An In Vitro Study to Evaluate the Antimicrobial Activity of a Zinc Citrate, Sodium Fluoride, Alum and Xylitol-Based Toothpaste Formulation.

INTRODUCTION: Periodontitis is a prevalent condition significantly affecting oral health. Comorbid conditions, such as diabetes, can heighten the severity of periodontal disease and overall oral health. Therefore, to enhance oral health and manage comorbid conditions, comprehensive periodontal care is essential. This approach could involve using toothpaste containing antimicrobial ingredients in routine oral care. This paper presents the results of an in vitro study analysing the antimicrobial properties of the test formulation containing zinc citrate, alum, sodium fluoride, and xylitol-based toothpaste (Stolin-R). These ingredients work together to help in providing comprehensive oral care by controlling growth of bacteria majorly responsible for periodontal disease and thus maintaining optimal oral hygiene. AIM: To determine the antimicrobial properties of zinc citrate, alum, sodium fluoride, and xylitol-based toothpaste formulation against key periodontal pathogens through in vitro analyses. MATERIALS AND METHODS: The antimicrobial efficacy of test formulation is evaluated through minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), and time-dependent antibacterial assessment against key periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Fusobacterium nucleatum, Prevotella intermedia, Streptococcus mutans, and Bacteroides fragilis. RESULTS: The test formulation demonstrated potent antimicrobial effectiveness against Bacteroides fragilis, Fusobacterium nucleatum, Porphyromonas gingivalis, Prevotella intermedia, Streptococcus mutans, and Tannerella forsythia, by exhibiting low MIC and MBC. Additionally, significant bacterial reduction, exceeding 99.99%, was observed within five minutes, emphasising its potential as an effective adjunct in combating periodontal infection. CONCLUSION: Zinc citrate, alum, sodium fluoride, and xylitol-based toothpaste formulation demonstrates significant antimicrobial activity against key periodontal pathogens, suggesting its potential as an effective agent for maintaining oral health and combating gingival infection.

Assessing the Knowledge, Attitude, and Practice of Orthopedicians for Pain Management by Multimodal Approach: A Prospective, Cross-Sectional, and Observational Survey.

BACKGROUND: The routine use of multimodal analgesic modality results in lower pain scores with minimum side effects and opioid utilization. MATERIALS AND METHODS:  A prospective, cross-sectional, observational study was conducted among orthopedicians practicing across India to assess the professional opinions on using analgesics to manage orthopedic pain effectively. RESULTS:  A total of 530 orthopedicians participated in this survey. Over 50% of the participants responded that tramadol with or without paracetamol was the choice of therapy for acute pain. Nearly 50% of the participants mentioned that multimodal interventions can sometimes help to manage pain. A total of 55.6% of participants mentioned that using Non-steroidal anti-inflammatory drugs was the most common in their clinical practice, while 25.7% of participants mentioned that they used tramadol more commonly in their clinical practice. As per clinical efficacy ranking, the combination of tramadol plus paracetamol (44.3%) was ranked first among analgesic combinations, followed by aceclofenac plus paracetamol (40.0%). The severity of pain (62.6%) followed by age (60.6%) and duration of therapy (52.6%) were the most common factors that should be considered while prescribing tramadol plus paracetamol combination. Gastrointestinal and renal are reported as the most common safety concerns encountered with analgesics. CONCLUSION:  The combination of tramadol and paracetamol was identified as the most preferred choice of analgesics for prolonged orthopedic pain management.

Effectiveness of Saccharomyces boulardii CNCM I-745 in Adult Indian Patients with Diarrhoea: A Real-world, Multicentre, Retrospective, Comparative Study.

