Rates and determinants of fast chronic kidney disease progression distinguished by nutritional status, and the impact of malnutrition on mortality - evidence from a clinical population.

BACKGROUND & AIMS: Malnutrition is a serious problem that influences morbidity, mortality, functional activity, and quality of life in patients with chronic kidney disease (CKD). However, there has not been much research done on how nutritional status appears to affect mortality in non-dialysis CKD patients. This study aimed to recognize the rates and predictors of fast CKD progression distinguished by nutritional status, and also sought to determine the impact of malnutrition on mortality in non-dialysis CKD patients. METHODS: This prospective cohort study (n = 360) involved non-dialysis CKD patients with index estimated glomerular filtration rate (eGFR) between the range of 15-89 ml/min/1.73 m2. Nutritional status was evaluated by using the "Pt-Global web tool/PG-SGA". A loss of eGFR >4 ml/min/1.73 m2 per year was considered to be a sign of fast CKD progression. Kaplan-Meier plots were used to evaluate the cumulative survival, and Cox-proportional hazard models were used to analyze the renal outcomes. RESULTS: Around 244 (67.8%) of patients have experienced a fast decline in kidney function. In the malnourished group, systolic blood pressure and hyperphosphatemia were observed to have increased hazards for fast CKD progression. The overall incidence of mortality and composite endpoints were found to be 13.9% & 37.6%, respectively. Death rates (11.6%) and composite endpoints (29.8%) were higher in the malnourished (severe & moderate) group. Cox regression hazard model reported 4 times increased hazards for death [HR 4.41 (1.99-9.77) 95% CI; P ≤ 0.005] and 3 times increased hazards for composite endpoints [HR 3.29 (2.10-5.16) 95% CI; P ≤ 0.005] for 'severely malnourished' category in reference to 'normal nutrition' category. CONCLUSIONS: Fast CKD progression was observed to be more common in malnourished patients. Systolic blood pressure and hyperphosphatemia were recognized as potential predictors of fast CKD progression. Moreover, malnutrition was found to be a significant predictor of mortality among non-dialysis CKD patients. The findings of this study advocate for early nutritional evaluation and timely dietary interventions to halt the progression of CKD.

A systematic review and meta-analysis for risk factor profiles in patients with resistant Acinetobacter baumannii infection relative to control patients.

BACKGROUND: Acinetobacter baumannii is a major cause of nosocomial infections and high mortality rates. Evaluation of risk factors for such resistant infections may aid surveillance and diagnostic initiatives, as well as, can be crucial in early and appropriate antibiotic therapy. OBJECTIVE: To identify the risk factors in patients with resistant A. baumannii infection with respect to controls. METHODS: Prospective or retrospective cohort and case-control studies reporting the risk factors for resistant A. baumannii infection were collected through two data sources, MEDLINE/PubMed and OVID/Embase. Studies published in the English language were included while animal studies were excluded. The Newcastle-Ottawa Scale was used to assess the quality of studies. The odds ratio of developing antibiotic resistance in patients with A. baumannii infection was pooled using a random-effect model. RESULTS: The results are based on 38 studies with 60878 participants (6394 cases and 54484 controls). A total of 28, 14, 25, and 11 risk factors were identified for multi-drug resistant (MDRAB), extensive-drug resistant (XDRAB), carbapenem-resistant (CRAB) and imipenem resistant A. baumannii infection (IRAB), respectively. In the MDRAB infection group, exposure to carbapenem (OR 5.51; 95% CI: 3.88-7.81) and tracheostomy (OR 5.01; 95% CI: 2.12-11.84) were identified with maximal pool odd's ratio. While previous use of amikacin (OR 4.94; 95% CI: 1.89-12.90) and exposure to carbapenem (OR 4.91; 95% CI: 2.65-9.10) were the foremost factors associated with developing CRAB infection. Further analysis revealed, mechanical ventilation (OR 7.21; 95% CI: 3.79-13.71) and ICU stay (OR 5.88; 95% CI: 3.27-10.57) as the most significant factors for XDRAB infection. CONCLUSION: The exposure of carbapenem, amikacin (previous) and mechanical ventilation were the most significant risk factors for multidrug, extensive-drug, and carbapenem resistance in patients with A. baumannii infection respectively. These findings may guide to control and prevent resistant infections by identifying the patients at higher risk of developing resistance.

Nutritional status, symptom burden, and predictive validity of the Pt-Global web tool/PG-SGA in CKD patients: A hospital based cross sectional study.

