The burden of Clostridioides difficile infections in South-East Asia and the Western Pacific: A narrative review.

BACKGROUND: Clostridioides difficile (formerly Clostridium difficile) is well-documented in Europe and North America to be a common cause of healthcare-associated gastrointestinal tract infections. In contrast, C difficile infection (CDI) is infrequently reported in literature from Asia, which may reflect a lack of clinician awareness. We conducted a narrative review to better understand CDI burden in Asia. METHODS: We searched the PubMed database for English language articles related to C difficile, Asia, epidemiology, and molecular characteristics (eg, ribotype, antimicrobial resistance). RESULTS: Fifty-eight articles that met eligibility criteria were included. C difficile prevalence ranged from 7.1% to 45.1 % of hospitalized patients with diarrhea, and toxigenic strains among all C difficile in these patients ranged from 68.2% to 91.9 % in China and from 39.0% to 60.0 % outside of China. Widespread C difficile ribotypes were RT017, RT014/020, RT012, and RT002. Recurrence in patients with CDI ranged from 3.0% to 17.2 %. Patients with CDI typically had prior antimicrobial use recently. High rates of resistance to ciprofloxacin, clindamycin, and erythromycin were frequently reported. CONCLUSION: The regional CDI burden in Asia is still incompletely documented, seemingly due to low awareness and limited laboratory testing. Despite this apparent under recognition, the current CDI burden highlights the need for broader surveillance and for application of preventative measures against CDI in Asia.

Implementation of equity and access in Indian healthcare: current scenario and way forward.

Introduction: The Indian healthcare system is evolving towards better healthcare implementation and coverage. However, even today, the health-care system faces several challenges, a few of which are yet to be addressed. The present review is aimed to delineate the past and present healthcare scenarios in India, health-care policies, and other initiatives for achieving universal health coverage (UHC). Methods: A literature search was done on various government databases, websites, and PubMed for obtaining data and statistics on healthcare funding, health insurance schemes, healthcare budget allocations, categories of medical expenses, government policies, and health technology assessment (HTA) in India. Results: The available data indicates 37.2% of the total population is covered by any health insurance of which 78% are covered by public insurance companies. Around 30% of the total health expenditure is borne by the public sector, and there is high out-of-pocket (OOP) expenditure on healthcare. Discussion: Several new health policies and schemes, an increase in 2021 budget for healthcare by 137%, vaccination drives, augmenting manufacturing of medical devices, special training packages, Artificial Intelligence/Machine Learning (AI/ML)-based standard treatment workflow systems to ensure proper treatment and clinical decision-making have been initiated by the government for improving healthcare funding, equity, and access.

Pneumococcal Vaccine Recommendations for Old-Age Home Indian Residents: A Literature Review.

Advancing age is accompanied by decreased immunity, poor health, and physiological changes, which render the elderly population highly susceptible to infectious diseases. We aim to identify the guidelines for pneumococcal vaccines in old-age facilities in India. We performed an extensive review of Indian literature (indexed and non-indexed publications) from 2010 to 2020 using search strings "Pneumococcal vaccine AND Recommendations AND India," "Pneumococcal vaccine AND Guidelines AND India," followed by a hand search to identify the most updated versions of recommendations. We reviewed immunization guidelines recommended by nine medical associations and societies in India-Association of Physicians of India (API), Geriatric Society of India (GSI), Indian Society of Nephrology (ISN), Mass Gathering Advisory Board Consensus Recommendation, Indian Medical Association (IMA), Indian Chest Society and National College of Chest Physicians (ICS-NCCP), Research Society for Study of Diabetes in India (RSSDI), Indian Association of Occupational Health Guidelines for Working Adults (IAOH), and API guidelines for immunization during COVID19 pandemic. All bodies recommend pneumococcal vaccines, sequence and preference of which depend on factors such as age, underlying conditions, and immune status. Integration of society recommendations and their implementation into public and private vaccination programs are required to promote adult immunization.

Systematic review and meta-analysis of comorbidities and associated risk factors in Indian patients of community-acquired pneumonia.