BACKGROUND: Multiple clinical studies have described the benefits of probiotic Saccharomyces boulardii (S. boulardii) CNCM I-745 against diarrhoea, but the real-world evidence supporting its use is lacking. OBJECTIVE: To evaluate effectiveness of the S. boulardii CNCM I-745 group in a real-world setting. METHODS: This was an electronic medical record (EMR)-based, retrospective, multicentre, comparative study in Indian adult patients presenting with diarrhoea managed between January 2020 and January 2022. Data of patients at the baseline visit, with a follow-up visit within 15 days, and who were administered S. boulardii CNCM I-745 (for the test group) or any other treatment modality excluding probiotics (for the control group) were considered. Effectiveness was evaluated on the basis of number of patients who did not complain of diarrhoea at follow-up. RESULTS: Of 30,385 adult patients with diarrhoea, 270 patients prescribed S. boulardii CNCM I-745 were included, while the control group comprised 1457 patients. The baseline median age of the test group was 47 years (range 19-86 years), while it was 44 years (range 19-100 years) for the control group. The majority of patients in both study groups were females (56.7% in the test and 51.5% in the control group). Median duration between visits was 5 days (range 1-15 days) in both study groups. In all, 77.8% patients (95% CI 72.34-82.59) in the test group did not complain of diarrhoea at follow-up, while the proportion was 15.8% (95% CI 13.95-17.76) in the control group (p < 0.05). Odds ratio (OR) for absence of diarrhoea in the S. boulardii CNCM I-745 group versus the control group was 18.7 (95% CI 13.6-25.7, p < 0.05). For subgroups on concomitant antibiotics, a significant advantage was noted again for the test versus the control group (76.8% versus 18.4%; p < 0.05; OR: 14.7 with 95% CI 8.8-24.4; p < 0.05). CONCLUSION: The effect of S. boulardii CNCM I-745 probiotic in controlling diarrhoea was better than anti-diarrhoeal and/or oral rehydration therapy in real-world clinical practice. The effect was similar even with concomitant antibiotic usage.

Management of Heart Failure in a Resource-Limited Setting: Expert Opinion from India.

Heart failure poses a global health challenge affecting millions of individuals, and access to guideline-directed medical therapy is often limited. This limitation is frequently attributed to factors such as drug availability, slow adoption, clinical inertia, and delayed diagnosis. Despite international recommendations promoting the use of guideline-directed medical therapy for heart failure management, personalized approaches are essential in settings with resource constraints. In India, crucial treatments like angiotensin II receptor blocker neprilysin inhibitors and sodium-glucose co-transporter 2 inhibitors are not fully utilized despite their established safety and efficacy. To address this issue, an expert consensus involving 150 specialists, including cardiologists, nephrologists, and endocrinologists, was convened. They deliberated on patient profiles, monitoring, and adverse side effects and provided tailored recommendations for guideline-directed medical therapy in heart failure management. Stressing the significance of early initiation of guideline-directed medical therapy in patients with heart failure, especially with sodium-glucose co-transporter 2 inhibitors, the consensus also explored innovative therapies like vericiguat. To improve heart failure outcomes in resource-limited settings, the experts proposed several measures, including enhanced patient education, cardiac rehabilitation, improved drug access, and reforms in healthcare policies.

Prospective Evaluation of Dental Practitioners' Knowledge, Attitude, and Practice Toward Adult Dental Pain Management: A Cross-Sectional Multicenter Study.

Background Dental pain among adults is a prevalent concern impacting oral health and quality of life. Dental pain management presents a significant challenge for dental practitioners in effectively alleviating patient discomfort. Among the medications available, non-steroidal anti-inflammatory drugs (NSAIDs) are considered the most effective analgesics in dental care. While numerous studies have been conducted to assess the role of antibiotics in dental practice, there is a scarcity of studies specifically examining the prescription patterns of analgesics. The primary aim of this study was to evaluate the knowledge, attitudes, and practices of dental practitioners (DPs) in India concerning the management of adult dental pain. Method This survey utilized a computer-aided questionnaire-based approach. A total of 110 dentists, including 16 from metropolitan areas and 84 from non-metropolitan cities practicing at dental healthcare setups, clinics, and hospitals, were interviewed as part of the survey. The participants comprised dental professionals specializing in prosthodontics, endodontics, orthodontics, periodontics, oral surgery, pedodontics, and oral medicine. The study was conducted between September 2022 and January 2023. Results The primary reason patients seek dental consultation, as reported by 95% of dentists, is tooth cavities, followed by tooth sensitivity, post-root canal treatment, and pulpitis. All surveyed dentists prescribed NSAIDs to their patients for managing dental pain. Local anesthesia (LA) was the second choice for 75% of dentists, prescribed to 23% of their patients. The primary use of NSAIDs was for patients experiencing severe pain and to manage post-procedure pain. Eighty percent of DPs recognized ketorolac as a fast-acting molecule, providing immediate relief within 10-15 minutes. Overall, analysis indicated that 98% of DPs are satisfied and 67% are extremely satisfied with ketorolac among monotherapies for dental pain management due to its quick onset of action, fast pain relief, and usefulness in post-surgical pain management. Conclusion NSAIDs like ketorolac, diclofenac, and aceclofenac were the preferred prescriptions for overall dental pain management. Dental practitioners associated ketorolac with fast pain relief, quick onset of action, and effectiveness in post-surgical pain management, emphasizing its lasting effects. The insights from the study contribute to enhancing dental pain management strategies.

