Drug utilization pattern of anti-diabetic drugs among type 2 diabetes

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 663 IJAMSCR |Volume 5 | Issue 2 | Apr - Jun - 2017 www.ijamscr.com Research article Medical research Drug utilization pattern of anti-diabetic drugs among type 2 diabetes mellitus patients – a prospective study Thushara. C 1 Sreeja. P A 2 Radhakrishnan. A P 3 1 Post graduate student Department of Pharmacy Practice Grace College of Pharmacy Kodunthirapully PO Palakkad Kerala India 2 Assistant Professor Grace College of Pharmacy Kodunthirapully PO Palakkad Kerala India 3 MBBS. MD Diabetologist Palakkad Diabetic Centre Kunnathoormedu Palakkad Kerala India Corresponding Author: Thushara. C Email id: thushumohangmail.com ABSTRACT Introduction Diabetes mellitus DM is emerging as major health problem. There has been worldwide increase in prevalence of DM especially in developing countries. With this increased prevalence of diabetes drug utilization study of antidiabetic drugs is very useful from health care viewpoint. Aim The aim of study was to investigate the drug utilization pattern in type-2 diabetic patients. Methods A prospective observational study was carried out in Palakkad Diabetic Centre Palakkad for 6 months. Patients with type-2 diabetes and on drug therapy with or without co morbidities and complications were included. Patients’ socio- demographic and clinical data were noted in a pre-designed proforma. Data was analyzed by using SPSS version 16 and Excel 2007. Result Total 428 patient were enrolled with Mean± SD age 57.72± 10.8 were females are more prevalent 52 and 77 had family history. Hypertension 26 was most common co-morbid disease followed by dyslipidemia 21. Totally 32 of patients were on Monotherapy and Metformin was commonly prescribed. In combination therapy Glimepiride and Metformin 77 were mostly consumed followed by Glibenclamide and Metformin 12 there was no evidence of Polypharmacy. Conclusion Metformin was the most commonly used drug. The prescribing trend also appears to be moving towards combination therapy particularly two drug therapy. All insulin preparations were human insulin. . Incidence of diabetes has been found higher in female as compared to male and majority of the patients develop diabetes in the most productive years of their life .This study contributes to the growing body of literature on drug utilization research. Keywords: Prevalence Co morbidities Drug utilization Poly Pharmacy ISSN:2347-6567 International Journal of Allied Medical Sciences and Clinical Research IJAMSCR

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 664 INTRODUCTION Drug utilization has been defined as the marketing distribution prescription and use of drugs in a society with emphasis on the resulting medical and social consequences. The principal aim of drug utilization studies DUS is to facilitate the rational use of drugs in population. DUS is an essential part of pharmacoepidemiology as it describes the extent nature and determinants of drug exposure and it is used to identify treatment adherence problems. 1 Diabetes represents a spectrum of metabolic disorders which has become a major health challenge worldwide. By the year 2030 over 85 percent of the world’s diabetic patients will be in developing countries. In India alone the prevalence of diabetes is expected to increase from 31.7 million in 2000 to 79.4 million in 2030 2. Diabetes results from the failure of the pancreas to produce a sufficient amount of insulin. Hormone that regulates the bodys use of glucose is insulin the pancreas produces a sufficient amount of insulin but if the insulin is blocked from the bodys cells and cannot be used. This causes patients to have abnormally high amounts of sugar in their urine and blood. Diagnosing a patient with diabetes is more complicated than measuring the glucose level of urine only one time. The diagnosis involves several hours of glucose-tolerance tests GTT. These tests measure the rate in which sugar is removed from the bloodstream and after the test are complete high glucose level indicates insufficient insulin and the patient is diagnosed with diabetes 3. Drug utilization studies can provide useful insight into the prescribing patterns and patient medication taking behavior 4. Since 1995 a dozen orally administered diabetes medications or combination of medications for the management of type-2 diabetes mellitus have been approved by FDA. They play a primary defense function against hyperglycemic events in comparison to insulin therapy. Traditionally in oral hypoglycemic agent therapy sulphonyl ureases have always been the agents of first choice while Biguanide and alpha-glucosidase inhibitors were unpopular. A good number of diabetes patients suffer from cardiovascular disease such as hypertension hyperlipidemia and ischemic heart disease 5. The present project was designed to study pattern of antidiabetic drug use in outpatient. METHODS This prospective observational study was carried out over a period of 6 months from December 2016 to May 2017 in patients attending Palakkad Diabetic Centre. The present study protocol was approved by institutional ethics committee. Newly diagnosed and patient who are not willing to participate were excluded from the study. The data was collected from prescription patient record book and patient interview. All necessary and relevant baseline information was collected on a standard patient data collection proforma which contains demographic data social history diagnosis data laboratory investigations treatment chart. For drug utilization we have analyzed 428 of type2 diabetes patients. STATISTICAL ANALYSIS Data was analysis was done by using SPSS16.0 Microsoft excel 2007 RESULTS In the present study 428 patients were participated 224 52 were females who were more when compared to males 48. mean ± SD age of the participant was 57.72± 10.8 most of the patient belong to age group of 51-60 33 followed by 61-70 32 Table 1. Mean duration of diabetes was 6.5± 4.5 and it was recorded that 77 of participants had a strong family history. In this study nearly half 50 had below matriculation education. Glycemic level were found to be high FBS 144± 53.8 and PPBS 219.18± 86.080. The data also shows that 2 n10 patients were smokers and 7 n28 being alcoholics.