BACKGROUND: Despite not being frequently recognized, malnutrition, a consequence of chronic kidney disease, negatively affects morbidity, mortality, functional activity, and patient's quality of life. Management of this condition is made more difficult by the dearth of knowledge regarding the symptom burden brought on by inadequate nutritional status. Additionally, there are multiple tools to evaluate nutritional status in CKD; but, Pt-Global web tool/PG-SGA used in oncology, has not been investigated in chronic kidney disease patients. This study aimed to explore the nutritional status, symptom burden and also investigate the predictive validity of Pt-Global web tool/PG-SGA among pre-dialysis diabetic and non-diabetic chronic kidney disease patients. METHODOLOGY: This cross-sectional study was carried out at a renal clinic of a tertiary care public teaching hospital. Nutritional status and symptom burden was evaluated by employing a 'Pt-Global web tool/PG-SGA' which is considered as a preeminent interdisciplinary tool in oncology and other chronic catabolic conditions. The predictive validity of the Pt-Global web tool/PG-SGA, referred as overall score for malnutrition was ascertained using Receiver Operating Curves (ROC). The conclusions were drawn using descriptive statistics, correlation, and regression analysis. RESULTS: In a sample of 450 pre-dialysis CKD patients, the malnutrition was present in 292(64.9%) patients. Diabetic CKD patients exhibit higher proportion of malnutrition 159(35.3%). The prevalence of malnutrition was exacerbated by eGFR reduction. The overall Pt-Global web tool/PGA-SGA score was significantly influenced by the symptoms of fatigue (81.5%), appetite loss (54.8%), physical pain (45.3%), constipation (31.78%), dry mouth (26.2%), and feeling full quickly (25.8%). The ROC analysis showed that the AUC for the total PG-SGA score was 0.988 (95% CI: 0.976-1.000), indicating that it is a reliable indicator of malnutrition. The sensitivity (84.2%) for identifying malnutrition was low when using the conventional tool cut off score of ≥9. Instead, it was discovered that a score of ≥3 had a greater sensitivity (99.3%) and specificity (44.3%) and was therefore recommended. CONCLUSIONS: This study not only presents empirical evidence of poor nutritional status in CKD patients but also reveals that it is worse in patients with diabetes, hypoalbuminemia, and poorer kidney function (well recognized risk factors for cardiovascular disease). Early diagnosis and management of symptoms contributing malnutrition will reduce mortality and CKD progression. The Pt-Global web tool/PG-SGA total score of 3 or more appears to be the ideal cut off score for identifying malnutrition, which can be utilized by dietician for improving malnutrition.

Lysosomal Acid Lipase Activity in Non-alcoholic Fatty Liver Disease as a Novel Diagnostic and Therapeutic Target: A Systematic Literature Review of Current Evidence and Future Directions.

Background and aim: Non-alcoholic fatty liver disease (NAFLD) presents with the accumulation of excessive intra-hepatic fat without significant alcohol intake. Multifactorial pathogenesis is reported to be involved. Reduced lysosomal acid lipase (LAL) activity is suggested as one of the novel-involved pathogenic mechanisms. This review summarizes the available evidence on the role of LAL activity in NAFLD pathogenesis. Methods: Four databases namely, PubMed/Medline, Science direct, Cochrane Library, and Google scholar were searched to identify relevant observational records evaluating the role of LAL activity in the pathogenesis of NAFLD. All studies were assessed for their quality by using Newcastle-Ottawa Scale or The Joanna Briggs Institute Critical Appraisal tools for cohort and cross-sectional studies, respectively. The estimates of LAL activity and other clinical outcomes were expressed as mean (SD) and number (%) as presented in the primary studies. Results: A total of nine good quality studies with 1711 patients with NAFLD and 877 controls from different groups (healthy volunteers, alcoholics, cryptogenic cirrhosis, and HCV-positive) were included. From the NAFLD group, 59.55% were males and the overall mean age ranged between the studies from 12.6 ± 8.5 months in pediatrics to 58.90 ± 13.82 years in adults. In the NAFLD group, the LAL activity varied from 0.53 ± 0.08 to 1.3 ± 0.70 (nmol/spot/hr) between the studies which was less than all control groups except cryptogenic cirrhosis patients (0.5 ± 0.15 nmol/spot/hr). Of the other outcomes of interest, ALT, AST, total cholesterol, triglyceride, and LDL cholesterol were found elevated in NAFLD patients than in controls. Conclusion: The current evidence suggests a potential correlation of reduced LAL activity with NAFLD pathogenesis according to its severity. Large-scale studies are recommended, more importantly in patients with NAFLD having no metabolic or genetic involvement. Further LAL can act as a new non-invasive diagnostic biomarker to identify that specific NAFLD subgroup.