Indian Consensus on the Role of Amitriptyline in Migraine Prophylaxis.

Migraine is a globally prevalent neurological disorder. Amitriptyline, a tricyclic antidepressant, has shown potential as a prophylactic treatment for migraine; however, its role as a first-line medication has been debated. A modified Delphi method was used to develop consensus statements on migraine and its management. The literature review identified knowledge gaps, and two survey rounds were conducted among a panel of experts. Consensus was reached for 12 out of 23 initial survey questions, whereas no consensus was reached for four questions after the deliberation in the second round. The results showed that migraine is highly prevalent among women aged 15-35 years in India. Amitriptyline is an effective monotherapy for prophylactic migraine management, with a recommended initial dose of 5-10 mg. A gradual titration over six months achieves optimal results. Amitriptyline is also safe for managing catamenial migraine and can be used at lower doses during pregnancy to alleviate symptoms. The outcomes of this study emphasize that amitriptyline should be considered as a primary prophylactic treatment for migraine because of its efficacy and safety. The evidence-based consensus achieved is intended to serve as guidance for healthcare practitioners in India, and it is anticipated that such adoption will lead to improvement in patient outcomes and an enhancement in the quality of life for those affected by migraines.

Effectiveness of Dapagliflozin as Add-On to Metformin with or without Other Oral Antidiabetic Drugs in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Database Study.

BACKGROUND: Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce. METHODS: An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed. RESULTS: A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m2). However, the change in BMI in the HbA1c subgroup ≥ 8% was noted to be -1.4 ± 10.4 kg/m2, which was not statistically significant (p = 0.08). In the overall study population, significant change in the SBP (-4.5 ± 14.9 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -4.5 ± 15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥ 8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5 ± 8.94 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.4 ± 8.91 mmHg; p < 0.05 for HbA1c subgroup ≥ 8%) was noted. CONCLUSIONS: Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.

Clinical and Demographic Characteristics of Patients with Coexistent Hypertension, Type 2 Diabetes Mellitus, and Dyslipidemia: A Retrospective Study from India.

BACKGROUND: Coexisting hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia (triple disease) can lead to greater risk of cardiovascular morbidity and mortality. The present study sought to comprehend the prevalence, demographic traits, clinical traits, and treatment patterns in Indian patients with these coexisting conditions. METHODS: An electronic medical record (EMR)-based, retrospective, multicenter, cross-sectional study was conducted, and data were collected for patients who were diagnosed with coexistent hypertension, T2DM, and dyslipidemia. Baseline patient variables evaluated were the percentage of patients with triple comorbidity, demographic characteristics, diagnostic laboratory parameters, and treatment pattern details. RESULTS: Data from 4793 centers (clinics) were included, with a total of 6,722,173 patients. Of these, 427,835 (6.36%) patients were found to have coexistent hypertension, T2DM, and dyslipidemia. Most of the patients belonged to the 40-64 year age group (62.10%) and were males (57.00%), while 27.40% patients had a body mass index (BMI) within normal limits, 43.30% patients were pre-obese, and 20.90% patients were class 1 obese. Further, 3402 patients (0.80%) had a recorded history of smoking. Mean glycated hemoglobin (HbA1c) for the patients included in the study was 8.35 ± 1.96 g%. Mean systolic blood pressure (SBP) was 138.81 ± 19.59 mm Hg, while mean diastolic blood pressure (DBP) was 82.17 ± 10.35 mm Hg; 27.60% cases had SBP < 130 mm Hg, while 28.37% cases had DBP < 80 mm Hg. The mean low-density lipoprotein (LDL), total cholesterol, and high-density lipoprotein (HDL) in mg/dl were 98.38 ± 40.39, 174.75 ± 46.73, and 44.5 ± 10.05, respectively. Of the enrolled cases, 55.64% had serum LDL below 100 mg/dl, 72.03% cases had serum cholesterol below 200 mg/dl, and 44.15% males and 71.77% females had serum HDL below the normal prescribed range. The most common monotherapy used for managing hypertension was angiotensin receptor blockers (ARB) (24.80%), followed by beta-blockers (24.30%). The most common combinations administered for management of hypertension were antihypertensives with diuretics (14.30%), followed by ARB plus calcium channel blockers (CCB) (13.30%). For dyslipidemia, the majority of patients (56.60%) received lipid-lowering medication in combination with drugs for other comorbidities. The most common antidiabetic agents prescribed were biguanides (74.60%). CONCLUSIONS: Coexistence of triple disease is not uncommon in the Indian population, with middle-aged patients diagnosed as pre-obese and obese being affected more commonly and receiving treatment for the same. The present study highlights that, though there are medications against the three chronic conditions, the rate of uncontrolled cases of hypertension, T2DM, and dyslipidemia remains high. Coexistence of triple disease increases the risk of cardiovascular and renal complications, which need to be closely monitored and effectively treated.

