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Background: Pharmacovigilance is the science which deals with adverse drug reactions (ADRs) appear after long and short drug treatment. ADRs monitoring is essential to gain knowledge of drugs reaction for betterment of mankind. In the present study, observation of ADRs in Type II diabetic patients was conducted in tertiary care hospitals, Bhopal. ADRs reported in the present study were diarrhea, myalgia, flatulence, palpitations, rash, itching, etc., in patients receiving oral hypoglycemic agents. So through this observation, we want to acknowledge the various adverse effects occurred by oral hypoglycemic agents for reduction of morbidity and mortality in Type II Diabetic patients. Aims and Objectives: (1) The objectives of the study were to ADRs monitoring in Type II Diabetic patients receiving oral anti-diabetic agents and (2) to compare ADRs in conventional versus newer anti-diabetic agents therapies in Type II Diabetic patients. Materials and Methods: 150 patients were enrolled for evaluating adverse effects with oral antidiabetic agents. All patients were followed up by medical history, history of drugs, and any severity of ADR. Causality was graded by Naranjo scale. Results: 45 patients (30%) with mean age of 64.6 year (SD = 2.41) complained adverse effects and out of which 17 (11.3%) patients were reported to the physician. The most common adverse effect was found with sulfonylureas, biguanides, and thiazolidinediones such as hypoglycemia, weight gain, gastrointestinal (GI) disturbances allergic reactions, and dizziness probability of adverse effects more common in females (64.17%) in comparison to male (35.29%) patients. Conclusion: In Type II Diabetic patients receiving oral antidiabetic agents provides a fruitful information about a ADRs and enhance knowledge about pharmacovigilance to health-care providers. However, predominance of adverse effects in female diabetic patients was reported. Hypoglycemia, weight gain, and GI tract disturbances were observed frequently with oral antidiabetic agent in middle age diabetic patients. By this information, we can prevent drug related complications and improve quality of life of a person
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Background: The aim was to evaluate the drug utilization pattern of oral antidiabetic drugs in type 2 diabetes mellitus outpatients and monitor adverse drug reactions (ADRs) associated with oral antidiabetic drugs.Methods: A retrospective observational study was carried out by collecting the data of type 2 diabetes mellitus patients visiting outpatient department of noncommunicable disease clinic of a tertiary care hospital for a period of one year. The data of demographic, drug utilization pattern and adverse drug reactions of patients on oral antidiabetic drugs was collected and entered in a proforma.Results: Total number of patients in this study were 39 out of which 21 (53.85%) patients were females and 18 (46.15%) patients were males. Majority of patients were in the age group 51-70 years (66.6%). Metformin was the most commonly prescribed drug 76.9% followed by Glibenclamide 17.9%. About 7.7% of patients who were taking oral antidiabetic drugs later switched over to insulin as their blood glucose levels were not controlled. Out of 18 (46.15%) patients, hypertension (38.5%) was the most common comorbid condition and a concomitant drug was prescribed was amlodipine 25.6%. Among all the adverse drug reactions observed, diarrhoea was the most common adverse drug reaction reported 76.9%.Conclusions: Metformin was the most commonly used oral antidiabetic drug. Diarrhoea was the common adverse drug reaction reported.