Adenine phosphoribosyl transferase deficiency leads to renal allograft dysfunction in kidney transplant recipients: a systematic review / A deficiência de adenina fosforibosiltransferase leva à disfunção do aloenxerto renal em receptores de transplante renal: uma revisão sistemática

Abstract Background: Adenine phosphoribosyl transferase (APRT) deficiency has great implications on graft survival in kidney transplant patients. This systematic review investigated the diagnostic pattern, treatment approach, and kidney transplant outcomes among kidney transplant patients with adenine phosphoribosyl transferase deficiency. Material and methods: Articles reporting the APRT enzyme deficiency and kidney allograft dysfunction were retrieved from PubMed/Medline, ScienceDirect, Cochrane library and Google scholar databases. Descriptive analysis was used to draw inferences. Results: The results from 20 selected studies covering 30 patients receiving 39 grafts had an average age of 46.37 years are presented. Graft survival time of more than 6 months was reported in 23 (76.7%) patients, while other 7 (23.3%) patients had graft survival time of less than 6 months. Only 4 (13.3%) patients had APRT deficiency before transplantation. After follow-up, one-third of the patients 10 (33.3%) had stable graft function, 1 patient had allograft loss, 8 (26.6%) patients had delayed graft function while the remaining 11 (36.6%) patients had chronic kidney graft dysfunction. Conclusions: APRT deficiency is an under-recognized, treatable condition that causes reversible crystalline nephropathy, leading to loss of allograft or allograft dysfunction. The study results showed that inclusion of genetic determination of APRT deficiency in the differential diagnosis of crystalline nephropathy, even in the absence of a history of nephrolithiasis, can improve renal outcomes and may improve allograft survival.

Resumo Antecedentes: A deficiência de adenina fosforibosiltransferase (APRT) tem grandes implicações na sobrevida do enxerto em pacientes transplantados renais. Esta revisão sistemática investigou o padrão diagnóstico, a abordagem de tratamento e os desfechos do transplante renal entre pacientes transplantados renais com deficiência de adenina fosforibosiltransferase. Material e métodos: Os artigos que relatam sobre a enzima APRT e a disfunção do aloenxerto renal foram recuperados do PubMed/Medline, ScienceDirect, Biblioteca Cochrane e bancos de dados do Google Acadêmico. Utilizou-se a análise descritiva para extrair inferências. Resultados: Foram incluídos participantes que receberam 39 enxertos, a maioria dos quais provenientes de doadores vivos seguidos por doadores falecidos e doadores cadáveres. Foi relatado tempo de sobrevida do enxerto superior a 6 meses em 23 (76,7%) pacientes, enquanto outros 7 (23,3%) pacientes tiveram tempo de sobrevida do enxerto inferior a 6 meses. Apenas 4 (13,3%) pacientes apresentaram deficiência de APRT antes do transplante. Após acompanhamento, um terço dos pacientes, 10 (33,3%) apresentaram função do enxerto estável, 1 paciente teve perda do aloenxerto, 8 (26,6%) pacientes apresentaram função retardada do enxerto, enquanto os 11 (36,6%) pacientes restantes tiveram disfunção crônica do enxerto renal. Conclusões: A deficiência de APRT é uma causa subestimada e reversível de nefropatia cristalina que leva à disfunção do aloenxerto renal ou à perda total do aloenxerto. Os resultados deste estudo pedem a inclusão desta condição no diagnóstico diferencial de nefropatia cristalina, mesmo na ausência de um histórico de nefrolitíase.

Adenine phosphoribosyl transferase deficiency leads to renal allograft dysfunction in kidney transplant recipients: a systematic review.

BACKGROUND: Adenine phosphoribosyl transferase (APRT) deficiency has great implications on graft survival in kidney transplant patients. This systematic review investigated the diagnostic pattern, treatment approach, and kidney transplant outcomes among kidney transplant patients with adenine phosphoribosyl transferase deficiency. MATERIAL AND METHODS: Articles reporting the APRT enzyme deficiency and kidney allograft dysfunction were retrieved from PubMed/Medline, ScienceDirect, Cochrane library and Google scholar databases. Descriptive analysis was used to draw inferences. RESULTS: The results from 20 selected studies covering 30 patients receiving 39 grafts had an average age of 46.37 years are presented. Graft survival time of more than 6 months was reported in 23 (76.7%) patients, while other 7 (23.3%) patients had graft survival time of less than 6 months. Only 4 (13.3%) patients had APRT deficiency before transplantation. After follow-up, one-third of the patients 10 (33.3%) had stable graft function, 1 patient had allograft loss, 8 (26.6%) patients had delayed graft function while the remaining 11 (36.6%) patients had chronic kidney graft dysfunction. CONCLUSIONS: APRT deficiency is an under-recognized, treatable condition that causes reversible crystalline nephropathy, leading to loss of allograft or allograft dysfunction. The study results showed that inclusion of genetic determination of APRT deficiency in the differential diagnosis of crystalline nephropathy, even in the absence of a history of nephrolithiasis, can improve renal outcomes and may improve allograft survival.

