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1.
Indian J Pharmacol ; 56(2): 97-104, 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38687313

ABSTRACT

OBJECTIVES: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs. MATERIALS AND METHODS: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range). RESULTS: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001). CONCLUSION: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines.


Subject(s)
Hypoglycemic Agents , India , Humans , Retrospective Studies , Hypoglycemic Agents/economics , Hypoglycemic Agents/therapeutic use , Cardiovascular Diseases/drug therapy , Cardiovascular Diseases/economics , Drugs, Generic/economics , Drugs, Generic/therapeutic use , Hypolipidemic Agents/economics , Hypolipidemic Agents/therapeutic use , Heart Disease Risk Factors , Drug Costs , Hypertension/drug therapy , Hypertension/economics , Diabetes Mellitus/drug therapy , Diabetes Mellitus/economics , Dyslipidemias/drug therapy , Dyslipidemias/economics , Antihypertensive Agents/economics , Antihypertensive Agents/therapeutic use , Costs and Cost Analysis
2.
Indian J Med Res ; 159(2): 130-141, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38528817

ABSTRACT

BACKGROUND OBJECTIVES: Irrational prescribing practices have major consequences on patient safety and also increase the economic burden. Real-life examples of impact of irrational prescription have potential to improve prescribing practices. In this context, the present study aimed to capture and evaluate the prevalence of deviations from treatment guidelines in the prescriptions, potential consequence/s of the deviations and corrective actions recommended by clinicians. METHODS: It was a cross-sectional observational study conducted in the outpatient departments of tertiary care hospitals in India wherein the 13 Indian Council of Medical Research Rational Use of Medicines Centres are located. Prescriptions not compliant with the standard treatment guidelines and incomplete prescriptions with respect to formulation, dose, duration and frequency were labelled as 'prescriptions having deviations'. A deviation that could result in a drug interaction, lack of response, increased cost, preventable adverse drug reaction (ADR) and/or antimicrobial resistance was labelled as an 'unacceptable deviation'. RESULTS: Against all the prescriptions assessed, about one tenth of them (475/4838; 9.8%) had unacceptable deviations. However, in 2667/4838 (55.1%) prescriptions, the clinicians had adhered to the treatment guidelines. Two thousand one hundred and seventy-one prescriptions had deviations, of which 475 (21.9%) had unacceptable deviations with pantoprazole (n=54), rabeprazole+domperidone (n=35) and oral enzyme preparations (n=24) as the most frequently prescribed drugs and upper respiratory tract infection (URTI) and hypertension as most common diseases with unacceptable deviations. The potential consequences of deviations were increase in cost (n=301), ADRs (n=254), drug interactions (n=81), lack of therapeutic response (n=77) and antimicrobial resistance (n=72). Major corrective actions proposed for consideration were issuance of an administrative order (n=196) and conducting online training programme (n=108). INTERPRETATION CONCLUSIONS: The overall prevalence of deviations found was 45 per cent of which unacceptable deviations was estimated to be 9.8 per cent. To minimize the deviations, clinicians recommended online training on rational prescribing and administrative directives as potential interventions.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Prescriptions , Humans , Cross-Sectional Studies , Tertiary Care Centers , India/epidemiology , Anti-Bacterial Agents/adverse effects , Drug Prescriptions
3.
Neurosci Lett ; 825: 137706, 2024 Mar 10.
Article in English | MEDLINE | ID: mdl-38431040

