Exclusive Real World Evidence Journal最新文献

{"title":"Comparing Calculated LDL with Direct Method: A Retrospective, Real-World Evidence Study on Diagnostic Lab Reports from A Single Center in India","authors":"Munjal Shah, N. Mehta, Vaibhav Bhosale, Srivani Palukuri, Mohini Gehlot","doi":"10.54136/erwej-0101-10001","DOIUrl":"https://doi.org/10.54136/erwej-0101-10001","url":null,"abstract":"Objective: To compare and validate the calculated LDL values from Friedewald and Anandaraja formulas with directly measured values in the Indian population. Material and Methods: The study was conducted on randomly selected 102 individuals of 16 to 88 years of age during December 2019. The direct LDL values were measured using selective solubilization assay, and Friedewald and Anandaraja formulas were used to calculate LDL for comparison. The correlations between direct and calculated methods were assessed using the linear regression method. Receiver operating characteristic analysis with nonparametric distribution was used to compare the sensitivity and specificity of the three methods. Results: The average LDL of direct method, 107.3 mg/dL, Friedewald formula, 89.7 mg/dL, and Anandaraja was 99.0 mg/dL. The relation between direct and calculated values assessed by linear regression showed 97% and 87% of correlation with Friedewald and Anandaraja, respectively. The ROC analysis inferred that direct (AUC 0.74; 95% CI 0.64-0.83) and Friedewald (AUC 0.71; 95% CI 0.61-0.81) methods had shown about 70% efficiency in predicting true positive and true negative dyslipidemia cases. In our dataset, the Anandaraja formula could not well differentiate positives from negative cases of dyslipidemia with merely 60% AUC. Conclusion: The underpredicted values from the Friedewald formula were associated with deranged cholesterol and HDL values, not triglycerides. Anandaraja formula overpredicted by 10 to 30 mg/dL when triglycerides were <150 mg/dL and underpredicted by 10-43 mg/dL while non-HDL was >140 mg/dL.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130498372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Birth Defects following Levetiracetam Use in Pregnancy – A Case Report","authors":"Mukul Pandey, P. Batra","doi":"10.54136/erwej-0101-10006","DOIUrl":"https://doi.org/10.54136/erwej-0101-10006","url":null,"abstract":"There is a lack of substantial data on the safety of Levetiracetam during pregnancy in the context of the potential teratogenic effect on the newborn. We report a probable case of levetiracetam birth defects in a newborn with multiple congenital anomalies.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121164531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Digital Technologies in Pediatric Diabetes Management During the Pandemic","authors":"D. Hasnani, V. Chavda, Shriji Hasnani, Vaishali Maheriya","doi":"10.54136/erwej-0101-10010","DOIUrl":"https://doi.org/10.54136/erwej-0101-10010","url":null,"abstract":"The outbreak of COVID-19 had created a significant impact on the medical community and has resulted in novel challenges to all the physicians. It is estimated by the International Diabetes Federation (IDF) that in 2019 there were 95,600 cases of type 1 diabetes (0 and 14 years of age) in India. Type 1 diabetes was identified to be an independent risk factor associated with in-hospital death in COVID-19. During the pandemic, due to fear of visiting the hospitals, there was an underrepresentation of new cases and due to delay in the diagnosis, there was a spike in the number of cases of diabetic ketoacidosis. The objective of the current review is to summarize the role of telemedicine in the management of pediatric diabetes. Various organizations such as the Research Society of Study of Diabetes in India (RSSDI), CDiC, and IFAC came forward to support the pediatric diabetes community through the supply of insulin, glucose strips and syringes. The efficiency of telehealth visits was enhanced by using diabetes technologies like insulin pumps, CGMs, and bluetooth glucose meters. As children got ample time to spend with their parents and perform the in-home physical activity, they had good glycemic control during the pandemic period in some cases.