Montelukast Group Research Articles

Effects of oral montelukast on pulmonary function and clinical symptoms in acute asthma exacerbations: a randomized, double-blind, placebo-controlled trial

Introduction: Montelukast is a leukotriene receptor antagonist that helps treat chronic asthma and allergic rhinitis by reducing inflammation and bronchoconstriction. However, oral montelukast’s effectiveness in managing acute asthma attacks has yet to be completely identified. Methods: This randomized, double-blind, placebo-controlled trial investigated the efficacy of oral montelukast in acute exacerbations of asthma. Seventy patients between 18 and 65 years of age with a primary diagnosis of asthma attack were included in the study and were randomly assigned to receive 10 mg of montelukast orally daily or placebo. Symptoms, signs, forced expiratory volume in 1 second (FEV1), and peak expiratory flow rate (PEFR) were evaluated. Results: Our findings showed a statistically significant difference between montelukast and placebo regarding FEV1 (78.05 ± 7.84 vs. 72.05 ± 12.00, P = 0.016), PEFR (322.86 ± 28.95 vs. 290.86 ± 44.21, P = 0.003), and wheezing (P = 0.022) on the fifth day of treatment. Additionally, FEV1 and PEFR values were compared in two subgroups of patients, ICS users (ICSU) and non-ICS users (NICSU), in both the montelukast and placebo groups. In the montelukast group, while PEFR improved significantly for day 5 in both the ICSU (P = 0.007) and NICSU (P = 0.027) subgroups, FEV1 only improved in the ICSU (P = 0.009) subgroup compared to placebo. Conclusion: The present study demonstrated that oral montelukast administered in acute asthma exacerbation could lead to better values of PEFR and FEV1 on pulmonary function and improvement of wheezing in terms of symptoms.

Time to Sustained Recovery Among Outpatients With COVID-19 Receiving Montelukast vs Placebo

The effect of montelukast in reducing symptom duration among outpatients with mild to moderate COVID-19 is uncertain. To assess the effectiveness of montelukast compared with placebo in treating outpatients with mild to moderate COVID-19. This randomized clinical trial (Accelerating COVID-19 Therapeutic Interventions and Vaccines [ACTIV]-6) was conducted from January 27 through June 23, 2023, during the circulation of Omicron subvariants. Participants aged 30 years or older with confirmed SARS-CoV-2 infection and 2 or more acute COVID-19 symptoms for less than 7 days were included across 104 US sites. Participants were randomized 1:1 to receive montelukast, 10 mg once daily, or matched placebo for 14 days. The primary outcome was time to sustained recovery (defined as ≥3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of health care utilization events (hospitalization, urgent care clinic visit, emergency department visit, or death); COVID-19 clinical progression scale score; and difference in mean time unwell. A modified intention-to-treat approach was used for the analysis. Among 1250 participants who were randomized and received the study drug or placebo, the median age was 53 years (IQR, 42-62 years), 753 (60.2%) were female, and 704 (56.3%) reported receiving 2 or more doses of a SARS-CoV-2 vaccine. Among 628 participants who received montelukast and 622 who received placebo, differences in time to sustained recovery were not observed (adjusted hazard ratio [AHR], 1.02; 95% credible interval [CrI], 0.92-1.12; P = .63 for efficacy). Unadjusted median time to sustained recovery was 10 days (95% CI, 10-11 days) in both groups. No deaths occurred, and hospitalizations were reported for 2 participants (0.3%) in each group; the composite of health care utilization events was reported for 18 participants (2.9%) in the montelukast group and 18 (2.9%) in the placebo group (AHR, 1.01; 95% CrI, 0.45-1.84; P = .48 for efficacy). Five participants (0.4%) experienced serious adverse events (3 [0.5%] in the montelukast group and 2 [0.3%] in the placebo group). In this randomized clinical trial of outpatients with mild to moderate COVID-19, treatment with montelukast did not reduce duration of COVID-19 symptoms. These findings do not support the use of montelukast for the treatment of mild to moderate COVID-19. ClinicalTrials.gov Identifier: NCT04885530.

