Pub Date : 2017-07-19DOI: 10.4172/2167-1052.1000e143
E. Yiannakopoulou
Nowadays there is ongoing interest in the development of biosimilars, as biosimilars are anticipated to lead to price competition and to lower healthcare costs The first biosimilar, Omnitrope®, a biosimilar agent of the Recombinant Human Growth Hormone [rhGH]; was approved in Europe by the European Medicines Agency in 2006. Since then, 20 biosimilars have been approved in Europe including hematopoietic growth factors, insulin, monoclonal antibodies.
{"title":"Biosimilars and Safety Issues","authors":"E. Yiannakopoulou","doi":"10.4172/2167-1052.1000e143","DOIUrl":"https://doi.org/10.4172/2167-1052.1000e143","url":null,"abstract":"Nowadays there is ongoing interest in the development of biosimilars, as biosimilars are anticipated to lead to price competition and to lower healthcare costs The first biosimilar, Omnitrope®, a biosimilar agent of the Recombinant Human Growth Hormone [rhGH]; was approved in Europe by the European Medicines Agency in 2006. Since then, 20 biosimilars have been approved in Europe including hematopoietic growth factors, insulin, monoclonal antibodies.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"181 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2017-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73168550","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}
Pub Date : 2017-06-15DOI: 10.4172/2167-1052.1000215
D. Marisavljević
Treatment-related Myelodysplastic Syndrome (t-MDS) is well known and serious complication of cancer treatment. However, MDS cases caused by therapy of common nonmalignant diseases are unusual and represent diagnosic and therapeutic challenge. We experienced a case of secondary MDS, possibly induced by trimetazidine dihydrochloride, which was spontaneously resolved by discontinuance of the drug. The main purpose of this report is to point at the importance of continuous and careful monitoring of pharmacovigilance data of different medications and their possible “relation” with some diseases or pathological conditions which are, in fact, adverse drug event.
{"title":"A Case of Secondary Myelodysplastic Syndrome Spontaneously Resolved by Discontinuance of Trimetazidine Dihydrochloride","authors":"D. Marisavljević","doi":"10.4172/2167-1052.1000215","DOIUrl":"https://doi.org/10.4172/2167-1052.1000215","url":null,"abstract":"Treatment-related Myelodysplastic Syndrome (t-MDS) is well known and serious complication of cancer treatment. However, MDS cases caused by therapy of common nonmalignant diseases are unusual and represent diagnosic and therapeutic challenge. We experienced a case of secondary MDS, possibly induced by trimetazidine dihydrochloride, which was spontaneously resolved by discontinuance of the drug. The main purpose of this report is to point at the importance of continuous and careful monitoring of pharmacovigilance data of different medications and their possible “relation” with some diseases or pathological conditions which are, in fact, adverse drug event.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"21 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87050629","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}
Pub Date : 2017-01-01DOI: 10.4172/2167-1052.1000219
K. Singh, Hemant R Kanase
Pharmacovigilance is a crucial part of drug development process which helps in assessing any drug’s adverse event profile. Years after the start of WHO’s International Drug Monitoring Programme, Government of India launched the Pharmacovigilance Programme of India (PvPI) in 2010. The main function of PvPI is monitoring the Adverse Drug Reactions (ADR) efficiently by setting up various Adverse Drug Reaction Monitoring Centres (AMC) across India and training personnel who can perform this function. PvPI has played an important role in generating awareness amongst healthcare professionals (HCPs) about the importance and the process of reporting ADRs which has led to a multifold increase in ADR reporting. There have been recent developments and advancements overseen by PvPI with a view to further increase the reach of pharmacovigilance across the country, which would further result in betterment in the ADR reporting. In this article, we try to give an overview of the PvPI, with a brief take on the history of the programme along with a look at the necessary steps being taken by the members of PvPI to improve the process of ADR reporting in the country.
