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" PLAVIX is FDA approved in patients with ACS (unstable angina or non–Q-wave myocardial infarction), whether patients are to be treated with or without PCI or CABG2." In clinical trials, the most common clinically important side effects of Plavix were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%)".PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. As with other antiplatelet agents, PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin."

Circulation. 2003 Nov 4;108(18):2195-7. Epub 2003 Oct 20. : Comment in: Circulation. 2003 Nov 4;108(18):e9047-8.
Effects of statins on platelet inhibition by a high loading dose of clopidogrel.
Muller I, Besta F, Schulz C, Li Z, Massberg S, Gawaz M.
Medizinische Klinik, Klinikum rechts der Isar und Deutsches Herzzentrum, Technische Universitat Munchen, Germany.
BACKGROUND: Recent studies suggested that some HMG-CoA reductase blockers might inhibit the antiplatelet activity of clopidogrel. Therefore, we analyzed how various statins together with a high loading dose of clopidogrel (600 mg) affect platelet aggregation. METHODS AND RESULTS: Seventy-seven patients with stable angina scheduled for elective coronary stenting were studied. Patients were randomized to receive atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin (each 20 mg), cerivastatin (0.3 mg), or placebo, plus a high loading dose of 600 mg of clopidogrel. ADP-induced platelet aggregation (5 and 20 micromol/L) was determined before and 2 and 4 hours after first clopidogrel administration. All patients were taking aspirin (100 mg/d) regularly. We found that none of the statins significantly influenced inhibition of platelet aggregation by clopidogrel. CONCLUSIONS: Concomitant use of statins with clopidogrel does not significantly inhibit antiplatelet activity, at least when clopidogrel is administered at a high loading dose of 600 mg.
1: Ann Thorac Surg. 2003 Nov;76(5):1593-7. : Coagulation monitoring and management of anticoagulation during cardiac assist device support.
Fries D, Innerhofer P, Streif W, Schobersberger W, Margreiter J, Antretter H, Hormann C.
Department of Anesthesia and Intensive Care Medicine, University of Innsbruck, Innsbruck, Austria.
dietmar.fries@uibk.ac.at
BACKGROUND: The incidence of clinically significant thromboembolic events due to the use of cardiac assist device systems remains high. Despite the considerable advances in cardiac assist device technology, the monitoring and management of the hypercoagulable coagulation status, resulting from foreign surfaces of the assist device system, altered rheologic conditions, and blood stasis in the recipient heart remain a challenge. Moreover septic complications and insufficient anticoagulation are responsible for thromboembolic events. METHODS: In addition to standard coagulation analysis, functional coagulation tests were performed including the use of a thrombelastographic monitoring system (ROTEG) and a platelet function analyzer (PFA-100). RESULTS: Severe biventricular ischemic heart failure developed in a 58-year-old man with acute myocardial infarction and he needed a biventricular assist device for a bridge to cardiac transplantation. Although the patient received acenocoumarol (Sintrom; Novartis Pharma, Vienna, Austria) and acetylsalicylic acid (Aspisol; Bayer AG, Leverkusen, Germany) as usual, ROTEG and the PFA-100 detected hypercoagulability while routine coagulation screening tests showed hypocoagulability. Moreover thrombus formation surrounding the canula of the left ventricular assist device was detected. Antithrombotic therapy with clopidogrel (Plavix) was initiated. Coagulation was closely monitored with modified thrombelastography and the PFA-100 to achieve sufficient but not overwhelming anticoagulation therapy. Three months after biventricular assist device implantation the patient underwent successful transplantation with no major blood loss. CONCLUSIONS: Thrombelastography should be the standard form of monitoring in such patients to decrease the risk of thromboembolic events and prevent bleeding complications.
1: Lakartidningen. 2003 Oct 9;100(41):3220-4, 3226-7. : [Clopidogrel before and after percutaneous coronary intervention: the PCI-CURE and CREDO studies do not support long-term therapy. Shorter treatment saves millions]
[Article in Swedish]
Eriksson P.