Comparative Efficacy of Mometasone Nasal Spray Combined with different Doses of Desloratadine, and Montelukast in Childhood Allergic Rhinitis: A Randomized Clinical Trial

Allergic rhinitis is a common childhood disease. Although various drugs have been used to treat allergic rhinitis, including nasal corticosteroids, antileukotrienes, and antihistamines, there is still controversy about the optimal dose and the best combination with the highest efficacy. Higher doses of antihistamines are recommended for better control of urticaria, but there is insufficient evidence regarding the efficacy of increased doses of antihistamines in allergic rhinitis. The aim of the study was to evaluate the effectiveness of different drug combinations in the treatment of children with allergic rhinitis. Sixty-four children with persistent moderate to severe allergic rhinitis were enrolled and randomly divided into 4 groups. All children received mometasone furoate nasal spray once daily. In addition to mometasone, each group received one of the following drugs or drug combinations: daily desloratadine, twice daily desloratadine, montelukast, or a combination of desloratadine and montelukast. The severity of symptoms before and after the intervention was evaluated based on the total nasal symptoms score, including sneezing, nasal congestion, nasal itching, and rhinorrhea. Sixty patients completed the study. The reduction of nasal congestion score and total nasal symptoms score in the groups receiving desloratadine twice a day and desloratadine plus montelukast was superior to the daily desloratadine group and daily montelukast groups According to this work, the treatment of allergic rhinitis with mometasone nasal spray with desloratadine twice a day or with the combination of desloratadine and montelukast was more effective than other treatment regimens.

The Effect of Montelukast Treatment on Elderly Patients Diagnosed with COVID-19

Abstract Background/Aims: The clinical course in COVID-19 patients can vary from asymptomatic cases to acute respiratory distress syndrome (ARDS), respiratory failure and multiorgan dysfunction. Clinical progression is thought to be mainly due to the release of proinflammatory cytokines. The most common symptoms are fever, cough, malaise, and shortness of breath. Montelukast, which is used in the treatment of seasonal allergic rhinitis and asthma, has brought its use in COVID-19 infection due to its anti-inflammatory and cytokine secretion-reducing effect. There are many studies in the literature that montelukast treatment has a positive effect on the prognosis and mortality of COVID-19. However, there are not enough studies evaluating the efficacy of montelukast treatment in elderly patients. The aim of our study is to evaluate the clinical and laboratory efficacy of montelukast treatment in patients aged 60 and over in COVID-19 disease, and to indicate the differences from the studies in the literature. Methods Our research was planned as a retrospective, single-center, observational study. The medical records of 75 COVID-19 patients aged 60 and over who were hospitalized in the internal medicine clinic of Ankara Bilkent City Hospital between September 2021 and December 2022 were included. Diagnosis of COVID-19 was confirmed with a reverse transcription polymerase chain reaction (RT-PCR) test from nasopharyngeal swab. Results Clinical findings and results were compared between the patients who received montelukast and the control group. There was no statistically significant difference between the two groups in terms of cough, dyspnea, gastroenteritis and oxygen theraphy requirement. There is no significant difference between the two groups in terms of the need for intensive care unit admission and mortality. The length of hospital stay was compared in both groups, it was 10.88±7.24 days in the control group and 10.51±5.44 days in the montelukast group, and there was no statistically significant difference between the groups. The laboratory parameters of the patients in both groups were compared. The neutrophil count and leukocyte count measured before hospitalization were found to be significantly lower in the patient group receiving montelukast (p=0.022, p=0.016). No significant difference was found in other laboratory parameters. Conclusions Although montelukast treatment has positive effects on prognosis in COVID-19 disease in the literature, a similar effect was not observed in the population aged 60 and over in our study. We did not find the positive effect of short-term montelukast treatment on the prognosis of patients aged 60 years and older who were hospitalized due to COVID-19. We thought that this was due to the low efficacy of montelukast in the elderly population. Our study is one of the first to examine montelukast therapy in the geriatric population with COVID-19.

The Effect of Montelukast on Urinary Symptoms in Children With Bladder Pain Syndrome: A Randomized Clinical Trial.