ABSTRACT

INTRODUCTION: Levodopa-induced dyskinesia (LID) is a debilitating motor feature in a subset of patients with Parkinson's disease (PD) after prolonged therapeutic administration of levodopa. Preliminary animal and human studies are suggestive of a key role of dopamine type 3 (D3) receptor polymorphism (Ser9Gly; rs6280) in LID. Its contribution to development of LID among Indian PD patients has remained relatively unexplored and merits further investigation. METHODS AND MATERIALS: 200 well-characterised PD patients (100 without LID and 100 with LID) and 100 age-matched healthy controls were recruited from the outpatient department of Institute of Neurosciences Kolkata. MDS-UPDRS (Unified Parkinson's Disease Rating Scale from International Movement Disorder Society) Part III and AIMS (abnormal involuntary movement scale) were performed for estimation of severity of motor features and LID respectively in the ON state of the disease. Participants were analysed for the presence of Ser9Gly single nucleotide variant (SNV) (rs6280) by polymerase chain reaction followed by restriction fragment length polymorphism techniques. RESULTS: The frequency of AA genotype (serine type) was more frequently present in PD patients with LID compared to PD patients without LID (50 % vs 28 %; P = 0.002; OR = 2.57, 95 % CI: 1.43 - 4.62). The abnormal involuntary movement scale score was significantly higher in PD patients with AA genotype compared to carriers of glycine allele (AG + GG) (4.08 ± 3.35; P = 0.002). CONCLUSION: We observed a significant association of serine type SNV (rs6280) in D3 receptor gene in a cohort of PD patients with LID from India. More severe motor severity was found in patients with glycine substitution of the same SNV. The current study emphasised the role of D3 receptor in the pathogenesis of LID.


Subject(s)
Dyskinesia, Drug-Induced , Parkinson Disease , Animals , Humans , Antiparkinson Agents/therapeutic use , Dyskinesia, Drug-Induced/genetics , Dyskinesia, Drug-Induced/drug therapy , Glycine , Levodopa/adverse effects , Parkinson Disease/drug therapy , Parkinson Disease/genetics , Polymorphism, Single Nucleotide , Receptors, Dopamine D3/genetics , Serine/genetics
4.
Indian J Nephrol ; 33(5): 340-347, 2023.
Article in English | MEDLINE | ID: mdl-37881738

ABSTRACT

Introduction: Therapy of proliferative lupus nephritis (PLN) is yet to be optimized. Standard of care for induction consists of intravenous (IV) cyclophosphamide (CYC) and steroids, which shows an improved outcome, but end-stage renal disease (ESRD) progression, increased mortality, and therapy-related adverse effects remain a major concern. The other treatment reported to induce early remission was the multitarget therapy comprising tacrolimus, mycophenolate, and steroid, but infections were high in the multitarget therapy. Considering azathioprine as a potentially safer and effective alternative anti-B-cell therapy, modified multitarget therapy (MMTT) was planned replacing mycophenolate with azathioprine. Material and Methods: A single-center, 24-week, open-label, randomized controlled trial comprising adults of age 18-65 years with biopsy-proven PLN was carried out. The intervention groups were 1) MMTT: tacrolimus 0.075 mg/kg/day and azathioprine 2 mg/kg/day and 2) IV CYC group with a starting dose of 0.75 (adjusted to 0.5-1.0) g/m2 every 4 weeks for 6 months. Both groups received 3 days of pulse methylprednisolone followed by a tapering course of oral prednisone therapy. Results: Among 100 randomized patients, 48 were in MMTT arm and 52 were in IV CYC arm. At the end of 24 weeks, overall remission (complete and partial) was comparable in both the arms: MMTT (86.36%) and IV CYC (87.75%). There was comparable proteinuria reduction and systemic lupus erythematosus disease activity index (SLEDAI) score improvement with recovery of complement level C3 in both groups. Major adverse events were numerically more in the IV CYC group, including one death from pneumonia. Conclusion: The MMTT arm is as effective as IV CYC in improving short-term outcome in PLN, with a comparable safety profile.

5.
J Assoc Physicians India ; 71(2): 11-12, 2023 Feb.
Article in English | MEDLINE | ID: mdl-37354468

ABSTRACT

AIM: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. METHODS: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. RESULTS: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. CONCLUSION: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.


Subject(s)
Hospitals , Cross-Sectional Studies , Prospective Studies , Drug Combinations , India
6.
Perspect Clin Res ; 13(2): 99-105, 2022.
Article in English | MEDLINE | ID: mdl-35573450