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Background: This comparative study was done to evaluate the change from baseline in HbA1c levels with teneligliptin vs. metformin treatments at week 12 among recently diagnosed type 2 DM patients attending Medicine OPD of Dr. B. C. Roy Hospital, Haldia, West Bengal (a tertiary care teaching hospital).Methods: In this prospective parallel group clinical study patients were divided into two groups. Group A patients were on metformin monotherapy therapy and Group B patients were on teneligliptin monotherapy. Data of 40 patients (20 patients in each group) were available for analysis in the present study. Secondary endpoints included changes from baseline FPG and 2h-PPG values at 12 weeks were evaluated. Safety and tolerability were assessed by the incidence of adverse events (AEs) throughout the study period.Results: The mean age of patients was 50.05±12.35 years and out of the entire patient population 70% were males and 30% were females. At the end of 12 weeks or 3 months of metformin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.52%, 16.2mg/dL, and 36.8mg/dL, respectively, and 37.75% of patients achieved the HbA1c target of <7%. At the end of 12 weeks or 3 months of teneligliptin therapy, mean HbA1c, FBG, and PPG were significantly reduced by 0.60%, 19.4mg/dL, and 49.8mg/dL, respectively (Table 2), and 40% of patients achieved the HbA1c target of <7%.Conclusions: Teneligliptin, a DPP4 inhibitor reduced HbA1C significantly compared with monotherapy of metformin in treatment naive patients at week 12. It also reduced FBG and 2-h PPBG as compared with metformin at week 12.
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Background: Type 2 diabetes mellitus (T2DM) is one of the most common non-communicable diseases associated with ‘atherogenic dyslipidemia’ The treatment of T2DM often is initiated with oral antidiabetic drugs, most of which not only decrease blood sugar levels effectively but also decrease the lipid levels. Hence the current study is aimed to determine the effectiveness of oral hypoglycemic agents in dealing with associated dyslipidemia.Methods: 150 T2DM patients were divided equally into five groups depending upon the oral antidiabetic drugs they received in solo or in combination for 24 weeks, with equal number of males and females in each group. After the written consent, a detail clinical history, clinical examination, Biochemical investigations including, glycosylated haemoglobin and lipid profile, chest X-ray and ECG were done.Results: After 24 weeks of study, the mean total cholesterol and mean triglycerides decreased significantly (p <0.05 to p <0.01) with monotherapy of metformin and teneligliptin as well as with combination of either metformin and glimepiride or metformin and teneligliptin. The decrease of LDL-C and VLDL-C was not statistically significant with any of the OAD drugs in solo or in combination. Similarly, HDL-C increased significantly (p <0.05) in Group I, III, IV and V; but was most effective with combination therapy. The atherogenic index of plasma also decreased (p <0.05) with metformin or its combination with either teneligliptin or glimepiride.Conclusions: Oral antidiabetic drugs are not only affordable and effective hypoglycemic agents but can also decrease serum lipids and thereby aids in the prevention and management of atherosclerosis and its complications in T2DM.
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Resumen: ANTECEDENTES: la hipoglucemia grave es causa frecuente de hospitalización en México. OBJETIVO: identificar las características clínicas y de laboratorio asociadas con hipoglucemia grave en pacientes consecutivos con hipoglucemia grave y azoados normales. PACIENTES Y MÉTODO: estudio prospectivo en el que del 11 agosto de 2011 al 31 mayo de 2013 se incluyeron pacientes con hipoglucemia grave y creatinina normal. Se registró edad, sexo, tiempo de evolución de la diabetes mellitus, tratamiento antidiabético, comorbilidades y depuración de creatinina en orina de 24 horas. RESULTADOS: ingresaron 234 pacientes con hipoglucemia grave, 21 9% tenían creatinina normal: 13 mujeres 62% y 8 38% hombres, con edad promedio de 64.76 años límites: 42-84; 13 62% eran mayores de 60 años; 15 71% tenían más de 5 años con diabetes mellitus 2 promedio de evolución de 9.2 años; 15 recibían glibenclamida 71%, 4 en combinación con insulina 19% y 8 con metformina 38%; 2 recibían rosiglitazona más insulina. Cuatro no tenían comorbilidades 19%; 14 tenían hipertensión arterial 71% y 3 neoplasia adenocarcinoma, carcinoma gástrico y carcinoma esofágico; 11 52% ingresaron con pérdida del estado de alerta; 5 con desorientación 24%, 4 con trastornos de conducta 19%, uno con dislalia 5%; 15 de 21 71% tenían grado avanzado de deterioro renal, a pesar de tener azoados normales. CONCLUSIONES: es importante determinar la depuración de creatinina en todos los niveles de atención, única guía para prescribir tratamientos seguros de acuerdo con la función renal. La glibenclamida debe prescribirse con cautela en adultos mayores, con más de 10 años de evolución de la diabetes mellitus 2 y evitarse en los sujetos con insuficiencia renal crónica documentada.