Objective: Comorbidities and risk factors have a major implication on incidence, complications, mortality, and management of community-acquired pneumonia complications and treatment outcomes. This study attempts to identify the same in the Indian population through a systematic review and meta-analysis. Methods: We screened observational studies (between January 1990 and February 2021) that reported potential comorbidities and other factors associated with increased risk of community-acquired pneumonia in the Indian population (⩾12 years) using PubMed, Google Scholar, and manual search. The risk of bias was identified using the Joanna Briggs Institute checklist for prevalence studies. Meta-analysis was conducted by using the random intercept logistic regression model. Results: Twenty-three studies were included in this analysis. The most prevalent comorbidities were chronic obstructive pulmonary disease (24.2%; 95% confidence interval: 16.4%-34.2%), hypertension (23.7%; 95% confidence interval: 13.6%-38.1%), and diabetes mellitus (16%; 95% confidence interval: 9.9%-24.7%). The prevalence of community-acquired pneumonia was high in patients with a current or previous history of smoking (51.4%; 95% confidence interval: 42.3%-61%) and advanced age ⩾50 years: (55.8%; 95% confidence interval: 48.4%-62%). Conclusions: Comorbid conditions like chronic obstructive pulmonary disease, hypertension, and diabetes mellitus and factors like advanced age and smoking history were common risk factors for community-acquired pneumonia in the Indian population.

Meningococcal Disease Burden in India: A Systematic Review and Meta-Analysis.

OBJECTIVE: To perform systematic review and meta-analysis of meningococcal disease burden in India. METHODS: We searched publications on meningococcal disease in India between 1996 and 2020 using PubMed and Google Scholar. Prevalence (proportion) of Meningococcal meningitis and Case-fatality ratio (CFR) were pooled using random effects model. Other outcomes were pooled qualitatively. RESULTS: The prevalence of Meningococcal meningitis in epidemic and endemic conditions was 12.1% (95% CI: 5.2-21.4) and 0.76% (95% CI: 0.3-1.4), respectively, with a CFR of 12.8% (95% CI: 6.8-20.4) in epidemic settings; N. meningitis caused 3.2% (95% CI: 1.6-5.3) of Acute Bacterial Meningitis (ABM) cases in endemic settings. The disease appeared in infants, adolescents, and adults with Serogroup A prevalence. Treatment and prophylaxis were limited to antibiotics despite increased resistance. CONCLUSION: The study reveals epidemic and endemic presence of the disease in India with high fatality and serogroup A prevalence. Further monitoring and immunization are required to prevent outbreaks.

A systematic literature review on the prevalence and etiology of meningitis among critically ill and hospitalized patients in India.

BACKGROUND: In India, owing to multiple factors, such as insufficient laboratory capacity, poor reporting systems due to limited access to healthcare facilities and limited disease surveillance programmes, the actual disease burden of meningitis is unknown and may be largely under-reported. OBJECTIVE: A systematic literature review was performed to describe: (a) the prevalence of meningitis; and (b) its etiological pathogen across different regions, age groups and patients with comorbidities. METHOD: A systematic literature search was conducted between 1990 and 2020 using PubMed and Google Scholar databases to identify Indian studies reporting the prevalence rates and etiology of meningitis. A total of 51 studies were included in the final analysis. RESULTS: A total of 38 studies reported prevalence of meningitis and 21 studies reported data on the etiology of meningitis in India. These studies included mixed patient populations: (a) pyogenic meningitis; (b) meningitis in sick or hospitalized patients with tuberculosis, acute febrile encephalopathy syndrome, septicaemia, invasive pneumococcal disease or respiratory compromise; and (c) meningitis patients with comorbidities. The prevalence of confirmed bacterial meningitis in the pediatric population (0-14 years) ranged between 0.5% and 61.8%. A total of seven studies reported the prevalence of meningitis in patients of all age groups (0-75 years), with prevalence ranging between 8.68% and 78.85%. Cryptococcal meningitis was predominant in patients with positive HIV/AIDS, with a prevalence ranging between 2.09% and 53.1%. Streptococcus pneumoniae was found to be the predominant pathogen causing meningitis across different regions of India, with a frequency ranging from 4% to 61.8% in patients of all age groups. CONCLUSION: This systematic literature review displayed the possible range of frequency of bacterial meningitis pathogens across a wide variety of age groups in different regions of India. Further studies are warranted to monitor meningitis cases, which may facilitate the development of prevention and treatment strategies in India.

Disease burden due to Group B Streptococcus in the Indian population and the need for a vaccine - a narrative review.

