Abstract
Objectives
The objective of the present study was to evaluate the Drug utilisation pattern in patients of diabetic nephropathy (stage 1–4) in a tertiary care hospital in South-Asia.
Methods
A cross-sectional observational study was conducted in the nephrology out-patient-department of a tertiary care hospital in South-Asia. WHO core prescribing, dispensing, and patient care indicators were evaluated, and adverse drug reactions (ADRs) encountered by the patients were analysed for causality, severity, preventability, and outcome.
Results
The most commonly prescribed antidiabetics in diabetic nephropathy patients were insulin (17.42%), followed by metformin (4.66%). Current drugs of choice SGLT-2 inhibitors were prescribed in a lesser frequency than expected. Loop diuretics and calcium channel blockers (CCBs) were the preferred antihypertensives. The use of ACE inhibitors (1.26%) and ARBs (3.45%) for hypertension was restricted to Stage 1 and 2 nephropathy. The patients were on 6.47 drugs on average. 30.70% of drugs were prescribed by generic names, 59.07% of the drugs were prescribed from the national essential drugs list and 34.03% of the prescribed drugs were supplied by the hospital. CTCAE grade 1 (68.60%) and grade 2 (22.09%) ADR severity was the highest.
Conclusions
Prescribing patterns in patients of diabetic nephropathy were adapted from relevant medical evidence, affordability and availability of the drugs. Generic prescribing, availability of drugs and ADR preventability in the hospital have a broad scope for improvement.
Acknowledgements
The authors thank the Department of Nephrology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, for granting them permission for carrying out the study. The authors also thank Mr. Manish Pawar, Clinical research coordinator and Biostatistician, Department of Pharmacology, Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, for reviewing the statistical analysis.
-
Research funding: None declared.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Informed consent was obtained from all individuals included in this study.
-
Ethical approval: Ethical approval was obtained from the Institutional Ethics Committee for Human Research, Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC) – Approval number: IEC/375/19.
References
1. Alicic, RZ, Rooney, MT, Tuttle, KR. Diabetic kidney disease: challenges, progress, and possibilities. Clin J Am Soc Nephrol 2017;12:2032–45. https://doi.org/10.2215/cjn.11491116.Search in Google Scholar
2. Lea-Henry, TN, Carland, JE, Stocker, SL, Sevastos, J, Roberts, DM. Clinical pharmacokinetics in kidney disease: fundamental principles. Clin J Am Soc Nephrol 2018;13:1085–95. https://doi.org/10.2215/cjn.00340118.Search in Google Scholar
3. Williams, DM, Nawaz, A, Evans, M. Renal outcomes in type 2 diabetes: a review of cardiovascular and renal outcome trials. Diabetes Ther 2020;11:369–86. https://doi.org/10.1007/s13300-019-00747-3.Search in Google Scholar PubMed PubMed Central
4. Sharma, A, Pagidipati, NJ, Califf, RM, McGuire, DK, Green, JB, Demets, D, et al.. Impact of regulatory guidance on evaluating cardiovascular risk of new glucose-lowering therapies to treat type 2 diabetes mellitus: lessons learned and future directions: lessons learned and future directions. Circulation 2020;141:843–62. https://doi.org/10.1161/circulationaha.119.041022.Search in Google Scholar
5. Sanyal, SN, Datta, SK, Banerjee, AK. Factors influencing prescribing decisions among physicians: an empirical study on generic drugs. Int J Pharmaceut Healthc Market 2017;11:330–60. https://doi.org/10.1108/ijphm-06-2016-0031.Search in Google Scholar
6. WHO International Working Group for Drug Statistics Methodology, WHO Collaborating Centre for Drug Statistics Methodology & WHO Collaborating Centre for Drug Utilization Research and Clinical Pharmacological Services. Introduction to drug utilization research [internet]. Who.int; 2003. Available from: https://apps.who.int/iris/bitstream/handle/10665/42627/924156234X.pdf?sequence=1&isAllowed=y [Accessed 20 Jan 2022].Search in Google Scholar
