Real World studies on undesirable effects of some Anti-Thrombotic Drugs in a tertiary Hospital

  • Meghna Mehta
  • Vidya Sagar Dr

Abstract

Introduction: Antithrombotic drugs include antiplatelet, anticoagulant and fibrinolytics. Antithrombotic drugs either block the formation of new clots, or prevent the growth of existing clots or reduce risk of complications from blood clots. These drugs are used in various Cardio and neurological diseases ranging from Angina, stroke to as Dual Antiplatelet Therapy (DAT) in post implantation of permanent medical devices. Antithrombotic drugs have numerous side effects from gastritis, prolonged bleeding, hemorrhage, tachycardia, tinnitus based on the class of drugs.


Study design and Objective: Though the undesirable effects of antithrombotic drugs are well established in controlled trails, there were rare studies in Real world population. Hence a prospective observational study was under taken to understand the undesirable effects in a Tertiary hospital in India and analyze the pattern based on age, gender, intended and indications of use and dosage regimen. The undesirable effects of Aspirin, Heparin and Clopidogrel were studied in 92 patients over a period of 6 months.


Results and Discussion: In the current study there were 8 cases were heparin was indicated and 50% of the patients complained of haemorrhage / bleeding and in 2 cases there is heavy bleeding during cut wounds. All this cases were found in patients where Heparin is used in Cardiology and neurological diseases and old age group on different indications of use. In 60 patients who are on Aspirin therapy 43 patients are in cardiology and 17 in neurological treatment. Most of the indications are for CAD, Myocardial Infraction (MI) and Angina. Important undesirable effects noted in the present study include SOB-9 patients, Tachycardia- 5, Blood in stools-4 patients, Tinnitus -3 patients and Ulcers in 3 patients. Of the 92 cases, Clopidogrel was prescribed for different indications of use in 24 patients. Of them 19 patients are in cardiology and 5 patients are in neurology treatment. Most commonly patients were diagnosed with MI, unstable angina and CVA Ischemic stroke, with observed undesirable effects like prolonged bleeding, dyspepsia, headache, indigestion, heart burn and tachycardia. The study clearly shows that prolonged bleeding was observed in 40% of the patients on clopidogrel mainly in segment with higher doses and on co-medication


Conclusion: The present study has shown similar undesirable effects evidenced in controlled clinical trials. However, the study indicates Intravenous administration of Heparin is advised than subcutaneous route and need for larger studies to substantiate the same. It is also recommended that patients on Aspirin should be recommended for low dose mainly in indications related to cardiovascular diseases than higher dosed. Most of the adverse effects are found in patients taking more than 75 mg and BID and TID. It could be related to dose induced effects and also the includes the age factor as most of them are geriatrics and not on anti-ulcer drugs. The study clearly shows that prolonged bleeding was observed in 40% of the patients on clopidogrel mainly in segment with higher doses and on co-medication. A case was reported on overdose of Clopidogrel which resulted in abnormalities in platelet aggregation that required emergency medical care.

Keywords: Antithrombotic Drugs, blood clot, Clopidogrel, Thromboembolic disease, Heparin Therapy

Downloads

Download data is not yet available.

References

1. Mega J.L., Simon T. Pharmacology of antithrombotic drugs: an assessment of oral antiplatelets and anticoagulant treatments. Lancet. 2015;386:281-291.
2. Rohla M., Weiss T.W., Wojta J., Niessner A., Huber k Double or triple antithrombotic combination therapy in patients who need anticoagulation and antiplatelet therapy in parallel. Eur. Hear. J. Cardovasc. Pharmacotherapy. 2015;1:191- 97.
3. Yusuf S., Zhao F., Mehta S.R., Chrolavicius S., Tognoni G., Fox K.K Effects of clopidogrelin addition to aspirin in patients with acute Coronary syndromes without ST-Segment Elevation. N.Engl.J.Med.2001;345:494-502.
4. Wysowski D.K., Nourjah p., Swartz L. Bleeding complications with warfarin use: A prevalent adverse effect resulting in regulatory action. Arch. Intern. Med.2007;167:1414-19.
5. Hoffman, M."Remodeling the blood coagulation cascade". Journal of Thrombosis and Thrombolysis. Aug 2003; 16(1–2):17–20.
doi:10.1023/B:THRO.0000014588.95061.28.
6. Long AT, Kenne E, Jung R, Fuchs TA, Renné T. "Contact system revisited: an interface between inflammation, coagulation, and innate immunity". Journal of Thrombosis and Haemostasis. March 2016;14(3):427-37.
7. Macfarlane RG. “An enzyme cascade in the blood clotting mechanism, and its function as a biochemical amplifier”. Nature. May 1964;202(4931):498-9.
doi:10.1038/202498a0
8. Davie EW, Ratnoff OD. “Waterfall sequence for intrinsic blood clotting”. Science. Sept 1964;145(3638):1310-2.
doi:10.1126/science.145.3638.1310
9. Osaki T, Kawabata S. “Structure and function of coagulogen, a clottable protein in horseshoe crabs”. Cellular and Molecular Life Sciences. Jun 2004; 61(11):1257–65.
doi:10.1007/s00018-004-3396-5
10. Douketis J.D., Spyropoulos A.C., Spencer F.A., Mayr M., Jaffer A.K., Eckman M.H., Dunn A.S., Kunz R. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(Suppl. 2)
11. Zaidenstein R., Eyal S., Efrati S., Akivison L., Michowitz M.K., Nagornov V., Golik A. Adverse drug events in hospitalized patients treated with cardiovascular drugs and anticoagulants. Pharmacoepidemiol. Drug Saf. 2002; 11:235-238
12. Hoonhout L.H., de Bruijne M.C., Wagner C., Asscheman H., van der Wal G., van Tulder M.W. Nature, occurrence and consequences of medication-related adverse events during hospitalization: Drug Safety. 2010; 33:853-864. doi: 10.2165/11536800-000000000-00000
13. Palta, S., Saroa, R., & Palta, A. Overview of the coagulation system. Indian journal of anaesthesia. 2014; 58(5)515-523.
doi: 10.4103/0019-5049.144643
14. Alquwaizani M, Buckley L, Adams C, Fanikos J. “Anticoagulants: A Review of the Pharmacology, Dosing, and Complications”. Current Emergency and Hospital Medicine Reports. June 2013; 1(2):83-97. doi:10.1007/s40138-013-0014-6
15. Poon E.G., Keohane C.A., Yoon C.S., Ditmore M., Bane A., Levtzion-Korach O., Moniz T., Rothschild J.M., Kachalia A.B., Hayes J., et al. Effect of Bar-Code Technology on the Safety of Medication Administration. Obstet. Gynecol. Surv. 2010; 65:629-630.
doi: 10.1097/OGX.0b013e3182021fe9
16. Alquwaizani M, Buckley L, Adams C, Fanikos J. “Anticoagulants: A, Review of the Pharmacology, Dosing, and Complications”. Current Emergency and Hospital Medicine Reports. June 2013; 1(2):83-97.
doi:10.1007/s40138-013-0014-6
Statistics
7 Views | 0 Downloads
How to Cite
Mehta, M., and V. Sagar. “Real World Studies on Undesirable Effects of Some Anti-Thrombotic Drugs in a Tertiary Hospital”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 3, Sept. 2022, pp. 42-53, doi:10.22270/ijdra.v10i3.552.