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

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.