Hjartcentrum, Norrlands Universitetssjukhus, Umea.
peter.eriksson@medicin.umu.se
The ideal time to start treatment with clopidogrel prior to a percutaneous coronary intervention, the most efficacious loading-dose and the optimal duration of treatment following the procedure are not known in detail. PCI-CURE and CREDO both support pre-treatment with clopidogrel. Extended treatment beyond the first few months after the procedure is not, however, supported by the data. Accordingly, 300 mg clopidogrel should be given at least 6 hours and ideally 12 hours before the procedure. If the intervention must be undertaken sooner, a doubling of the loading-dose is recommended. After the procedure, clopidogrel 75 mg once daily should be continued for one to three months.
Circulation. 2003 Aug 26;108(8):921-4. Epub 2003 Aug 18. : Comment in: Circulation. 2003 Aug 26;108(8):910-1.
Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial.
Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators.
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.

BACKGROUND: Statins primarily metabolized by cytochrome P450 3A4 (CYP3A4) reportedly reduce clopidogrel's metabolism to active metabolite, thus attenuating its inhibition of platelet aggregation ex vivo. However, the clinical impact of this interaction has not been evaluated. METHODS AND RESULTS: Clopidogrel for the Reduction of Events During Observation (CREDO) was a double-blind, placebo-controlled, randomized trial comparing pretreatment (300 mg) and 1-year (75 mg/d) clopidogrel therapy (clopidogrel) with no pretreatment and 1-month clopidogrel therapy (75 mg/d) (control) after a planned percutaneous coronary intervention. All patients received aspirin. The 1-year primary end point was a composite of death, myocardial infarction, and stroke. We performed a post hoc analysis to evaluate the clinical efficacy of concomitant clopidogrel and statin administration, categorizing baseline statin use to those predominantly CYP3A4-metabolized (atorvastatin, lovastatin, simvastatin, and cerivastatin) (CYP3A4-MET) or others (pravastatin and fluvastatin) (non-CYP3A4-MET). Of the 2116 patients enrolled, 1001 received a CYP3A4-MET and 158 a non-CYP3A4-MET statin. For the overall study population, the primary end point was significantly reduced in the clopidogrel group (8.5% versus 11.5%, RRR 26.9%; P=0.025). This clopidogrel benefit was similar with statin use, irrespective of treatment with a CYP3A4-MET (7.6% clopidogrel, 11.8% control, RRR 36.4%, 95% CI 3.9 to 57.9; P=0.03) or non-CYP3A4-MET statin (5.4% clopidogrel, 13.6% control, RRR 60.6%, 95% CI -23.9 to 87.4; P=0.11). Patients given atorvastatin or pravastatin had similar 1-year event rates. Additionally, concomitant therapy with statins had no impact on major or minor bleeding rates. CONCLUSIONS: Although ex vivo testing has suggested a potential negative interaction when coadministering a CYP3A4-metabolized statin with clopidogrel, this was not clinically observed statistically in a post hoc analysis of a placebo-controlled study.
1: Aliment Pharmacol Ther. 2003 Aug 15;18(4):443-9. : High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease.
Ng FH, Wong SY, Chang CM, Chen WH, Kng C, Lanas AI, Wong BC.
Department of Medicine, Ruttonjee Hospital, Hong Kong.