Unique Properties of Yeast Probiotic Saccharomyces boulardii CNCM I-745: A Narrative Review.

Probiotics, both bacterial and yeast, have long been associated with a beneficial health history and human well-being. Among yeasts, Saccharomyces is a genus that is efficacious in rendering better human health, with Saccharomyces boulardii (S. boulardii) CNCM I-745 being classified as a probiotic agent. The present review highlights the unique properties of S. boulardii and its rolein the prevention of antibiotic-associated diarrhea (AAD) and pediatric acute gastroenteritis (PAGE) in comparison to bacterial probiotics. Its unique properties,such as viability over a wide pH range, inability to acquire antibiotic resistance genes, and property to achieve a steady state rapidly, have given S. boulardii an edge over bacterial probiotics. In AAD patients, prophylactic use of S. boulardii has shown a significantly lower risk of AAD (in comparison to controls) and restored the diversity of gut microbiota. Among Indian children with PAGE, S. boulardii CNCM I-745 was found superior to Lactobacillus rhamnosus GG and four strains of Bacillus clausii in shortening the duration of diarrhea and reducing the length of hospital stay. S. boulardii CNCM I-745 being considered a safe probiotic for use in children and adults also finds recommendations in several international guidelines for the management of acute diarrhea. The current review discusses evidence for the proven efficacy and safety of S. boulardii CNCM I-745 as a probiotic for preventing gastrointestinal disorders.

Efficacy and In-Use Tolerance of Venusia Baby Moisturizer for Skin Hydration in Babies With Dry and/or Normal Skin.

Introduction Skin hydration is important for maintaining adequate skin barrier function. After delivery, the baby's skin faces the most difficult challenge as they are exposed to the exterior world's environmental changes, friction, and microorganisms. The management is further complicated by the availability of a large range of infant skin-care products with varying claims. The first-ever Indian study on babies was done to analyze the test product (Venusia baby moisturizer; Dr. Reddy's Laboratories Ltd., Hyderabad, India) in order to bring scientific clarity to consumers. This product is devoid of parabens, alcohol, and animal origin (Dr. Reddy's Laboratories Ltd., Hyderabad, India) and is designed for skin hydration and in-use tolerance in babies with dry and/or normal skin. The endpoints were hydration and clinical evaluation of the skin, evaluated using a moisture meter scale (MMSC; Delfin Technologies Ltd., Kuopio, Finland) and parent self-assessment questionnaire, respectively. Material and methods A total of 136 healthy babies aged between six months to two years were enrolled in a four-group, monocentric, non-randomized, evaluator-blinded study: Group 1 (Venusia baby cream for dry skin), Group 2 (Venusia baby lotion for Dry Skin), Group 3 (Venusia baby cream for normal skin), and Group 4 (Venusia baby lotion for normal skin). The endpoints were hydration and clinical evaluation of the skin, evaluated using an MMSC and parent self-assessment questionnaire, respectively. Results In babies with dry skin, skin hydration was improved with Venusia baby cream (37.50%) and Venusia baby lotion (66.40%). Additionally, 66.66% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby cream; 76.47% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby lotion. In babies with normal skin, skin hydration was improved with Venusia baby cream (12.20%) and Venusia baby lotion (7.20%); 59.37% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby cream; and 84.84% of participants strongly agreed that the baby's skin became softer and smoother after the application of Venusia baby lotion. Conclusion Significant improvement was seen in skin hydration using Venusia baby cream and Venusia baby lotion in babies with dry skin and normal skin. No skin intolerances and product-related adverse or serious adverse events were clinically observed or reported during the study duration. Venusia baby lotion had the highest effect (66.4%) on skin hydration in babies with dry skin, where there was a significant shift from dry skin to normal skin range.