Enzyme replacement therapy in lysosomal acid lipase deficiency (LAL-D): a systematic literature review.

Background: Lysosomal acid lipase deficiency (LAL-D) is a very rare genetic abnormality caused by LIPA gene mutation. The disease has two distinct clinical variants in humans: Wolman disease in infants and cholesteryl ester storage disease in children and adults. Both conditions are characterized by elevated serum transaminases, dyslipidaemia, severe liver steatosis and accelerated fibrosis or cirrhosis, contributing to its high rate of early mortality. Recently sebelipase alfa (recombinant human LAL) was launched to address its underlying pathology. This systematic review evaluates the safety and efficacy of sebelipase alfa for LAL-D. Methods: This systematic review was performed following the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Clinical trial records were systematically searched in PubMed/Medline, ClinicalTrials.gov., Cochrane Library and Google Scholar up to September 2020. Records that have reported at least one of the included outcomes were included. Baseline and endpoint mean and standard deviation (SD) for all outcomes were recorded. For safety, frequency and overall distribution of different adverse events were included. Results: A total of seven records from five individual studies with 110 LAL-D patients were included into this study. The mean age ranged from 2.57 months in infants to 31.6 years among adults. Serum transaminases (alanine aminotransferase and aspartate aminotransferase), serum lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), gamma-glutamyl transferase and liver volume were included as efficacy outcomes. Final pooled results were synthesized as a change from baseline to end of the treatment. A significant effect on both serum transaminases and other serum lipid was achieved (p < 0.01), while non-significant differences were seen for GGT and liver volume as p = 0.35 and p = 0.08 was observed. Mostly the adverse events related to the infusions were infrequent and mild-to-moderate in severity. Conclusion: Sebelipase alfa as an enzyme replacement provides an effective, safe and well tolerated treatment in both variants of LAL-D. Plain language summary: A systematic literature review on safety and efficacy of enzyme replacement therapy in lysosomal acid lipase deficiency Lysosomal acid lipase deficiency (LAL-D) is a rare, progressive, genetic disorder caused by functional mutations in the LIPA gene, which encodes LAL enzyme. This enzyme maintains lipid homeostasis by hydrolysing the cholesterol esters and triglycerides. Patients with deficient LAL activity are seen with abnormal liver functions which keep them at a high risk of early mortality. Clinical diagnosis of this disease is very challenging due to both its low prevalence and low awareness among patients/clinicians and additionally due to its overlap with other liver/lipid disorders. Also, owing to lack of safe and effective treatment, dietary modifications and some lipid modifying drugs are usually used to control the LAL-D manifestations. Recently, recombinant human LAL named as sebelipase alfa (Kanuma™, Alexion Pharmaceuticals, Inc., New Haven, Connecticut, USA) was approved in 2015 for the European Union and subsequently in the United States as an enzyme replacement therapy for LAL deficiency. The initial clinical trial data indicate that sebelipase alfa produces a significant improvement in all of the wide range of LAL-D manifestations. However, the cumulative evidence is not reported regarding its safety and effective use. Therefore, a systematic literature review of all the clinical trial records by following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines was undertaken. From all of the available clinical trial records, 110 LAL-D patients treated with sebelipase alfa were included. Serum transaminases, serum lipids, gamma-glutamyl transferase (GGT) and liver volume were included as efficacy outcomes. Final pooled results were synthesized as a change from baseline to end of the treatment. A significant effect on both serum transaminases and other serum lipids was achieved (p < 0.01), while non-significant differences were observed for GGT and liver volume, with p = 0.35 and p = 0.08 respectively. Mostly the adverse events related to the infusions were infrequent and mild-to-moderate in severity. The enzyme replacement provides an effective, safe and well tolerated treatment in both variants of LAL-D.

Cross-cultural adaptation and psychometric evaluation of Hindi version of Diabetes Self-Management Profile-Self Report in Indian type 1 diabetes patients.

