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Abstract
N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. Aim and objective: The main aim of the study is to compare the efficiency of 2 antiplatelet drugs, Aspirin 81 mg (drug-A) and Clopidogrel 75 mg (drug-B), as N-of-1 trial in the treatment of peripheral artery disease. Method: Single patient N-of-1 Trial. A 4week study period was selected for each drug therapy, in order to allow each treatment an adequate time to manifest its clinical effects. A washout period of 1 week was used between the two drug therapies to eliminate or reduce the carryover effect of the treatment used in the previous time period. Results: The study shows that Clopidogrel (drug-B) was found clinically effective than aspirin in peripheral artery disease. Discussion: Clopidogrel (Drug-B) directly inhibits platelet adhesion, whereas aspirin inhibits only secondary activation of platelets. Conclusion: It was found that Clopidogrel (drug-B) treatment has potent efficiency in patients with symptomatic peripheral artery disease in compared with aspirin in preventing ischemic events.
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References
- [1]. Graham H. Bevan, Khendi T. White Solaru, Evidence-Based Medical Management of Peripheral Artery Disease, Arteriosclerosis, Thrombosis, and Vascular Biology, 40(3), 2020, 541-5
- [2]. P. Abdulhannan, D. A. Russell, S. Homer-Vanniasinkam, Peripheral arterial disease: a literature review, British Medical Bulletin, 104(1), 2012, 21–39
- [3]. Schirmang T, Ahn SH, Murphy TP, et al. Peripheral arterial disease: update of overview and treatment, Med Health R, 92, 2009, 398-402.
- [4]. Hirsch, AT, Haskal, ZJ, et al. ACC/AHA 2005 Practice Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic) AHA journals, Circulation 2006, 113:e463
- [5]. Flu HC,Tamsma J, Lindeman JHN, et al. A systematic review of implementation of established recommended secondary prevention measures in patients with PAOD, Eur J VascEndovasc Sur, 39, 2010, 70-86
- [6]. Francisco J Serrano Hernandoa, Antonio Martín Conejeroa Peripheral Artery Disease: Pathophysiology, Diagnosis and Treatment, Rev EspCardiol. 60(9), 2007, 969-82,
- [7]. Khot UN, Khot MB, Bajzer CT, Sapp SK, Ohman EM, Brener SJ, Prevalence of conventional risk factors in patients with coronary heart disease, JAMA, 290, 2003, 898-904
- [8]. Kravitz RL, Niedzinski EJ, Hay MC, Subramanian SK, Weisner TS. What ever happened to N-of-1 trials? Insiders’ perspectives and a look to the future. Milbank Q, 86(4), 2008, 533-555.
- [9]. NaihuaDuana Richard L.Kravitzb Christopher H.Schmidc Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness Journal of Clinical Epidemiology, 66(8), Supplement, 2013, S21-S28
- [10]. Francisco J. Serrano Hernando and Antonio Martín Conejero, Peripheral Artery Disease: Pathophysiology, Diagnosis, and Treatment, Rev EspCardiol, 60(9), 2007, 969-82
- [11]. John P Cooke, The pathophysiology of peripheral arterial disease: rational targets for drug intervention, Vascular Medicine, 2, 1997, 227-230
- [12]. Kallirroi I Kalantzi, Maria E Tsoumani; Ioannis A Goudevenos; Alexandros D Tselepis. Pharmacodynamic Properties of Antiplatelet Agents, Expert Rev ClinPharmacol, 5(3), 2012, 319-336.
- [13]. Ornelas, A., Zacharias-Millward, N., Menter, D.G. et al. Beyond COX-1: the effects of aspirin on platelet biology and potential mechanisms of chemoprevention. Cancer Metastasis Rev 36, 2017, 289–303. https://doi.org/10.1007/s10555-017-9675-z
References
[1]. Graham H. Bevan, Khendi T. White Solaru, Evidence-Based Medical Management of Peripheral Artery Disease, Arteriosclerosis, Thrombosis, and Vascular Biology, 40(3), 2020, 541-5
[2]. P. Abdulhannan, D. A. Russell, S. Homer-Vanniasinkam, Peripheral arterial disease: a literature review, British Medical Bulletin, 104(1), 2012, 21–39
[3]. Schirmang T, Ahn SH, Murphy TP, et al. Peripheral arterial disease: update of overview and treatment, Med Health R, 92, 2009, 398-402.
[4]. Hirsch, AT, Haskal, ZJ, et al. ACC/AHA 2005 Practice Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic) AHA journals, Circulation 2006, 113:e463
[5]. Flu HC,Tamsma J, Lindeman JHN, et al. A systematic review of implementation of established recommended secondary prevention measures in patients with PAOD, Eur J VascEndovasc Sur, 39, 2010, 70-86
[6]. Francisco J Serrano Hernandoa, Antonio Martín Conejeroa Peripheral Artery Disease: Pathophysiology, Diagnosis and Treatment, Rev EspCardiol. 60(9), 2007, 969-82,
[7]. Khot UN, Khot MB, Bajzer CT, Sapp SK, Ohman EM, Brener SJ, Prevalence of conventional risk factors in patients with coronary heart disease, JAMA, 290, 2003, 898-904
[8]. Kravitz RL, Niedzinski EJ, Hay MC, Subramanian SK, Weisner TS. What ever happened to N-of-1 trials? Insiders’ perspectives and a look to the future. Milbank Q, 86(4), 2008, 533-555.
[9]. NaihuaDuana Richard L.Kravitzb Christopher H.Schmidc Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness Journal of Clinical Epidemiology, 66(8), Supplement, 2013, S21-S28
[10]. Francisco J. Serrano Hernando and Antonio Martín Conejero, Peripheral Artery Disease: Pathophysiology, Diagnosis, and Treatment, Rev EspCardiol, 60(9), 2007, 969-82
[11]. John P Cooke, The pathophysiology of peripheral arterial disease: rational targets for drug intervention, Vascular Medicine, 2, 1997, 227-230
[12]. Kallirroi I Kalantzi, Maria E Tsoumani; Ioannis A Goudevenos; Alexandros D Tselepis. Pharmacodynamic Properties of Antiplatelet Agents, Expert Rev ClinPharmacol, 5(3), 2012, 319-336.
[13]. Ornelas, A., Zacharias-Millward, N., Menter, D.G. et al. Beyond COX-1: the effects of aspirin on platelet biology and potential mechanisms of chemoprevention. Cancer Metastasis Rev 36, 2017, 289–303. https://doi.org/10.1007/s10555-017-9675-z