Effectiveness of Omeprazole in Acid Peptic Disease: A Real-World, Patient-Reported Outcome Measures Study.

Objectives This prospective study assessed the effectiveness and patient satisfaction of four-week omeprazole therapy in acid peptic disease (APD). Methods This was an observational, post-marketing, real-world evidence, patient-reported outcome (PRO) measures study. Patients visiting the five study sites across India with symptoms of APD, and who were prescribed oral omeprazole (20/40 mg per day) for at least four weeks were enrolled after obtaining informed consent. Study assessments included frequency and severity of symptoms and overall satisfaction reported by the patients using the Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire. The satisfaction with therapy was reported by the patients using the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire. Both PAGI-SYM and TSQM were reported by patients on days 14 and 28. Omeprazole safety was assessed based on the adverse events reported by the patients. Results A total of 96 (62 males and 34 females) patients were included in the study, of which 38.54% had significant findings related to APD at baseline. The proportion of patients with symptoms reduced to 16.67% on day 14 and 8.33% on day 28 with omeprazole therapy. The PAGI-SYM total scores at baseline were 41.32 (15.487), which reduced to 20.86 (11.620) on day 14 (p < 0.0001), and to 8.93 (8.361) on day 28 (p < 0.0001). Significant reductions were also seen in individual symptom scores. The TSQM total scores increased to 36.67 (range: 13 to 63) on day 28 from 34.69 (range: 12 to 58) on day 14. Improvement in scores for all domains of TSQM (effectiveness, convenience, and global satisfaction) was seen on day 28. Improvement in reflux symptoms was reported by 46.74% and 68.48% of patients on day 14 and day 28, respectively. Four (4.17%) patients reported adverse events, which were of mild severity and were unrelated to omeprazole. Conclusions Omeprazole provides significant improvement in PAGI-SYM and TSQM questionnaires on day 14 and day 28. Patients reported the omeprazole-based therapy as effective, convenient, and satisfactory. Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, and reflux oesophagitis.

Dyspepsia - The Indian perspective: A cross sectional study on demographics and treatment patterns of Dyspepsia from across India (Power 1.0 study).