BACKGROUND: No validated measures exist for evaluating diabetes self-management in Indian type 1 diabetes (T1D) patients. OBJECTIVE: To cross culturally adapt and evaluate the psychometric properties of Hindi version of Diabetes Self-Management Profile-Self Report (DSMP-SR-Hindi) in Indian T1D patients. METHODS: Total 160 T1D patients and their parents participated in the study. The mean age of patients was 13.5 ± 2.5 years and HbA1c was 8.6 ± 2.2%. RESULTS: Exploratory factor analysis employing principle axis factoring with promax rotation was conducted. Monte Carlo parallel analysis identified three sub-scales instead of five sub-scales proposed in original version. Because of underlying ceiling and floor effects and insufficient loadings, five items were eliminated. Consequently, final Hindi version of DSMP-SR contained 19 items from DSMP-SR-24. Internal consistencies were adequate for overall scale (Cronbach's α = 0.835), identified sub-scales (Cronbach's α = 0.702-0.802) and comparable between genders. DSMP-19 total scores (r = -0.74) and three subscales correlated significantly with HbA1c (SMBG and Corrective Adjustments [r = -0.58], Exercise [r = -0.48], and Conformity to Diet and Insulin Routine [r = -0.64]). For every one SD improvement (11.2 marks) in DSMP-SR-Hindi score, odds of falling into poor glycaemic group (HbA1c > 7.5%) dropped to 0.242 times (95% CI 0.144-0.405; P < .001). CONCLUSIONS: DSMP-SR-Hindi is a reliable and valid self-report measure of diabetes self-management behavior in Indian T1D patients. The revealed three subscales are reliable to use in isolation and across the genders. It will help in monitoring patient's progress in stepwise manner, ranging from their basic understanding of prescribed regimen to taking advance corrective actions in face of altered needs.

Insulin-Related Lipohypertrophy: Lipogenic Action or Tissue Trauma?

Lipohypertrophy has been suggested as an outcome of lipogenic action of insulin and/or injection-related tissue trauma. In a cross-sectional study, we evaluated the predictors of lipohypertrophy in 372 type 1 diabetes patients (mean age 17.1 years) receiving subcutaneous insulin with pen and/or syringes for ≥3 months. On examining injection sites with inspection and palpation technique, 62.1% patients demonstrated lipohypertrophy. Univariate analysis showed that gender, BMI, HbA1c, injection device, rotation, injection area, needle length, insulin regimen, and total daily dose of insulin were associated with lipohypertrophy (p < 0.05). Notably, the mean needle reuse was comparable in patients with or without lipohypertrophy (8.1 vs. 7.2, p = 0.534). In multivariate logistic regression, gender, HbA1c, TDD, injection devices, and needle length lost its significance. Further, injections over smaller area (≤8.5 × 5.5 cm) and non-rotation of sites were found to be strongest independent predictor of lipohypertrophy (p < 0.0005 for both) with increased odds of 23.2 (95% CI 9.1-59.2) and 6.3 (95% CI 3.4-11.9) times, respectively. Being underweight was also a significant independent predictor (odds ratio [OR] 13.0 [95% CI 2.2-75.2], p = 0.004). Compared to rapid plus long-acting analogs, regular insulin plus long-acting analogs and conventional premixed insulin users had 3.2 (95% CI 1.5-6.8, p = 0.003) and 4.6 (95% CI 1.4-15.7, p = 0.014) fold higher risk of lipohypertrophy (mean injection frequency 4.01 vs. 4.01 vs. 2.09, respectively). Sub-group analysis showed that lipohypertrophy was 79% less likely in patients with multiple daily injections (≥4) than twice-daily regimen (OR 0.21, p < 0.0005). Moreover, lipohypertrophy was reduced to half with bolus doses of rapid-acting insulin analogs than regular insulin (p = 0.003), even though mean injection frequency was comparable (4.01 vs. 3.93, p = 0.229). This difference was statistically insignificant for basal doses with NPH or long-acting analogs (p = 0.069). Therefore, injection area, rotation, BMI, and insulin regimen are the best predictors of lipohypertrophy and together could correctly identify lipohypertrophy status in 84.4% patients with excellent discrimination capability (AUC = 0.906, p < 0.0005). In conclusion, findings of our study suggest that delivering rapidly absorbed insulin analogs over large injection area along with greater split of total daily doses reduce insulin-induced lipogenesis and outplay tissue trauma added through frequent injections and needle reuse.

Prevalence of depression and its associated factors among patients of chronic kidney disease in a public tertiary care hospital in India: A cross-sectional study.