Streptococcus agalactiae, a Gram-positive bacterium, causes invasive infection known as Group B streptococcal disease (GBS). It is a leading cause of neonatal death and complications prior to delivery. The burden of GBS is unknown in India despite the high incidence of preterm and stillbirths. In this study, we performed a narrative review of the available literature (published in the last 10 years) on the epidemiology of GBS, using PubMed and Google Scholar, to understand its impact in India and evaluate potential strategies to prevent the disease in the high-risk population, that is, neonates. The review showed that the incidence of early- and late-onset GBS in neonates (per 1000 live births) was in the ranges of 0.090-0.68 and 0.0-0.07 respectively. The overall case fatality rate reported in only one study was 0.63. In pregnant women, the prevalence of GBS colonization was 2-62% and its transmission to their newborns varied from 6.7% to 11.1%. The serotype distribution of GBS is unclear, but some studies reported the distribution of types Ia, Ib, II, III, V, VII among pregnant women in India. The associated risk factors for GBS colonization in pregnant women are unclear but a few studies suggest the role of age and multigravida, while the risk factors in neonates include preterm birth, prolonged rupture of membrane (⩾18 h), maternal fever, obstetric complications, and prolonged labor >18 h. Screening of GBS is not a routine practice in India and intrapartum antibiotics prophylaxis is limited to only in risk conditions to prevent neonatal disease transmission. A few studies also suggest that high birth rate, poor detection methods, and financial constraints limit routine GBS screening in a developing country such as India. Hence, maternal vaccination is the most promising strategy to prevent neonatal GBS and Pfizer's hexavalent GBS conjugate vaccine (GBS6) is being developed for GBS neonatal disease.

Disease Burden Due to Respiratory Syncytial Virus in Indian Pediatric Population: A Literature Review.

Respiratory syncytial virus (RSV) is one of the leading causes of lower respiratory tract infections in young children. Globally, there is huge disease burden, high treatment cost, and health impact beyond acute episodes due to RSV which necessitate development and implementation of preventive strategies for the control of RSV infection. The disease burden due to RSV in pediatric population across India is still not clearly understood so this literature review was therefore conducted to gather data on disease burden due to RSV in Indian pediatric population. Systematic literature search was performed using PubMed and Google search with different medical subject headings from 2007 to 2020. Studies performed in Indian pediatric population were selected for review. Literature review revealed that in India, epidemiology of RSV infection is well documented in young children (0-5 years) as compared to children from other age groups. The rates of RSV detection in various studies conducted in younger children (0-5 years) vary from 2.1% to 62.4% in India which is higher as compared to children from other age groups. In India, RSV mainly peaks around rainy to early winter season, that is, during months of June through October while smaller peak was noted during December, January, and February. In 2020, higher RSV-associated disease burden was reported among children (<5 years) in low-income and lower-middle-income countries. Considering significant disease burden due to RSV in young Indian children, availability of RSV vaccine would be crucial to prevent RSV infections in children and its spread in the community.

Developing Adult Vaccination Ecosystem in India: Current Perspective and the Way Forward.

INTRODUCTION: A high burden of vaccine-preventable diseases, increasing elderly population, immunosenescence, and emerging drug resistance emphasize the need for robust adult immunization in India. While immunization guidelines from various societies exist, there is inadequate implementation of the same. AIM: We undertook this narrative review of the adult vaccination ecosystem in India to (i) gain insights into existing adult vaccination practices, (ii) identify barriers to adult vaccination and possible solutions, and (iii) improve collaboration between various stakeholders to help establish adult vaccination centers in the country. RESULTS: Besides the high cost and lack of insurance coverage, the lack of adult vaccination centers contributes to the low coverage of adult immunization. DISCUSSION: These challenges can be addressed through multiple approaches including community awareness and immunization programs, setting up mobile vaccination vans, patient/consumer education, and adequate training of healthcare providers. Successful implementation of these strategies requires active collaboration between the government, hospitals, different stakeholders, and policymakers.

Estimating the Public Health and Economic Impact of Introducing the 13-Valent Pneumococcal Conjugate Vaccine or 10-Valent Pneumococcal Conjugate Vaccines into State Immunization Programs in India.