ABSTRACT

Purpose: This multicentric questionnaire-based study was undertaken to address the lack of systematic background data on the knowledge, attitudes, and practices among Indian physicians related to antimicrobial use and resistance. Materials and Methods: A validated structured study questionnaire was used for capturing respondent particulars, antimicrobial prescribing habits, knowledge of antimicrobial resistance (AMR), ways of choosing and learning about antibiotics, agreement or disagreement with certain perceptions regarding antibiotics, selection of antibiotics in specific settings, and suggestions regarding rationalizing antimicrobial use in the practice setting. Summary statistical analysis of the pooled data was done. Results: Five hundred and six respondents with a mean (standard deviation) age of 31.4 (8.71) years participated in the study. Three hundred and twenty-seven were medical and 179 surgical discipline clinicians. Overall, the theoretical knowledge about antimicrobials was satisfactory, but areas of concern were noted in the attitude and practice domains. A substantial proportion of participants failed to identify the correct choice of antibiotics in the case-based scenarios. 38.33% reported not attending a single continuing medical education on antimicrobials during the past year. Statistically significant differences were not observed in the KAP quotient scores between medical and surgical discipline respondents. Conclusions: Despite satisfactory background knowledge regarding the rational use of antimicrobials and AMR patterns, there are discrepancies in the physicians' prescribing attitude and thus strengthen the case for instituting specific interventions to improve antimicrobial prescribing.

7.
Indian J Pharmacol ; 54(1): 51-57, 2022.
Article in English | MEDLINE | ID: mdl-35343208

ABSTRACT

The use of monoclonal antibodies has expanded beyond the realm of autoimmune disease and cancer therapeutics to communicable diseases. Their antiviral activities were evaluated in some diseases such as SARS MERS (Middle East Respiratory Syndrome) and Ebola. In recent times, antispike SARS-CoV-2 monoclonal antibody cocktails (casirivimab with imdevimab and bamlanivimab with etesevimab) and single agent sotrovimab have received emergency use authorization for treatment of nonhospitalized COVID-19 patients with mild-to-moderate disease at high risk of disease progression. This review summarizes their mechanism of action, salient pharmacokinetic profile, safety and clinical trial (ongoing and completed) data. Despite evidence to support its use for the indication, the high cost of these biologics may make it unaffordable for many patients, but further clinical studies on their cost-benefit profile shall provide useful information to the scientific community and patients.


Subject(s)
COVID-19 Drug Treatment , SARS-CoV-2 , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , Antibodies, Neutralizing , Humans
8.
J Trop Pediatr ; 68(2)2022 02 03.
Article in English | MEDLINE | ID: mdl-35201359

ABSTRACT

OBJECTIVES: This study compared the risk of hypoglycemia within 72 h of life in infants with and without exposure to antenatal dexamethasone in the late preterm period (34-366/7 week's gestational age). METHODS: This prospective cohort study was conducted in a tertiary care neonatal unit of Eastern India from May 2021 to November 2021. Babies in the exposed group received at least one dose of antenatal dexamethasone in the late preterm period between 7 days before delivery and birth. 'Complete course' of antenatal steroid was defined as four doses of injection dexamethasone at 12 h intervals and <4 doses were considered as 'Partial course'. Primary outcome was incidence of hypoglycemia within 72 h of life, defined as whole blood glucose <45 mg/dl. RESULTS: Total 298 infants (98 in control, 134 in partial and 66 in complete group) were assessed for final outcome. No significant difference in outcomes were seen in the exposed group compared to unexposed group. However, incidence of hypoglycemia within 72 h (complete vs. partial p= 0.008, complete vs. control p=0.005) and 12 h of life (complete vs. partial p=0.013, complete vs. control p=0.013) was significantly less in complete steroid group. Logistic regression analysis revealed complete course of antenatal corticosteroid significantly decreased the risk of hypoglycemia [adjusted odds ratio, 95% confidence interval (CI) 0.15 (0.03-0.69), p=0.015]. Number needed to be exposed for one additional benefit was 7 (95% CI, 6.35-22.14). CONCLUSION: Complete course of dexamethasone administered to mothers at risk of late preterm delivery reduces risk of neonatal hypoglycemia within 72 h of life.