BACKGROUND: In average-risk patients, the new anti-platelet agent, clopidogrel, causes less upper gastrointestinal adverse events than aspirin. However, there are no safety data on the use of clopidogrel in high-risk patients. AIM: To evaluate the safety of clopidogrel in patients with peptic ulcer disease in a retrospective cohort longitudinal study. METHODS: During the period from January 2000 to May 2002, 70 patients who were prescribed clopidogrel (75 mg/day) for a previous history of non-aspirin-related peptic ulcer disease or a history of aspirin-related gastrointestinal complications (dyspepsia or peptic ulcer) were recruited. The occurrence of ulcer complications (bleeding/perforation/obstruction) was the primary end-point. RESULTS: After a median follow-up of 1 year, nine patients (12%) developed gastrointestinal bleeding and one had a perforated peptic ulcer. Clopidogrel-associated gastrointestinal bleeding was significantly more common in patients with a history of gastrointestinal bleeding than in those without (22% vs. 0%; P = 0.007; odds ratio, 1.3; 95% confidence interval, 1.1-1.5). CONCLUSIONS: Clopidogrel is associated with a high incidence of upper gastrointestinal bleeding in high-risk patients. A previous history of gastrointestinal bleeding appears to be a predictor of adverse gastrointestinal events
1: Am J Cardiol. 2003 Aug 1;92(3):285-8. : Comparison of clinical benefits of clopidogrel therapy in patients with acute coronary syndromes taking atorvastatin versus other statin therapies.
Wienbergen H, Gitt AK, Schiele R, Juenger C, Heer T, Meisenzahl C, Limbourg P, Bossaller C, Senges J; MITRA PLUS Study Group.
Herzzentrum Ludwigshafen, Ludwigshafen, Germany. HarmWnbrgn@aol.com
In clinical practice, we found no significant difference between atorvastatin therapy or other statin therapies in the clinical outcomes of patients with acute coronary syndromes receiving clopidogrel therapy. In patients receiving atorvastatin therapy, clopidogrel therapy was associated with a significant decrease in mortality and stroke during univariate analysis and a moderate trend of reduced mortality and stroke without statistical significance in the multivariate analysis.
1: Can J Cardiol. 2003 Aug;19(9):1041-6. : Clopidogrel is associated with better in-hospital and 30-day outcomes than ticlopidine after coronary stenting.
L'Allier PL, Aronow HD, Cura FA, Bhatt DL, Albirini A, Schneider JP, Topol EJ, Ellis SG.
Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, USA.
philippe.lallier@sympatico.ca
BACKGROUND: Recent reports of fatal ticlopidine-induced blood dyscrasias have led many interventional cardiologists to administer clopidogrel instead of ticlopidine for coronary stenting. Most studies have demonstrated similar outcomes and a more favourable safety profile supporting this change in practice patterns. OBJECTIVES: To assess the clinical outcomes in patients who received clopidogrel rather than ticlopidine after coronary stenting. METHODS: Between June 1996 and December 1998, 652 patients received a clopidogrel-based periprocedural regimen (300 mg loading dose followed by 75 mg daily in addition to acetylsalicylic acid 325 mg daily) and 1717 patients received a ticlopidine-based regimen (500 mg loading dose followed by 250 mg bid in addition to acetylsalicylic acid 325 mg daily). In-hospital and 30-day outcomes were assessed in the two groups. RESULTS: At 30 days, unadjusted mortality was 0.3% in the clopidogrel group versus 1.5% in the ticlopidine group, and myocardial infarction (MI) was also reduced in the clopidogrel group (4.0% versus 6.5%). No difference was found in the rate of repeat revascularization (1.4% versus 1.2%). The combination of death/MI/repeat revascularization at 30 days was reduced by 32%, an absolute difference of 2.9% (6.2% versus 9.1%). On multivariate analysis, clopidogrel was found to be an independent predictor of freedom from nonfatal MI (odds ratio [OR] 0.64, 95% CI 0.41 to 0.99, P=0.04), the composite of death or MI (OR 0.62, 95% CI 0.40 to 0.95, P=0.03) and the composite of death/MI/revascularization (OR 0.69, 95% CI 0.48 to 1.00, P=0.05). CONCLUSION: After coronary stenting, in a large, nonrandomized, consecutive patient experience, clopidogrel appears to be associated with more favourable clinical outcomes than ticlopidine, without increasing the risk of bleeding or peripheral vascular complications.
Clin Ther. 2003 Aug;25(8):2155-81. : The role of clopidogrel in the management of acute coronary syndromes.
Wodlinger AM, Pieper JA.
