Adverse drug reactions monitoring of newer oral hypoglycemic drugs in a tertiary care hospital of North India: a prospective study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20174372Keywords:
DPP-IV Inhibitors, PPAR α/γ agonist, SGLT-2 inhibitorsAbstract
Background: Diabetes Mellitus (DM) is a metabolic disorder characterized by hyperglycemia. In majority of patients oral hypoglycemic drugs remain the primary agents in management of DM. Currently there are variety of new drugs are approved in management of DM of which safety is established in clinical trials but there surveillance is needed for reporting newer adverse effects which are not documented yet.
Methods: 112 patients were screened with the help of a predefined inclusion and exclusion criteria for the study and followed up for three months. The drugs which are relatively new and have been in the market for around 5-7 years were taken as new drug. These include specifically the following drugs: DPP-IV Inhibitors, PPAR α/γ agonist, SGLT-2 inhibitors. They were screened and investigated suitably for any ADRs. The severity of the adverse drug reactions was graded according to the Hartwig’s Severity Assessment Scale and Naranjo Scale was used for causality assessment between the drug and suspected reaction.
Results: Maximum ADRs reported belonged to gastro intestinal system (53%). DPP-IV inhibitors showed maximum number of ADRs i.e. 70.6%. Majority of ADRs reported were mild i.e. 52.9%. Overall 15.2% patients reported ADRs. Majority of ADRs reported (70.6%) belonged to category ‘possible’.
Conclusions: All three class of newer oral hypoglycemics seems reasonably safe to be used in general practice. As the number of patients were small, we need larger study to substantiate the findings.
Metrics
References
Global burden of diabetes. International Diabetes federation. Diabetic atlas fifth edition 2011, Brussels. Available at: http://www.idf.org/diabetesatlas.
Chen L, Magliano DJ, Zimmet PZ. The worldwide epidemiology of type 2 diabetes mellitus: present and future perspectives. Nature reviews endocrinology.
Camastra S, Bonora E, Del Prato S, Rett K, Weck M, Ferrannini E. EGIR (European Group for the Study of Insulin Resistance). Effect of obesity and insulin resistance on resting and glucose-induced thermogenesis in man. Int J Obes Relat Metab Disord. 1999 Dec;23(12):1307-13.
González EL, Johansson S, Wallander MA, Rodríguez LA. Trends in the prevalence and incidence of diabetes in the UK: 1996-2005. J. Epidemiol. Community Health. 2009;63:332-6.
Hunt KJ, Schuller KL. The increasing prevalence of diabetes in pregnancy. Obstet Gynecol Clin North Am. 2007;34(2):173-99.
Pratley RE, Salsali A. Inhibition of DPP-4: A new therapeutic approach for the treatment of type 2 diabetes. Curr Med Res Opin, 2007 Apr;23(4):919-31.
Barnett A. DPP-4 inhibitors and their potential role in the management of type 2 diabetes. Int J Clin Pract. 2006 Nov;60(11):1454-70.
Abdul GM, DeFronzo R. Dapagliflozin for the treatment of type 2 diabetes. Expert Opin Pharmacother. 2013;14:1695-703.
Lee YJ, Lee YJ, Han HJ. Regulatory mechanisms of Na/glucose cotransporters in renal proximal tubule cells. Kidney Int Suppl. 2007;(106):S27-35.
Hummel CS, Lu C, Loo DD, Hirayama BA, Voss AA, Wright EM. Glucose transport by human renal NA?/D-glucose cotransporters SGLT1 and SGLT2. Am J Physiol Cell Physiol. 2011;300:C721.
Nauck MA. Update on developments with SGLT2 inhibitors in the management of type 2 diabetes. Drug Des Devel Ther. 2014;8:1335-80.
Scheen A. Pharmacokinetic and pharmacodynamic profile of empagliflozin, a sodium glucose cotransporter 2 inhibitor. Clin Pharmacokinet. 2014;53(3):213-25.
Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S, Bhansali A, et al. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of Saroglitazar 2 and 4 mg compared with placebo in type 2 diabetes mellitus patients having hypertriglyceridemia not controlled with atorvastatin therapy (PRESS VI). Diabetes technology & therapeutics. 2014 Feb 1;16(2):63-71.
Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S, Bhansali A, et al. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of saroglitazar 2 and 4 mg Compared to pioglitazone 45 mg in diabetic dyslipidemia (PRESS V). J Diabetes Sci Technol. 2014;8:132-41.
Russell A, Daneshtalab N, Lewanczuk RZ, Jamali F. Rheumatoid arthritis does not reduce the pharmacodynamic response to valsartan. J. Clin Pharmacol. 2004;44:245-52
Handbook of resolutions and decisions of the World Health Assembly and Executive Board, In: WHA16.36 Clinical and Pharmacological Evaluation of Drugs, vol. World Health Organization, Geneva; 1973:11948-1972.
Gandhi TK, Borus J, Burdick E, Poon EG, Seger AC, Weingart SN. Outpatient prescribing errors and the impact of computerized prescribing. J. Gen. Intern. Med. 2005;20(9):837-41.
Lazarou J, Pomeranz BH, Corey P. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200-5.
Benkirane R, Pariente A, Achour S, Ouammi L, Azzouzi A, Soulaymani R. Prevalence and preventability of adverse drug events in a teaching hospital: a cross-sectional study. East Mediterr Health J. 2009;15:1145-55.
World Health Organization. Safety of medicines. A guide to detecting and reporting adverse drug reactions - why health professionals need to take action. Geneva: World Health Organization; 2002.
World Health Organization. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre. Uppsala: Uppsala Monitoring Centre, World Health Organization; 2000.
Hartwig SC, Siegel J and Schneider PJ. Preventability and Severity Assessment in Reporting Adverse Drug reactions. American Journal of Hospital Pharmacy. 1992;49:2229-31.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology & Therapeutics. 1981 Aug 1;30(2):239-45.
Kajiwara A, Saruwatari J, Sakata M, Morita K, Kita A, Oniki K, et al. Risk factors for adverse symptoms during dipeptidyl peptidase-IV inhibitor therapy: a questionnaire-based study carried out by the Japan Pharmaceutical Association Drug Event Monitoring project in Kumamoto Prefecture. Drug Saf. 2013 Oct;36(10):981-7.
Chatterjee S, Majumder A, Subir R. Observational Study of Effects of Saroglitazar on Glycaemic and Lipid Parameters on Indian Patients with Type 2 Diabetes. Sci Rep. 2015;5:7706.
Defronzo RA, Hissa MN, Garber AJ, Gross JL, Duan RY, Ravichandran S. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes care. 2009 Sept;32(9):1649-55.
Gooßen K, Gräber S. Longer term safety of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab. 2012 Dec;14(12):1061-72.
Tarapués M, Cereza G, Figueras A. Association of musculoskeletal complaints and gliptin use: review of spontaneous reports. Pharmacoepidemiol Drug Saf. 2013 Oct; 22(10):1115-8.
Pai V, Paneerselvam A, Mukhopadhyay S, Bhansali A, Kamath D, Shankar V, et al. A Multicenter, Prospective, Randomized Double-blind Study to Evaluate the Safet and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V). Journal of Diabetes Science and Technology. 2014;8(1):132-4.
Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S, Bhansali A, et al. A Multicenter, Prospective, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared with Placebo in Type 2 Diabetes Me llitus Patients Having Hypertriglyceridemia Not Controlled with Atorvastatin Therapy (PRESS VI). Diabetes Technology & Therapeutics. 2014;16(2):63-71.
Vasilakou D, Karagiannis T, Athanasiadou E. Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med. 2013;159(4):262-74.
Downloads
Published
How to Cite
Issue
Section