Subject(s)
Hypoglycemia , Premature Birth , Respiratory Distress Syndrome, Newborn , Adrenal Cortex Hormones , Developing Countries , Dexamethasone , Female , Gestational Age , Humans , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemia/prevention & control , Infant , Infant, Newborn , Pregnancy , Premature Birth/epidemiology , Prenatal Care , Prospective Studies
10.
Curr Drug Res Rev ; 14(1): 20-23, 2022.
Article in English | MEDLINE | ID: mdl-34872487

ABSTRACT

The incidence of carbapenem-resistant gram-negative (CRGNB) bacterial infections has increased globally. The wide diversity of strains, multiplicity of infections, and rapid development and spread of resistance are a matter of great concern both in community and hospital settings. Cefiderocol is a novel injectable siderophore containing cephalosporin with potent microbicidal activity against most carbapenem-resistant Enterobacteriaceae (CRE). It has recently been approved by USFDA for the treatment of complicated urinary tract infections (cUTI) caused by susceptible gram-negative microorganisms. This review focuses on the salient pharmacological profile of the drug and the clinical studies that were undertaken. Cefiderocol is first in class injectable siderophore cephalosporin showing potency against carbapenem- resistant Enterobacteriaceae. It has recently been approved by US FDA for the treatment of adult patients with complicated urinary tract infections (cUTI) caused by susceptible Gram-negative microorganisms, where there are limited or no alternative treatment options.


Subject(s)
Carbapenem-Resistant Enterobacteriaceae , Gram-Negative Bacterial Infections , Urinary Tract Infections , Adult , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Carbapenems/pharmacology , Carbapenems/therapeutic use , Cephalosporins/pharmacology , Cephalosporins/therapeutic use , Female , Gram-Negative Bacteria , Gram-Negative Bacterial Infections/drug therapy , Gram-Negative Bacterial Infections/microbiology , Humans , Male , Siderophores/pharmacology , Siderophores/therapeutic use , Urinary Tract Infections/drug therapy , Urinary Tract Infections/microbiology , Cefiderocol
11.
Indian J Pharmacol ; 54(6): 407-416, 2022.
Article in English | MEDLINE | ID: mdl-36722552

ABSTRACT

BACKGROUND: The concept of listing essential medicines can lead to improved supply and access, more rational prescribing, and lower costs of drugs. However, these benefits hinge on the prescription of drugs from an Essential Medicines List (EML). Several studies have highlighted the problem of underutilization of EMLs by prescribers. Therefore, as part of prescription research by the Indian Council of Medical Research-Rational Use of Medicines Centres Network, we evaluated the extent of prescription of drugs not listed in the National List of Essential Medicines (NLEM). MATERIALS AND METHODS: Prescriptions of outpatients from participating centers were included after obtaining verbal/written informed consent as approved by the Ethics Committee, and evaluated for prescription of drugs from the NLEM 2015. RESULTS: Analysis of 4838 prescriptions from 13 tertiary health-care institutes revealed that 2677 (55.33%) prescriptions had at least one non-NLEM drug prescribed. In all, 5215 (31.12%) of the total 16,758 drugs prescribed were not in NLEM. Of these, 2722 (16.24%) were single drugs and 2493 (14.88%) were fixed-dose combinations (FDCs). These comprised 700 different drug products - 346 single drugs and 354 FDCs. The average number of non-NLEM drugs prescribed per prescription was 1.08, while the average number of all drugs prescribed was 3.35 per prescription. It was also found that some of the non-NLEM drugs prescribed had the potential to result in increased cost (for example, levocetirizine), increased adverse effects (dextromethorphan), and less effectiveness (losartan) when compared to their NLEM counterparts. Nonavailability of an essential drug (oral hydroxocobalamin) was another important finding of our study. CONCLUSION: This study highlights the extent and pattern of drugs prescribed from outside the NLEM at the tertiary health-care level and the need for training and enhanced awareness among prescribers for greater utilization of the NLEM.