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128164950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ezetimibe- A Novel Add on Treatment Strategy to Achieve Targeted LDL in Patients with Uncontrolled LDL Levels on High Dose Statin Alone","authors":"Mudit Sabharwal","doi":"10.54136/erwej-0202-10028","DOIUrl":"https://doi.org/10.54136/erwej-0202-10028","url":null,"abstract":"Background: The lowering of low-density lipoprotein cholesterol (LDL-C) is the primary target of therapy in the primary and secondary prevention of cardiovascular events. Statins are the most prescribed lipid-lowering drugs, but many patients fail to achieve the target low-density lipoprotein (LDL) level with statin alone or at higher doses. The add-on therapy of 'Ezetimibe' to statin monotherapy has resulted in a synergistic effect in reducing LDL levels and achievements of lipid targets. Cholesterol comes from two sources. endogenous and exogenous. Rather than inhibiting one source, it is better to inhibit two sources. While statins inhibit endogenous production, Ezetimibe decreases absorption of cholesterol. Indian patients are also observed to have low HDL which is another risk factor for heart diseases. We aimed to assess the efficacy of the combination of atorvastatin plus ezetimibe in Indian patients with dyslipidemia and to see whether it can reduce LDL levels and Improve HDL and triglyceride levels. Objective: (1) To find out LDL reduction by addition of ezetimibe in combination with statin in Indian patients. (2) To find out increase in HDL levels by adding ezetimibe in combination with statin along with the reduction in triglyceride levels in Indian patients. Methods: The retrospective data from EMR of the patients diagnosed with a high level of LDL and satisfying the study's inclusion criteria were collected. The patients at the baseline were given monotherapy. Those who did not achieve the desired LDL were given treatment with Atorvastatin high dose (40 mg and 80 daily) and were allocated to the add-on therapy with Ezetimibe at 10 mg/day after 3 months. The groups (monotherapy and combined therapy) were compared at baseline and subsequent follow-up visits. Data were analyzed using R studio 1.2.1335 and Microsoft Excel. Statistical significance was considered at p<0.05. Results: The LDL level showed a significant decrease after 18 months from baseline till the subsequent follow-up visits. The reduction observed in the serum concentration of LDL was from 167.95 ± 12.85 mg/dL to 91.9 ± 10.39 mg/dL (p < 0.001) in 40 mg group and from 164.76 ± 9.9 mg/dL to 106.71 ± 17.17 mg/dL (p < 0.001) in 80 mg group. Furthermore, the rate of achieving an LDL level <100 mg/dL increased from 0% to 45.28% in the 40 mg group and from 0% to 35.24% in 80 mg group and showed significantly greater improvement (p = 0.001). Conclusion: Compared with high doses of statin, the combination of statin with Ezetimibe not only achieves targeted serum lipid levels, suggesting that combination therapy should be a priority when statin resistance or poor efficacy occurs with the higher dose of statin monotherapy. Keyword: LDL; HDL; Triglycerides; Atorvastatin; Ezetimibe","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123383712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors Affecting Treatment Interruption and its Correlation with Days Off with the Treatment in Diabetes","authors":"N. Agarwal, Ambrish Singh, S. Rana","doi":"10.54136/erwej-0101-10009","DOIUrl":"https://doi.org/10.54136/erwej-0101-10009","url":null,"abstract":"Background: Treatment interruption in chronic conditions, especially diabetes mellitus, can significantly affect glycemic control, affecting the onset of a diabetes-related complication. Objectives: To evaluate the factors associated with the treatment interruption and compare them with the days off from the treatment. Materials and Methods: 491 diabetes patients were included in the survey at Diabetes, Obesity & Thyroid center, Gwalior between September 2018 to December 2018. Responses were recorded using a detailed questionnaire comprising of 25 questions. Responses were recorded in “Yes” or “No” format. Responses were compared with the days off from the treatment talking five months as a cut-off. Results: Treatment interruption was more common within five months of starting the treatment. Reasons such as financial problem (p=0.722), no one to accompany them for a visit (p=0.640), non-availability of medicines (p=0.020), busy in family obligation (p=0.381), not aware of the consequences of missing the doses (p=0.139), and lack of awareness to take medication (p=0.450) were insignificant responses when compared between the cut off of five months of day's off. Most of the patients were shifted to alternate medicine within five months of starting the treatment (120/62; p<0.001). Side effects were another significant factor associated with the treatment interruption within five months of starting the treatment (229/98; p<0.001). Those with a family history of diabetes (p=0.013), were current smokers (p=0.008), and were married (p=0.044) had early treatment interruption. Conclusion: Patients who did not have sufficient time to visit the diabetes centre, had an inclination towards the alternative medicine for diabetes treatment, side effects of the medication, and beliefs of the patient that diabetes medication has the long-life medication period have made the patients stop the treatment within five months of starting the treatment. Family history of diabetes, current smoking, and those who were married had early treatment interruption.