Abstract Context: Atherosclerotic cardiovascular disease (ASCVD) remains a leading cause of global morbidity and mortality. Statins and antiplatelet agents are crucial for their prevention, but poor awareness and adherence to them impacts outcomes. Aims: This study aims to evaluate awareness, adherence, and the effect of statin therapy on lipid profiles in ASCVD patients, along with adherence to antiplatelet therapy. Settings and Design: A cross sectional observational study was done in 300 ASCVD patients, divided into primary ( n = 118) and secondary ( n = 182) prevention groups. Methodology: Structured questionnaires assessed awareness and adherence to statin and antiplatelet therapy. Lipid profiles were measured before and after statin therapy. Informed consent was obtained from all participants in English, Hindi, and Marathi to ensure comprehension across languages. Statistical Analysis Used: Descriptive statistics and correlation analysis evaluated awareness, adherence, socioeconomic status (SES), and lipid outcomes. Results: Most patients were from lower socioeconomic backgrounds. Awareness (42%) and adherence (70%) were higher in secondary prevention than in primary (33% and 50%). Statins significantly improved low-density lipoprotein, total cholesterol and showed weak correlation of SES with adherence in secondary prevention group. SES showed weak correlation with adherence. Conclusions: Despite lipid improvement with statins, awareness and adherence to statin and antiplatelet therapy remain inadequate, highlighting the need for focused patient education.
Abstract Introduction: Combination therapy with semaglutide and sodium-glucose cotransporter-2 (SGLT2) inhibitors is increasingly recommended for type 2 diabetes mellitus because of its cardiometabolic and renoprotective benefits. However, concerns remain regarding diabetic ketoacidosis (DKA) and euglycemic DKA (euDKA), particularly during combination exposure. Objectives: To evaluate disproportionality signals for DKA and euDKA associated with semaglutide, individual SGLT2 inhibitors, and their combination exposure using the Food and Drug Administration Adverse Event Reporting System (FAERS). Materials and Methods: A retrospective pharmacovigilance disproportionality analysis was conducted using FAERS reports (Q4/2003–Q3/2025) accessed through OpenVigil 2.1. Semaglutide, individual SGLT2 inhibitors, and their combination exposure were evaluated for DKA and euDKA using Medical Dictionary for Regulatory Activities Preferred Terms. Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Chi-square statistics, and 95% confidence intervals (CIs) were calculated according to Evans criteria. Results: All evaluated drugs demonstrated significant disproportionality signals for DKA and euDKA. Semaglutide monotherapy showed positive signals for DKA (ROR: 5.63; 95% CI: 5.10–6.22) and euDKA (ROR: 18.91; 95% CI: 16.50–21.68). SGLT2 inhibitors demonstrated markedly stronger signals, particularly empagliflozin for euDKA (ROR: 453.36; 95% CI: 420.80–488.44). Combination exposure further amplified signal strength. Semaglutide–empagliflozin combination showed strong signals for DKA (ROR: 55.44; 95% CI: 46.84–65.63), while the semaglutide–empagliflozin interacting-role analysis for euDKA demonstrated extreme disproportionality (ROR: 2425.49). Conclusion: Semaglutide and SGLT2 inhibitor combination therapy demonstrated strong disproportionality signals for DKA and euDKA in FAERS. These findings support heightened clinical vigilance, ketone monitoring, and further prospective studies to clarify absolute risk and underlying mechanisms.