Temple University School of Pharmacy, Philadelphia, Pennsylvania 19140, USA.
awodling@temple.edu
BACKGROUND: Despite significant advances in the management of coronary heart disease, myocardial infarction (MI) is still associated with a mortality rate of 45%. Acetylsalicylic acid (ASA) has been the oral antiplatelet drug of choice until recently. Thienopyridines such as clopidogrel have been shown to provide significant benefits in the management of acute coronary syndromes (ACS), either as an alternative to or in combination with ASA therapy. OBJECTIVE: The purpose of this article was to review the available scientific literature evaluating the use of clopidogrel in the management of ACS. METHODS: Relevant published data were identified through searches of the English-language literature indexed on MEDLINE and International Pharmaceutical Abstracts through April 2003. Search terms included thienopyridines, platelet aggregation inhibitors, clopidogrel, ticlopidine, acute coronary syndrome, myocardial infarction, and percutaneous coronary intervention. Pertinent conference abstracts were also included. RESULTS: The results of 3 large clinical trials-Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE), Effect of Pretreatment with Clopidogrel and Aspirin Followed by Long-Term Therapy in Patients Undergoing Percutaneous Coronary Intervention (PCI-CURE), and Clopidogrel for the Reduction of Events During Observation (CREDO)-support prolonged use of clopidogrel (up to 12 months) in combination with ASA in patients with non-ST-segment elevation MI and patients undergoing a percutaneous coronary intervention (PCI). A significant increase in bleeding events was observed in the group that received clopidogrel plus ASA compared with ASA alone in the CURE (major bleeding, P = 0.001; minor bleeding, P < 0.001) and PCI-CURE (minor bleeding, P = 0.03) trials. Use of the combination of clopidogrel and ASA with other antiplatelet and/or anticoagulant agents has not been studied extensively. CONCLUSIONS: Use of the combination of clopidogrel and ASA for up to 9 months is recommended for the medical management of non-ST-segment elevation MI and after a PCI. The increased risk of bleeding must be taken into account, and use of this combination with other agents that affect bleeding risk should be considered carefully.
Heart Vessels. 2003 Jul;18(3):123-9. : A comparison of 1-month and 6-month clopidogrel therapy on clinical and angiographic outcome after stent implantation.
Pekdemir H, Cin VG, Camsari A, Cicek D, Akkus MN, Doven O, Parmaksiz T.
Department of Cardiology, Faculty of Medicine, University of Mersin, Mersin, Turkey.
hpekdemir@hotmail.com
In this study, we aimed to disclose the net effect of long-term (6-month) clopidogrel treatment as compared to that of short-term (1-month) treatment in the poststenting period. A total of 278 patients with successful stent implantation were involved in the study. After preloading with 300 mg of clopidogrel orally (p.o.) 24 h prior to the procedure, randomly selected patients were given either 75 mg p.o. for 1 month (group A) or 75 mg p.o. for 6 months (group B). The patients were followed up clinically and underwent control angiography at 6 months regardless of their clinical status to delineate the coronary anatomy and assess quantitative computer-assisted (QCA) analysis. In 140 (50.4%) patients (group A), 244 (50.6%) stents were used to treat 237 coronary lesions, and in 138 patients (group B), 238 (49.4%) stents were used to treat 238 coronary lesions. There was no difference between the groups with respect to any of the clinical characteristics, intracoronary thrombus, antiaggregant therapy, the type of lesion, vessel score index, and baseline QCA parameters. In 62 patients binary in-stent restenosis (ISR) was determined with no statistical difference between the groups (group A: 20.7% vs group B: 23.9%, P = not significance). There was also no difference between the two groups at 6 months regarding QCA parameters. Thirty-seven of the 62 patients with restenosis have developed major adverse coronary events such as death, myocardial infarction, and target vessel revascularization (group A: 12.9% vs group B: 13.8%, P = not significant). In patients with chronic coronary syndrome, in the poststenting period, 6-month clopidogrel use as an adjunct to aspirin has shown no benefit over 1 month use with respect to clinical outcome and angiographic outcome, such as restenosis rate, follow-up, minimal luminal diameter, late loss, lost index, and net gain.