7. Montvida, O, Shaw, J, Atherton, JJ, Stringer, F, Paul, SK. Long-term trends in antidiabetes drug usage in the U.S.: real-world evidence in patients newly diagnosed with type 2 diabetes. Diabetes Care 2018;41:69–78. https://doi.org/10.2337/dc17-1414.Search in Google Scholar PubMed
8. Devi, DP, George, J. Diabetic nephropathy: prescription trends in tertiary care. Indian J Pharmaceut Sci 2008;70:374–8. https://doi.org/10.4103/0250-474x.43007.Search in Google Scholar
9. Ajiboye, O, Segal, JB. National trends in the treatment of diabetic nephropathy in the United States. J Clin Pharm Therapeut 2017;42:311–7. https://doi.org/10.1111/jcpt.12516.Search in Google Scholar PubMed
10. Adherence to long-term therapies evidence for action [internet]. Who.int. Available from: https://www.who.int/chp/knowledge/publications/adherence_full_report.pdf [Accessed 21 Jan 2022].Search in Google Scholar
11. Sahu, RK, Yadav, R, Prasad, P, Roy, A, Chandrakar, S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springerplus 2014;3:695. https://doi.org/10.1186/2193-1801-3-695.Search in Google Scholar PubMed PubMed Central
12. Harris, ST, Patorno, E, Zhuo, M, Kim, SC, Paik, JM. Prescribing trends of antidiabetes medications in patients with type 2 diabetes and diabetic kidney disease, a cohort study. Diabetes Care 2021;44:2293–301. https://doi.org/10.2337/dc21-0529.Search in Google Scholar PubMed PubMed Central
13. Alavudeen, SS, Alakhali, KM, Ansari, SMA, Khan, NA. Prescribing pattern of antihypertensive drugs in diabetic patients of Southern Province, Kingdom of Saudi Arabia. Ars Pharm 2015;56:109–14. https://doi.org/10.4321/s2340-98942015000200005.Search in Google Scholar
14. Haneda, M, Utsunomiya, K, Koya, D, Babazono, T, Moriya, T, Makino, H, et al.. A new classification of diabetic nephropathy 2014: a report from joint committee on diabetic nephropathy. J Diabetes Invest 2015;6:242–6. https://doi.org/10.1111/jdi.12319.Search in Google Scholar PubMed PubMed Central
15. The use of the WHO-UMC system for standardised case causality assessment [Internet]. Who.int. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf [Accessed 21 Jan 2022].Search in Google Scholar
16. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [internet]. Cancer.gov. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf [Accessed 21 Jan 2022].Search in Google Scholar
17. Schumock, GT, Thornton, JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538.Search in Google Scholar
18. Saeedi, P, Petersohn, I, Salpea, P, Malanda, B, Karuranga, S, Unwin, N, et al.. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the International Diabetes Federation Diabetes Atlas, 9th ed. Diabetes Res Clin Pract 2019;157:107843. https://doi.org/10.1016/j.diabres.2019.107843.Search in Google Scholar PubMed
19. Chawla, R, Madhu, SV, Makkar, BM, Ghosh, S, Saboo, B, Kalra, S, et al.. RSSDI-ESI clinical practice recommendations for the management of type 2 diabetes mellitus 2020. Int J Diabetes Dev Countries 2020;40:1–122. https://doi.org/10.1007/s13410-020-00819-2.Search in Google Scholar
20. American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2021. Diabetes Care 2021;44:S111–24. https://doi.org/10.2337/dc21-s009.Search in Google Scholar
21. James, PA, Oparil, S, Carter, BL, Cushman, WC, Dennison-Himmelfarb, C, Handler, J, et al.. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014;311:507–20. https://doi.org/10.1001/jama.2013.284427.Search in Google Scholar PubMed
22. Whelton, PK, Carey, RM, Aronow, WS, Casey, DEJr, Collins, KJ, Dennison Himmelfarb, C, et al.. 2017 ACC/AHA/AAPA/ABCNMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. J Am Coll Cardiol 2018;71:2199–269. https://doi.org/10.1016/j.jacc.2017.11.005.Search in Google Scholar PubMed
23. Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney Int 2021;99:S1–87. https://doi.org/10.1016/j.kint.2020.11.003.Search in Google Scholar PubMed