Abstract Background: Antimicrobial agents (AMAs) are often used in the pediatric population without age-specific dosing guidelines, leading to concerns over efficacy, resistance, and cost. This study evaluated prescription patterns, AMA utilization, treatment outcomes, cost of therapy, and parental awareness in children admitted with infectious diseases in a tertiary care hospital. Materials and Methods: This was a cross-sectional observational study conducted over 18 months in 378 children aged >1 month to ≤12 years who received at least one AMA following ethics committee permission and written informed consent. Pediatric drug utilization was assessed using Child Defined Daily Dose (cDDD), Child Drug Utilization Index (cDUI), and Prescribed Daily Dose (PDD)/cDDD ratio. Treatment outcome was measured with the duration of the febrile period and hospitalization. Parental awareness was measured through a validated questionnaire. Cost analysis included direct and indirect costs. Descriptive statistics were used. Results: Average number of AMAs was 2.7/patient. Ceftriaxone (21.2%) was the most commonly prescribed AMA, with PDD/cDDD ratios >1.8 across age groups. Vancomycin had appropriate dosing (PDD/cDDD ~1.0), while piperacillin-tazobactam showed underdosing. Empirical therapy resulted in clinical improvement in 65.1%. The average total treatment cost was INR 13,997, with indirect costs constituting 64.8%. While 95.5% of parents were aware of their child’s illness, awareness of AMA side effects and antimicrobial resistance was low (34.2% and 16.6%, respectively). Awareness correlated positively with socioeconomic status. Conclusion: AMA usage in hospitalized children was mainly as per guidelines and within expected utilization ranges, although dose variations exist. Clinical outcomes were favorable, with minimal direct costs. Enhancing parental education on AMA use and resistance is essential for optimizing pediatric care.
The previous article in this series provided an overview of qualitative research, how it compares and contrasts with quantitative research, and an introduction to qualitative research approaches and designs. In this article, we delve deeper into the process of choosing an appropriate qualitative research design.
Abstract Introduction: Selective serotonin reuptake inhibitors act primarily on serotonin, whereas serotonin–norepinephrine reuptake inhibitors (SNRIs) modulate both serotonin and norepinephrine, potentially influencing their anxiolytic effects. Brain-derived neurotrophic factor (BDNF), a key mediator of neuroplasticity, may play a role in anxiety reduction, but comparative data across antidepressants remain limited. Objective: To compare the effects of desvenlafaxine and escitalopram on anxiety and somatic symptoms, examine correlations between serum BDNF and anxiety improvement, and evaluate whether BDNF predicts reduction in anxiety symptoms in patients with major depressive disorder (MDD) with comorbid anxiety. Methodology: In this randomized, open-label, parallel-group study (CTRI/2021/11/038260), patients with MDD (Hamilton Rating Scale for Depression [HAM-D] 8-23) and comorbid anxiety (Hamilton Anxiety Rating Scale [HAM-A] >17) received desvenlafaxine 50 mg ( n = 20) or escitalopram 10 mg ( n = 19) daily for 8 weeks. Depression, anxiety, and somatic symptoms were assessed using HAM-D, HAM-A, and somatic symptom scale-8 (SSS-8) scales. Serum BDNF was measured at baseline and week 8. Multiple regression included age, sex, and baseline HAM-A as covariates. Results: Of 54 screened, 39 patients completed the study. Both treatments significantly improved HAM-D, HAM-A, and SSS-8 scores. Desvenlafaxine showed greater improvement in somatic symptoms ( P = 0.012) and a higher rise in BDNF (113.5 ± 97.0 vs. 57.4 ± 70.7 pg/ml). In the desvenlafaxine group, BDNF change correlated strongly with HAM-A reduction ( r = −0.69, P = 0.001) and independently predicted anxiety improvement (β = −0.66, R 2 =0.50, P = 0.003). Conclusion: Only desvenlafaxine demonstrated a predictive relationship between BDNF increase and anxiety reduction, supporting BDNF’s potential as a biomarker for SNRI response.