Montelukast by inhibiting leukotriene receptors in the bladder can prevent the activation of mast cells. We investigated the effectiveness of Montelukast in reducing the symptoms of children with bladder pain syndrome (BPS). In this randomized clinical trial, children were allocated into groups of intervention (Montelukast and oxybutynin) and the control (oxybutynin). At the beginning and after 14 days, questions from mothers of children about their urinary condition were asked about the frequency of nocturnal enuresis, frequent urination, urinary incontinence, urinary urgency, and their pain severity. There was no significant difference between two groups in terms of frequency of nocturnal enuresis, frequent urination, urinary incontinence, and urinary urgency. Regarding the frequency of pain distribution, the frequency of pain-free people in the Montelukast group was higher than control group (84.4% vs 56.3%, P = .023). The results showed that adding Montelukast to oxybutynin has a significant decrease in pain in children with BPS.

Comparing the effectiveness of oral montelukast versus cetirizine in the management of allergic rhino-conjunctivitis and its effect on quality of life among children: A randomized, double-blind clinical trial

Background: Allergic rhino-conjunctivitis (AR) is a common disorder in children, which causes significant morbidity and impact on learning and day-to-day activities. Objectives: To compare effectiveness of montelukast versus cetirizine in AR and its effect on the quality of life (QoL) among children aged 6-12 years, attending Asthma Clinic, Faculty of Medicine, University of Ruhuna, Sri Lanka. Method: This was a randomized, double-blind, parallel-group trial; 'Group A' was given montelukast with a cetirizine dummy; 'Group B' was given cetirizine with a montelukast dummy. Primary endpoint was to compare improvement of nasal, eye and night symptom scores. Secondary endpoint was to compare the QoL between the groups. Total symptoms were assessed at baseline, one month, two months and three months. Results: There were 176 children (62.5% boys) with a mean age of 8.82 ± 1.79 years. Fifteen children were lost to follow-up, 7 from the montelukast and 8 from the cetirizine group. There was a significant reduction in all symptoms (p<0.05) every month in both treatment groups. Whilst montelukast group had more improved day and night symptom scores than cetirizine group, statistically significant improvement was seen only in the 3rd month (t-4.10 p <0.001). Mean QoL score showed no significant difference between the two groups at onset (montelukast 9.01±9.4 and cetirizine 15.9 ± 10.4; t-0.369; p=0.712). Both groups showed a statistically significant improvement in all domains of QoL by completion of treatment (p<0.05). Upon completion, the montelukast group showed a significantly better QoL than the cetirizine group. Conclusions: Both cetirizine and montelukast showed remarkable improvement in the symptoms and better QoL in children. Study outcomes in all clinical domains and QoL were more significantly improved in montelukast group than in cetirizine group when treatment was continued for 3 months.

The Efficacy of Montelukast in Reducing the Risk of Warning Signs and Subsequent Dengue Shock Syndrome in Adult Dengue Fever Patients.

Dengue fever continues to pose significant health challenges globally, with recent outbreaks in Bihar, India, prompting a search for effective therapeutic interventions. This study assesses the effectiveness of Montelukast, traditionally used for asthma, in mitigating the severity of dengue fever symptoms and its progression to dengue shock syndrome (DSS). To evaluate the impact of Montelukast on the prevalence of dengue warning signs and the incidence of DSS in adult patients. A prospective observational study was conducted at the Indira Gandhi Institute of Medical Sciences(IGIMS), Patna, India, from August 2022 to October 2023, enrolling 500 patients diagnosed with dengue fever. Participants were divided into two groups. About 250 were treated with Montelukast and 250 received standard care. Outcomes measured included the incidence of warning signs, DSS, length of hospital stay, and 30-day mortality. The Montelukast group exhibited a 24% lower prevalence of dengue warning signs compared to the control group, with 90 out of 250 patients (36%) in the Montelukast group versus 150 out of 250 patients (60%) in the control group (p < 0.001). The incidence of DSS was significantly reduced in the Montelukast group, with 4 out of 250 patients (1.6%) compared to 21 out of 250 patients (8.4%) in the control group (odds ratio: 0.178, p < 0.001). Furthermore, Montelukast users experienced shorter hospital stays (average 4.52 days vs. 6.54 days, T-statistic: -7.59, p = 1.58×10-13) and a reduced 30-day mortality rate, with 5 out of 250 patients (2%) in the Montelukast group versus 12 out of 250 patients (5%) in the control group (p < 0.03). Montelukast significantly lowers the incidence of dengue warning signs and DSS, shortens hospital stays, and decreases mortality rates among dengue patients, supporting its potential integration into existing dengue treatment protocols. This study highlights the need for further clinical trials to confirm these findings and fully understand the therapeutic mechanisms of Montelukast in dengue management.