BACKGROUND: Dyspepsia includes a spectrum of symptoms ranging from epigastric pain and early satiety to postprandial fullness. The worldwide prevalence of dyspepsia is 20-30%. It is slightly higher in the Western population and occurs more frequently among women. While the precise prevalence of dyspepsia in India is not available, different studies estimate that it affects 7.6-49% of the Indian population. Through our current study, we wanted to understand the demographics, clinical profile, patient presentation, and management in India. We also wanted to document the pattern of use of proton pump inhibitors (PPI) and patient satisfaction with PPIs in Indian patients with dyspepsia. MATERIALS AND METHODS: This pan-India, multi-centric, cross-sectional, questionnaire-based, noninterventional, observational study was conducted between February and October 2021 in patients >18 years of age with a clinical diagnosis of any form of dyspepsia. Descriptive statistics were used for categorical variables, and between-group comparisons were made using Fischer's exact test, with p < 0.05 denoting statistical significance. RESULTS: A total of 3,739 patients from across 29 states of India participated in the study. Most of the patients were male (70.8%) and were from urban areas (56.8%). The highest percentage of patients were aged 31-40 (33.8%), and most patients (60.2%) had dyspepsia for a duration of 6-12 months. Patients with functional dyspepsia (FD) (78.5%) were significantly higher compared to organic dyspepsia (OD) (21.5%) (p < 0.001). The most frequent presenting symptoms were epigastric pain, nausea, vomiting, and heartburn. A quarter (25.6%) of the dyspepsia patients were associated with various comorbid conditions, of which diabetes mellitus, hypertension, and irritable bowel syndrome are the most common ones. A total of 619 patients in the study were on concomitant medications, of which the most common were antidiabetic drugs (271/619, 43.8%). Rabeprazole was the most frequently used PPI (2467/3739, 66.0%) among the study participants. The patient satisfaction analysis showed that, overall, patients were satisfied with PPIs, as most patients (~80%) agreed to almost all questions. The analysis for individual PPIs showed the highest "agree" responses in the rabeprazole group for almost all questions (12 of 13). Around 86.4% of patients on rabeprazole agreed with "immediate relief from acidity," 84.9% for "gives me complete relief," and 85.9% for "relief from nighttime acidity symptoms." CONCLUSION: Our study involving over 3,700 Indian patients with Dyspepsia adds to the growing knowledge of dyspepsia in India. Dyspepsia is more prevalent in males and in the 31-50 age group. FD is the most common form. Overall, patients were satisfied with PPIs in dyspepsia management in India. Patients on rabeprazole showed higher levels of medication adherence, satisfaction with symptom relief, convenience of therapy, and safety compared to patients on other PPIs. Against the backdrop of a paucity of reliable data about dyspepsia in India, our study results provide valuable insights into Dyspepsia and its management in an Indian setting.

A Real-World Perspective of Co-amoxiclav Prescription Pattern With Probiotics for Pediatric Patients With Respiratory Tract Infections: Results of Quantitative and Qualitative Approach in Indian Outpatient Settings.

BACKGROUND: Probiotics are co-prescribed with co-amoxiclav to prevent antibiotic-associated diarrhea (AAD). The study assesses the co-prescription pattern of probiotics with co-amoxiclav in pediatric patients with respiratory tract infections (RTIs). METHODS: This was a mixed methods research study with a retrospective study and a prospective survey. The retrospective part included a multicenter, observational, real-world study utilizing patients' electronic medical records for three years (2018-2020) from seven outpatient pediatric clinics and hospitals. The qualitative evaluation was performed with a predefined questionnaire. RESULTS: The patients having RTIs (N=984) were prescribed Clamp® (46.7%), CAA (23.8%), and CAM (29.5%). The mean age of the patients was 4.05 years, with 59.25% males and most patients having upper RTIs. Co-amoxiclav was prescribed twice daily for one to 15 days. A significantly lesser number of probiotic co-prescriptions were observed with Clamp® (19.57%) than with CAA (38.46%) and CAM (29.31%) at baseline (p<0.001). Similar findings were observed for follow-up visits one and two. Saccharomyces boulardii, Bacillus clausii,and lactic acid bacillus were the most commonly co-prescribed probiotics. The qualitative evaluation indicated that most clinicians were aware of the co-amoxiclav-related gastrointestinal side effects and the benefits of probiotics in preventing them. CONCLUSION: The frequency of co-prescriptions of probiotics with Clamp® among pediatric patients with RTIs was significantly less, potentially indicating better gastrointestinal tolerability.

A real-world retrospective study of omeprazole-domperidone combination in managing acid peptic disease with PRoton-pump Inhibitors in patients with type 2 DiabEtes mellitus (PRIDE-2).

Background: Proton-pump inhibitors, along with a prokinetic agent, are widely used to provide symptomatic relief amongst patients with acid peptic disease (APD). This article evaluates the effectiveness and safety of the omeprazole-domperidone combination amongst patients with type 2 diabetes mellitus for the management of APD. Methods: PRIDE-2 (PRoton-pump Inhibitor in patients with type 2 DiabEtes mellitus) is a retrospective study reviewing electronic medical records of patients with type 2 diabetes mellitus and APD who were receiving the omeprazole-domperidone combination and visiting multiple Indian healthcare settings between March 2018 and April 2021. The effectiveness outcome of the therapy was evaluated in terms of resolution of APD symptoms at visit 5 (120 days after baseline visit) compared with visit 1 (baseline visit). Safety was determined in terms of reported adverse events (AEs) during the treatment period (120 days). Results: A total of 174 patients were included in the study. The mean age of the patients was 51.5±9.6 years, with the majority (59.8%) being men. A significant proportion of patients reported relief from APD symptoms, including abdominal pain (91.6%), epigastric burning (68.7%), nausea (89.5%), flatulence (100.0%), loss of appetite (93.6%), and altered bowel movements (94.7%) (p<0.001 for each) at visit 5 compared with visit 1. No serious AEs were reported. Conclusion: Omeprazole-domperidone combination was beneficial in providing symptomatic relief to patients with diabetes and APD. The combination therapy was well tolerated, with few reports of minor AEs.