Subject(s)
Biomedical Research , Drugs, Essential , Tertiary Care Centers , India , Prescriptions
12.
Indian J Pharmacol ; 54(6): 417-422, 2022.
Article in English | MEDLINE | ID: mdl-36722553

ABSTRACT

BACKGROUND: Mucormycosis is a rare but serious fungal infection which has dramatically increased in post-COVID patients. There is a paucity of safety data on amphotericin B (amphoB) used for mucormycosis treatment. OBJECTIVES: The objective of this prospective, observational, active safety surveillance study was to evaluate the safety profile of amphoB in a cohort of hospitalized patients who were on the drug for suspected mucormycosis. MATERIALS AND METHODS: All suspected adverse drug reactions (ADRs) in hospitalized mucormycosis patients who had received amphoB were analyzed. The nature, severity, outcome of the ADRs were recorded and analyzed. RESULTS: Of the 77 patients enrolled, 70% had documented history of prior COVID-19 infection. 96% had comorbidities, the most common being diabetes. Majority received conventional amphotericin B deoxycholate formulation. 97% experienced at least one suspected ADR and the median ADR/patient was 3. Out of 214 ADRs, 91 were serious but there were no ADR-related deaths. The most common ADRs were hypokalemia (31.78%), infusion-related reactions (22.43%), and anemia (17.29%). Thirty-three patients had serum potassium <2.5 mEq/L, while 11 had serum magnesium <1.25 mg/dL. Doubling of pretreatment creatinine level was noted in 15 patients. Seventy percent ADRs were of "possible" category as per the World Health Organization Uppsala Monitoring Centre categorization. CONCLUSION: AmphoB deoxycholate use in mucormycosis patients was associated with a high incidence of electrolyte abnormalities and infusion-related reactions. All ADRs subsided with medical management and none were fatal. The safety data generated from this study may be useful in resource-limited settings where the far more expensive liposomal formulation is not being used.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Mucormycosis , Humans , Mucormycosis/drug therapy , Mucormycosis/epidemiology , Amphotericin B/adverse effects , Pharmacovigilance , Prospective Studies , Tertiary Care Centers , India/epidemiology
13.
J Family Med Prim Care ; 10(5): 1981-1986, 2021 May.
Article in English | MEDLINE | ID: mdl-34195135

ABSTRACT

OBJECTIVES: One of the most prevalent autoimmune disease globally, rheumatoid arthritis (RA) is caused by interplay of multiple inflammatory mediators in specific joints. Altered redox balance is one of the key factors in pathophysiology of RA. This study aims to find whether oxidative stress in peripheral blood neutrophil correlates with the disease activity and disability associated with it. METHODS: Ten healthy controls and 29 RA patients with moderate to severe disease activity (DAS28 score >3.2) were recruited and reactive oxygen species (ROS) level in peripheral blood neutrophil was measured using flow cytometry at baseline visit and after 6 months follow-up. Functional status of RA patients was measured using Health Assessment Questionnaire Disability Index (HAQ-DI). RESULTS: RA patients showed significantly higher level of ROS in compared to healthy control. DAS28 correlated well with ROS at baseline visit (Pearson's r = +0.63) as well as follow-up visit (Pearson's r = +0.75). HAQ-DI showed weak positive correlation at baseline visit (Pearson's r = 0.1) but it was negative at follow-up visit (Pearson's r = -0.19). CONCLUSIONS: Oxidative stress mirrors the disease activity in RA and can be considered as a biomarker, but it is not related with functional ability of the patients.

14.
J Antimicrob Chemother ; 76(4): 1094-1101, 2021 03 12.
Article in English | MEDLINE | ID: mdl-34244744

ABSTRACT

OBJECTIVES: Data from point prevalence surveys (PPSs) in India are scarce. Conducting PPSs is especially challenging in the absence of electronic medical records, a lack of dedicated resources and a high patient load in resource-poor settings. This multicentre survey was conducted to provide background data for planning and strengthening antimicrobial stewardship programmes across the country. METHODS: This inpatient PPS was conducted over 2 weeks in May 2019 simultaneously across five study centres in India. Data about patient characteristics, indications for antimicrobials use and details of each antimicrobial prescribed including supportive investigation reports were collected in predesigned forms. RESULTS: A total of 3473 admitted patients in wards and ICUs were covered across five study centres. Of these, 1747 (50.3%) patients were on antimicrobials, with 46.9% patients being on two or more antimicrobials. Out of the total antimicrobials prescribed, 40.2% of the antimicrobials were prescribed for community-acquired infection requiring hospitalization followed by surgical prophylaxis (32.6%). Third-generation cephalosporins and drugs from the 'Watch' category were prescribed most commonly. Only 22.8% of the antimicrobials were based on microbiology reports. CONCLUSIONS: The survey demonstrated a high use of antimicrobials in admitted patients with a considerable proportion of drugs from the 'Watch' category. The targets for interventions that emerged from the survey were: improving surgical prophylaxis, decreasing double anaerobic cover, initiating culture of sending cultures and de-escalation with targeted therapy.


