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Efficacy of Pidotimod in reducing recurrent respiratory tract infections in Indian Children

Authors:
  • Dr Varsha's Health Solutions
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... Two previous studies have reported excellent overall efficacy and safety of pidotimod in RRIs. 9,10 Authors performed this study to assess the efficacy and safety of Pidotimod in addition to standard of care in children with RRIs from India. ...
... 7-10 Two reports from India also confirm the similar outcomes with reduction in recurrences in children with or without asthma. 9,10 Overall, clinical evidence from these studies affirmatively confirms that pidotimod in children with RRIs is associated with reduction in RRI recurrences, duration of episodes, antibiotic use, visits to paediatric clinics, and reduced rate of hospitalizations. ...
... All these contribute to the improved attendance at school or kindergarten. [7][8][9][10] The observed benefits with pidotimod in RRIs are because of modulation of both innate and adaptive immunity contributing to improved outcomes in RRIs. 8,16 These findings therefore consolidate the role of pidotimod as one of the first-line therapies that can be considered in children with RRIs to improve the rate and ...
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Background: Recurrent respiratory infections (RRIs) are common in children especially in age 1 to 6 years. Pidotimod, an immunostimulant has been found to lower the recurrences of RRIs and improve the quality of life. The Objective of this study was to assess the efficacy and safety of pidotimod in children with recurrent respiratory infections (RRIs).Methods: In this single-centre, prospective, observational study, children aged 2 to 15 years diagnosed with RRIs were included. RRIs were defined as occurrence of 3 or more episodes of acute respiratory infections (ARIs) or more than 15 days of respiratory symptoms in the past 3 months. These children were treated with pidotimod in addition to standard care treatment. Treatment duration was two months and the follow-up continued for three months. Number of RRIs and severity of RRIs, antibiotic courses and rate of hospitalization before and after treatment were compared.Results: In total 25 children included in the study, mean age was 7.34±3.63 years. Among them, 68% were males. After treatment with pidotimod, there was significant reduction in mean number of ARI episodes (3.84±0.85 at baseline to 0.48±0.51 at follow-up, p<0.0001). Also, there was significant reduction in the duration of acute infectious episodes (p<0.0001), need of antibiotic courses (p<0.0001) and rates of hospitalization (p<0.0001). No safety concerns were identified and pidotimod was well tolerated.Conclusions: Addition of pidotimod to the standard treatment in children with RRIs significantly reduces the recurrence, duration of repeat infectious episodes, need of antibiotic treatments and future rates of hospitalizations. These findings support previous data.
... clinical study in 55 children with RRIs, confirming, in subjects treated with pidotimod, the changes in the metabolomic profile observed in the previous study [16]. Seven studies were selected from the literature review on pidotimod, including 5 low-quality randomised clinical trials (RCTs), assessed using the GRADE method [16][17][18][19][20], 1 systematic review and 1 meta-analysis assessed with AMSTAR II [21,22], of low and moderate quality respectively. ...
... This intervention group was compared to a control group of 20 children who were given a placebo. At the end of the 6 month follow-up period, several new acute respiratory infectious events of 0.09 + 0.29 were reported in the patients treated with pidotimod vs 2.90 + 0.64 in the group treated with the placebo (p = 0.001) [20]. ...
Article
Full-text available
Recurrent respiratory infections (RRIs) are a common clinical condition in children, in fact about 25% of children under 1 year and 6% of children during the first 6 years of life have RRIs. In most cases, infections occur with mild clinical manifestations and the frequency of episodes tends to decrease over time with a complete resolution by 12 years of age. However, RRIs significantly reduce child and family quality of life and lead to significant medical and social costs. Despite the importance of this condition, there is currently no agreed definition of the term RRIs in the literature, especially concerning the frequency and type of infectious episodes to be considered. The aim of this consensus document is to propose an updated definition and provide recommendations with the intent of guiding the physician in the complex process of diagnosis, management and prevention of RRIs.
... In a multicentric placebo-controlled randomized trial, children who received pidotimod had fewer acute respiratory infection (ARI) episodes as compared to controls, and pidotimod use was not associated with significant adverse effects [15]. A clinical trial in children aged 2-10 year with >6 annual respiratory infections showed that pidotimod (used in the same regimen as in our study) significantly reduced the incidence of infections, and of asthma episodes [16]. However, the authors did not explore the frequency of asthma episodes. ...
Article
Objective: To study whether addition of pidotimod to inhaled corticosteroid (ICS) therapy enhances control in children with persistent asthma, as compared to ICS therapy alone. Design: Triple-blinded, randomized controlled trial. Setting: Allergy and Asthma Clinic, Department of Pediatrics, at a tertiary care hospital between May, 2018 and June, 2019. Patients: 79 children (5-12 years) with newly diagnosed persistent asthma as per Global Initiative for Asthma guidelines. Interventions: Children received 7 mL (400 mg per 7 mL) twice-a-day for 15 day, followed by 7 mL once-a-day for 45 days of either pidotimod (n=39) or placebo (n=40). In addition, both groups received inhaled budesonide via metered dose inhaler and spacer, throughout the study. Children were followed up every 4 weeks for a total of 12 weeks. At each follow-up visit, peak expiratory flow (PEF) and asthma symptom score and medicine adverse effects were recorded. Main outcome measures: Change in PEF at 12 weeks compared to baseline. Secondary outcomes were PEF at each follow-up visit, asthma symptom score at each visit, change in asthma symptom score at 12 weeks, and adverse event profile. Results: The median (IQR) change in PEF (from baseline to 12 weeks) was 13.0% (0.8%, 28.3%) in pidotimod group (n=35) vs 17.7% (4.3%, 35.2%) in placebo group (n=35), (P=0.69). All the secondary outcomes were also comparable between the two groups. There were no significant adverse effects observed. Conclusion: Addition of pidotimod for 8 weeks to standard ICS therapy did not enhance asthma control compared to placebo.