Effectiveness of Rabeprazole and Other Proton Pump Inhibitors in Managing GERD with Varying Severity: A Retrospective, Real-world EMR-based Study (POWER GERD Study).

Purpose: To evaluate the effectiveness of rabeprazole and other proton pump inhibitors (PPIs) in providing symptomatic relief in patients with varying severity of gastroesophageal reflux disease (GERD). Methods: In this multicenter retrospective study, electronic medical records (EMRs) of GERD patients prescribed with PPIs at two Indian clinics/hospitals were reviewed (2016-2020). Rabeprazole's effectiveness was assessed at different follow-up visits and compared with other PPIs. Results: Overall, 269 patients (moderate and severe GERD: 84.39%) were included in three groups, viz rabeprazole, pantoprazole, and esomeprazole groups. A significant proportion of patients experienced quick and complete symptomatic relief at visit 1 with rabeprazole compared to the baseline visit, which gradually increased till visit 4 for both daytime [viz heartburn (38.78-93.88%; p < 0.001)] and nocturnal symptoms [viz sleep disturbances (62.92-97.75%; p < 0.001)]. Rabeprazole provided quick relief at visit 1 when compared with pantoprazole for daytime heartburn (38.78 vs 5.56%; p = 0.01), daytime epigastric pain (66.04 vs 12.12%; p = 0.049), and nocturnal water brash (60.71 vs 16.13%; p = 0.015), and when compared with esomeprazole for nocturnal nausea (82.61 vs 20.00%; p = 0.013). Further, the proportion of patients exhibiting complete treatment response was relatively higher in the rabeprazole group (83.33%) than in the pantoprazole (62.07%) and esomeprazole (65.67%) groups at visit 4. Conclusion: Rabeprazole was effective in providing quick and sustained relief for both daytime and nocturnal GERD symptoms in patients with moderate and severe GERD. Rabeprazole also demonstrated greater effectiveness when compared with pantoprazole and esomeprazole in reducing the severity of multiple GERD symptoms. How to cite this article: Lawate P, Jilawar N, Vyas K, et al. Effectiveness of Rabeprazole and Other Proton Pump Inhibitors in Managing GERD with Varying Severity: A Retrospective, Real-world EMR-based Study (POWER GERD Study). J Assoc Physicians India 2023;71(10):37-44.

An Evidence-Based Retrospective Study for the Management of Acid Peptic Disease With Omeprazole, a Proton Pump Inhibitor, in Indian Patients With Type 2 Diabetes Mellitus (PRIDE-1).

Background In this study, we aimed to assess the effectiveness of omeprazole therapy in the management of acid peptic disease (APD) among type 2 diabetes mellitus (T2DM) patients. Methodology In this multicenter retrospective study, electronic medical records (EMRs) of T2DM patients with APD who were prescribed omeprazole between March 2018 and April 2021 at multiple Indian healthcare settings were reviewed. The resolution of APD symptoms was assessed at visit five (120 days after the index visit) and compared to visit one (index visit). Safety was established in terms of reported adverse events during the study period. Results Overall, 174 patients were included. The majority of patients (63.8%) were males with a mean age of 48.6 ± 11.03 years. After receiving omeprazole therapy, a significant number of patients reported improvement in symptoms such as abdominal pain (98.2%), epigastric burning (74.2%), altered bowel movements (62.1%), and nausea (80.5%) (p < 0.001 for each). Complete resolution was observed in all patients who complained about flatulence (100.0%) and loss of appetite (100.0%) (p < 0.001 for each). The drug was found to be well tolerated. Conclusions Omeprazole therapy was well tolerated and highly effective in resolving APD symptoms among T2DM patients receiving fixed oral hypoglycemic agents.