24. Tsujii, T. Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: a short-term open, randomized multicenter study. BPH Medical Therapy Study Group. Benign prostatic hyperplasia. Int J Urol 2000;7:199–205. https://doi.org/10.1046/j.1442-2042.2000.00175.x.Search in Google Scholar PubMed
25. Würzner, G, Gerster, JC, Chiolero, A, Maillard, M, Fallab-Stubi, CL, Brunner, HR, et al.. Comparative effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia and gout. J Hypertens 2001;19:1855–60. https://doi.org/10.1097/00004872-200110000-00021.Search in Google Scholar PubMed
26. Nathan, DM, DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care 2014;37:9–16. https://doi.org/10.2337/dc13-2112.Search in Google Scholar PubMed PubMed Central
27. Melo, KFS, Bahia, LR, Pasinato, B, Porfirio, GJM, Martimbianco, AL, Riera, R, et al.. Short-acting insulin analogues versus regular human insulin on postprandial glucose and hypoglycemia in type 1 diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr 2019;11:2. https://doi.org/10.1186/s13098-018-0397-3.Search in Google Scholar PubMed PubMed Central
28. Kudva, YC, Basu, A, Jenkins, GD, Pons, GM, Quandt, LL, Gebel, JA, et al.. Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. Diabetes Care 2005;28:10–4. https://doi.org/10.2337/diacare.28.1.10.Search in Google Scholar PubMed
29. Hanif, K, Bid, HK, Konwar, R. Reinventing the ACE inhibitors: some old and new implications of ACE inhibition. Hypertens Res 2010;33:11–21. https://doi.org/10.1038/hr.2009.184.Search in Google Scholar PubMed
30. Hegde, A. Diuretics in acute kidney injury. Indian J Crit Care Med 2020;24:S98–9. https://doi.org/10.5005/jp-journals-10071-23406.Search in Google Scholar PubMed PubMed Central
31. Shete, MM. Cilnidipine: next generation calcium channel blocker. J Assoc Physicians India 2016;64:95–9.Search in Google Scholar
32. Ishii, N, Matsumura, T, Kinoshita, H, Fukuda, K, Motoshima, H, Senokuchi, T, et al.. Nifedipine induces peroxisome proliferator-activated receptor-gamma activation in macrophages and suppresses the progression of atherosclerosis in apolipoprotein E-deficient mice. Arterioscler Thromb Vasc Biol 2010;30:1598–605. https://doi.org/10.1161/atvbaha.109.202309.Search in Google Scholar
33. King, P, Peacock, I, Donnelly, R. The UK prospective diabetes study (UKPDS): clinical and therapeutic implications for type 2 diabetes: therapeutic implications of the UKPDS. Br J Clin Pharmacol 1999;48:643–8. https://doi.org/10.1046/j.1365-2125.1999.00092.x.Search in Google Scholar PubMed PubMed Central
34. Gabler, M, Picker, N, Geier, S, Foersch, J, Aberle, J, Martin, S, et al.. Real-world clinical outcomes and costs in type 2 diabetes mellitus patients after initiation of insulin therapy: a German claims data analysis. Diabetes Res Clin Pract 2021;174:108734. https://doi.org/10.1016/j.diabres.2021.108734.Search in Google Scholar PubMed
35. Kwon, S, Kim, YC, Park, JY, Lee, J, An, JN, Kim, CT, et al.. The long-term effects of metformin on patients with type 2 diabetic kidney disease. Diabetes Care 2020;43:948–55. https://doi.org/10.2337/dc19-0936.Search in Google Scholar PubMed
36. Simpson, SH, Lee, J, Choi, S, Vandermeer, B, Abdelmoneim, AS, Featherstone, TR. Mortality risk among sulfonylureas: a systematic review and network meta-analysis. Lancet Diabetes Endocrinol 2015;3:43–51. https://doi.org/10.1016/s2213-8587(14)70213-x.Search in Google Scholar
37. Mann, JFE, Ørsted, DD, Brown-Frandsen, K, Marso, SP, Poulter, NR, Rasmussen, S, et al.. Liraglutide and renal outcomes in type 2 diabetes. N Engl J Med 2017;377:839–48. https://doi.org/10.1056/nejmoa1616011.Search in Google Scholar PubMed
38. Kitada, M, Ogura, Y, Nitta, K, Fujii, M, Kanasaki, K, Konishi, K, et al.. Effect of switching to teneligliptin from other dipeptidyl peptidase-4 inhibitors on glucose control and renoprotection in type 2 diabetes patients with diabetic kidney disease. J Diabetes Invest 2019;10:706–13. https://doi.org/10.1111/jdi.12917.Search in Google Scholar PubMed PubMed Central
39. Schnell, O, Standl, E, Cos, X, Heerspink, HJ, Itzhak, B, Lalic, N, et al.. Report from the 5th cardiovascular outcome trial (CVOT) summit. Cardiovasc Diabetol 2020;19:47. https://doi.org/10.1186/s12933-020-01022-7.Search in Google Scholar PubMed PubMed Central