Subject(s)
Anti-Bacterial Agents , Anti-Infective Agents , Anti-Bacterial Agents/therapeutic use , Hospitalization , Humans , Prevalence , Tertiary Care Centers
15.
Indian J Med Res ; 153(1 & 2): 219-226, 2021.
Article in English | MEDLINE | ID: mdl-33818480

ABSTRACT

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.


Subject(s)
COVID-19 Drug Treatment , COVID-19/prevention & control , Health Personnel , Hydroxychloroquine , Cross-Sectional Studies , Female , Humans , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Male , Pre-Exposure Prophylaxis
16.
Toxins (Basel) ; 13(1)2021 01 14.
Article in English | MEDLINE | ID: mdl-33466571

ABSTRACT

Since its introduction as a treatment for strabismus, botulinum toxin (BoNT) has had a phenomenal journey and is now recommended as first-line treatment for focal dystonia, despite short-term clinical benefits and the risks of adverse effects. To cater for the high demand across various medical specialties, at least six US Food and Drug Administration (FDA)-approved formulations of BoNT are currently available for diverse labelled indications. The toxo-pharmacological properties of these formulations are not uniform and thus should not be used interchangeably. Synthetic BoNTs and BoNTs from non-clostridial sources are not far from clinical use. Moreover, the study of mutations in naturally occurring toxins has led to modulation in the toxo-pharmacokinetic properties of BoNTs, including the duration and potency. We present an overview of the toxo-pharmacology of conventional and novel BoNT preparations, including those awaiting imminent translation from the laboratory to the clinic.


Subject(s)
Botulinum Toxins/pharmacology , Botulinum Toxins/therapeutic use , Drug Compounding , Drug Development , Bacterial Toxins/pharmacology , Bacterial Toxins/therapeutic use , Botulinum Toxins/chemistry , Drug Prescriptions , Humans , Nervous System Diseases/drug therapy , Neuromuscular Agents/pharmacology , Neuromuscular Agents/therapeutic use , Neuromuscular Junction/drug effects , Recombinant Proteins/pharmacology , Recombinant Proteins/therapeutic use
17.
Indian J Endocrinol Metab ; 25(4): 283-292, 2021.
Article in English | MEDLINE | ID: mdl-35136733

ABSTRACT

OBJECTIVES: This meta-analysis of randomized clinical trials (RCT) intends to evaluate the efficacy of DPP4 Inhibitors (DPP4I) compared with placebo, other antidiabetics (or DPP4I) on renal outcomes, adverse events (AEs), and all-cause mortality. METHODS: We searched relevant scientific database for RCTs with DPP4I and prespecified renal end point. The effect size (mean difference or risk ratio) was reported with its 95% confidence interval. RESULTS: Eight RCTs (n = 39040 participants) were included in the analysis. The rate of change in eGFR was not different in DPP4 inhibitor and control group. DPP4I use beyond 52 weeks did not worsen albuminuria progression (RR 0.88; 95% CI 0.80 to 0.96; high quality evidence) compared to placebo. The risk of AEs within 52 weeks (RR 0.93; 95% CI 0.80 to 1.08; moderate quality evidence), beyond 52 weeks (RR 0.98; 95% CI 0.97 to 1.00; low quality evidence), and all-cause mortality (RR 1.04; 95% CI 0.96 to 1.12; very low quality evidence) were similar to placebo. In head-to-head comparison between two DPP4I studies, no significant differences were found between alogliptin and vildagliptin for improvement in eGFR, UACR, or AE at 24 weeks. CONCLUSIONS: DPP4I do not seem to provide persuasive benefit in the renal outcomes or all-cause mortality in diabetes mellitus, though there was no evidence for increased AEs.

