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.

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.

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.

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.

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.

Efficacy of a Combination of Metformin and Vildagliptin in Comparison to Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Evidence Study.

BACKGROUND: Early use of combination therapy in diabetes patients may lead to sustained glycemic control and thereby reduce the progression of diabetic complications. Given the limitation of the traditional stepwise intensification strategy, early combination therapy can be an effective approach. Therefore, this study aims to assess the real-world efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus (T2DM) patients in India. METHODS: This was an observational, retrospective, non-interventional study based on electronic medical records (EMRs) of 2740 T2DM patients, retrieved from 2010 onwards from 22 diabetes centres across India. Adult drug naïve patients with a 5-year history of T2DM treated with either metformin or a combination of metformin and vildagliptin for at least 3 months were considered for this study. Efficacy assessment was done to evaluate the post-treatment HbA1c levels and patients requiring additional oral antidiabetic drugs (OADs) at the time of follow-up visit. Patients were also analyzed for the occurrence of adverse events. RESULTS: Out of the total, 2452 patients were in metformin only arm, and 288 patients were in metformin plus vildagliptin treatment arm. A more significant reduction in HbA1c level was observed in metformin plus vildagliptin arm than metformin only arm (median: -0.5% vs 0%, respectively; p<0.001). Patients requiring additional OAD at follow-up were significantly lesser in the metformin plus vildagliptin arm than the metformin only arm (15.6% vs 35.2%, respectively; p<0.001). The adverse events were comparable across the two arms, and commonly reported adverse events were giddiness, fatigue and gastric discomfort. CONCLUSION: The findings of this EMR-based real-world study emphasizes the need for early initiation of combination therapy (metformin plus vildagliptin) over metformin monotherapy for achieving better glycemic control.

An Industry Perspective on Risks and Mitigation Strategies Associated with Post Conduct Phase of Clinical Trial.

OBJECTIVE: To discuss the potential risks and their mitigation strategies in the post-conduct phase of the trial. BACKGROUND: Risk management is very important for the clinical trial (CT) to ensure that the trial delivers its desired outcome(s) in terms of achieving protocol objective and regulatory compliance. METHODOLOGY: Experienced members of the clinical operation team of a pharmaceutical major underwent a series of sessions to identify risks associated with the post-conduct phase of CT and developed mitigation strategies based on own experiences and guidance documents. The risks were categorized into major, minor and critical risks. RESULTS: In the post-conduct phase of a clinical trial, critical risk identified were; failure to communicate to the stakeholder about premature termination of the trial, mismatch of statistical analysis results and protocol objective/ regulatory requirement, clinical study report (CSR) noncompliant with regulatory requirements or delay in CSR preparation. Safety checks suggested to mitigate these risks including the development of related checklist or shell of relevant documents and its review by clinical development, quality assurance (QA) and regulatory affairs (RA) team prior to finalization. Additionally, six major and five minor risk areas were identified and safety checks were suggested. CONCLUSION: Sponsors must act proactively to ensure a systematic approach to conduct various post conduct trial activities and the plans to mitigate the risks that could affect the quality and outcome of the clinical trial. Future Perspective: A close coordination with all stakeholders for timely anticipation of risks and execution of mitigation strategies are required for successful CT outcomes.

Potential Risks and Mitigation Strategies During the Conduct of a Clinical Trial: An Industry Perspective.

BACKGROUND: Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring is an essential tool to identify the risks associated with conduct of any trial. This article is a result of extensive research conducted by a reputed pharmaceutical company to identify the potential stages of risks associated with the conduct phase of trial that could impact the overall quality and safety of a trial. METHODS: The skillful and experienced team members of a reputed pharmaceutical company involved in conducting clinical trials underwent brainstorming sessions to assess and categorize the risks associated with each stage of conduct phase of a clinical trial. They also developed a mitigation plan based on their experiences, best practices and applicable guidance documents. RESULTS: During conduct phase, risks are associated with preparation of site master and trial master file, courier of study supply to site(s) including investigational product prior to site initiation visit, patient recruitment, telephonic monitoring, adverse or serious adverse event monitoring, site monitoring visit(s), collected case report form pages forward to data management vendor, data query clarification and site close-out visit. CONCLUSION: A close working relationship with all the persons associated with the clinical trial, timely monitoring and prospective mitigation planning is required for the conduct of a high quality trial.