Influence of Leukotriene Pathway Polymorphism on Responsiveness to Montelukast, Budesonide Plus Formoterol in Patients with Asthma

Variability between patients in response to montelukast, and budesonide / formoterol inhalation powder may be related to genetic variation and non-genetic factors. this paper aims to determine association between polymorphism in leukotriene pathway candidate gene with lung function outcomes in Iraqi patients with asthma receiving montelukast, budesonide plus formoterol inhaler in comparison with healthy control. This research was done on a study group of 80 Baghdad-based Iraqi patients. 40 asthmatic patients receiving montelukast were in the first group, while 40 asthmatic patients on budesonide / formoterol inhalation powder (160/4.5mcg/dose) were in the second group. Screening for the presence of ALOX5 rs2115819, LTA4H rs2660845 and CysLTR1 rs320995 SNPs allelic variants genes were determined using conventional PCR technique and sequencing. In montelukast group, the % change in FEV1 in patients with the GG genotype for ALOX5 (rs2115819) SNP were significantly improved after montelukast intake compared with those carrying AA or AG genotypes. For budesonide / formoterol inhalation powder patients group, the included polymorphism had no significant association with the %change in FEV1. As a conclusion Asthmatic patients carrying AA genotype for ALOX5 rs2115819 may not achieved the optimal response to montelukast treatment. Budesonide / formoterol inhalation powder cannot be used effectively in patients with ALOX5 rs2115819 polymorphism.

Unlocking the Power of Probiotics: A Potential Game-Changer in Allergic Rhinitis Management

OBJECTIVE: To study effects of probiotics on clinical symptoms of the allergic rhinitis and their remission in comparison with conventional treatment. Study Design: Randomized Clinical Trial Place and Duration of the study: Department of ENT &amp; Head and Neck Surgery, PIMS hospital, Islamabad, from January 2021 to June 2021. METHODOLOGY: After approval from ethical review board, the study was started by recruiting 102 patients. The patients randomized into the two groups: Control group (group A) and treatment group (group B). Group A in which patient was given Nasal spray, Montelukast, and Anti allergic and Group B in which oral Probiotics 4 billion colony forming units/g once daily was given along with the other medication for first four weeks and then Nasal spray, Montelukast and Probiotic given for the next four weeks followed by only Nasal spray and probiotic for the last four weeks. The study lasted 12 weeks, after treatment began. Severity of AR was assessed at each visit using the Specific Symptoms Score (SSS) and Nasal Symptom Scores (NSS). RESULTS: We find age of patients in group A and B was as 24.25±8.93 vs 25.86±8.78 (p=0.361). In group A 47.1% were male &amp; 52.9% were female and in group B 49.0% were male and 51.0% were female. The nasal symptom score in group A and B at baseline was as 13.84±0.78 vs 14.12±0.82 (p =0.086), at 4 weeks was as 12.76±0.79 vs 11.86±0.94 (p =0.000), at 8 weeks was 10.78±0.86 vs 8.96±0.82 (p =0.000) and at 12 weeks was 9.73±0.78 vs 6.00±0.80 (p =0.000). Similarly, the specific symptoms score in group A and B at baseline was 42.43±1.75 vs 42.80±1.67 (p =0.274), at 4 weeks was as 36.25±1.73 vs 33.69±1.66 (p =0.000), at 8 weeks was 27.31±1.74 vs 21.69±1.69 (p =0.000) and at 12 weeks was as 21.22±1.89 vs 6.69±1.69 (p =0.000). CONCLUSION: Probiotics are beneficial in improving symptoms (nasal symptoms and specific symptoms scores) in patients with allergic rhinitis along with decreased remission of the symptoms after completion of therapy.