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 665 Table 1 Distribution of Diabetic patients according to age n 428 Age in years No: of patients PERCENTAGE 20-30 4 1 31-40 22 5 41-50 80 18 51-60 140 33 61-70 136 32 71-80 46 11 Figure 1 Distribution of diabetic patients according to age Table 2 The co morbid conditions found to be 26 n181 had hypertension 21 n149 had dyslipidemia 7 46. The major complications are retinopathy 22 n153 and 14 had neuropathy n 102.3. Table 2 Distribution of co morbidities and complications Co morbidities and complications Number of patients percentage Hypertension 181 26 Dyslipideamia 149 21 Thyroid 46 7 Chronic kidney disease 15 2 Cardio vascular disease 9 1 Retinopathy 153 22 Neuropathy 102 14 Foot ulcer 24 3 Skin diseases 29 4

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 666 Figure 2 Distribution of co morbidities and complications Table 3 Among all the patients 32 n138 were treated with Monotherapy and 68 n 290 were on combination therapy. Table: 3 Distribution based on drug therapy Drug therapy No: of patients Percentage MONO THERAPEY 138 32 TWO DRUGCOMBINATION THERAPY 290 68 Table 4 shows that anti- diabetic drug utilization pattern among the study population. Antidiabetic agents prescribed were injectable agents different types of insulin and oral antidiabetic drugs of different groups sulfonylureas biguanides thiozolidionediones Dipeptidyl peptidase 4 DPP-4 inhibitors. All prescribed insulin preparations were human insulin. Among drug combinations 64 n229 of patients were received oral hypoglycemic while 36 129 were received insulin preparations. The study reveals that in oral hypoglycemic Monotherapy metformin 27 was the most prescribed drug metformin was the most commonly prescribed drug. Among the combinations metformin and Glimepiride 77 was most commonly prescribed followed by Metformin and Glibenclamide 12 27 and Metformin and Gliclazide 11 25 Table 5. Table 4 Drug utilization of Antidiabetic drugs- Monotherapy ATC code Drugs Total number of drugs prescribed Percentage A10AB INSULIN 129 36 A10BA02 METFORMIN 98 27 A10BB12 GLIMEPIRIDE 58 17 A10BG03 PIOGLITAZONE 59 16 A10BH01 SITAGLIPTIN 14 4