Chronic kidney disease (CKD) patients are at high risk of depressive disorders because of considerable psychological stress due to physical and social changes brought on by disease. The aim of this study is to assess the prevalence of depression in patients with CKD and the factors affecting it at a public tertiary care hospital. This cross-sectional study was carried out at the renal clinic of a tertiary care hospital. Data on 612 patients diagnosed with CKD from September 2014 to April 2016 was obtained. Nine-item Patient Health Questionnaire from PRIME-MD was used to assess the depression. Of all the patients, 55.9% had no depression. Mild depression was found to affect 28.4% of the patients followed by moderate depression, moderately severe, and severe depression (11.8%, 3.8%, and 0.8%, respectively). According to multiple logistic regression, the occurrence of depression was significantly higher with age below 60 years [odds ratio (OR) 1.6, 0.8-2.7; P<0.05], male gender (OR 1.3, 0.9-3.1; P<0.05), no treatment funding (OR 2.6, 1.2-4.5; P<0.05), education less than grade 12 (OR1.3, 1.3-3.2; P<0.05), monthly income ≤INR 20,000 (OR 1.6, 1.1-3.6; P<0.05), CKD stage V (OR 1.3, 1.02.9; P <0.05), Patients on hemodialysis (hD) (OR 2.6, 1.2-4.5; P<0.05), comorbidities ≥3 (OR 1.7, 1.1-2.9; P<0.05), overweight (OR 2.5, 1.3-2.9; P<0.05), and duration of CKD >2 (OR 2.2, 1.3-4.3; P<0.05). About 44% of the patients were found to have depression. Patients' age, gender, body mass index, treatment funding, education status, income, CKD duration and stage, HD status, and comorbidities were found to be significant factors affecting depression.

Direct Cost for Treating Chronic Kidney Disease at an Outpatient Setting of a Tertiary Hospital: Evidence from a Cross-Sectional Study.

BACKGROUND: Chronic kidney disease (CKD) has a high morbidity and mortality in developing countries. And this burden is also increasing rapidly in India. Unaffordability due to high cost of medication and hemodialysis remains one of the major barriers in the successful treatment of CKD. OBJECTIVES: To determine the direct cost involved in treating CKD at an outpatient department of a public tertiary care hospital. METHODS: This cross-sectional study was carried out at a public tertiary care hospital. Patients diagnosed with CKD by a physician were included in the study after obtaining a written informed consent. All the relevant data were collected on a predesigned case record form. RESULTS: The results are based on data obtained from 150 patients. The average age of the patients was 55.7 ± 10.1 years. The average number of drugs per prescription was found to be 6.5 ± 1.7. The annual average costs of treatment for patients on medication only and for patients on hemodialysis plus medication were Rs 25,836 (US $386) and Rs 2,13,144 (US $3181), respectively (Rs = Indian rupee). Treatment cost was found to be statistically significantly higher in patients on hemodialysis, treatment support by employer, patients with a smoking habit, patients with comorbidities, and patients with end-stage renal disease. Calcium tablets, vitamin D sachets, iron supplements, torsemide, and amlodipine were the top five medications prescribed. CONCLUSIONS: Reimbursement, patient's dialysis status, habits, and comorbidities were found to have a significant effect on the direct cost of treatment.

Evidence-based information leads to reduction in inappropriate drug prescribing: Results from Indian older inpatients.

BACKGROUND: Although several guidelines for appropriate prescribing are available, inappropriate drug prescription remains noteworthy problem among older adults. Indian older patients are also not spare from this issue and existing literature indicates a fair level of inappropriate drug use (IDU). OBJECTIVES: Identified potentially IDU and documented their reduction based on provided evidence-based information and also identified possible predictors of IDU in older inpatients. SETTING: Three years prospective study included 1510 inpatients aged 60 years or over, of both sexes. IDU identified using the Modified Updated AGS Beers Criteria 2012. RESULTS: The patients had an average age of 67.10 ± 0.23 years and on an average were prescribed 9.29 ± 0.11 medications. Using AGS Beers Criteria 2012, total IDU was found to be 21% (n = 325). Of total 287 patients received only one inappropriate drug whereas 38 patients received two or more inappropriate drug(s). According to first list of criteria long acting benzodiazepines, anticholinergics, nitrofurantoin and digoxin were most common IDU. Prescription of theophylline in insomnia followed by aspirin in gastric ulcer and calcium channel blocker in constipation were listed from second list of criteria. 31% reductions in IDU were observed based on evidence-based information regarding each identified inappropriate drugs. CONCLUSIONS: The findings of this study provide evidence that provision of unbiased evidenced based information is the best possible means for improvement of pharmacotherapy in older patients.

Prevalence and determinants of use of potentially inappropriate medications in elderly inpatients: a prospective study in a tertiary healthcare setting.