40. Heerspink, HJL, Sjöström, CD, Jongs, N, Chertow, GM, Kosiborod, M, Hou, FF, et al.. Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD randomized controlled trial. Eur Heart J 2021;42:1216–27. https://doi.org/10.1093/eurheartj/ehab094.Search in Google Scholar PubMed PubMed Central
41. Halimi, S, Vergès, B. Adverse effects and safety of SGLT-2 inhibitors. Diabetes Metab 2014;40:S28–34. https://doi.org/10.1016/s1262-3636(14)72693-x.Search in Google Scholar
42. Krieger, EM, Drager, LF, Giorgi, DMA, Pereira, AC, Barreto-Filho, JAS, Nogueira, AR, et al.. Spironolactone versus clonidine as a fourth-drug therapy for resistant hypertension: the ReHOT randomized study (resistant hypertension optimal treatment). Hypertension 2018;71:681–90. https://doi.org/10.1161/hypertensionaha.117.10662.Search in Google Scholar PubMed
43. Clay, PG, Graham, MR, Lindsey, CC, Lamp, KC, Freeman, C, Glaros, A. Clinical efficacy, tolerability, and cost savings associated with the use of open-label metronidazole plus ceftriaxone once daily compared with ticarcillin/clavulanate every 6 hours as empiric treatment for diabetic lower-extremity infections in older males. Am J Geriatr Pharmacother 2004;2:181–9. https://doi.org/10.1016/j.amjopharm.2004.09.006.Search in Google Scholar PubMed
44. Oesterle, A, Laufs, U, Liao, JK. Pleiotropic effects of statins on the cardiovascular system. Circ Res 2017;120:229–43. https://doi.org/10.1161/circresaha.116.308537.Search in Google Scholar PubMed PubMed Central
45. Shen, L, Vavalle, JP, Broderick, S, Shaw, LK, Douglas, PS. Antianginal medications and long-term outcomes after elective catheterization in patients with coronary artery disease: shenet al. Clin Cardiol 2016;39:721–7. https://doi.org/10.1002/clc.22594.Search in Google Scholar PubMed PubMed Central
46. Vankar, SG, Dutta, P, Kohli, HS, Bhansali, A. Efficacy & safety of continuous erythropoietin receptor activator (CERA) in treating renal anaemia in diabetic patients with chronic kidney disease not on dialysis. Indian J Med Res 2014;139:112–6.Search in Google Scholar
47. Taksande, SR, Worcester, EM. Calcium supplementation in chronic kidney disease. Expet Opin Drug Saf 2014;13:1175–85. https://doi.org/10.1517/14740338.2014.937421.Search in Google Scholar PubMed
48. Huang, W, Glass, CK. Nuclear receptors and inflammation control: molecular mechanisms and pathophysiological relevance. Arterioscler Thromb Vasc Biol 2010;30:1542–9. https://doi.org/10.1161/atvbaha.109.191189.Search in Google Scholar
49. Elbarbary, NS, Ismail, EAR, Zaki, MA, Darwish, YW, Ibrahim, MZ, El-Hamamsy, M. Vitamin B complex supplementation as a homocysteine-lowering therapy for early stage diabetic nephropathy in pediatric patients with type 1 diabetes: a randomized controlled trial. Clin Nutr 2020;39:49–56. https://doi.org/10.1016/j.clnu.2019.01.006.Search in Google Scholar PubMed
50. Calderón-Ospina, CA, Nava-Mesa, MO. B Vitamins in the nervous system: current knowledge of the biochemical modes of action and synergies of thiamine, pyridoxine, and cobalamin. CNS Neurosci Ther 2020;26:5–13. https://doi.org/10.1111/cns.13207.Search in Google Scholar PubMed PubMed Central
51. High level expert group report on universal health coverage for India [internet]. Gov.in. Available from: https://niti.gov.in/planningcommission.gov.in/docs/reports/genrep/rep_uhc0812.pdf [Accessed 21 Jan 2022].Search in Google Scholar
52. Zolnierek, KBH, Dimatteo, MR. Physician communication and patient adherence to treatment: a meta-analysis: a meta-analysis. Med Care 2009;47:826–34. https://doi.org/10.1097/MLR.0b013e31819a5acc.Search in Google Scholar PubMed PubMed Central
53. Chantelau, EA, Praetor, R, Praetor, J, Poll, LW. Relapsing insulin-induced lipoatrophy, cured by prolonged low-dose oral prednisone: a case report. Diabetol Metab Syndrome 2011;3:33. https://doi.org/10.1186/1758-5996-3-33.Search in Google Scholar PubMed PubMed Central
Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/jbcpp-2023-0003).