{"title":"Pharmacovigilance Programme of India: The Beginning, Current Status and Recent Progress","authors":"K. Singh, Hemant R Kanase","doi":"10.4172/2167-1052.1000219","DOIUrl":"https://doi.org/10.4172/2167-1052.1000219","url":null,"abstract":"Pharmacovigilance is a crucial part of drug development process which helps in assessing any drug’s adverse event profile. Years after the start of WHO’s International Drug Monitoring Programme, Government of India launched the Pharmacovigilance Programme of India (PvPI) in 2010. The main function of PvPI is monitoring the Adverse Drug Reactions (ADR) efficiently by setting up various Adverse Drug Reaction Monitoring Centres (AMC) across India and training personnel who can perform this function. PvPI has played an important role in generating awareness amongst healthcare professionals (HCPs) about the importance and the process of reporting ADRs which has led to a multifold increase in ADR reporting. There have been recent developments and advancements overseen by PvPI with a view to further increase the reach of pharmacovigilance across the country, which would further result in betterment in the ADR reporting. In this article, we try to give an overview of the PvPI, with a brief take on the history of the programme along with a look at the necessary steps being taken by the members of PvPI to improve the process of ADR reporting in the country.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"31 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78064355","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}
Pub Date : 2016-12-30DOI: 10.4172/2167-1052.1000214
M. C. Rios, E. Mota, S. LayanaTyara, E. Fraga, Saulo Makerran Araújo Loureiro, T. V. Nascimento, Â. Antoniolli, D. P. Lyra-Júnior, A. França
Recent changes in the treatment of hepatitis C have increased the demands for medical care and pharmacovigilance. The aim of this study was to evaluate the epidemiological profile, drug therapy, and response to treatment of chronic hepatitis C patients treated with interferon plus ribavirin in combination with Telaprevir (TVR) or Boceprevir (BOC), in an outpatient hospital in Northeast Brazil. A retrospective review of patient records archived at the Hepatology Unit of the University Hospital of the Federal University of Sergipe was conducted. A total of 48 treatments were analyzed, with TVR (35) being the most used antiviral drug. The overall Sustained Virologic Response (SVR) rate after a 48-week treatment course was 61.5% among patients who received TVR and 50% among patients who received BOC. However, the SVR rate was lower when intention-to-treat was considered, decreasing to 22.8% for TVR treatment, and 15.4% for BOC treatment. Cirrhosis was one of the main characteristics of patients with suspension of treatment due to adverse reactions associated with TVR use. During combination drug treatment, adverse reactions caused by the different drugs are cumulative, creating a scenario that is difficult to control. These findings indicate the need for multidisciplinary care, and for review of therapeutic indications or even evaluating the anticipation of treatment of chronic carriers of hepatitis C, in order to achieve better results. The availability of new direct antiviral drugs will negate the need for a therapy associated with significant adverse reactions and low therapeutic response.
{"title":"Treatment of Hepatitis C with First Generation Protease Inhibitors","authors":"M. C. Rios, E. Mota, S. LayanaTyara, E. Fraga, Saulo Makerran Araújo Loureiro, T. V. Nascimento, Â. Antoniolli, D. P. Lyra-Júnior, A. França","doi":"10.4172/2167-1052.1000214","DOIUrl":"https://doi.org/10.4172/2167-1052.1000214","url":null,"abstract":"Recent changes in the treatment of hepatitis C have increased the demands for medical care and pharmacovigilance. The aim of this study was to evaluate the epidemiological profile, drug therapy, and response to treatment of chronic hepatitis C patients treated with interferon plus ribavirin in combination with Telaprevir (TVR) or Boceprevir (BOC), in an outpatient hospital in Northeast Brazil. A retrospective review of patient records archived at the Hepatology Unit of the University Hospital of the Federal University of Sergipe was conducted. A total of 48 treatments were analyzed, with TVR (35) being the most used antiviral drug. The overall Sustained Virologic Response (SVR) rate after a 48-week treatment course was 61.5% among patients who received TVR and 50% among patients who received BOC. However, the SVR rate was lower when intention-to-treat was considered, decreasing to 22.8% for TVR treatment, and 15.4% for BOC treatment. Cirrhosis was one of the main characteristics of patients with suspension of treatment due to adverse reactions associated with TVR use. During combination drug treatment, adverse reactions caused by the different drugs are cumulative, creating a scenario that is difficult to control. These findings indicate the need for multidisciplinary care, and for review of therapeutic indications or even evaluating the anticipation of treatment of chronic carriers of hepatitis C, in order to achieve better results. The availability of new direct antiviral drugs will negate the need for a therapy associated with significant adverse reactions and low therapeutic response.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"68 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2016-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87654434","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}