AIM: To determine the prevalence and predictors of potentially inappropriate medications (PIM) prescribing in elderly inpatients using the modified American Geriatrics Society (AGS) updated Beers criteria 2012 and comparing it with the Beers criteria 2003. METHODS: The prospective observational study was carried out between September 2011 and May 2012 at a public teaching hospital. Elderly inpatients aged ≥60 years were included. Multivariate logistic regression analysis was used to determine the predictors of PIM prescribing. RESULTS: The results were based on data of 502 patients; more than half (60%) were males and 66% were aged between 60-69 years with a mean (standard deviation [SD]) of 68 (7) years. Mean (SD) number of diagnoses and medications were three (1) and nine (4), respectively. A total of 81 (16%) patients were prescribed with at least ≥1 PIM according to modified AGS updated Beers criteria 2012, compared with 11% according to Beers criteria 2003. On multivariate regression, important predictors for PIM prescribing were found to be age ≥80 years (odds ratio [OR] 2.46, 95% confidence interval (CI) 1.27-3.12; P = 0.03), male sex (OR 1.35, 95% CI 1.06-1.84; P = 0.03), more than three diagnoses (OR 2.47, 95% CI 1.59-3.39; P = 0.04), ≥6 medications prescribed (OR 1.16, 95% CI 1.02-1.35; P = 0.03) and ≥10 days of hospital stay (OR 1.59, 95% CI 1.09-2.31; P = 0.02). CONCLUSIONS: The results show that PIM prescribing is common among hospitalized elderly Indian patients. It is feasible to reduce this practice through the provision of appropriate unbiased information to healthcare professionals.

Drug-drug interactions and their predictors: Results from Indian elderly inpatients.

BACKGROUND: In view of the multiple co-morbidities, the elderly patients receiving drugs are prone to suffer with drug interactions since they receive a greater number of drugs. OBJECTIVE: The study was undertaken to determine the prevalence of drug interactions, as well as their predictors. METHODS: The prescriptions of a total of 1510 inpatients were collected prospectively for 1.5 years from inpatients wards of public tertiary care teaching hospital. All the prescriptions were checked for drug interactions using the Micromedex® Drug-Reax database-2010 and Stockley's Drug Interactions. Regression analyses sought to determine predictors for the drug interaction. RESULTS: The patients, with the average age of 67.2 ±0.2 years, were prescribed an average of 9.15 ±0.03 medications. It was found that out of 1510 prescriptions of inpatients, 126 (8.3%) prescriptions had one or more than one drug interaction. All the identified interactions were severe in nature. The top most interacting drugs were acetylsalicylic acid and anticoagulant (n=59). The second top most interacting drug combination was clopidogrel and proton pump inhibitors (n=51). The most commonly involved drugs in interactions were C (cardiovascular system) and A (alimentary tract and metabolism). Using multivariate binary logistic regression, multiple drugs (Odds Ratio=4.5; 95% Confidence Interval: - 2.38 -9.47) and multiple diagnoses (Odds Ratio=2.6; 95%CI: -1.40 -5.57) were found to be significant predictors for drug interaction. CONCLUSIONS: The results of this study substantiate the occurrence of severe drug interactions among Indian elderly inpatients. In order to provide safer pharmaceutical care, the active involvement of clinical pharmacists is a potential option.

Drug-drug interactions and their predictors: results from Indian elderly inpatients / Interacciones medicamentosas y sus predictores: resultados de pacientes indios hospitalizados

Background: In view of the multiple co-morbidities, the elderly patients receiving drugs are prone to suffer with drug interactions since they receive a greater number of drugs. Objective: The study was undertaken to determine the prevalence of drug interactions, as well as their predictors. Method: The prescriptions of a total of 1510 inpatients were collected prospectively for 1.5 years from inpatients wards of public tertiary care teaching hospital. All the prescriptions were checked for drug interactions using the Micromedex® Drug-Reax database-2010 and Stockley’s Drug Interactions. Regression analyses sought to determine predictors for the drug interaction. Results: The patients, with the average age of 67.2 ±0.2 years, were prescribed an average of 9.15 ±0.03 medications. It was found that out of 1510 prescriptions of inpatients, 126 (8.3%) prescriptions had one or more than one drug interaction. All the identified interactions were severe in nature. The top most interacting drugs were acetylsalicylic acid and anticoagulant (n=59). The second top most interacting drug combination was clopidogrel and proton pump inhibitors (n=51). The most commonly involved drugs in interactions were C (cardiovascular system) and A (alimentary tract and metabolism). Using multivariate binary logistic regression, multiple drugs (Odds Ratio=4.5; 95% Confidence Interval: - 2.38 -9.47) and multiple diagnoses (Odds Ratio=2.6; 95%CI: -1.40 -5.57) were found to be significant predictors for drug interaction. Conclusion: The results of this study substantiate the occurrence of severe drug interactions among Indian elderly inpatients. In order to provide safer pharmaceutical care, the active involvement of clinical pharmacists is a potential option (AU)