Montelukast Sodium to Prevent and Treat Bronchopulmonary Dysplasia in Very Preterm Infants: A Quasi-Randomized Controlled Trial.

Bronchopulmonary dysplasia (BPD) is the most common chronic lung disease in preterm infants and lacks effective methods for prevention and treatment. The aim of this study is to explore the efficacy and safety of montelukast in preventing or treating BPD in preterm infants. The preterm infants with BPD risk factors were divided randomly into a montelukast group and a control group. In the montelukast group, preterm infants were given 1 mg/kg of montelukast sodium daily. There was no placebo in the control group. There was no significant difference in the incidence of moderate or severe BPD between the two groups (31.8% vs. 35%). The duration of respiratory support in the montelukast group was shorter than that in the control group (36.4 ± 12.8 d vs. 43.1 ± 15.9 d, p = 0.037). The pulmonary severity score (PSS) at 21 days of life in the montelukast group was significantly lower than that in the control group (0.56 ± 0.13 vs. 0.62 ± 0.14, p = 0.048). There were no significant differences in the duration of mechanical ventilation, length of stay, hospitalization expenses, or incidence of adverse events. Although montelukast cannot alleviate the severity of BPD, it may shorten the duration of respiratory support and decrease the PSS in very preterm infants. There were no significant adverse drug events associated with montelukast treatment.

Assessing the risk of intentional self-harm in montelukast users: an updated Sentinel System analysis using ICD-10 coding

Background Montelukast prescribing information includes a Boxed Warning issued in March 2020 regarding neuropsychiatric adverse events. A previous Sentinel System study of asthma patients from 2000 to 2015 did not demonstrate an increased risk of intentional self-harm measured using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, with montelukast compared to inhaled corticosteroids (ICS). Methods Using a new user cohort study design, we examined intentional self-harm events in patients aged 10 years and older who were incident users of either montelukast or ICS as monotherapy, with a diagnosis of asthma, between October 1, 2015, to June 30, 2022, in the Sentinel System. We measured intentional self-harm using ICD-10-CM codes, which may have better accuracy for capturing suicide attempts than ICD-9-CM codes. We used inverse probability of treatment weighting to balance baseline covariates. We performed subgroup analyses by age group, sex, psychiatric history, and pre/post Boxed Warning era and conducted sensitivity analyses varying type of care setting of the outcome and exposure episode gaps. Results Among 752,230 and 724,855 patients in the montelukast and ICS exposure groups respectively, we found no association between montelukast use and self-harm compared to ICS use [Hazard Ratio (95% Confidence Interval): 0.96 (0.85, 1.08)]. This finding was consistent across all subgroups, and sensitivity analyses. Conclusion Our results cannot exclude other neuropsychiatric idiosyncratic reactions to montelukast. Compared to the previous Sentinel study, this study identified about double the rate of self-harm events, suggesting a greater sensitivity of ICD-10 codes for measuring self-harm than ICD-9.

Role of Montelukast in modulation of response to sepsis in preterm infants: a randomized-controlled trial

BackgroundSince inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. In searching the literature, no previous research addressed the role of Montelukast in neonatal sepsis; hence, this study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes.MethodsAn open-label, randomized controlled intervention trial conducted on 40 late preterm newborn infants (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n = 20), infants received oral Montelukast once daily for 10 days (infant's weight < 2 kg received 1.5 mg whereas > 2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n = 20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary clinical and laboratory outcomes were reported along hospital admission.ResultsBaseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73 ± 50.25 versus 119.54 ± 58.46; p = 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn’t differ between both groups (p = 0.256). No documented significant adverse effects of Montelukast during the study period.ConclusionsIn late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes.Trial registrationThe study was approved by Mansoura Faculty of Medicine institutional research board (IRB) (MS/17.06.95) and it was registered in clinical trials database (clinicaltrials.gov, ID: NCT04474327; registered July 16, 2020).

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

Montelukast, a selective leukotriene receptor antagonist, is a commonly prescribed allergy medication but its potential association with neuropsychiatric adverse events is concerning. 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. 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). 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. 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.

