Retrospective analysis of neoplasms in patients using angiotensin receptor blockers.

In recent years, regulatory agencies have raised concerns about the presence of potentially carcinogenic substances in certain formulations of Angiotensin Receptor Blockers (ARBs). Specifically, nitrosamines and azido compounds have been identified in some ARB products. Nitrosamines are known to have carcinogenic properties and are associated with an increased risk of neoplasms. Spontaneous safety reports from the EudraVigilance Data Analysis System (EVDAS) database were analyzed to investigate cases of neoplasms associated with ARBs. A disproportionality analysis was conducted, calculating the reporting odds ratio (ROR) and 95% confidence intervals (CIs) using a case/non-case approach for each ARB drug. The EVDAS database contained 68,522 safety reports related to ARBs (including Azilsartan, Candesartan, Irbesartan, Olmesartan, Losartan, Valsartan, and Telmisartan), among which 3,396 (5%) cases were associated with neoplasms. The majority of these cases were reported in Germany (11.9%), followed by France (9.7%). Approximately 70% of the reports were submitted by healthcare professionals such as physicians and nurses. Among the ARBs, valsartan had the highest ROR for neoplasm (ROR 1.949, 95% CI 1.857-2.046). This association remained significant when comparing ARBs with other classes of antihypertensive drugs, including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics. Our study identifies a possible signal of an association between ARBs, particularly valsartan, and the risk of neoplasms. However, further observational and analytical studies are necessary to confirm these findings and elucidate the underlying mechanisms.

A comprehensive quality control and cost comparison study of branded and generic angiotensin receptor blockers.

This study was designed to assess both the quality and cost aspects of various branded and generic formulations of angiotensin receptor blockers, specifically Irbesartan, Losartan Potassium, Olmesartan Medoxomil, Telmisartan, and Valsartan. The collected samples underwent distinct quality evaluations using the methods outlined in different global Pharmacopoeias (British Pharmacopoeia/European Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia). These drugs were characterized using Fourier-Transform Infrared Spectroscopy and Nuclear Magnetic Resonance techniques, while their quality and concentration were analysed using High Performance Liquid Chromatography. The release profile of the drugs was examined through dissolution testing. Additionally, a cost comparison analysis was carried out by determining the prevailing market prices of the drugs. The evaluated branded and generic angiotensin receptor blockers were found to meet the established standards for impurities, active drug content, and dissolution as set by these Pharmacopoeias, indicating their optimal quality. Notably, the generic drugs exhibited significantly lower costs compared to their branded counterparts. This study confirms that the quality of generic angiotensin receptor blockers is equivalent to that of their branded counterparts. Consequently, these findings support the practicality of utilizing generic drugs as a more economically sustainable and cost-effective approach to managing diseases, especially those of chronic nature.

SCAPS study on the effect of various hole transport layer on highly efficient 31.86% eco-friendly CZTS based solar cell.

Copper Zinc Tin Sulphide (CZTS) is a propitious semiconductor for active absorber material in thin-film solar cells (SCs). Here, SC architecture comprising FTO/ZnS/CZTS/variable HTLs/Au is discussed. Fluorine-doped tin oxide (FTO) and gold (Au) are used as front and back contacts, respectively. Zinc sulphide (ZnS) is used as an active electron transport layer (ETL), while different Cu-based materials (Cu2O, CuO, CuI, and CuSCN) are used as hole transport layers (HTL). A one-dimensional solar cell capacitance simulator (SCAPS-1D) is utilized to simulate the SC structure. Among different Cu-based HTLs, Cu2O is preferred as a potential candidate for high cell performance of CZTS-based SC. The effects of various layer parameters such as thickness, doping density, and carrier concentrations, electron affinity of HTL and absorber, respectively, are also discussed. After optimization of the device, variation of operating temperature and the effect of series and shunt resistance are also taken into consideration. The optimized results of thickness and acceptor concentration (NA) of absorber material are 1.5 µm and approx. 1.0 × 1019 cm-3, respectively. In addition, the function of HTL (with and without) in the designed SC structure is also studied. Capacitance-voltage (C-V) characteristics are also discussed to get an insight of built-in potential. We have achieved cell performances viz. efficiency = 31.86%, short circuit current density = 32.05 mA/cm2, open circuit voltage = 1.19 V, and fill factor = 83.37%.