Abstract: BACKGROUND: Severe hypoglycemia is a frequent cause of hospitalization in Mexico. OBJECTIVE: To identify the clinical and laboratory characteristics associated to severe hypoglycemia in consecutive patients with severe hypoglycemia and normal creatinine serum values. PATIENTS AND METHOD: A prospective study was done from August 11, 2011 to May 31, 2013, including patients with severe hypoglycemia and normal creatinine serum values. Age, sex, time of evolution of diabetes mellitus 2, antidiabetic treatment, comorbidities and 24-hour urine creatinine clearance were recorded. RESULTS: From 234 patients with severe hypoglycemia admitted, 21 9% had normal creatinine: 13 women 62% and 8 38% men, with a mean age of 64.76 years range: 42-84; 13 62% were older than 60 years; 15 71% had more than 5 years with DM2 mean evolution of 9.2 years; 15 received glibenclamide 71%, 4 in combination with insulin 19% and 8 with metformin 38%. Two received rosiglitazone plus insulin. Four patients had not comorbidities 19%; 16 had arterial hypertension 71% and 3, neoplasms adenocarcinoma, gastric carcinoma and esophageal carcinoma. Eleven patients 52% were admitted with syncope, 5 with disorientation 24%, 4 with conduct disorders 19% and one with dyslalia 5%; 15 of 21 patients 71% had advanced degrees of renal impairment, despite normal creatinine serum values. CONCLUSIONS: It is important to perform creatinine clearance at all levels of care, the only guide for safe treatments according to kidney function. Glibenclamide should be cautiously prescribed in older adults with a history of more than 10 years of diabetes mellitus 2 and should be avoided in those with documented chronic renal failure.
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OBJECTIVE:To evaluate the availability and equipment of antidiabetic drugs in public hospitals from Shaanxi prov-ince. METHODS:Using a standardized methodology developed by WHO and Health Action International,the availability and equipping rate of the most common oral antidiabitic drugs were investigated and evaluated in public hospitals of Shaanxi province. RESULTS:The availability and equipping rate of tertiary hospitals and secondary hospitals were all higher than those of community health service centers. Among generic drugs,the availability of metformin was the highest (94.4%),and those of glibenclamide and repaglinide were the lowest(5.6%). Among original drugs,the availability of acarbose was the highest(68.1%). The equip-ping rate of original drugs was higher than that of generic drugs. The equipping rate of generic drugs(25.0%)was higher than that of original drugs(12.5%)in community health service center,but the equipping rates of generic drugs and original drugs were in low level. CONCLUSIONS:General hospitals (especially tertiary hospitals) have high equipping rate of original antidiabetic drugs,the community health services have low availability and equipping rate. Comprehensive measures should be taken to im-prove the availability of drugs in primary medical institutions and ensure drug use of chronic disease patients in primary hospitals.
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Objective To summarize the current status and trend of hypoglycemic agents of diabetic inpatients in different departments of Chinese PLA General Hospital.Methods The clinical data of diabetic patients admitted to Chinese PLA General Hospital from January 2000 to May 2014 were collected(those hospitalized in the department of endocrinology were excluded).A total of 10 041 patients were selected by stratified random sampling.The type of hypoglycemic agents in different departments and the variation on anti-hyperglycemic drugs with time were retrospectively analyzed.Results Of all the patients in non-endocrinological wards, 50.2% were treated with insulin, 36.9% with metformin, 21.3% with α-glycosidase inhibitor, and 18.9% with sulfonylureas.Metformin, α-glucosidase inhibitors, pre-mixed 30R, and insulin glargine were more commonly used than other anti-hyperglycemic agents, accounting for 36.9%, 21.0%, 14.0%, 8.7%, respectively.Metformin, sulfonylureas, α-glucosidase inhibitor, and different types of insulin were more widely applied in internal medicine while insulin therapy was more frequently used in surgical department.During the past 15 years, the proportions of insulin, glinides, α-glucosidase inhibitor, and thiazolidinediones application were gradually increased, while the proportions of sulfonylureas and metformin treatment were on the decline trend.Conclusion Most of the inpatients were treated with oral antidiabetic drugs.Metformin, α-glucosidase inhibitor, pre-mixed 30R, and insulin glargine were the most frequently prescribed agents for the inpatients.