Assessment of Pain Management After Orthognathic Surgery by the Administration of Montelukast: An Original Research.

Opioid may cause undue risk after surgical procedures like orthognathic surgeries. The present study was aimed to determine how the preoperative administration of oral montelukast affected the degree of postoperative discomfort following bimaxillary orthognathic surgery (BOS). This study included all skeletal class III subjects scheduled for BOS. The participants were split into placebo and montelukast groups at random. Every patient received a 10-mL serving of apple juice an hour prior to the surgery; however, for the intervention group, a montelukast 10 mg pill was dissolved in the juice. The same surgical team and general anesthetic guidelines were used for all procedures. The visual analog scale (VAS) was used to calculate postoperative pain at designated intervals. The significance level for the statistical analysis was determined using the Statistical Package for the Social Sciences (SPSS) version 23. The control subjects had a higher level of pain at all the intervals than the intended drug test group. Also, the control group needed more analgesics than the test group. There was one observation made that the length of the surgery had an impact on the postoperative pain. Preoperative montelukast medication may be useful in minimizing postoperative discomfort following bimaxillary orthognathic surgery. More research is required for greater relevance.

Evaluating the safety and efficacy of the leukotriene receptor antagonist montelukast as adjuvant therapy in obese patients with type 2 diabetes mellitus: A double-blind, randomized, placebo-controlled trial.

Background: Type 2 diabetes mellitus (T2DM) is common with obesity. Metformin is a first-line therapy for this condition. However, it has only a minor impact on weight loss in some patients. Aim: This study aimed to evaluate the effectiveness, tolerability, and safety of combining montelukast therapy with metformin in obese diabetic patients. Methods: One hundred obese diabetic adult patients were recruited and randomized into two equal groups. Group 1 received placebo plus metformin 2g/d, and Group 2 received 2g/d metformin plus 10mg/d montelukast. Demographic, anthropometric measurements (e.g., body weight, body mass index [BMI], and visceral adiposity index), lipid profile, diabetes control measures (fasting blood glucose, glycated hemoglobin [HbA1c], and homeostatic model assessment for insulin resistance [HOMA-IR]), adiponectin, and inflammatory markers (e.g., TNF-α, IL-6, and leukotriene B4) were assessed and reported for each group at baseline and after 12weeks of treatment. Results: Both interventions significantly reduced all the measured parameters, except for adiponectin and HDL-C, levels of which increased compared to baseline data (p < 0.001). The montelukast group significantly improved in all parameters compared to the placebo group (ANCOVA test p < 0.001). The percentage changes in BMI, HbA1c, HOMA-IR, and inflammatory markers were 5%, 9%, 41%, and 5%-30%, respectively, in the placebo group compared to 8%, 16%, 58%, and 50%-70%, respectively, in the montelukast group. Conclusion: Montelukast adjuvant therapy was superior to metformin-only therapy in diabetes control and weight loss, most likely due to its increased insulin sensitivity and anti-inflammatory properties. The combination was tolerable and safe throughout the study duration. Clinical Trial Registration: [Clinicaltrial.gov], identifier [NCT04075110].

Effect of Montelukast on Treatment of Coronavirus Pneumonia (COVID-19): A Systematic Review

Background: The coronavirus disease 2019 (COVID‐19) exhibits the most important global public health emergency. Montelukast (MTL), a prototype cysteinyl leukotriene receptor antagonist, is commonly considered in the therapy of exercise- and aspirin-induced asthma. The purpose of this study was to present a systematic review of the literature on the effectiveness of MTL against severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and exuberant immune activation in COVID‐19 disease. Methods: PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were searched from the database on August 15, 2021and updated on November 19, 2022. Two reviewers independently screened articles, appraised methodological quality, and extracted the data. Results: A total of 118 related reports were recognized after eliminating duplicates. Of these, 30 references were screened based on titles and abstracts. After removing unrelated studies, 20 studies were included in the full-text review and evaluated for appropriateness. Finally, eight studies fitting the inclusion criteria for data extraction were selected. One of them was a prospective, randomized, controlled, and single-blinded study, three were open-label randomized or non-randomized controlled clinical trials, two were retrospective studies, and two were case series or comparative studies. A total of 1083 patients infected with COVID-19 infection (999 adults and 84 children) were examined on the effectiveness of MTL on symptom severity as well as hospitalization length. The results of the mentioned studies showed a low risk of clinical deterioration in the MTL group. In addition, the length of hospital stay was low in the treatment group compared to the standard management. Conclusion: MTL as a potential adjuvant therapy in COVID-19 may improve lung injury, inflammation, and symptoms. Moreover, the use of MTL could decrease the severity and mortality of COVID-19. Additional well-designed randomized controlled trials are necessary to approve the role of MTL in SARS-CoV-2 prevention or COVID-19 symptoms improvement.