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132214902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Pharmacotherapies for Alcoholic Liver Disease: A Retrospective Real-World Evidence Study","authors":"Sandip Shah, S. Gupta","doi":"10.54136/erwej-0202-10021","DOIUrl":"https://doi.org/10.54136/erwej-0202-10021","url":null,"abstract":"Background: Ursodeoxycholic acid (UDCA), a hepatoprotective agent demonstrates several beneficial effects on liver biochemistry measures and thus, it might be useful for the management of Alcoholic liver disease (ALD). Objective: To evaluate the pharmacotherapies for ALD using retrospective real-world evidence. Methods: In this retrospective study, the Electronic Medical Records (EMRs) of patients with ALD who were prescribed various pharmacotherapies between January 2021 and April 2021 at two Indian healthcare settings were reviewed. The effectiveness outcomes were assessed in terms of mean difference and proportion of patients showing improvement in the levels of liver enzymes (Aspartate aminotransferase [AST], Alanine aminotransferase [ALT] and γ-glutamyl transferase [GGT]) and conjugated bilirubin from baseline to 30-days follow-up. Results: A total of 298 patients were included and divided into two study groups - scientific and herbal groups. The scientific group included patients prescribed with drugs like UDCA, pentoxifylline, ademetionine, metadoxine, and nutritional supplementation. The herbal group included patients prescribed with four different Herbal Preparations. Of 193 patients in the scientific group, a majority (76.7%; n=148/193) of the patients received UDCA; of these, 107 patients' data were available at the 30-days follow-up. In the herbal group (n=105), a majority (62.9%; n=66/105) of the patients received Herbal Preparation 1, and 78 patients had data at follow-up. The elevated levels of liver enzymes (AST, ALT, GGT) at baseline were significantly reduced (p<0.05) at follow-up in patients prescribed with UDCA vs. Herbal Preparation 1. The change from baseline to 30 days in conjugated bilirubin was significantly higher in the UDCA vs. Herbal Preparation 1 (-45.2% vs. -33.5%, p<0.001). There was considerable improvement in the proportion of patients with elevated AST and ALT in the UDCA group. No serious adverse events were reported in either of the groups. Conclusion: The present study demonstrates that UDCA and Herbal Preparation 1 are majorly used in the management of ALD. UDCA has shown a substantial hepatoprotective effect as evident by significant improvements in the liver biochemistry of ALD patients as compared to the Herbal Preparation 1. Overall, the data from the current study suggests the use of UDCA as an initial therapy for ALD patients with altered liver enzymes.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"72 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122652545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dyslipidaemia - Current and Future Treatment Paradigm","authors":"A. Kochar","doi":"10.54136/erwej-0101-10007","DOIUrl":"https://doi.org/10.54136/erwej-0101-10007","url":null,"abstract":"Dyslipidaemia is one of the major risk factors for coronary vascular disorders. Dyslipidaemia prevention and management can have a great impact on cardiovascular morbidity and mortality. There are many lipid-modifying pharmacological medicines on the market, and more are being developed. New guidelines recommend aggressive lipid-lowering targets depending on the atherosclerotic cardiovascular (ASCVD) risk. Depending on the risk of these risks, new guidelines advocate aggressive lipidlowering targets. For many years, statins had been the standard care, and demonstrated to reduce the risk of cardiovascular events. Novel molecules such as PCSK9 inhibitors, selective inhibitors of microsomal triglyceride transfer protein, small interfering RNA (siRNA), and antisense oligonucleotide drugs, could be interesting new additions to effective lipid-lowering therapy, are now accessible. We look into the history, method of action, key clinical studies, and side effects of therapeutic targets for dyslipidaemia to see where they fit into the therapy armamentarium now and in the future.","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"68 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127231258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Characteristics