Pub Date : 2016-12-30DOI: 10.4172/2167-1052.1000213
A. Abuzaid, M. Osman, A. Elkhawad
It is unclear whether the persistence of Type 2 Diabetes (T2D)-associated insulin resistance in Wistar rats is entirely dependent on obesity and dyslipidemia or other factors are involved. We wanted to reveal whether alleviation of obesity and dyslipidemia by quercetin would sufficiently cure the insulin resistance in diabetic Wistar rats. For this purpose, ninety, male Wistar rats were randomized into three experimental groups (n=30): Normal Control (NC) fed chow diet, Diabetic Control (DC) fed High-Fat, High- Sucrose Diet (HFHSD) and diabetic, Quercetin-Treated (QT) fed the HFHSD and gavaged with quercetin at 50 mg.kg-1 bw.day-1. On Days 0, 60 and 120, Body Mass Index (BMI) and Abdominal Circumference:Thoracic Circumference (AC:TC) ratio were measured on ten rats from each group. Rats were then euthanized and fasting blood samples were withdrawn and used to quantify plasma glucose, Triacyclglycerols (TAG), LDL-cholesterol, total cholesterol, C-Reactive Protein (CRP) and insulin concentrations. Insulin resistance score, Relative Pancreatic Weight (RPW, %) and number of islet of Langerhans were also determined. We show that quercetin normalized BMI, AC:TC ratio, RPW (%) and dyslipidemia, and enhanced the islets number of Langerhans in the QT rats on Day 120 relative to the NC rats. In the diabetic DC rats, AC:TC ratio correlated positively with hyperglycemia and negatively with RPW (%). Quercetin lowered, but failed to normalize hyperinsulinemia, insulin resistance score, hyperglycemia and CRP in the QT rats relative to the NC rats suggesting that other factors are involved in the insulin resistance pathogenesis in T2D Wistar rats. Our data also suggest that AC:TC ratio is a predictor of the obesity-induced T2D in Wistar rats.
{"title":"Quercetin Curtails Obesity and Dyslipidemia, but Not Insulin Resistance in Long-Term Type 2 Diabetic Male Wistar Rats Fed the High-Fat, High-Sucrose Diet","authors":"A. Abuzaid, M. Osman, A. Elkhawad","doi":"10.4172/2167-1052.1000213","DOIUrl":"https://doi.org/10.4172/2167-1052.1000213","url":null,"abstract":"It is unclear whether the persistence of Type 2 Diabetes (T2D)-associated insulin resistance in Wistar rats is entirely dependent on obesity and dyslipidemia or other factors are involved. We wanted to reveal whether alleviation of obesity and dyslipidemia by quercetin would sufficiently cure the insulin resistance in diabetic Wistar rats. For this purpose, ninety, male Wistar rats were randomized into three experimental groups (n=30): Normal Control (NC) fed chow diet, Diabetic Control (DC) fed High-Fat, High- Sucrose Diet (HFHSD) and diabetic, Quercetin-Treated (QT) fed the HFHSD and gavaged with quercetin at 50 mg.kg-1 bw.day-1. On Days 0, 60 and 120, Body Mass Index (BMI) and Abdominal Circumference:Thoracic Circumference (AC:TC) ratio were measured on ten rats from each group. Rats were then euthanized and fasting blood samples were withdrawn and used to quantify plasma glucose, Triacyclglycerols (TAG), LDL-cholesterol, total cholesterol, C-Reactive Protein (CRP) and insulin concentrations. Insulin resistance score, Relative Pancreatic Weight (RPW, %) and number of islet of Langerhans were also determined. We show that quercetin normalized BMI, AC:TC ratio, RPW (%) and dyslipidemia, and enhanced the islets number of Langerhans in the QT rats on Day 120 relative to the NC rats. In the diabetic DC rats, AC:TC ratio correlated positively with hyperglycemia and negatively with RPW (%). Quercetin lowered, but failed to normalize hyperinsulinemia, insulin resistance score, hyperglycemia and CRP in the QT rats relative to the NC rats suggesting that other factors are involved in the insulin resistance pathogenesis in T2D Wistar rats. Our data also suggest that AC:TC ratio is a predictor of the obesity-induced T2D in Wistar rats.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"1 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2016-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89832750","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}
Pub Date : 2016-10-21DOI: 10.4172/2167-1052.1000212
Acevski Stevche, M. Jordan, Sterjev Zoran, Zareski Rubin, Kapedanovska Nestorovska Aleks, ra, S. Ljubica