INTRODUCTION: Although the pneumococcal conjugate vaccine (PCV) has been introduced into select state immunization programs (SIPs) in India, many children remain unvaccinated. Recently, India's Advisory Committee on Vaccines & Immunization Practices recommended PCV on the pediatric immunization schedule nationally. This study estimates the public health and economic impact of introducing either Pfizer's 13-valent PCV (PCV13-PFE), GlaxoSmithKline's 10-valent PCV (PCV10-GSK), or Serum Institute of India's 10-valent PCV (PCV10-SII) into every pediatric SIP. METHODS: A model was developed to predict the disease cases, deaths, and costs associated with implementing PCV13-PFE, PCV10-GSK, or PCV10-SII in SIPs compared to no vaccination program across a 5-year period (2021-2025). State and national-level uptake rate and clinical and economic input parameters were collected from published literature. Disease outcomes included invasive pneumococcal disease, inpatient and outpatient pneumonia, and otitis media. Costs were estimated as vaccine-related costs and direct medical costs incurred to the healthcare system. Results were reported by individual state and aggregated nationally. RESULTS: Estimated over 5 years, implementing PCV13-PFE in SIPs could avert 12.1 million cases and save 626,512 lives among children under 5 years old compared to no vaccination. This corresponds to net national cost savings of over $1.0 billion. Both lower-valent PCVs are estimated to provide less economic savings than PCV13-PFE inclusive of vaccine-related costs. Compared with PCV13-PFE, implementing PCV10-GSK or PCV10-SII nationally is estimated to have a smaller public health impact, with PCV10-GSK averting 8.4 million cases (436,577 deaths) and PCV10-SII preventing 10.3 million cases (531,545 deaths) in India compared to no vaccination, respectively. CONCLUSION: Implementation of PCV13-PFE throughout India is estimated to provide greater public health and economic benefits than PCV10-GSK or PCV10-SII SIPs. Our analysis highlights the substantial disease cases, deaths, and health system cost savings that may be realized from implementing PCV programs throughout India.

Systematic Literature Review on Burden of Clostridioides difficile Infection in India.

BACKGROUND: Owing to limited diagnostic facilities and surveillance protocols, there is a paucity on the prevalence data of Clostridioides difficile infections (CDIs) in developing countries such as India. OBJECTIVE: The aims of these studies are (1) to determine the prevalence of CDI in India, (2) to understand the risk factors of CDI, and (3) to determine the impact of different diagnostic methods on reported CDI rates. METHOD: A systematic literature search was conducted using PubMed and Google Scholar database to identify Indian studies reporting the prevalence of CDI. A total of 31 studies, published between 1990 and 2020 were included in the final analysis. A chi-square test was used to determine statistically significant association between prevalence rates, accuracy of different diagnosis methods, and antibiotic usage rates of CDI. RESULTS: The prevalence of CDI was in the range of 3.4% to 18%, and the difference between regional prevalence of CDI was statistically significant (P < .001). The use of antibiotics, hospital stay, comorbidities, recent surgery, and the use of proton-pump inhibitors was considered as risk factors for the development of CDI. Compared to other regions, the rate of antibiotic usage was significantly higher in North India (P < .001). Among different diagnostic methods, C. difficile detection was significantly higher with enzyme-linked immunosorbent assay (18.02%) versus other multiple testing methods used (P < .001). CONCLUSION: There is a significant burden of CDI across the country. Further surveillance studies are required to monitor changes in prevalence of CDI, risk factors, and accuracy of diagnosis methods for a better understanding of the disease burden in India.

A Systemic Literature Review and Meta-Analysis Reporting the Prevalence and Impact of Methicillin-Resistant Staphylococcus aureus Infection in India.

AIM AND OBJECTIVE: This systematic review and meta-analysis was conducted to assess the prevalence, burden and epidemiology of methicillin-resistant S. aureus (MRSA). This systemic review was also aimed to highlight the challenges in the diagnosis and management of methicillin-resistant S. aureus (MRSA) in India (for all age groups). We also examined the published literature on the available treatment options and the role of prevention in the management of MRSA in India. By summarizing the currently available data, our objectives were to highlight the need for the prevention of MRSA infections and also emphasize the role of vaccination in the prevention of MRSA infections in India. METHODOLOGY: Electronic databases such as PubMed and databases of the National Institute of Science Communication and Information Resources and Indian Council of Medical Research Embase were searched for relevant literature published from 2005/01/01 to 2020/05/13 in English language, according to the predefined inclusion and exclusion criteria. A manual search was also conducted using the key term "MRSA 'or' Methicillin Resistant Staphylococcus aureus 'and' India." An independent reviewer extracted data from the studies using a structured Microsoft Excel spreadsheet, and a meta-analysis of proportion for MRSA prevalence with a corresponding 95% confidence interval (CI) for all included individual studies were performed. RESULT: A total of 34 studies involving 16 237 patients were included in the final meta-analysis. The pooled proportion of patients with MRSA infection was 26.8% (95% CI: 23.2%-30.7%). The MRSA infection was more prevalent among male patients (60.4%; 95% CI: 53.9%-66.5%) as compared to female patients (39.6%; 95% CI: 33.5%-46.1%), while the prevalence of MRSA was higher among adults (18 years and above; 32%; 95% CI: 5%-80%) in comparison to pediatric patients (0-18 years; 68%; 95% CI: 20%-94.8%). The degree of heterogeneity was found to be significant. CONCLUSION: The prevalence of MRSA in India was relatively high at 27% with a higher proportion observed among men aged >18 years. The high prevalence of MRSA infections in India necessitates the implementation of surveillance and preventive measures to combat the spread of MRSA in both hospital and community settings.

