Effects of Glibenclamide and Glimepiride Compared in Type II DM Patients in Accordance with Lipid Parameters, ESF and Glycated Haemoglobin
Total Page:16
File Type:pdf, Size:1020Kb
British Journal of Applied Science & Technology 10(3): 1-10, 2015, Article no.BJAST.17537 ISSN: 2231-0843 SCIENCEDOMAIN international www.sciencedomain.org Effects of Glibenclamide and Glimepiride Compared in Type II DM Patients in Accordance with Lipid Parameters, ESF and Glycated Haemoglobin K. Chandra Mouli Krishna1, B. Sowmya2, Bandopadhyay Mamata3 and M. Prasad Naidu4* 1NRI Institute of Medical College, Sangivalasa, Visakhapatnam -531162, Andhra Pradesh, India. 2Kamala Nursing Home, Marripalem, Visakhapatnam - 530018, Andhra Pradesh, India. 3Department of Pharmacology, Maharaja Institute of Medical Sciences, Nellimarla, Vizinagaram - 535217, Andhra Pradesh, India. 4Department of Biochemistry, Narayana Medical College and Hospital, Nellore-524003, Andhra Pradesh, India. Authors’ contributions This work was carried out in collaboration between all authors. All authors read and approved the final manuscript. Article Information DOI: 10.9734/BJAST/2015/17537 Editor(s): (1) Gautam R. Ullal, Course Director Neuroscience and Foundations of Clinical Medicine, Medical University of Americas, West Indies. Reviewers: (1) Ayşenur Yeğin, Clinical Biochemistry, Antalya Research and Educational Hospital, Turkey. (2) Anonymous, The Third Hospital of Hebei Medical University, China. (3) Anonymous, MGM Medical College, Navi-Mumbai, India. Complete Peer review History: http://sciencedomain.org/review-history/9912 Received 17th March 2015 th Original Research Article Accepted 5 June 2015 Published 27th June 2015 ABSTRACT The population of Indian adults suffering from diabetes is expected to increase threefold, from 19.4 million in 1995 to 57.2 million in 2025. The objective of the study was to evaluate the efficacy and safety of antidiabetic drug and to find out their cardio protective action in patients with diabetes mellitus. In all, 60 patients who were newly diagnosed with Type II diabetes mellitus or who were already on treatment for Type II diabetes mellitus were enrolled in our study. The study was conducted on patients suffering from Type II diabetes mellitus for a period of 6 months from December 2011 to June 2012. These were patients attending the Medical and Surgical OPD’s of Maharajah’s Institute of Medical Sciences (MIMS) Hospital, Nellimarla, Vizianagaram district, _____________________________________________________________________________________________________ *Corresponding author: E-mail: [email protected]; Krishna et al.; BJAST, 10(3): 1-10, 2015; Article no.BJAST.17537 Andhra Pradesh. Estimations of Hb%, FBS, HbA1C, Lipid Profile, ECG and Ejection Systolic Fraction (ESF) were done and compared, where HbA1C concentration was lower in the glimepiride group. Significant reduction in the total cholesterol, serum triglyceride and LDL cholesterol was observed in the Glimepiride + Metformin combination. It also increased the HDL cholesterol levels which were not observed with Glibenclamide + Metformin for the study period of 12 weeks. Thus, the Glimepiride/Metformin combination may be considered to be a better combination in patients with increased lipid parameters in comparison with Glibenclamide/Metformin combination in patients with Type II diabetes. Keywords: Diabetes mellitus; lipid profile; ejection systolic fraction; cardiovascular diseases; Glibenclamide and Glimepiride. 1. INTRODUCTION hypoglycemic therapy as the dominant aim, but the pathogenic endogenous changes due to Diabetes, with its associated acute and long-term diabetes mellitus occur from the onset of complications, and the myriad of disorders hyperglycemic condition, in which very commonly associated with it, is a major health hazard [1]. In the atherosclerogenic risky lipid profile features keeping with the scenario of most developing gradually develop in spite of good glycemic countries, India has long passed the stage of a control [9]. The lipid profile is a very important diabetes epidemic [2]. The problem has now prognostic marker for diabetes mellitus reached, in scientific language, "pandemic" complicated with cardiovascular manifestations proportions. To put it simply, it has crossed the such as atherosclerosis, myocardial infarction, dividing line in which it is a problem associated decreased peripheral circulation and gangrene, with individuals, no matter how large this number stroke, and neurovascular complications, etc. may be, and is now a problem in public health of Thus assessing the lipid profile parameters like a large magnitude, growing astronomically each LDL (Low Density Lipoprotein), VLDL (Very Low year. More than a matter of individual health and Density Lipoprotein), and HDL (High Density well being, the pandemic calls for