Experience with mepolizumab in adults with severe eosinophilic asthma: a case series from India.

Severe asthma can be associated with eosinophilic or allergic phenotypes or both. Eosinophilic inflammation is associated with exacerbations and disease severity due to biological activity of interleukin-5 (IL-5). Patients with severe asthma have reported reduced lung function and poor health-related quality of life (HRQoL) and may require systemic corticosteroids for its management. Thus, treatment targeting IL-5 can help improve quality of life and reduce the use of systemic corticosteroids in severe asthma. Mepolizumab is approved for treating severe eosinophilic asthma as it helps reduce exacerbations, improve lung function and asthma control, and reduce the use of systemic glucocorticoids. This further helps in enhancing HRQoL of these patients. This case series includes four adult patients suffering from severe eosinophilic asthma who were treated with mepolizumab.

Efficacy and Safety of Terbinafine 500 mg Once Daily in Patients with Dermatophytosis.

INTRODUCTION: Dermatophytosis are the most common fungal infections globally. Terbinafine is considered to have good potency against dermatophytes, but resistance to terbinafine is on the rise. OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of terbinafine 500 mg given once daily in treatment of patients with superficial dermatophytosis. MATERIALS AND METHODS: It was a retrospective questionnaire-based survey. Each doctor was given survey questionnaire booklet containing survey forms. Clinical response was graded according to the improvement in the affected lesion. Mycological cure was defined as negative microscopy under potassium hydroxide examination and a negative culture in Sabouraud's dextrose agar. Patients were divided into three groups depending on the duration of therapy, Group A - terbinafine 500 mg for 2 weeks, Group B - terbinafine 500 mg for 4 weeks, and Group C - terbinafine 500 mg for 6 weeks. RESULTS: Total 50 doctors completed the survey involving 440 patients. In Group A, out of 194 patients, 87% (n = 169) patients showed very good response. In Group B, out of 211 patients, 92% (n = 194) of the patients showed very good response with >75% improvement in their lesion. In Group C, out of 35 patients, 80% (n = 30) patients showed very good response. Adverse drug reactions of mild to moderate intensity related to terbinafine were seen in 57 patients. CONCLUSION: Our survey indicates that terbinafine in a dose of 500 mg given once daily was efficacious and safe in the treatment of patients with dermatophytosis.

A Study to derive distribution of carotid intima media thickness and to determine its COrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population (SCORE-India).

BACKGROUND: There is presently no data to describe normal distribution of carotid intima-media thickness (CIMT), an established measure of subclinical atherosclerosis, in Indian subjects. METHODS: In this multi-centric study, 1229 subjects with age ≥30 years and no previous cardiovascular disease (CVD) underwent CVD risk factor assessment and CIMT measurement. Mean far wall common carotid artery IMT was measured on both sides and averaged. RESULTS: Mean age of the subjects was 48.0±12.0 years and 54.2% were men. CIMT measurement was feasible in 1157 subjects. Mean, median and 75th percentile values of CIMT for different age-groups were derived for men and women separately. There was a progressive increase in CIMT with increasing age (P<0.001) and men had higher CIMT values than women (0.608±0.12mm vs. 0.579±0.11mm, P<0.001). The CIMT values were also higher in diabetics (0.635±0.10mm) and hypertensives (0.624±0.10mm) as compared to non-diabetics (0.589±0.12mm, P<0.001) and non-hypertensives (0.592±0.12, P 0.02) respectively. Among continuous variables, age, systolic blood pressure and fasting blood glucose had strong to modest correlation with CIMT (Pearson's r 0.524, 0.282 and 0.192 respectively, all P values <0.001), whereas body mass index, diastolic blood pressure and serum triglycerides exhibited weak but still statistically significant relationship (Pearson's r 0.069, P 0.019; Pearson's r 0.065, P 0.026; and Pearson's r 0.094, P 0.001, respectively). CONCLUSIONS: This is the first study to provide age- and gender-specific distribution of CIMT in Indian subjects free from CVD. This information should help facilitate further research and clinical work involving CIMT in India.