© 2023 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Investigating periprostatic adipose tissue as a driving force of prostate cancer progression: a new source of information for the advancement of targeted therapy in metastatic prostate cancer
- Reviews
- Pathophysiological effects of cadmium(II) on human health-a critical review
- The role of synbiotics in improving inflammatory status in nasopharyngeal carcinoma patients
- Anti-ageing effects of FDA-approved medicines: a focused review
- Diagnosis and management of uterine fibroids: current trends and future strategies
- Importance of moderate-to-vigorous physical activity during the COVID-19 pandemic: a systematic review and meta-analysis
- Original Articles
- Healthcare workers’ knowledge of evidence-based guidelines for prevention of ventilator-associated pneumonia in Hodeida, Yemen
- Comparison of cardiac autonomic function across complete glycaemic spectrum
- Prognostic value of heart rate variability in acute coronary syndrome
- Insights into the protective capacity of human dental pulp stem cells and its secretome in cisplatin-induced nephrotoxicity: effects on oxidative stress and histological changes
- Caffeine impairs anticonvulsant effects of levetiracetam in the maximal electroshock seizure threshold test in mice
- Antioxidant activity in off and on-pump coronary artery bypass grafting and valve replacement surgery
- A drug utilisation pattern in non-dialysis patients of diabetic nephropathy in a government-run tertiary care hospital in South-Asia
- Inguinal lymphadenectomy in penile cancer patients: a comparison between open and video endoscopic approach in a multicenter setting
- A randomized controlled trial to evaluate the efficacy of electrical vestibular nerve stimulation (VeNS), compared to a sham control for the management of sleep in young adults
- Short Communication
- The role of Bruton’s kinase inhibitors (BTKi) in accelerated Chronic Lymphocytic Leukemia (a-CLL): a case of successful response to acalabrutinib
- Letter to the Editor
- A hypothesis that Notopterol may be effective in COVID-19 via JAK/STAT and other signaling pathways
Articles in the same Issue
- Frontmatter
- Editorial
- Investigating periprostatic adipose tissue as a driving force of prostate cancer progression: a new source of information for the advancement of targeted therapy in metastatic prostate cancer
- Reviews
- Pathophysiological effects of cadmium(II) on human health-a critical review
- The role of synbiotics in improving inflammatory status in nasopharyngeal carcinoma patients
- Anti-ageing effects of FDA-approved medicines: a focused review
- Diagnosis and management of uterine fibroids: current trends and future strategies
- Importance of moderate-to-vigorous physical activity during the COVID-19 pandemic: a systematic review and meta-analysis
- Original Articles
- Healthcare workers’ knowledge of evidence-based guidelines for prevention of ventilator-associated pneumonia in Hodeida, Yemen
- Comparison of cardiac autonomic function across complete glycaemic spectrum
- Prognostic value of heart rate variability in acute coronary syndrome
- Insights into the protective capacity of human dental pulp stem cells and its secretome in cisplatin-induced nephrotoxicity: effects on oxidative stress and histological changes
- Caffeine impairs anticonvulsant effects of levetiracetam in the maximal electroshock seizure threshold test in mice
- Antioxidant activity in off and on-pump coronary artery bypass grafting and valve replacement surgery
- A drug utilisation pattern in non-dialysis patients of diabetic nephropathy in a government-run tertiary care hospital in South-Asia
- Inguinal lymphadenectomy in penile cancer patients: a comparison between open and video endoscopic approach in a multicenter setting
- A randomized controlled trial to evaluate the efficacy of electrical vestibular nerve stimulation (VeNS), compared to a sham control for the management of sleep in young adults
- Short Communication
- The role of Bruton’s kinase inhibitors (BTKi) in accelerated Chronic Lymphocytic Leukemia (a-CLL): a case of successful response to acalabrutinib
- Letter to the Editor
- A hypothesis that Notopterol may be effective in COVID-19 via JAK/STAT and other signaling pathways