Allocation of the resources in health care and finding a way how to prioritize spending within health care systems are hot issue, even in the developed countries. Introduction of new medical products and technologies is one important driver for increased health care costs. COPD is among top five causes of morbidity and mortality worldwide. The aim of this study is to evaluate cost effectiveness of antimicrobial regiments for treatment of acute exacerbation of COPD. Cost effectiveness analysis was performed based on data from two published observational, “real world” studies carried in Institute for occupational Health of Macedonia. Methodology is based on calculation of ICER in as many steps as needed until all exclusion criteria`s are met. All ICER`s are interpreted using cost effectiveness plane. Amoxicillin with clavulanic acid and cefuroxime dominated over other antibiotic regiments. Doxycycline, cefuroxime, cefpodoxime and moxifloxacin are cost-effective alternatives. When deciding, size of the available budget and patient’s willingness to pay will be key factors. The results of this study provide data and useful information which antibiotic will give best expected outcomes, with least produced costs.
{"title":"Cost Effectiveness Analysis of Antibiotic Regimens Used in Outpatient Treatment of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)","authors":"Acevski Stevche, M. Jordan, Sterjev Zoran, Zareski Rubin, Kapedanovska Nestorovska Aleks, ra, S. Ljubica","doi":"10.4172/2167-1052.1000212","DOIUrl":"https://doi.org/10.4172/2167-1052.1000212","url":null,"abstract":"Allocation of the resources in health care and finding a way how to prioritize spending within health care systems are hot issue, even in the developed countries. Introduction of new medical products and technologies is one important driver for increased health care costs. COPD is among top five causes of morbidity and mortality worldwide. The aim of this study is to evaluate cost effectiveness of antimicrobial regiments for treatment of acute exacerbation of COPD. Cost effectiveness analysis was performed based on data from two published observational, “real world” studies carried in Institute for occupational Health of Macedonia. Methodology is based on calculation of ICER in as many steps as needed until all exclusion criteria`s are met. All ICER`s are interpreted using cost effectiveness plane. Amoxicillin with clavulanic acid and cefuroxime dominated over other antibiotic regiments. Doxycycline, cefuroxime, cefpodoxime and moxifloxacin are cost-effective alternatives. When deciding, size of the available budget and patient’s willingness to pay will be key factors. The results of this study provide data and useful information which antibiotic will give best expected outcomes, with least produced costs.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"28 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2016-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85333060","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}
Pub Date : 2016-10-05DOI: 10.4172/2167-1052.1000211
D. Chellappan, C. Mayuren, asamy
{"title":"Cellulitis â Current Management Approach Through Complementary and Alternative Medicine","authors":"D. Chellappan, C. Mayuren, asamy","doi":"10.4172/2167-1052.1000211","DOIUrl":"https://doi.org/10.4172/2167-1052.1000211","url":null,"abstract":"","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"106 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2016-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74846547","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}
Pub Date : 2016-08-30DOI: 10.4172/2167-1052.1000210
M. Takeuchi, S. Shintani, Akira Takayama, Y. Yano, M. Miura, H. Motohashi
Yokukansan is a Japanese traditional medicine that has been used for behavioral and psychological symptoms of dementia. Although the efficacy of Yokukansan have been reported, few studies have focused on its adverse effects. In this study, the adverse effects in hospitalized patients treated with Yokukansan were evaluated retrospectively and compared with those listed in the Japanese Adverse Drug Event Report database from the Pharmaceutical and Medical Device Agency. A total of 21 patients who were prescribed Yokukansan at Rakuwakai Otowa Hospital from April 2013 to September 2013 were registered as subjects for this study. Patient profiles, such as age, gender, serum potassium levels, AST and ALT, were evaluated. Serum potassium levels decreased significantly from 4.3 ± 0.6 mEq/L to 3.6 ± 0.4 mEq/L after treatment with Yokukansan, and 61.9% of the patients demonstrated hypokalemia. In addition, the pre-treatment serum potassium levels were associated with the induction of hypokalemia by Yokukansan. The onset date of hypokalemia was varied from 2 to 1,154 days in Otowa data and from 2 to 1,533 days in JADER data. In terms of the number of days to the onset of hypokalemia, there was no significant difference between the Rakuwakai Otowa Hospital and results of Japanese Adverse Drug Event Report database. It is necessary to pay attention to patients during the treatment with Yokukansan, even if treatment period was long term.