... PDT resulted in a significantly lower number of recurrences in the overall study population as well as in those with existing asthma (44.2% in PDT and 25% in placebo groups). No AEs were reported in this study [24]. ...
... There were no AEs in any of the children. [24] Del-Rio-Navarro et al. Thus, in nearly 40% of children, the incidence rate of ARIs was reduced with the use of immunostimulant, and ARI-susceptible children can derive benefits from immunostimulant treatment. ...
Article
Full-text available
Pidotimod, an immunostimulant, is researched for over two decades. Current evidence indicates its utility in a variety of indications in children as well as in adults. Its immunostimulant activity has been firmly established in the management of recurrent respiratory infections in children with or without asthma. Compared to standard of care alone, addition of pidotimod to standard of care significantly prevents the recurrences and reduces the severity and duration of acute episodes, ultimately resulting in reduced visits to pediatric clinics and lower absenteeism at school. In adults, pidotimod is effective in the prevention and treatment of acute infectious exacerbations of chronic bronchitis and chronic obstructive pulmonary disease (COPD). Further, it has been evaluated in indications such as pneumonia, hand-food-mouth disease, bronchiectasis, and chronic idiopathic urticaria. From a total of 32 studies conducted in child (24 studies) and adult (8 studies) population, this in-depth review discusses the current evidence of pidotimod. With further exploration, the immunostimulant activity of pidotimod might be extended to different immunological disorders.
... 47 In a study from India in 63 children, aged 2-10 years with RRIs, pidotimod was found to be associated with significant reduction in recurrence of episodes in both asthmatic and nonasthmatic children and was not associated with any adverse effects. 49 Pidotimod has also shown effectiveness in asthma patients which marks the presence heightened allergenic responses. In different clinical studies, pidotimod improved the clinical factors like frequency of RRI, number of days with infection, forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), as well as immunological parameters like IL-4, INF-γ, IgE, secretion of IgA and activation of complement markers. ...
Article
Full-text available
Recurrent respiratory infections (RRIs) are one the major contributors of morbidity and mortality in Indian population especially in children below 5 years of age. Though being commonly encountered, there are no guidelines or consensus opinions available to help assist physicians in management of RRIs. There are various gray areas that need standard approach including definition of RRIs, current management options, approach with use of immunostimulants and other agents. This document represents the opinion consensus from Indian experts involved in management of RRIs and provides expert opinions on various aspects of RRI to assist physicians with uniform approach in diagnosing and treating RRIs. R espiratory diseases are important contributor to the global health. Acute respiratory infections (ARIs) cause substantial morbidity and mortality in children especially below 5 years of age. Globally, it is estimated that 11.9 million severe and 3 million very severe acute lower respiratory infections (ALRIs) resulted in hospital admissions. 1 ARI is common in India. Studies from South India have reported prevalence of 27-59.1% in children <5 years. 2,3 From global deaths of nearly 1.9 million with ARIs, 70% were reported in Africa and Southeast Asia. 4 Economic and social burden of ARIs is also colossal. In India, cost associated with ARI was found to be high relative to median per capita income. 5 This burden increased with recurrence of these infections. Recurrent respiratory infections (RRIs) are common occurrence in young children. During first 5 years of life, a child could develop 4-8 episodes of respiratory infections, which mainly affect the lower respiratory tract. Recurrence of 3 or more episodes of acute infections in a previous 6-month period suggests RRIs. 6,7 RRIs substantially burden the healthcare service. A recent evaluation suggests that 90th percentile in the number of acute respiratory illness was 98% with 9.6 ARIs per years in children above this limit. 8 In developing countries, on an average every child has 5 episodes of ARI/year accounting for 30-50% of the total pediatric outpatient visits and 20-30% of the pediatric admissions. Recent community-based estimates from prospective study report 70% of the childhood morbidities among children aged less than 5 years are due to ARI. 9 Various factors are determinant of RRIs in children. Beside normal, healthy children, presence of atopic disease, chronic diseases and immunodeficiency contribute to the RRIs development and progression. 10
Chapter
Upper respiratory infections are prevalent in the childhood period. Upper respiratory tract infections (URTIs) include nasopharyngitis (common cold), pharyngitis, rhinosinusitis, laryngitis, and laryngotracheitis [1]. Viruses are responsible for the vast majority of URTIs [2]. A myriad of virus species and subspecies may cause URTIs [3]. Influenza virus, adenovirus, respiratory syncytial virus (RSV), and rhinovirus are the leading causative agents [2]. The course of the URTIs is mostly benign.
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