Potential Risks and Mitigation Strategies Before the Conduct of a Clinical Trial: An Industry Perspective.

Conduct of clinical trials has undergone substantial changes over the last two decades. Newer markets, evolving guidelines and documentation and high cost involved in conducting the trials have led pharmaceutical companies to prepare a risk mitigation plan. Extensive monitoring of potential risks is an essential element of clinical trials which helps to ensure quality and integrity of a clinical investigation. Every clinical trial has pre (before the trial), conduct and post phase. This article which has been developed as a result of extensive research at ground level by a reputed pharmaceutical company to identify the potential stages of risks that could affect the overall quality and safety of a trial and its outcome during the pre-phase of trial (the stage of the trial where the study design is being planned before initiation of the clinical trial). It includes risks associated with basic study concept, protocol design, Confidential Disclosure Agreement (CDA) and Clinical Trial Authorization (CTA) application signing, vendors of central drug laboratory, site and investigator selection, Clinical Research Coordinator (CRC) meet, Informed Consent Form (ICF), Case Report Form (CRF)/ Status Report Form (SRF) preparation, Ethics Committee (EC) submission, etc. have been highlighted. The risk based mitigation strategy (to develop an effective risk monitoring plan before staring a clinical trial) has also been suggested by authors. A well-tailored and integrated plan, recognition of potential risks and their mitigation strategy can result in the pre exclusion or end to end solution of all the risks associated with pre- phase of clinical trials.

Efficacy and safety of nadifloxacin for bacterial skin infections: results from clinical and post-marketing studies.

INTRODUCTION: Skin and soft tissue infections involve microbial invasion of the skin and underlying soft tissues and are estimated to affect 7-10% of hospitalized patients worldwide. Nadifloxacin, a topical fluoroquinolone, has been shown to be effective against aerobic Gram-negative, Gram-positive (including MRSA and coagulase-negative staphylococci), and anaerobic bacteria. However, there is paucity of data comparing efficacy and safety of 1% nadifloxacin with other anti-bacterials for skin infections in Indian patients. METHODS: This article presents the results of one post-marketing surveillance (PMS) and three randomized, open, non-blinded, multi-centric clinical studies that compared nadifloxacin with mupirocin and framycetin, and nadifloxacin with fusidic acid. Patients in India, aged from 1 to 65 years old, suffering from mild to moderate bacterial skin infections including impetigo, secondarily infected wounds, folliculitis, infected atopic dermatitis, and furunculosis were randomly allocated to three treatment groups within the studies. Efficacy was assessed by the evaluation of symptoms of erythema, exudation, swelling, pruritus, crusting, pain and tenderness in all the studies. RESULTS: A total of 272 subjects were enrolled in the study and subjects were randomly assigned to one of the three treatment groups; 92 in the nadifloxacin group, 90 in the mupirocin group, and 90 in the framycetin group. A significant reduction in the mean scores for bacterial infection symptoms in the nadifloxacin groups was observed when compared to mupirocin, framycetin and fusidic acid groups. Both physician and patients rated nadifloxacin as excellent (complete remission of symptoms) on a 4-point scale in the studies. No adverse events (AEs) were reported in the clinical studies. In the PMS, only two patients (of 329, 0.6%) reported AEs including burning and itching, one in each patient that had resolved at the time of reporting. CONCLUSION: Nadifloxacin, a fluoroquinolone, is a new alternative topical agent in the treatment of bacterial skin infection with minimal AEs.