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The purpose of this study was to evaluate the therapeutic options for diabetes treatment and their potential side effects, in addition to analyzing the risks and benefits of tight glycemic control in patients with diabetic kidney disease. For this review, a search was performed using several pre-defined keyword combinations and their equivalents: “diabetes kidney disease” and “renal failure” in combination with “diabetes treatment” and “oral antidiabetic drugs” or “oral hypoglycemic agents.” The search was performed in PubMed, Endocrine Abstracts and the Cochrane Library from January 1980 up to January 2015. Diabetes treatment in patients with diabetic kidney disease is challenging, in part because of progression of renal failure-related changes in insulin signaling, glucose transport and metabolism, favoring both hyperglycemic peaks and hypoglycemia. Additionally, the decline in renal function impairs the clearance and metabolism of antidiabetic agents and insulin, frequently requiring reassessment of prescriptions. The management of hyperglycemia in patients with diabetic kidney disease is even more difficult, requiring adjustment of antidiabetic agents and insulin doses. The health team responsible for the follow-up of these patients should be vigilant and prepared to make such changes; however, unfortunately, there are few guidelines addressing the nuances of the management of this specific population.
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Humans , Blood Glucose/drug effects , /drug therapy , Diabetic Nephropathies/drug therapy , Hypoglycemic Agents/therapeutic use , Renal Insufficiency, Chronic/drug therapy , Blood Glucose/metabolism , Creatinine/metabolism , Disease Progression , /complications , /metabolism , Diabetic Nephropathies/metabolism , Glomerular Filtration Rate/drug effects , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/metabolism , Patient Compliance , Renal Insufficiency, Chronic/etiology , Renal Insufficiency, Chronic/metabolismABSTRACT
To compare the economic efficacies of the oral antidiabetic drugs in National Essential Medicine for treating type 2 diabetes mellitus.200 diabetic patients with body mass indices between 19-27 kg/m2 were assigned into 5 groups:group A received glibenclamide,group B glipizide,group C metformin,group D glibenclamide +metformin,and group E glipizide + metformin.Pharmacoeconomic evaluation was performed by cost-effectiveness analysis( CEA ).Fasting glucose level in patients treated with these 5 drugs all decreased significantly,as well as HbA1c.Glibenclamide was more in line with the principles of pharmacoeconomics,but should be used carefully for its serious and prolonged hypoglycemia,especially in elderly patients.According to the method of cost-effectiveness analysis,it was more economical to use metformin to control fasting glucose level while it is more reasonable to use glipizide to control the postprandial glucose whereas controlling of postprandial blood glucose is considered as a priority.Glipizide+mefformin combination may be recommended to the patients whose blood glucose level is poorly controlled by a single drug alone.
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OBJECTIVE: To investigate the application and trend of oral antidiabetic drugs in our hospital. METHODS: The use of oral antidiabetic drugs in our hospital in 2006 was analyzed retrospectively in respect of consumption sum, DDDs, drugs daily cost (DDC) and drugs utilization index (DUI) etc. RESULTS: The top 3 antidiabetic drugs in respect of consumption sum were acarbose, gliquidone and glipizide. The top 3 antidiabetic drugs in respect of DDDs were metformin, glipizide and acarbose. CONCLUSION: The use of oral antidiabetic drugs used in our hospital is rational on the whole, leading the list were biguanides, sulfonylurea and glycosidase-inhibitors.