18.
Sustainability ; 13(22): 12427, 2021 Nov 10.
Article in English | MEDLINE | ID: mdl-37692052

ABSTRACT

This paper highlights the potential for learning and virtual collaboration in international research teams to contribute towards sustainability goals. Previous research confirmed the environmental benefits of carbon savings from international virtual conferences. This paper adds the social and economic dimensions by using a combination of qualitative and quantitative methods to measure the constraints and benefits for personal development, economic costs, efficiency and team learning of holding international virtual conferences (VCs). Using the Sustainable and Healthy Food Systems (SHEFS) research programme as a case study, we analysed VC participant survey data to identify strengths, weaknesses, opportunities, and threats of VCs. We estimated 'saved' GHG emissions, costs, and time, of using VCs as an alternative for a planned in-person meeting in Chennai, India. Hosting VCs reduced North-South, gender, and researcher inclusivity concerns, financial and travelling time costs, and substantially reduced emissions. For one international meeting with 107 participants, changing to a virtual format reduced the per capita GHG emissions to half the annual global average, and avoided 60% of travel costs. The benefits of VCs outweighed weaknesses. The main strengths were inclusivity and access, with 20% more early/mid-career researchers attending. This study identified opportunities for international research partnerships to mitigate their carbon footprint (environmental benefit) and enhance inclusivity of early/mid-career, women and Global South participants (social benefit), whilst continuing to deliver effective collaborative research meetings (economic benefit). In doing so, we present a holistic view of sustainability opportunities for virtual collaboration.

19.
Trans R Soc Trop Med Hyg ; 115(7): 785-791, 2021 07 01.
Article in English | MEDLINE | ID: mdl-33216125

ABSTRACT

BACKGROUND: To address the reasons for inappropriate use of antimicrobials, it is important to understand the knowledge, attitude and practices (KAP) of all pertinent stakeholders. This multicentric survey is aimed at understanding the KAP quotients of the community regarding antimicrobial use and antimicrobial resistance (AMR), as such information is lacking in India. METHODS: A cross-sectional survey was conducted by face-to-face interviews across five centers in India using a validated, field-tested questionnaire incorporating KAP domain questions. Scores were appropriately assigned to the questions. RESULTS: The mean (SD) age of the respondents was 35.2 (12.61) y and 62% had a graduate or higher level of education. The median (IQR) KAP scores were 10 (8-12), 5 (3-5) and 2 (2-3) out of a maximum of 18, 5 and 6, respectively. Higher educational and socioeconomic levels were associated with better attitude scores, but knowledge levels were comparable. Correlations between KAP scores were poor. CONCLUSIONS: This study reveals that laypeople have appropriate knowledge and attitude regarding antibiotic use and AMR to some degree but there are important lacunae and practices are often wanting. These issues need to be addressed in sustained public awareness and motivation campaigns to improve the rational use of antibiotics in India.


Subject(s)
Anti-Infective Agents , Health Knowledge, Attitudes, Practice , Anti-Bacterial Agents/therapeutic use , Cross-Sectional Studies , Humans , India , Surveys and Questionnaires
20.
Indian J Crit Care Med ; 24(7): 570-574, 2020 Jul.
Article in English | MEDLINE | ID: mdl-32963442

ABSTRACT

In the current COVID-19 pandemic, evidence to justify the use of any specific antiviral drug with proven efficacy is not yet available. Antiviral drug development always remains a challenge to the scientists. Remdesivir has emerged as a promising molecule, based on results of clinical trials and observational studies and has receieved marketing approval for COVID-19 treatment under "emergency use authorization" in countries such as United States. Remdesivir is a newer antiviral drug that acts as an RNA-dependent RNA polymerase (RdRp) inhibitor targeting the viral genome replication process. Therapeutic efficacy was first demonstrated by suppressing viral replication in Ebola-infected rhesus monkeys. It is available for parenteral use with reasonable safety and tolerability profile. Multiple clinical trials are going on in many countries to evaluate its safety, efficacy and tolerability. Positive outcome will make the drug capable of meeting the demand generated by both the current pandemic and future outbreak. HOW TO CITE THIS ARTICLE: Choudhury S, Chakraborty DS, Lahiry S, Chatterjee S. Past, Present, and Future of Remdesivir: An Overview of the Antiviral in Recent Times. Indian J Crit Care Med 2020;24(7):570-574.

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