Proportionate clinical burden of respiratory diseases in Indian outdoor services and its relationship with seasonal transitions and risk factors: The results of SWORD survey.

BACKGROUND: The Global Burden of Disease data suggest that respiratory diseases contribute to high morbidity in India. However, the factors responsible for high morbidity are not quite clear. Therefore, the Seasonal Waves Of Respiratory Disorders (SWORD) study was planned to estimate the point prevalence due to respiratory diseases in Indian OPD services and its association with risk factors and change in seasons. METHODS: In this point prevalence observational multicenter study conducted during 2017-18, participating physicians recorded information of consecutive patients in response to a questionnaire. The study was conducted on four predetermined days representing transition of Indian seasons i.e., February (winter), May (summer), August (monsoon), and November (autumn). RESULTS: The eligible number of patients from across 302 sites in India was 25,177. The mean age of study population was 46.1±18.1 years, 14102(56.0%) were males and 11075(44.0%) females. The common diagnoses were: asthma(29.8%), chronic obstructive pulmonary disease (COPD),15.6%, respiratory tract infections (RTIs),11.3%, and tuberculosis(8.7%). All these conditions showed significant seasonal trends (Asthma 31.4% autumn vs. 26.5% summer, COPD 21.1% winter vs. 8.1% summer, RTIs 13.3% winter vs. 4.3% summer, and tuberculosis 12.5% autumn vs. 4.1% summer, p<0.001 for each respectively). After adjustment for risk factors, asthma was significantly associated with exposure to molds (OR:1.12,CI:1.03-1.22), pet animals (OR:1.07,CI:1.01-1.14), recent-travel (OR:1.22,CI:1.13-1.32), and rain-wetting (OR:1.27,CI:1.15-1.40); and RTIs with rain-wetting (OR:1.53,CI:1.34-1.74), and recent-travel (OR:1.17,CI:1.05-1.30). CONCLUSIONS: The SWORD study showed wide seasonal variations in outpatient attendance of patients with common respiratory conditions. Novel risk-factors associated with respiratory diseases were also identified.

Prevalence, time trends and treatment practices of asthma in India: the Global Asthma Network study.

Objective: The objective of this subanalysis of data from centres across urban areas in India of the Global Asthma Network (GAN) was to study 1) the prevalence of symptoms of asthma in children and adults, 2) the change in prevalence of asthma and its trigger factors since the International Study of Asthma and Allergies in Childhood (ISAAC), and 3) current asthma treatment practice. Methods: In this cross-sectional, multicentre, school-based and self-administered questionnaire, responses from children aged 6-7 years and 13-14 years, and their respective parents, were analysed. Results: The GAN Phase I study included 20 084 children in the 6-7-year age group, 25 887 children in the 13-14-year age group and 81 296 parents. The prevalence of wheeze in the previous 12 months was 3.16%, 3.63% and 3.30% in the three groups, respectively. In comparison to the ISAAC studies, there was a significant reduction in the prevalence of current wheeze (p<0.001). Bivariate analysis revealed a significant reduction in the prevalence of trigger factors. Almost 82% of current wheezers and 70% of subjects with symptoms of severe asthma were not clinically diagnosed as having asthma. The daily use of inhaled corticosteroids (ICS) was less than 2.5% in subjects with current wheeze and those with symptoms of severe asthma but less than 1% used daily ICS when asthma remained undiagnosed. Conclusion: The prevalence of current wheeze and its causal factors showed a significant reduction compared to previous ISAAC studies. Among subjects with current wheeze and symptoms of severe asthma, the problem of under-diagnosis and under-treatment was widespread.

Global Asthma Network Phase I, India: Results for allergic rhinitis and eczema in 127,309 children and adults.