Montelukast Attenuates Retraction of Expanded Flap by Inhibiting Capsule Formation around Silicone Expander through TGF-β1 Signaling.

Tissue expansion has tremendous applications in plastic surgery, but flap retraction provides insufficient tissue for use. Inspired by the use of montelukast to suppress capsular contracture, the authors investigated the effects of montelukast on capsule formation around the expander and retraction of the expanded scalp of the rat. Thirty-six male Sprague-Dawley rats were randomly divided into control and montelukast groups. In each group, 12 expanded flaps with or without capsules were harvested for histologic and molecular analysis; the six remaining expanded flaps were transferred to repair defects. Myofibroblast and transforming growth factor-β1 expression in the capsule was determined using immunofluorescence. Capsule ultrastructure was observed using transmission electron microscopy. Related protein expression in the capsules was detected using Western blot analysis. A comparison of control and montelukast groups revealed that areas of the harvested expanded flaps with capsules were greater (2.04 ± 0.11 cm 2 versus 2.42 ± 0.12 cm 2 , respectively; P = 0.04); the retraction rate decreased (41.3% ± 2.16% versus 28.13% ± 2.17%, respectively; P < 0.01). However, the increased areas and decreased retraction disappeared after capsule removal. The number of myofibroblasts declined. Thin, sparse collagen fibers were observed in the capsules. The expression of COL1, COL3, TGF-β1, EGR1, and phosphorylated ERK1/2 in the capsules decreased. Furthermore, the recipient area repaired by the transferred expanded flap was increased from 4.25 ± 0.39 cm 2 to 6.58 ± 0.31 cm 2 ( P < 0.01). Montelukast attenuates retraction of the expanded flap by inhibiting capsule formation through suppressing transforming growth factor-β1 signaling. This study provides novel insights into a method for increasing the area of the expanded flap.

Histopathological evaluation of induced pulmonary fibrosis under the effect of montelukast

Pulmonary fibrosis (PF) is an interstitial lung disease leading to scarring of the lung. There are several types of lung fibrosis as familial pulmonary fibrosis, idiopathic pulmonary fibrosis, and others associated with non-specific&#x0D; &#x0D; interstitial pneumonia. The most common type is idiopathic pulmonary fibrosis which is an unknown cause. Lung fibrosis causes changes in the histology of the lung by the disappearance of the lung parenchyma, replaced by an inflammatory infiltrate, and mild thickening of the pulmonary artery. The management of pulmonary fibrosis included Azathioprine, corticosteroid, and N-acetyl cysteinyl in 2011 but in 2014 this guideline was removed and replaced by nintedanib and pirfenidone. This study used Pirfenidone, as standard therapy for the treatment of pulmonary fibrosis, and montelukast is Cysteinyl leukotrienes (CysLT) antagonist which binds to its receptor (CysLTE4) located on smooth muscle cells of the respiratory airway causing anti-inflammatory effect by inhibition of inflammatory markers as TGFβ1. Sixty male rats were divided into five groups,12 rats for each group where the control group received distilled water by gastric gavage, the induction group received bleomycin intratracheally as a single dose, the pirfenidone group received pirfenidone 50mg/kg, montelukast group received montelukast 20mg/kg and the combination group received a half dose of pirfenidone and montelukast. After twenty-eight days after the treatment with montelukast or pirfenidone sacrifice rats and collect the organ (lungs) from each group were then placed in buffer formalin 10% for histopathological study. After 14 days from bleomycin dose, results show that bleomycin cause massive disappearance of pulmonary parenchyma that was replaced by an inflammatory infiltrate and medial thickening of the pulmonary artery in all groups, but montelukast and pirfenidone show normal lung paranchyma and pulmonary artery after 28 days of treatment in pirfenidone, montelukast, and combination groups.&#x0D; In conclusion, that bleomycin changes the histology of the lung causing induction of lung fibrosis in all groups after 14 days except control group but pirfenidone, montelukast, and combination of half dose of pirfenidone with a half dose of montelukast return the lung to normal architecture after 28 days of treatment.