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 667 Figure 3 DRUG UTILIZATION MONO-THERAPY Table 4 Drug utilization of oral hypoglycemics- combination therapy Drugs Total number of drugs prescribed Percentage METFORMIN+GLIMEPIRIDE 179 77 METFORMIN+GLIBENCLAMIDE 27 12 METFORMIN+GLICLAZIDE 25 11 Figure 4 DRUG UTILIZATION- COMBINATION THERAPIES DISCUSSION A drug utilization study is considered to be one of the most effective methods to assess and evaluate the prescribing attitude of physician and help to promote rational use of drugs. Type 2 DM is a non-autoimmune complex heterogeneous and polygenic metabolic syndrome where the body fails to produce enough insulin characterized by abnormal glucose homeostasis. The burden of diabetes is to a large extent the consequence of macro vascular coronary artery disease peripheral vascular disease and atherosclerosis and micro vascular retinopathy neuropathy and nephropathy complications of the disease 1 . The life-style modifications and dietary changes and the pharmacological treatment an integral component in the management of diabetes 7. In our study the prevalence of diabetes mellitus is more in females 52 than males 48. The middle aged group people40-60yrs are more prevalence to the diabetes mellitus similar results were obtained in study the of drug utilization pattern and effectiveness analysis in diabetes mellitus conducted by Premalatha Das6.

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 668 Duration of diabetes has a significant role in its management. Patients who have diabetes for 5 years could usually be managed with single drug therapy while combination therapy is required in patients having diabetes for more than this period. In the present study most of the patients 48.9 had a diabetic history of 5 years a finding consistent with that of other studies 7 8. Co-morbidity has been shown to intensify health care utilization and to increase medical care costs for patients with diabetes. The associated Co morbid conditions seen with diabetes mellitus are hypertension dyslipaedemia neuropathy nephropathy and retinopathy. About 20-60 of diabetic patients are associated with hypertension as a co morbid condition 9. Our study also was in agreement with published standards where hypertension being the most common condition 26 n181 followed by dyslipaedemia 21 n149 10.The history suggested that a strong family background was noticed in the study 77 n329. The management of Type 2 diabetes can be complicated by hypoglycemia which can seriously limit the pursuit of glycemic control. Here too metformin has advantages over insulin and some types of insulin secretagogues by decreasing excess hepatic gluconeogenesis without raising insulin levels it rarely leads to significant hypoglycemia when used as a monotherapy. Metformin is widely considered an ideal first-line agent for the treatment of Type 2 diabetes. As like the Nigerian study Metformin being most commonly used drug for all Type II DM. In uncontrolled cases sulfonylureas or Insulin was added as the combination therapy as per ADA guidelines and WHO where Metformin seems to first line drug followed 11. In this study combination of biguanides and sulphonylureas was found to be most effective and this was consistent with a studies conducted in Kathmandu Nepal and Mangalore India 12 13. The combination therapy 68 is more in use in the current study area setting and is more preferred in order to control the FBS of the patients a common finding observed with early study of V. Sivasankari et.al 1 on drug utilization pattern of anti-diabetic drugs and Khushali et.al 14 on evaluation of anti- diabetic prescriptions which also suggests that combination of biguanides and sulfonylureas were most frequently used combination and are most effective. Our study states that 2-drug combination is more in use. In 2-drug combination Metformin+Glimeperide 77 was most commonly prescribed than other combinations like Metformin+Glibenclamide 12 Metformin+ Gliclazide 11 a common finding identified with early study of Bela Patel et.al 15 on patterns of anti-diabetic drugs use but which is in contrast with a study conducted by V.Sivasankari on drug utilization pattern of anti-diabetic drugs states that glibenclamide+metformin was most commonly prescribed drug. In contrast to sivasankari MD et al our study also shows that combination of biguanides and sulphonylureas was found to be most effective and this was consistent with a studies conducted in Kathmandu Nepal and Mangalore India. Poly pharmacy was commonly reported in a studies conducted in developing countries whereas average number of drugs used per prescription in our study was 1.7±0.52 which is consistent with the study conducted in Nepal and Chennai 1617. Polypharmacy has been reported as one of the causes of adverse drug reactions 18. Polypharmacy and ADR were less in our study indicating minimal and rational prescribing practices. This showed that rational approach reduced the complications and improved the glycemic control. In our study 70 of them were literate hence the compliance was also good. CONCLUSION Metformin was the most commonly used drug. The prescribing trend also appears to be moving towards combination therapy particularly two drug therapy. All insulin preparations were human insulin. Hypertension was most common associated co morbidity in diabetic patients. Incidence of diabetes has been found higher in female as compared to male and majority of the patients develop diabetes in the most productive years of their life .This study contributes to the growing body of literature on drug utilization research. Acknowledgement We would like to give thank to all respondents for their valuable time. We are grateful to the Palakkad Diabetic Centre family and Diabetologist Dr. Radhakrishnan A.P.