an effort in Lipoprotein) from the point of diagnosis of which attention must be paid in bringing social diabetes is very much essential, such that the awareness [3]. Recent WHO (World Health care of the patients increases and subsequently Organization) projections suggest that the leading to a decrease in various type of number of adults suffering from diabetes in India complications [10]. is expected to increase threefold, from 19.4 million in 1995 to 57.2 million in 2025 [4]. The Efficacy variables taken in this study were Presently it is 50.8 million in 2010. It has been percentage decrease in FBS, HbA1C,TC (Total confirmed that between 10% to 12% of urban Cholesterol),TG (Triglycerides), LDL, VLDL and population and 4% to 6% of rural population of the percentage increase in HDL, ESF (Ejection India have diabetes now [5]. systolic fraction) and Hb% (Hemoglobin Percentage) over 12 weeks period. The Safety Diabetes mellitus is characterized by variables, adverse drug reactions of anti-diabetic hyperglycemia, altered metabolism of lipids, drugs, hematological, laboratory and clinical carbohydrates & proteins; and an increased risk parameters were monitored over the period of of complications from vascular disease [6]. study [11]. The aim of this study is to evaluate Diabetes mellitus will eventually cause cardiac, the cardio protective effects of Glibenclamide vascular, renal, hematological, ocular, neuronal and Glimepiride in Diabetes Mellitus patients and complications and will result in end organ failure the objective of the study was to evaluate the [7]. The standard of care therapy available for efficacy and safety of these drugs. diabetes mellitus is insulin and oral hypoglycemic drugs. FBS (Fasting Blood Sugar) and HbA1C 2. MATERIALS AND METHODS (Glycated Hemoglobin) are now the most important parameters for diagnosis and 2.1 Objects management of diabetes [8]. Patients were prescribed with a starting dose of Patients with diabetes mellitus are primarily 5 mg of Glibenclamide, 1 mg of Glimepiride and receiving insulin or anti-diabetic drugs with 500 mg of Metformin orally, which was minimum 2 Krishna et al.; BJAST, 10(3): 1-10, 2015; Article no.BJAST.17537 required dose at which subjects showed clinical 2.6 Exclusion Criteria improvement. If no clinical or hematological response, the dose was escalated to a maximum The patients with Type I DM, with sever of 10 mg Glibenclamide, 4 mg of Glimepiride and debilitating diseases like renal failure and 1000 mg of Metformin, once in 2 weeks. cardiovascular diseases, Myocardial Infarction, Patients were supplied with the drug on a weekly recent infections, major surgeries and irregular basis and were requested to return the unused dietary habits have been excluded in this study. tablets. After obtaining informed consent, the The objective of the study was to evaluate the patients were randomly allocated to group. On efficacy of Glibenclamide and Glimepiride in the initial contact, the demographic data, clinical cardiac protection and to evaluate the safety of history and physical examination of the patient these drugs. were noted. Patient was asked to come for follow-up on 2.2 Sample Collection weekly basis and outcome variables were reassessed if felt necessary on examination. At Standard diagnostic laboratory procedures were the time of enrollment every patient was given a implemented in the sample collection and green colored follow-up card, on which were estimation of the dependent variables for all the written his name, enrollment number, patients of both the groups. Baseline laboratory identification number, address, group to which he investigations like Estimation of Hb% by using belonged and date of next follow up. Patients Hemoglobinometry (Sahli’s Method, from both the groups either continued with their determination of FBS by using Glucose oxidase respective treatment regimens or were put on peroxidase method (GODPOD Method), standard anti-diabetic therapy depending on the estimation of HbA1c by using Chromatography efficacy and safety of the treatment regimens at based HPLC assay. The study was conducted the discretion of the clinician. ECG and Ejection for a period of 6 months during the period of Systolic Fraction values were reviewed by the December 2011 to June 2012, on patients investigator and even by the consultant suffering from Type II Diabetes Mellitus attending Cardiologist of MIMS Hospital. All the obtained the Medical and Surgical OPD’s of Maharajah’s results were tabulated and compared using Institute of Medical Sciences (MIMS) Hospital, Student “t” test and graphical representation was Nellimarla, Vizianagaram district, Andhra done accordingly. Pradesh. The approval of Ethics committee (IEC) of MIMS 2.3 Lipid Profile Measurement was taken before the start of the study. Total 60 patients who were newly diagnosed with Type