{"title":"Hypokalemia and Related Symptoms by Yokukansan in Patients with Behavioral and Psychological Symptoms of Dementia (BPSD): A Retrospective Study of Elderly Inpatients","authors":"M. Takeuchi, S. Shintani, Akira Takayama, Y. Yano, M. Miura, H. Motohashi","doi":"10.4172/2167-1052.1000210","DOIUrl":"https://doi.org/10.4172/2167-1052.1000210","url":null,"abstract":"Yokukansan is a Japanese traditional medicine that has been used for behavioral and psychological symptoms of dementia. Although the efficacy of Yokukansan have been reported, few studies have focused on its adverse effects. In this study, the adverse effects in hospitalized patients treated with Yokukansan were evaluated retrospectively and compared with those listed in the Japanese Adverse Drug Event Report database from the Pharmaceutical and Medical Device Agency. A total of 21 patients who were prescribed Yokukansan at Rakuwakai Otowa Hospital from April 2013 to September 2013 were registered as subjects for this study. Patient profiles, such as age, gender, serum potassium levels, AST and ALT, were evaluated. Serum potassium levels decreased significantly from 4.3 ± 0.6 mEq/L to 3.6 ± 0.4 mEq/L after treatment with Yokukansan, and 61.9% of the patients demonstrated hypokalemia. In addition, the pre-treatment serum potassium levels were associated with the induction of hypokalemia by Yokukansan. The onset date of hypokalemia was varied from 2 to 1,154 days in Otowa data and from 2 to 1,533 days in JADER data. In terms of the number of days to the onset of hypokalemia, there was no significant difference between the Rakuwakai Otowa Hospital and results of Japanese Adverse Drug Event Report database. It is necessary to pay attention to patients during the treatment with Yokukansan, even if treatment period was long term.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"5 1","pages":"01-07"},"PeriodicalIF":0.0,"publicationDate":"2016-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75112954","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}
Pub Date : 2016-08-08DOI: 10.4172/2167-1052.1000208
H. Toklu
Many patients use herbs/herbal supplements as an alternative and or adjunct to their prescribed medicine. Herbal products are preferred by population, because they are natural; and they are believed to be “safe” and “have less side effects” than the “synthetic drugs”. On the other hand, plants contain a number of active ingredients that produce the physiological effect in the body. If an herb/herbal product is claimed to have beneficial effect on a certain health condition, then it must be capable to change the physiological system; i.e., exert a pharmacological response. Therefore, it may likely possess side effects as well.