Abstract Background: Topical therapy is the primary treatment for uncomplicated skin infections such as impetigo, and mupirocin is commonly used. However, growing resistance to topical agents is of concern. Ozenoxacin, a nonfluorinated quinolone, is a promising new agent due to its bactericidal action and low minimum inhibitory concentrations against skin pathogens. We assessed the effectiveness of ozenoxacin in comparison to mupirocin in the topical treatment of impetigo and other uncomplicated skin infections in a hospital outpatient setting. Materials and Methods: A parallel-arm, open-label, randomized controlled trial (CTRI/2023/04/051498) was done with subjects (≥2 months age) having impetigo, folliculitis, or other uncomplicated skin infections at various sites, with a Skin Infection Rating Scale (SIRS) score of at least 4. Ninety patients were randomized and received either mupirocin 2% ointment or ozenoxacin 1% cream twice daily for 7 days (45 each). Skin lesion size was determined using graduated tracing paper, and the 7-component SIRS score was assessed on a four-point scale. Treatment-emergent adverse events were recorded. Results: The median skin lesion area significantly decreased in both the groups. Change in SIRS score was 7.0 (5.0–9.0) (median [interquartile range]) in the mupirocin group versus 6.5 (5.0–8.0) in the ozenoxacin group ( P = 0.872). Clinically, 81.8% of the participants on mupirocin showed success at the end of 7 days of treatment compared to 85% on ozenoxacin ( P = 0.875). Complete resolution was observed in 70.5% versus 75%, respectively ( P = 0.807). No significant adverse events emerged, and adherence was good to excellent in both arms. Conclusions: Topical ozenoxacin is effective in clearing uncomplicated skin infections with satisfactory adherence. It is an evidence-based alternative to mupirocin and can be tried if mupirocin resistance is encountered.
Abstract Background: High-alert medications (HAMs) are drugs that pose an elevated risk of serious harm to patients when administered improperly. Safe administration and regulation of high-risk medicines are considered a global priority in health care. Therefore, healthcare providers’ awareness of HAM is crucial for patient safety. Hence, this study aimed to assess healthcare professionals’ knowledge of HAM in a tertiary care hospital. Materials and Methods: In this cross-sectional study, the doctors and nurses from outpatient clinics, inpatient wards, intensive care units (ICUs), and emergency departments were recruited through convenience sampling. They were distributed a validated questionnaire to evaluate the awareness of HAM. Descriptive data were presented as frequencies and proportions. Results: Four hundred and twenty-nine healthcare professionals participated in this study. Of the respondents, 62.9% were aged 21–25 years, 85.5% were female, and 76.5% were nurses. Nearly 60% of the respondents provided correct responses regarding the administration of epinephrine, calcium gluconate and insulin; however, their knowledge of chemotherapeutic drug administration was relatively poor. Regarding HAM regulation, 50% of the respondents provided accurate responses on special HAM labeling, heparin and insulin storage, and pediatric measuring units. Participants with 1–5 years and > 10 years of clinical experience were more likely to correctly answer knowledge statements. Participants working in ICUs had significantly higher odds of responding correctly. Conclusion: Approximately 69.5% of healthcare professionals had good knowledge of the administration and regulation of HAMs. Thus, structured clinical exposure, supported by continuous education and technology-enabled safety measures, would improve the safe use of HAMs.
Abstract Introduction: Ascorbic acid (Vitamin C) is a potent water-soluble antioxidant. It neutralizes free radicals, inhibits lipid peroxidation, and regenerates Vitamin E. It stimulates collagen synthesis, inhibits collagen-degrading enzymes, protects elastin, and reduces hyperpigmentation by inhibiting melanogenesis. However, existing studies on Vitamin C-based anti-aging therapies show considerable variability, highlighting the need for a meta-analysis to clarify efficacy and guide clinical practice. Materials and Methods: This meta-analysis included randomized controlled trials published up to March 2025. The studies that compared Vitamin C delivered topically or via mesotherapy, iontophoresis, or microneedling were included. PubMed and Ovid were searched, and study selection, data extraction, and risk of bias (RoB) assessment were conducted independently by two reviewers. Outcomes included changes in melanin, hydration, elasticity, and erythema. Random-effects meta-analyses were performed using mean differences with 95% confidence intervals. Results: A total of 185 records were identified. Out of them, four studies met the inclusion criteria. One study had a low RoB, while three showed a high risk. Meta-analysis revealed that Vitamin C-based interventions significantly reduced facial melanin compared with control. There was also a statistically significant decrease in skin hydration and elasticity. Conclusion: The results show that Vitamin C-based therapies effectively reduce facial melanin, improving hyperpigmentation in aging skin. However, there is a need for well-designed, larger trials with longer follow-up to confirm broader anti-aging effects.
Abstract Purpose/Aim: “Compassionate use” of drugs refers to providing access to new drugs for patients with life-threatening diseases who have exhausted all other therapeutic options or patients with diseases for which no other therapeutic modalities are currently available in the market. While the U.S. and many European countries have established structured regulatory, ethical, and pharmacovigilance pathways for compassionate drug use, India lacks a comprehensive and consistent regulatory, ethical, and pharmacovigilance framework for compassionate drug use. This paper aims to critically examine the existent regulatory, ethical, pharmacovigilance, and legal frameworks for compassionate use of drugs in India and propose actionable recommendations for a compassionate drug use system tailored to the Indian context. Methods: A comprehensive review of existing policies and legal framework governing compassionate drug use in India was employed with comparative evaluation against international compassionate drug use frameworks. Supplementary review of literature on pharmacovigilance and ethics guidelines was used to assess systematic gaps in monitoring and implementation. Results: India’s existing guidelines for compassionate use of drugs have no clearly defined legal structures or accountability mechanisms. The absence of an ethical, pharmacovigilance, and legal framework in India contributes to ambiguity in access and patient safety concerns. Conclusions: There is an urgent need to develop a formal regulatory framework for compassionate drug use in India, integrating mandatory ethics committee oversight and pharmacovigilance systems. Such a framework would ensure equitable access to potentially lifesaving drugs while safeguarding patient safety and regulatory accountability.
Abstract Stem cell interventions (SCIs) hold great promise, but there is little international scientific evidence to support their clinical use, and there are several critical issues persist that need to be resolved. However, many of these clinics operate outside the boundaries of scientific evidence and ethical standards, putting vulnerable patients at risk. India has emerged as a global hub for stem cell-based therapies due to the global surge in stem cell and regenerative therapies, but there is still a need for robust regulation. A critical component in ensuring the safety and efficacy of SCIs is the diligent reporting of adverse drug reactions (ADRs) and adverse events (AEs). Adverse event reporting is a crucial tool to mitigate the risks of unproven SCIs and ensuring their safe and effective use. This review examines the specific factors contributing to the underreporting of ADRs related to SCIs in India and suggests appropriate recommendations based on the study’s findings. Strengthening AE data collection and analysis will enable regulatory authorities to identify risks, implement safeguards, and inform healthcare professionals and the public, ultimately fostering safer, evidence-based adoption of SCIs.
Purpose:Urticaria is a disease where there is development of short-lived itchy wheals (hives), angioedema, or both.[1] With a lifetime prevalence of up to 22%, it is a widespread skin disorder that affects the general population. Urticarial episodes lasting longer than 6 weeks are considered chronic spontaneous urticaria (CSU).[23] Bilastine is a novel second-generation H1-antihistamine approved by the Drugs Controller General of India for the symptomatic treatment of CSU. Till date, there are very few studies in the Indian population comparing the efficacy and safety of bilastine with second-generation antihistaminic. Hence, the study was planned to assess and compare the efficacy and safety of desloratadine and bilastine in patients of CSU. Aim:The aim of the study was to evaluate and compare the efficacy of desloratadine and bilastine in patients of CSU. Materials and Methods:It was a randomized, open-label, parallel group, comparative study conducted in 60 patients of CSU attending the dermatology outpatient department of a tertiary care teaching hospital. Patients were divided into 2 groups of 30 each. They received either desloratadine 5 mg or Bilastine 20 mg once daily for 6 weeks, and efficacy and safety were assessed at 2-, 4- and 6-week follow-up visit. Results:Difference in MTSS was significant in bilastine as well as desloratadine, which showed that bilastine was equally efficacious as desloratadine. Adverse events were reported more in the desloratadine group. Conclusion:Bilastine is equally efficacious as desloratadine, and a favourable safety profile may make it a more tolerable H1-antihistaminic than desloratadine.
Registry studies are types of real-world studies (RWS), which are used to generate clinical evidence regarding therapeutic use, potential benefits, or risks of a medical product in real-world medical practice, and to support regulatory decisions. RWS are conducted using real-world data (RWD), which are collected for patient care management, but not collected in compliance with good clinical practice standards for documentation. Hence, ensuring data quality, integrity, and reliability for studies using RWD is difficult. It is important to ensure the quality of research, data, and evidence during the planning and conduct of registry studies. This brief review discusses the elements critical to ensuring quality during planning and reporting of RWS.
This narrative review examines the evolving perspectives on polypharmacy within geriatric pharmacotherapy, emphasizing transition from numerical definitions to clinical appropriateness. It addresses the complex relationship between polypharmacy and health outcomes in older adults. It integrates data from emerging technologies in medication management, prescribing criteria tools, and deprescribing interventions. Appropriate polypharmacy can be helpful for managing multimorbidity, whereas inappropriate polypharmacy raises the risk of adverse events and mortality. Deprescribing interventions effectively reduce polypharmacy and potentially inappropriate medications, particularly in long-term care settings. To address existing gaps, we have proposed a deprescribing scoring tool that allows healthcare professionals to evaluate each medication's evidence base, risk profile, and alignment with patient goals. Prioritizing clinical relevance over medication count, along with innovative strategies such as deprescribing and new technologies, can improve therapeutic outcomes and quality of life for aging populations.
Abstract Background: The Institute for Healthcare Improvement (IHI) Global Trigger Tool detects generic patient harm yet is not tailored to antiretroviral therapy (ART)-associated adverse drug events (ADEs) in adults living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome – a critical pharmacovigilance gap in care. Aim: The study is aimed at developing and preliminarily validating an HIV-specific trigger tool for ADE surveillance. Materials and Methods: Candidate triggers were compiled from literature, expert consultation, and patient interviews, then refined through a four-round modified Delphi survey of clinicians and pharmacovigilance specialists. Inter-rater reliability (κ) and content validity indices (CVIs) were calculated. The finalized tool was pilot-tested by retrospective review of 60 randomly selected ART patient records. Results: Consensus produced 52 triggers, organized into two domains (specific and nonspecific) and 13 specific subcategories. The expert agreement was substantial (κ =0.67). The scale-level CVI averaged 0.95. Pilot application detected 96 trigger occurrences, yielding 60 confirmed ADEs (positive predictive value = 62.5%). Switch or substitution of ART (22%) was the most common trigger, while acute kidney injury accounted for 17% of ADEs. Conclusion: The newly developed trigger tool demonstrates strong content validity and practical utility for identifying ART-related ADEs in adult HIV populations. Comparative studies against conventional detection methods are required to establish sensitivity and broader applicability across diverse healthcare settings.
Abstract Context: Protocol deviations (PDs) are not uncommon in clinical trials (CTs) and understanding their nature can help mitigate their occurrence. Aims: To audit PDs in archived regulatory CTs conducted at a single research department over a 25-year period. Subjects and Methods: We included archived regulatory CTs and excluded ongoing studies and academic studies. Data were extracted from trial master files and PD forms filed with the Institutional Ethics Committee. PDs were categorized by type, category, and whether corrective and preventive actions (CAPAs) were taken. Statistical Analysis: Both descriptive and inferential statistics were applied to the data. Chi-square tests compared PD frequencies between pandemic and nonpandemic periods and content analysis was used for qualitative categorization. Results: A total of 21 regulatory CTs yielded 526 PDs, of which 85.2% were minor and 14.8% were major, respectively. The majority (42%) related to follow-up visits beyond the allowed window, and 37% to sample collection, processing, and storage. Only 0.8% were consent-related. There was a significant increase in PDs during the coronavirus disease 2019 (COVID-19) pandemic ( P < 0.00001), with 85% of PDs in six trials attributed to pandemic-related disruptions. The most frequent CAPA was re-counselling participants (39%). Conclusions: Most PDs were minor and manageable, but the COVID-19 pandemic led to a significant rise in deviations.
Decentralized clinical trials (DCTs) are increasingly recognized by the stakeholders for their potential to enhance flexibility, accessibility, and convenience. However, their widespread implementation continues to encounter challenges. Recognizing the pivotal role of diverse stakeholders in clinical trial success, we aimed to explore stakeholder perspectives on DCT opportunities, challenges, and strategies for effective implementation. This paper presents the qualitative findings from a broader mixed-methods online survey involving stakeholders with experience in DCTs. A total of 288 individuals from various regions and organizations, including sponsors, contract research organizations (CROs), technology vendors, hospital personnel, and medical research professionals, participated in the survey from 38 countries. A semantic thematic analysis approach following Braun and Clarke’s (2006) six-step methodology was employed to interpret the open-ended responses. Thematic analysis revealed ten major themes encompassing 61 verbatim quotes. Trial design and protocol optimization emerged as the dominant theme, emphasizing context-specific rather than universal DCT approaches. Hybrid DCT models were strongly preferred as practical solutions, balancing innovation with operational feasibility. Patient-centric design and technology adoption highlighted the critical importance of trust-building and addressing digital literacy disparities. Additional themes addressed training needs, operational challenges, regulatory compliance, and stakeholder collaboration. Successful DCT implementation requires coordinated, patient-centered approaches tailored to specific trial contexts. While DCTs address many barriers of conventional clinical trials, strategic planning emphasizing hybrid models, comprehensive stakeholder training, and cultural adaptation is essential to ensure patient safety, data integrity, and sustainable adoption.
Abstract Background: Rising healthcare expenses are an alarming issue globally. Healthcare professionals have the opportunity to substitute generics instead of branded medicines to reduce the cost of medicines, hence the overall reduced cost of health care. Objective: To assess the knowledge, attitude, and practice of healthcare professionals in Indore district regarding generic medicines and examine demographic associations. Subjects and Methods: This questionnaire-based cross-sectional survey was conducted among 122 healthcare professionals using a prevalidated 30 questionnaire. Data were collected via Google Forms. Responses were analyzed descriptively and through Chi-square tests. Results: Most participants (91%) correctly defined generic medicines, 75.4% were aware of bioequivalence requirements, and 70.5% acknowledged therapeutic equivalence. While 54.9% felt that branded medicines. Awareness of the Medical Council Act (78.7%) and Jan Aushadhi scheme (88.5%) was high. Over 75% prescribed generic medicines, but 61.5% reported perceived differences in efficacy. Chi-square analysis showed significant associations between gender, age, facility type, and perception of safety, efficacy, and bioequivalence, while years of practice had no significant impact. Conclusion: Healthcare professional in Indore prescribe generics widely, but misconceptions about efficacy and quality persist. Targeted continuing medical education programs, stricter regulatory monitoring, and patient awareness initiatives may help strengthen confidence in generic prescribing.
Abstract Objective: The objective of this study was to explore the effect of rosuvastatin on disease severity, inflammatory, and angiogenic markers in plaque psoriasis patients having cardiovascular (CV) risk. Methodology: In this nonrandomized, assessor blind clinical trial, plaque psoriasis patients were allocated to rosuvastatin add-on ( n = 24) or standard therapy group ( n = 24) depending upon baseline CV risk. The primary outcome was the mean change in psoriasis area and severity index (PASI) score at 12 weeks from baseline. Other outcomes were PASI 50 and PASI 75, change in dermatology life quality index (DLQI) scores, lipid profile, serum high-sensitivity C-reactive protein, vascular endothelial growth factor, and interleukin-17 levels. Results: At 12 weeks, the mean (standard deviation) change from baseline PASI was −2.34 (2.81) in the rosuvastatin and −1.93 (3.33) standard therapy groups ( P = 0.38). The rosuvastatin group exhibited an earlier and consistent improvement in disease severity; 3 (17.64%) patients receiving rosuvastatin achieved PASI 50 at 4 weeks compared to none in the standard. The difference in mean change in DLQI and biochemical parameters between the two groups was not statistically significant. Both the groups had comparable safety profile. Conclusion: Rosuvastatin may be considered a potential add-on treatment in plaque psoriasis patients having intermediate or high CV risk.