of Vaginitis and Effectiveness of Fenticonazole - An Observational Study from India","authors":"S. Modi, Bhuvaneshwari Deka","doi":"10.54136/erwej-0202-10029","DOIUrl":"https://doi.org/10.54136/erwej-0202-10029","url":null,"abstract":"Objective: To characterise vaginitis among menstrual and menopausal women and to determine the effectiveness of Fenticonazole for the treatment of vaginitis. Methods: A retrospective study was conducted on 86 women attending the gynecology clinic. The patients underwent screening for symptoms of vaginitis. The clinical and demographic characteristics were compared between menstrual and menopausal women. Results: Based on the clinical examination, it was identified that 80 (93.02%) patients had symptoms of vaginal discharge (white discharge) and 51 (59.30%) of patients had a vaginal fungal infection. Mean age was 34.73 (10.13) years, and 52.04 (14.38) years and mean BMI 26.74 (3.31) and 29.32 (3.22) were significantly different among menstrual women and menopausal women respectively. Also, inflammatory smear and vaginitis both were found to be higher among menstrual women. It was identified that Fenticonazole was effective in the treatment of vaginitis. Conclusion: In this observational study, vaginitis was identified in 51 (59.30%) patients, and Fenticonazole was found to be effective in treating vaginitis. Keywords: Vaginitis, Vulvovaginal candidiasis, Fenticonazole, Menopausal","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131908717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Case of Primary Myxoid Liposarcoma of the Heart Masquerading as Massive Pericardial Effusion","authors":"Bhargavi Ilangovan, A. S., Archana Lakshmanan, Jeganniwas Kannan","doi":"10.54136/erwej-0202-10024","DOIUrl":"https://doi.org/10.54136/erwej-0202-10024","url":null,"abstract":"Tumors of the heart are very rare and are mostly benign. Sarcomas are extremely rare in the heart. Myxoid Liposarcomas can arise primarily from the heart and the pericardium or can be metastatic disease from elsewhere. The patients present with pericardial effusion of pressure effects. Echocardiography, cardiac MRI and biopsy usually clinches the diagnosis. Surgery is the only curative option for this tumor and is seldom possible due to the location and advanced nature at presentation. We are reporting this case due to its rarity and to emphasize the need for multi-institutional studies to improve the outcomes. Keywords: Myxoid liposarcoma; Surgery; Cardiac fluid; Massive Pericardial Effusion","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"115 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116593089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Single-step DIPSI 75g Glucose Tolerance Test-For Diagnosis of Gestational Diabetes Mellitus","authors":"Ramya Vandanasetti, T. Sundari, U. G","doi":"10.54136/erwej-0202-10022","DOIUrl":"https://doi.org/10.54136/erwej-0202-10022","url":null,"abstract":"Background: Gestational Diabetes Mellitus (GDM) refers to glucose intolerance diagnosed at onset or first recognition during pregnancy. Women with GDM are at risk for maternal and foetal complications, so it is important to screen all pregnant women. The present study was carried out to determine the significance and use of the 75 g Oral Glucose Challenge Test (OGCT) using the Diabetes in Pregnancy Study Group India (DIPSI) criteria for screening of GDM. Objectives: This study was planned to analyze the incidence of GDM in pregnant women attending antenatal care clinic, using DIPSI criteria 75 g OGCT in the first trimester or at the first antenatal visit. Methods: In this prospective observational study, 451 pregnant women attended the antenatal clinic for the first visit at gestation between 6 and 20 weeks. 75 g oral glucose is administered irrespective of whether she is in the fasting or non-fasting state, without regard to the time of the last meal and GDM was diagnosed, and treatment started. Maternal and fetal outcomes were measured. Results: The incidence of GDM using DIPSI criteria (>140 md/dL) was 20.8% in the first trimester or first antenatal visit. Incidence of maternal and foetal complications was lower in our study when compared to other studies. Conclusion: It is concluded that a 75 g glucose challenge test at 6-20 weeks of gestation with a cut-off value of 140 mg/dl is a reliable screening test for GDM. Keywords: Gestational diabetes mellitus; Oral glucose challenge test (OGCT); Glucose intolerance; DIPSI criteria","PeriodicalId":312076,"journal":{"name":"Exclusive Real World Evidence Journal","volume":"47 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115617513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}