Asetaminofenin indüklediği nefrotoksisiteye karşı montelukastın önleyici etkisi: Deneysel bir çalışma

Objective: Montelukast, an asthma drug, has an anti-inflammatory effect on tissues. We aimed to investigate therapeutic effect of montelukast (MK) on acetaminophen (APAP) - induced renal damage in rat models. Material and Methods: Twenty-four rats were randomly divided into four groups of six animals each. APAP was administered intraperitoneally as a single dose of 1000 mg/kg/day. In the treatment group, MK dose was 10 mg/kg and administered by oral gavage after APAP. The other groups were APAP + Saline group and the control group. We measured tissue malondialdehyde (MDA), reduced glutathione (GSH), and Nitric oxide (NO) levels to determine the nephrotoxicity. Results: Serum Blood Urea Nitrogen (BUN) and creatinine levels were measured significantly higher in APAP group than rats in the control and APAP + MK groups. The level of GSH was significantly diminished in APAP-treated rats. However, the administration of MK significantly increased the level of GSH in the MK treatment group. Tissue MDA levels in rats treated with APAP alone were significantly higher compared to the control group and APAP + MK group. The level of NO was measured as elevated in APAP treated group. However, NO levels in the MK treatment group were significantly lower than APAP treated group. Furthermore, some morphological recoveries were observed in the MK treatment group compared to APAP alone group. Conclusion: MK has beneficial effects on APAP-induced renal toxicity and dysfunction. However, clinical studies are needed to demonstrate appropriate use and effects. Keywords: acetaminophen, kidney, montelukast, nephrotoxicity, oxidative stress

A comparative study of efficacy and safety of montelukast versus acebrophylline as add-on therapy to inhaled corticosteroids in bronchial asthma

Background: Non-responding to standard doses of inhalational corticosteroids (ICS) remains a challenge in the management of asthma, requiring add-on therapy. Acebrophylline, a theophylline derivative, with multiple mechanisms of action and properties, could work as a suitable alternative to montelukast as an add-on therapy. Aims and Objectives: The aim of this study was to compare the efficacy and safety of montelukast versus acebrophylline as an add-on therapy to ICS in the treatment of bronchial asthma. Materials and Methods: One hundred bronchial asthma patients, fulfilling inclusion/exclusion criteria, were enrolled and randomized in a 1:1 ratio into two groups of 50 each to receive either oral montelukast 10 mg OD or oral acebrophylline 200 mg OD with budesonide. Inhaled salbutamol was permitted as rescue medication during acute exacerbations. Primary outcome measures were change in pulmonary function test (PFT) parameters and asthma control questionnaire (ACQ) scores at baseline and 12 weeks. Adverse events, if any were recorded. Results: There was a statistically significant difference in the improvement of mean PFT parameters at the end of 12 weeks in the montelukast group (P &lt; 0.001), but not in acebrophylline group (P = 0.253). Montelukast was more efficacious than acebrophylline in improving PFT parameters at 6 and 12 weeks. Both treatment modalities significantly improved ACQ score at 12 weeks (P &lt; 0.001), the difference between two groups was not statistically significant (1.4 ± 0.53 in Group A vs. 1.32 ± 0.44 in Group B, P = 0.436). No significant adverse effects were seen in both groups. Conclusion: Montelukast, with low-dose ICS, had better efficacy over acebrophylline. Both montelukast and acebrophylline improved the quality of life in mild-to-moderate persistent asthma patients by decreasing nocturnal symptoms and the need for rescue medications.