Antecedentes: en función de las múltiples comorbilidades, los pacientes ancianos que reciben varios medicamentos son susceptibles de sufrir interacciones medicamentosas ya que reciben gran cantidad de medicamentos. Objetivo: El estudio se realizó para determinar la prevalencia de interacciones medicamentosas, así como sus predictores. Métodos: Se recogió prospectivamente la medicación total de 1510 pacientes hospitalizados de los servicios de internamiento de un hospital terciario universitario. Se revisaron todas las interacciones de los participantes usando Micromedex® Drug-Reax database-2010 y el Stockley’s Drug Interactions. Los análisis de regresión trataron de determinar los predictores de la interacción medicamentosa. Resultados: Los pacientes, con una media de 67,2 ±0.2 años, tenían prescritos de media 9.15 ±0.03 medicamentos. De las 1510 prescripciones de pacientes hospitalizados, 126 (8,3%) tenía una o más interacciones. Todas las interacciones identificadas eran de naturaleza grave. Los medicamentos más interactuante era el ácido acetilsalicílico y los anticoagulantes (n=59). La segunda combinación interactuante más frecuente era clopidogrel y los inhibidores de la bomba de protones (n=51). Los medicamentos más frecuentemente involucrados en interacciones eran del grupo C (aparato cardiovascular) y A (tracto alimentario y metabolismo). Usando la regresión logística binaria, se encontró que ‘varios medicamentos’ (Odds Ratio=4.5; Intervalo de Confianza 95%: - 2.38 -9.47) y ¿varios diagnósticos’ (Odds Ratio=2.6; 95%CI: -1.40 - 5.57) eran predictores significativos de las interacciones medicamentosas. Conclusión: Los resultados de este estudio demuestran la aparición de interacciones medicamentosas graves entre los pacientes indios hospitalizados. Para proporcionar una atención farmacéutica más segura, el empleo de farmacéuticos clínicos es una opción posible (AU)

Anti-counterfeit technologies: a pharmaceutical industry perspective.

Growth of international free trade and inadequate drug regulation have led to the expansion of trade in counterfeit drugs worldwide. Technological protection is seen to be the best way to avoid this problem. Different technologies came into existence like overt, covert, and track and trace technologies. This review emphasises ideal technological characteristics, existing anti-counterfeit technologies, and their adoption in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Even the pharmaceutical companies have been employing these technologies in order to detain illegitimate drugs in their supply chain.

Prevalence and assessment of factors contributing to adverse drug reactions in wards of a tertiary care hospital, India.

BACKGROUND: Adverse drug reactions account for the highest proportion among the causes of morbidity and mortality in clinical wards and are posing a considerable challenge. Hence, the objective of this study was to find out the prevalence of adverse drug reactions and the factors which contribute to their prevalence. METHODS: A prospective patient record review was carried out at a tertiary care hospital in North India from August 2010-May 2011. A total of 1033 subjects admitted to hospital for any kind of treatment were included while patients admitted in the ward because of adverse drug reactions were excluded. The ward where we collected the data includes multispecialty and cardiovascular wards. The causality, severity, and preventability of adverse drug reactions were assessed using Naranjo, modified Hartwig, and Schumock and Thornton criteria, respectively. Kolmogorov-Smyrnov, chi -square and multiple logistic regression tests were used to determine adverse drug reactions ascribed to drugs. RESULTS: Out of 1033 patients whose records were assessed, 167(16.2%) experienced one or more adverse drug reactions. The metabolic systems, which accounted for 49(24.6%) were most frequently affected by adverse drug reactions, followed by gastrointestinal, 45(22.6%); hematological, 28(14.1%) and cutaneous, 21(10.6%) systems. The drug classes most frequently associated with the reactions were antibiotics 40(20.1%), diuretics 35(17.6%) and anticoagulants 30(15.1%). According to the selected preventability scale, 72(36.2%) adverse drug reactions were classified as probably or definitely preventable. About 165(83%) of the reactions were type A, which represents augmentation of the pharmacological action of a drug. Number of drugs, length of hospitalization and number of diagnosis were identified as significant predisposing factors for ADRs. CONCLUSION: The result of this study suggested that adverse drug reactions were significant causes of superimposed health problems that occur following hospitalization. The major risk factors associated with ADR include number of drugs, length of hospitalization and number of diagnosis. Based on the findings a rigorous study is recommended to determine the burden and identify the risk factors of adverse drug reactions to target interventions.