients are needed.
Topics: Acetates; Administration, Oral; Animals; Anti-Asthmatic Agents; Asthma; Chronic Disease; Cyclopropanes; Drug Combinations; Female; Glutathione; Guinea Pigs; Histamine; Liver; Lung; Male; Malondialdehyde; Oxidative Stress; Oxygen Radical Absorbance Capacity; Patents as Topic; Plant Extracts; Quinolines; Sulfides; Tea
PubMed: 30539707
DOI: 10.2174/1872211313666181211123903