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Thushara. C et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-52 2017 663-669 669 REFERENCES 1. V. Sivasankari MD et al. drug utilization pattern of anti-diabetic drugs in a rural area of Tamilnadu south india – a prospective observational study Int J Pharm Bio Sci 41 2013 514 – 519. 2. Alti Arpana et al. A Study on Drug Utilization Pattern and Effectiveness of Oral Hypoglycemic Agents in Diabetes Mellitus 37 magazine.pharmatutor.org 3. H. Sun T. Jiang S. Wang H. Bing Y. Zhang D. Piao Y. Chong Na W HanP The effect of LXR ChREBP and Elovl6 in liver and white adipose tissue on medium- and long-chain fatty acids diet-induced insulin resistance 26 2013. 4. Boccuzzi SJ Wogen J Fox J Sung JCY Shah AB Kim J. Utilization of oral hypoglycemic agents in a drug insured U. S. population. Diabetes Care 248 2001 1411-1415. PubMed 5. Sahil Shah et al. a study on drug utilization pattern of anti-diabetic drugs in rural areas of islampur and kasegaon at Maharashtra IJRPC 71 2017 60-62. 6. Premalata Das Balbhadra Prasad Das Gajedra Prasad Rauniar et al. Drug utilization Pattern And Effectiveness Analysis in Diabetes Mellitus at a Tertiary Care Centre in Eastern Nepal Indian Journal of physiology and pharmacology 553 2011 272-280. 7. Upadhyay DK Palaian S Ravi Shankar P Mishra P Sah AK. Prescribing pattern in diabetic outpatients in a tertiary care teaching hospital in Nepal. J Clin Diagn Res 3 2007 248-55. 8. Kannan Arshad Kumar S. A study on drug utilization of oral hypoglycemic agents in type-2 diabetic patients. Asian J Pharm Clin Res 4 2011 60-4 9. Arauz – Pacheco C Parrot MA Raskin P. The treatment of hypertension in adult patients with diabetes. Diabetes care 251 2002 134-47. 10. Das et al drug utilization pattern and effectiveness analysis in diabetes mellitus at a tertiary care centre in eastern Nepal Indian J Physiol Pharmacol 553 2011. 11. Adibe M.O. Okonta J.M. Outpatient utilization of anti-diabetic drugs in the south eastern Nigeria. Int .J. Drug Dev and Res. 11 2009 27-36. 12. Jha N. Cost Analysis for Management of Type 2 Diabetes: A Case Study of Rural and Urban Setting. J Nepal Health Res Counc 22 2004 55–59. 13. Rajeswari S Adikariprabha M.R. Drug utilization study in Geriatric type 2 diabetic patients. Journal of Clinical and Diagnostic Research 15 2007 440 – 443. 14. Khushali G. Acharya Kartik N Shah Nialy D.Solanki et al Evaluation of Anti-Diabetic Prescription cost andAdherence to Treatment guidelines: A prospective cross-sectional study at a tertiary care teaching hospitalJournal of Basic and Clinical Pharamacy 44 2013 82-87. 15. Bela Petel Bharit Oza Kamlesh Patel et al. Pattern Of Anti Diabetic Drug Use In Type 2 Diabetic Patients In A Medicine Outpatient Clinic Of A Tertiary Care Teaching Hospital International Journal of Basic and Clinical Pharmacology 24 2013 485-491 16. Drug utilization study in diabetology outpatient setting of a tertiary hospital. Indian J Pharmacol 35 2003 237– 240. 17. Sutharson L Hariharan RS Vamsadhara C. Drug utilization study in diabetology outpatient setting of a tertiary hospital. Indian J Pharmacol 35 2003 237–240. 18. Kidon MISee Y. Adverse drug reactions inSingaporean Children. Singapore Med J. 45 2004 574-577. How to cite this article: Thushara. C Sreeja. P A Radhakrishnan. A P. Drug utilization pattern of anti-diabetic drugs among type 2 diabetes mellitus patients – a prospective study. Int J of Allied Med Sci and Clin Res 2017 52: 663-669. Source of Support: Nil. Conflict of Interest: None declared.

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