Streptococcus pneumoniae as a Cause of Community-Acquired Pneumonia in Indian Adolescents and Adults: A Systematic Review and Meta-Analysis.

BACKGROUND: Streptococcus pneumoniae is one of the primary cause of community-acquired pneumonia (CAP) worldwide. However, scant data are available on the prevalence of etiological organisms for CAP in adolescent and adult Indian population. OBJECTIVE: We performed a systematic review and meta-analysis to determine the contribution of S. pneumoniae in the causation of CAP in Indian patients aged 12 years or above. METHODOLOGY: We performed a systematic search of both indexed and non-indexed publications using PubMed, databases of National Institute of Science Communication and Information Resources (NISCAIR), Annotated Bibliography of Indian Medicine (ABIM), Google Scholar, and hand search including cross-references using key terms 'community acquired pneumonia AND India'. All studies, published between January 1990 and January 2017, that evaluated Indian patients aged above 12 years with a confirmed diagnosis of CAP were eligible for inclusion. Our search retrieved a total of 182 studies, of which only 17 and 12 qualified for inclusion in the systematic review of all etiological organisms, and meta-analysis of S. pneumonia, respectively. RESULTS: A total of 1435 patients met the inclusion criteria. The pooled proportion of patients with S. pneumoniae infection was 19% (95% confidence interval [CI]: 12%-26%; I2 = 94.5% where I2 represents heterogeneity, P < .01). Other major etiological agents are Mycoplasma pneumoniae (15.5% [1.1%-35.5%]), Klebsiella pneumoniae (10.5% [1.6%-24.0%]), and Legionella pneumophila (7.3% [2.5%-23.8%]). CONCLUSIONS: Analysis found approximately a one-fifth proportion of adult Indian patients of CAP with S. pneumoniae infection, suggesting it as a leading organism for causing CAP compared with other etiological organisms.

Modeling Possible Inclusion of Pneumococcal Conjugate Vaccine into the National Immunization Program for Infants in India.

BACKGROUND: India is home to up to 28 million infants born annually, and yet to a large extent these children do not benefit from the protection provided by a pneumococcal conjugate vaccine (PCV) immunization program. The Government of India, with support from Gavi, The Vaccine Alliance (in short, Gavi), has committed to a pilot implementation of PCV. There are few public health impact evaluations available for India, and equally limited epidemiologic data. OBJECTIVES: To estimate the potential impact of an infant pneumococcal vaccination program in India. METHODS: Using a well-established pneumococcal disease impact model parameterized with local data to the extent possible, we calculated the potential impact of introducing an infant PCV program in India. The model considered direct vaccine protection by PCV10 or PCV13, focusing on children younger than 5 years, while varying vaccine uptake according to the implementation method (i.e., state-level programs [Gavi funding] or a government-supported national immunization program [NIP]). RESULTS: With state-level PCV13 programs comprising 25% uptake across the country, approximately 1.9 million cases of pneumococcal disease and approximately 77,000 deaths could be prevented annually. An NIP with PCV13 could prevent approximately 7.6 million cases of pneumococcal disease and approximately 0.3 million pneumococcal deaths annually, compared with no vaccination, considering 100% vaccine uptake. These results are likely to have underestimated the additional potential benefits of herd effects in unvaccinated children and adults. CONCLUSIONS: Incorporation of PCV into an Indian vaccination program for infants is predicted to have a substantially positive health impact. Gavi funding of state-level programs is an important step toward achieving the full benefits of an NIP in India.

Analytical and Clinical Evaluation of an Immunoassay for Estimating Immunogenicity of Infliximab and Etanercept in Indian Population.