{"title":"Pharmacovigilance of Herbal Medicine: Herbavigilance","authors":"H. Toklu","doi":"10.4172/2167-1052.1000208","DOIUrl":"https://doi.org/10.4172/2167-1052.1000208","url":null,"abstract":"Many patients use herbs/herbal supplements as an alternative and or adjunct to their prescribed medicine. Herbal products are preferred by population, because they are natural; and they are believed to be “safe” and “have less side effects” than the “synthetic drugs”. On the other hand, plants contain a number of active ingredients that produce the physiological effect in the body. If an herb/herbal product is claimed to have beneficial effect on a certain health condition, then it must be capable to change the physiological system; i.e., exert a pharmacological response. Therefore, it may likely possess side effects as well.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"16 1","pages":"01-03"},"PeriodicalIF":0.0,"publicationDate":"2016-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81128194","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}
Pub Date : 2016-08-03DOI: 10.4172/2167-1052.1000205
R. Pirolo, A. Bettiol, Jenny Bolcato, G. Franchin, P. Deambrosis, M. Sambataro, A. Paccagnella, P. Giusti, A. Chinellato
Aim: The main purpose for a good management of the diabetic disease is to avoid blood glucose swings. This study aims to analyze the diabetic management focusing on iatrogenic hypoglycemia, the therapeutic failure and the Body Mass Index (BMI). Methods: Diabetic patients were divided into insulin/secretagogue drugs (insulin/SD), Glucagon Like Peptide-1 Receptor Agonist (GLP-1RA) and Dipeptidylpeptidase-4 inhibitors (DPP-4i). An algorithm was created to identify hypoglycemic events, considering fracture discharge, access to emergency for coma or driving mishaps, and Self- Monitoring Blood Glucose. The achievement of glycated hemoglobin (HbA1c) target level (≤ 7%) and BMI target (≤ 25 kg/m2) were analyzed as well. Results: 16.23% out of 16,549 patients had at least one hypoglycemic event. Patients taking insulin/SD (94.39%) had a major risk of hypoglycemia (OR=2.01 p<0.001), while the groups with GLP-1 RA (1.87%) and DPP-4i (3.47%) show an OR of 0.59 (p<0.001) and 0.44 (p<0.001), respectively. The therapeutic target of HbA1c was achieved only in patients treated with DPP-4i (6.85% p<0.001). The BMI remained over the target threshold both before and during treatment for all groups but increased only for patients with insulin/SD (from 29.29 to 29.58 kg/m2). The major decrease in the number of BMI off-target patients was reported for the DPP-4i group (86.2% and 80.1% before and during treatment). Conclusions: The DPP-4i treatment did not associate with hypoglycemia and allowed HbA1c target achievement. Insulin/SD therapy, in contrast, correlated with an increased risk of hypoglycemic events, weight gain, and failure to achieve hematic target with HbA1c.
{"title":"The Difficulty of Diabetic Therapy: An Observational Retrospective Studyfrom Actual Clinical Practice","authors":"R. Pirolo, A. Bettiol, Jenny Bolcato, G. Franchin, P. Deambrosis, M. Sambataro, A. Paccagnella, P. Giusti, A. Chinellato","doi":"10.4172/2167-1052.1000205","DOIUrl":"https://doi.org/10.4172/2167-1052.1000205","url":null,"abstract":"Aim: The main purpose for a good management of the diabetic disease is to avoid blood glucose swings. This study aims to analyze the diabetic management focusing on iatrogenic hypoglycemia, the therapeutic failure and the Body Mass Index (BMI). Methods: Diabetic patients were divided into insulin/secretagogue drugs (insulin/SD), Glucagon Like Peptide-1 Receptor Agonist (GLP-1RA) and Dipeptidylpeptidase-4 inhibitors (DPP-4i). An algorithm was created to identify hypoglycemic events, considering fracture discharge, access to emergency for coma or driving mishaps, and Self- Monitoring Blood Glucose. The achievement of glycated hemoglobin (HbA1c) target level (≤ 7%) and BMI target (≤ 25 kg/m2) were analyzed as well. Results: 16.23% out of 16,549 patients had at least one hypoglycemic event. Patients taking insulin/SD (94.39%) had a major risk of hypoglycemia (OR=2.01 p<0.001), while the groups with GLP-1 RA (1.87%) and DPP-4i (3.47%) show an OR of 0.59 (p<0.001) and 0.44 (p<0.001), respectively. The therapeutic target of HbA1c was achieved only in patients treated with DPP-4i (6.85% p<0.001). The BMI remained over the target threshold both before and during treatment for all groups but increased only for patients with insulin/SD (from 29.29 to 29.58 kg/m2). The major decrease in the number of BMI off-target patients was reported for the DPP-4i group (86.2% and 80.1% before and during treatment). Conclusions: The DPP-4i treatment did not associate with hypoglycemia and allowed HbA1c target achievement. Insulin/SD therapy, in contrast, correlated with an increased risk of hypoglycemic events, weight gain, and failure to achieve hematic target with HbA1c.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"1 1","pages":"01-06"},"PeriodicalIF":0.0,"publicationDate":"2016-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82784583","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}
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