Background: The Global Asthma Network phase I study in India aimed to study the prevalence, time trends, and associated risk factors of allergic rhinitis and eczema among 6-7-year-old, and 13-14-year-old school children and their parents. Objectives: The objective of the study was to understand the current prevalence and associated risk factors of Allergic Rhinitis and Eczema in India among 6-7-year-olds, 13-14-year-olds and in their parents/guardians for newer directions to health care providers, policy makers and academicians. Methods: Cross-sectional, multicenter study using self- and parent-administered questionnaire among randomly selected school children aged 6 to 7 years from 8 centers and 13 to 14 years from 9 centers and their respective parents/guardians across India. Results: Prevalence of allergic rhinitis (AR) (%, 95% CI) among 20,084 6-7-year-olds (children), 25,887 13-14-year-olds (adolescents), and 81,296 adults/parents was 7.7% (7.4%-8.1%), 23.5% (23.0%-24.1%), and 9.8% (9.55%-9.96%) and that of eczema was 2.5% (2.3%-2.7%), 3.5% (3.27%-3.71%), and 9.9% (9.7%-10.1%), respectively. Among 6-7-year-olds, AR and eczema showed a significantly (P < .001) declining time trend since the International Study of Asthma and Allergies in school children phase III in 2002-2003. Among 13-14-year-olds, AR (P < .01) but not eczema showed a significant temporal decline. Coexisting atopic condition, parental history of atopy, and some environmental factors consistent with previous studies were significant risk factors among children and adolescents. AR or eczema in either parent strongly predicted the same atopic condition among their adolescent offspring. Among adults, coexisting atopic condition was the strongest predictor of either AR or eczema. Conclusions: There is a slight declining time trend of AR and eczema in India over 2 decades among children and adolescents. Nearly 10% of Indian adults suffer from AR and eczema. Although genetic factors had the strongest association for AR and eczema among all age groups, certain early-life and environmental exposures need consideration to devise preventative strategies.

Characteristics and Outcomes of Hospitalized Young Adults with Mild Covid -19.

BACKGROUND: Stormy course has been reported among hospitalized adults with COVID-19 in high- and middle-income countries. To assess clinical outcomes in consecutively hospitalized patients with mild covid-19 in India we performed a study. METHODS: We developed a case registry of successive patients admitted with suspected covid-19 infection to our hospital (n=501). Covid-19 was diagnosed using reverse transcriptase polymerase chain reaction (RT-PCR). Demographic, clinical, investigations details and outcomes were recorded. Descriptive statistics are presented. RESULTS: Covid-19 was diagnosed in 234 (46.7%) and data compared with 267 (53.3%) negative controls. Mean age of covid-19 patients was 35.1±16.6y, 59.4% were <40y and 64% men. Symptoms were in less than 10% and comorbidities were in 4-8%. History of BCG vaccination was in 49% cases vs 10% controls. Cases compared to controls had significantly greater white cell (6.96+1.89 vs 6.12+1.69x109 cells/L) and lower lymphocyte count (1.98+0.79 vs 2.32+0.91x109 cells/L). No radiological and electrocardiographic abnormality was observed. All these were isolated or quarantined in the hospital and observed. Covid-19 patients received hydroxychloroquine and azithromycin according to prevalent guidelines. One patient needed oxygen support while hospital course was uncomplicated in the rest. All were discharged alive. Conversion to virus negative status was in 10.2±6.4 days and was significantly lower in age >40y (9.1±5.2) compared to 40-59y (11.3±6.1) and ≥60y (16.4±13.3) (p=0.001). CONCLUSIONS: This hospital-based registry shows that mildly symptomatic or asymptomatic young covid-19 patients have excellent prognosis.

Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data.

Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever. Several filgrastim biosimilars have now been approved in USA, Europe and elsewhere since 2008, based on the reference product which has lost patent exclusivity; however their immunogenicity and safety is controversial. We conducted a retrospective, post market study between 1991 and May 2018 using VigiBase®. The study included all adverse events with case reports ≥150. Overall, 11,183 adverse drugs reaction reports were identified during observation period; of which 5764; 51.5% reports concerned to Neupogen®, the originator, and rest consists of Leucostim® (N = 680), Zarzio® (N = 622), Grasin® (N = 545), Nivestim® (N = 359) and Tevagrastim® (N = 152) biosimilars. When compared with the originator, Grasin® was associated with higher reporting of pyrexia (11.5% vs 7.9%, ROR 1.52, IC025 1.12), myalgia (37% vs 2.2%, ROR 25.94, IC025 2.11) and back pain (11.3% vs 4%, ROR 3.09, IC025 2.32). Zarzio® was associated with increased reporting of arthralgia (4.5% vs 2.9%, ROR 1.59, IC025 1.25) and neutropenia (11.4% vs 4%, ROR 2.59, IC025 3.07). Bone pain was reported more often with Nivestim® (14.4% vs 8.3%, ROR 1.87, IC025 5.30). Drug ineffectiveness was reported in cases with Zarzio® (35.9%), Nivestim® (19.4%) and Tevagrastim® (42.2%). Authors observed significant differences among originator and biosimilars in particular to efficacy, adverse events reported and time to onset of occurrences. Large epidemiologic studies are needed to further confirm these finding and provide additional insights.

Studies on Antimicrobial and Immunomodulatory Effects of Hot Aqueous Extract of Acacia nilotica L. Leaves against Common Veterinary Pathogens.

Acacia nilotica is a plant species that is almost ubiquitously found in different parts of the world. Various preparations of it have been advocated in folk medicine for the treatment of tuberculosis, leprosy, smallpox, dysentery, cough, ophthalmia, toothache, skin cancer as astringent, antispasmodic, and aphrodisiac since immemorial times. The present study investigates the antibacterial, antifungal, antiviral, and immunomodulatory potential of hot aqueous extract (HAE) of Acacia nilotica leaves. On dry matter basis, the filtered HAE had a good extraction ratio (33.46%) and was found to have carbohydrates, glycosides, phytosterols, phenolic compounds, saponins, and flavonoids as major constituents. HAE produced dose dependent zone of inhibition against Klebsiella pneumoniae, Pseudomonas aeruginosa, E. coli, Bacillus cereus, Staphylococcus aureus, and Streptococcus uberis and fungal pathogens Aspergillus niger and Aspergillus fumigates; however, no antiviral activity was recorded against IBR virus. HAE of A. nilotica revealed both proliferative and inhibitory effects on the rat splenocytes and IL-10 release depending on the dose. Detailed studies involving wide spectrum of bacterial, fungal, and viral species are required to prove or know the exact status of each constituents of the plant extract.

Isolation and antibiotic sensitivity of Streptococcus pneumoniae infections with involvement of multiple organs in lambs.

Respiratory diseases particularly lamb pneumonia is a multifactorial disease involving the interaction between host, etiological agent and environment. The present study was carried out to determine the causative agent of an outbreak of pneumonia in a sheep flock and to establish its pathogenicity and public health importance. The incidence occurred in sheep unit at Madhurikund farm of University (DUVASU), Mathura, Uttar Pradesh, India. At the time of incidence, the population of sheep at the farm was 90. Affected animals were clinically examined and nasal swabs and blood samples were collected from live animals, while morbid materials were collected from dead animals after postmortem examination. The etiological agent was isolated and characterized with conventional microbiological and biochemical methods. Streptococcus pneumoniae was the bacteria isolated from blood, different organs and cerebrospinal fluid. The antibiotic sensitivity revealed resistant to multiple drugs viz., penicillin, tetracycline, erythromycin, chloramphenicol, enrofloxacin and ciprofloxacin. Pathological examination revealed multiple involvements of organs with different degrees of inflammation and haemorrhages of the lower respiratory tract, lungs, liver, heart and kidney. Further, its pathogenicity was established by histopathological examination. In conclusion, presence of multi drug resistant Streptococcus pneumoniae in weaning lambs with the involvement of multiple organs appears to be an emerging zoonotic threat to human particularly in shepherds. This seems to be the first report of isolation of multi drug resistant Streptococcus pneumoniae from outbreak in lambs with multiple organ involvement in India.