BACKGROUND / OBJECTIVES: Biologic anti-TNFs in India have improved the patient management. Significant proportions of patients lose response over time or do not respond. Possible explanations are suboptimal trough anti-TNFa concentrations or antibodies to anti-TNFs. The aim of this project was to set up and standardize an independent laboratory to test immunogenicity of anti-TNF biologics (infliximab and etanercept). METHODS: Three rheumatologists piloted this project approved by independent ethics committee and carried out in compliance with ICH/GCP guidelines. Pfizer supplied immunogenicity kits (Promonitor® - ELISA) to the independent laboratory (SRL labs). After informed consent, blood (5 mL) was collected before infusion of infliximab (n=8) or injection of etanercept (n=8). RESULTS: Mean age of 16 patients was 42.06 ± 12.89 years. While 4 patients tested negative for infliximab, one patient tested low positive and 3 patients were positive. Anti-infliximab antibody was detected in 1/8 patient (12.5%) and the blood level of infliximab was negligible. DISCUSSION: Anti-infliximab antibodies are found in 12%-44% of patients vis-a`-vis anti-etanercept antibodies (0%-18%). Anti-etanercept antibodies are without apparent effect on effectiveness or adverse events. When anti-TNFa are used, therapeutic drug monitoring is of help for optimal clinical outcomes. It might be more cost effective to adjust anti TNFa dosages according to serum drug concentrations. Clinicians should have access to immunogenicity testing facility in India. The results of the study were as per the observed percentages across the world. CONCLUSIONS: This study met its objective of setting up and standardizing an independent laboratory for immunogenicity testing of anti-TNF biologics in India.

Literature review of rheumatoid arthritis in India.

AIM: Rheumatoid arthritis (RA) can lead to severe disability. This literature review assessed the descriptive epidemiology, comorbidities and extra-articular manifestations, functioning abilities and quality of life, and treatment patterns of RA patients in India. METHOD: A literature review of all observational studies published from 1985 to 2012 was conducted using MEDLINE and Embase. Quantitative and qualitative findings were summarized. RESULTS: Twenty-eight studies were identified for data extraction. Seven described the descriptive epidemiology of RA, 14 described comorbidities and extra-articular manifestations, nine described the functioning abilities and quality of life among patients, and 10 provided information on treatments. CONCLUSION: This review is confined to studies with small sample sizes, cross-sectional designs, and/or clinical settings that may not be representative of the entire Indian population. There is a need for more robust studies, as conclusions for the entire Indian RA population cannot be drawn from only the current observational studies.

Alternate Day versus Once Daily Atorvastatin for Primary Prevention of (CHD) in Naïve Patients of Dyslipidemia.

INTRODUCTION: Statins (or HMG-CoA reductase inhibitors) have become drug of choice for raised Low-Density Lipoprotein Cholesterol (LDL-C) in treating. Of these, Atorvastatin, because of its prolonged 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase inhibition has been considered for alternate day therapy in primary prevention of (CHD). OBJECTIVES: To compare the efficacy and safety of daily versus alternate day 10 mg Atorvastatin on reduction of lipid levels in patients of dyslipidemia and to evaluate the number of patients reaching the target Low-Density Lipoprotein (LDL) goals in these groups. METHODOLOGY: In this comparative, randomized, parallel group, non-blinded study, 100 naïve dyslipidemic patients in low to moderate risk group as per NCEP ATP (III) Guidelines were divided in two groups. Group A (n=50) received Atorvastatin 10 mg every alternate day for three months and Group B (n=50) received Atorvastatin 10 mg daily for three months. Apart from general examination and baseline investigations, lipid profile was also done. Efficacy was assessed by the percentage reduction in LDL and attainment of LDL goals as per NCEP ATP III Guidelines at the end of the study. Safety of the medication was assessed. RESULTS: Atorvastatin 10 mg daily produced a significant reduction in Total Cholesterol (TC), LDL, Very Low Density Lipoprotein (VLDL) as compared to Atorvastatin 10 mg alternate day. The increase in the HDL level was also greater with a daily dose as compared to alternate day (but not statistically significant). In Low risk category 86.12 % patients (n=31) on daily dose reached their LDL-C goal vis-a-vis 66.67% (n=18) of patients on alternate day therapy. In the moderate risk category 100 % of daily Atorvastatin patients (n=10) achieved their LDL-C goal versus 33.33% patients (n=4) on alternate day therapy. Adverse events with alternate day therapy (n=4) were less as compared with daily treatment (n=10). CONCLUSION: Atorvastatin 10 mg daily was found to be safe and efficacious in patients with dyslipidemia compared to an alternate day therapy.

Evaluation of factors that motivate participants to consent for non-therapeutic trials in India.

BACKGROUND AND RATIONALE: Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. METHODS: This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. RESULTS: The most common motivation among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were 'invited to participate by the treating physician' (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). CONCLUSIONS: The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends.