EMAIL: lyn.jones pfizer POSITION: IR SPECIFIC DISCIPLINE: Medicinal chemistry KEYWORDS: HIV, reverse transcriptase SCIENCE AND SOCIETY: One of the major problems with treating HIV infection is its ability to mutate. In this poster, we will present our successful work in the design and development of small molecules that can inhibit an essential process in the life cycle of HIV. These molecules are also active against the clinically relevant mutant viruses. ANY IMPLICATIONS: MPWORK: Gwyn Prosser MP MPHOME: Julian Brazier TD MP DESIGN AND DEVELOPMENT OF NOVEL AND POTENT ANTIVIRAL COMPOUNDS FOR THE TREATMENT OF HIV INFECTION Lyn H. Jones, Catherine Burt, Romu Corbau, Steve Irving, Don Middleton, Charles Mowbray, Manos Perros, Chris Phillips, Rob Webster, Mike Westby.
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Ex vivo measurements of platelet activity have traditionally been difficult to relate to clinical events. There are two small trials examining clinical outcomes in the setting of an inadequate response to clopidogrel. Matetzky et al. evaluated response to clopidogrel therapy among 60 patients undergoing percutaneous coronary intervention PCI ; in the setting of ST segment elevation MI. Platelet activity was assessed before and after clopidogrel administration via optical aggregometry, and by a cone and platelet analyser. In the.
On June 4, 2004, the PRoFESS Steering Committee discontinued the ASA component of the clopidogrel + ASA treatment arm after release of the MATCH trial data showed no benefit for combination therapy. PRoFESS Prevention Regimen for Effectively Avoiding Second Strokes. Available at: : clinicaltrials.gov ct show NCT00153062?order 1. Accessed March 31, 2006.
To assess whether aspirin use confounded the clopidogrel results, we analyzed the subset of patients who reported aspirin use at 6 months FIGURE 4 ; . The adjusted cumulative mortality and death or MI data in the aspirin cohort mimicked the results for adjusted outcomes in the 6- and.
The most commonly inappropriately prescribed medication was ticlopidine. By contrast, ticlopidine is rarely used in the United States, because clopidogrel, a safer alternative to aspirin, is available. However, clopidogrel was not available in Japan at the time of the study, which may have led to a higher prevalence of inappropriate use than would have been the case if it had been available. The fact that ticlopidine was also commonly prescribed in Italy [30, 42], where clopidogrel was also unavailable, may provide support for this hypothesis. When ticlopidine was excluded from the list, the prevalence of potentially inappropriate medication use independent of the disease or condition decreased from 21.1% to 16.4%, thus remaining in the range of previous studies. Anticholinergics and antihistamines, long-acting benzodiazepines, short-acting dipyridamole, and short-acting nifedipine were other medications on the list that were frequently used. The prevalence of inappropriate prescription of dipyridamole and nifedipine use in this study was slightly higher than in other studies. Propoxyphene was commonly used in the United States, but was not prescribed for the subjects of this study because it was unavailable in Japan. The prevalence of the antiarrhythmic and cloxacillin.
GUIDANCE FOR THE USE OF CLOPIDOGREL PLAVIX ; IN NHS FIFE Formulary Choice In patients with GI disturbance due to aspirin or history of ulcer * , a formulary choice of PPI should be added to aspirin in preference to trying clopidogrel. Clop9dogrel should only be used first line in patients who are hypersensitive to aspirin. In patients with continued ischaemic strokes or TIAs despite aspirin, add dipyridamole m r 200mg twice daily to aspirin. In patients with recurrent TIAs or strokes despite using an aspirin dypiridamole combination or who are unable to tolerate dipyridamole mainly due to headache ; , the combination of aspirin and clopidogrel cannot currently be recommended in view of the possibility of significant increased risk of bleeding. Stroke patients already being prescribed this combination should be reviewed and treatment discussed with the stroke physician as appropriate.
S 05 VIRTUAL COLONOSCOPY : THE NEW TOOL FOR SCREENING ! D. Bielen, Leuven, KUL. Colorectal cancer is even today a major health issue, being third most frequent cancer worldwide 1 ; . Fortunately, these tumors develop in 70-90 % of the cases from pre-existing benign polyps over 5-10 years. Early screening for and removal of these polyps is therefore indicated 2 ; . For persons at high risk 2- to 4-fold lifetime risk ; the American Gastroenterological Association AGA ; recommends just conventional colonoscopy starting at age 40 or 10 years prior to the age of diagnosis in a first-degree relative 3 ; . The population, with a lifetime risk of 4-6 %, has a large choice : FOBT fecal occult blood test ; , sigmoidoscopy, combination of FOBT and sigmoidoscopy, conventional colonoscopy and double contrast barium enema. Screening should start at age 50. Conventional colonoscopy is accepted being gold standard, although it has no 100 % sensitivity 4 ; . Large scale screening for colorectal cancer with conventional colonoscopy can lead to increased workload for gastroenterologists and even waiting lists for patients! This opens and cromolyn, for example, clopidogrel and surgery.
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Reperfusion of the infarct-related artery is by far the most important therapy administered to patients suffering from acute MI. Fibrinolysis is the most common method of reperfusion used worldwide for patients with STelevation MI. Primary PCI is the preferred reperfusion therapy for STEMI. Compared with fibrinolytic treatment primary PCI reduces short- and long-term mortality and reinfarction rate by 30% to 40%, shortens hospital stay and reduces later need for hospital care. Therefore, if available, primary PCI today is the treatment of choice for STEMI. The Reperfusion therapy should be combined with antithrombotic agents, aspirin and unfractionated heparin, with a movement toward lower doses of long-term aspirin and lower doses of unfractionated heparin UFH ; . Studies have also been completed on the use of enoxaparin and fondaparinux as very effective alternatives to heparin. Clinical trial data support the early use of glycoprotein IIb IIIa inhibitors along with aspirin, UFH, and clopidogrel ; in patients undergoing primary percutaneous coronary intervention for acute STEMI. Clopidogrl has also been shown to improve angiographic and clinical outcomes in patients with STEMI who are undergoing thrombolysis or being treated medically. The new ACC AHA recommendations support clopidogrel pretreatment and long-term therapy and
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Rationale and Study Design of the CARESS Clop8dogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis ; Trial Hugh Markus, E. Bernd Ringelstein, on behalf of the CARESS Investigators, St George's Medical School, London, UK; Westfalische Wilhems Universitat, D-48129 Munster, Germany; Germany. Clinically silent, cerebral microemboli can be detected by transcranial Doppler ultrasound TCD ; monitoring in the form of characteristic microembolic signals MES ; . MES have been shown to be caused by platelet aggregates, and predict future transient or permanent ischemic strokes in patients with recent symptomatic carotid stenosis. The addition of clopidogrel to acetylsalicylic acid ASA ; provides prolonged, incremental benefit in patients with unstable angina and non-Q-wave myocardial infarction. The principal objective of CARESS Steering Committee Co-chairmen: H. Markus, MD and E. Bernd Ringelstein, MD ; is to determine whether the administration of clopidogrel on top of ASA is superior to ASA alone in reducing the frequency of TCD-detectable MES in patients with recent symptomatic carotid stenosis. The main inclusion criteria are: symptomatic carotid stenosis 50%; ipsilateral transient ischemic attack or ischemic stroke in the previous 3 months; and occurrence of MES as confirmed by initial TCD. Major exclusion criteria are potential cardiac embolic sources, confounding co-medication with antithrombotic drugs other than ASA ; , and imminent carotid endarterectomy within 14 days ; . The planned sample size is 100 patients. Patients are randomized, on a double-blind basis, to receive either clopidogrel 300 mg loading dose on Day 1 followed by 75 mg day thereafter ; or placebo; all patients receive ASA 75 mg day. The duration of treatment is 7 1 days. The primary endpoint is the percentage of MES-positive patients at Day 7 1 day ; . Secondary endpoints are: 1 ; the percentage of MES-positive patients at 24 hours after study drug initiation; 2 ; the rate of embolization number of MES per hour ; at 24 hours and at Day 7 1; and 3 ; percentage change from baseline for platelet tests performed on platelet-rich plasma at Day 7 1 day ; collagen-induced platelet aggregation, soluble P-selectin, prothrombin fragment F1 + 2 and Ddimers ; . Evaluation criteria for safety include the incidence of adverse events, cerebrovascular events, life-threatening and major bleeding and of all bleeding events. Between February 2001 and mid-November 2002, 68 patients have been enrolled at 10 study sites in France, Germany, Switzerland and the United Kingdom. CARESS will help to clarify whether cerebral microemboli consist of platelet aggregates that are sensitive to antiplatelet therapy and whether such microemboli are a reliable surrogate marker of efficacy for evaluation of potent antiplatelet regimens. Moreover, CARESS is expected to provide further evidence of the benefit of using clopidogrel on top of ASA for the secondary prevention of atherothrombotic events.
N the CAPRIE Clopidogrrel versus Aspirin in Patients at Risk of Ischaemic Events ; study, 1 clopidogrel Plavix ; was no more effective than aspirin at preventing further vascular events in patients with recent ischaemic stroke. The MATCH Management of ATherothrombosis with Lcopidogrel in High-risk patients ; study, on the other hand, was aimed at assessing whether the addition of aspirin to clopidogrel could have a greater benefit than clopidogrel alone in the prevention of vascular events in high-risk patients with recent ischaemic stroke or transient ischaemic attack TIA and
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N my view a transient ischemic attack TIA ; is a medical emergency as 10% of patients with a TIA will have a stroke a medical catastrophe ; within 90 days of a TIA. Because 50% of these patients 5% of all TIAs ; will have their stroke within 2 days of the TIA, time is of the essence. I believe we can significantly reduce the risk of stroke following a TIA if we do the following: Send the patient immediately for a CBC, CR, CK, and AST. Have the patient take the following: 1. ASA 325 mg STAT and then 81 mg OD. 2. Clopidogrel bisulfate Plavix ; 300 mg STAT and then 75 mg OD. 3. Atorvastatin Lipitor ; 20 mg STAT and simvastatin Zocor ; 40 mg STAT then OD. 4. Ramipril Altace ; 2.5 mg STAT or perindopril erbumine Coversyl ; 2 mg STAT then gradually titrate the dose to ramipril 10 mg or perindopril erbumine 8 mg over 7 to 10 days. If necessary, further reduce BP gradually with other medications. Refer the patient urgently to the Stroke Prevention Clinic at Vancouver General Hospital see the "Stroke prevention clinic" box at right ; . The Clinic has rapid access to CT head scans and carotid artery doppler ultrasound. The current wait time to consultation is 2 weeks. This prescription style is contrary to my normal pharmacological practice of "start low, go slow, and aim.
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Outcome 1: clopidogrel versus ASA in first 24 hours after randomisation No. of events, placebo versus clopidogrel RR ; CV death, MI or stroke Day 1: 34 versus 27 0.80 ; Day 2: 67 versus 54 0.81 ; Day 3: 89 versus 75 0.85 ; CV death, MI, stroke, or severe ischaemia Day 1: 135 versus 89 0.66 ; , p 0.01 Day 2: 233 versus 162 0.70 ; , p 0.001 Day 3: 288 versus 217 0.75 ; , p 0.001 CV death, MI, stroke, refractory ischaemia: Clopidogrel: event rate 3.5% ASA: event rate 4.2% RR 95% CI ; 0.82 0.69, 0.98 ; CV death, MI, stroke, severe ischaemia Clopidogrel: event rate 5.2% ASA, event rate 6.7% RR 95% CI ; 0.77 0.67 to 0.89 ; CV death, MI or stroke Clopidogrel: event rate 2.1% ASA: event rate 2.5% RR 95% CI ; 0.82 0.65 to 1.04 and decadron.
Inhibition Studies in Human Liver Microsomes. Human liver microsomes 50 100 g ; , bupropion 500 M ; and either clopidogrel or ticlopidine 0.1 - 10 M ; were equilibrated in 0.1 N sodium phosphate buffer, pH 7.4, at 37C for 3 min. After addition of 25 l NADPHregenerating system, reactions were allowed to proceed for 15 min and analyzed as described for the bupropion hydroxylase assay. The effect of nucleophilic trapping agents 10 mM gluthathione or N-acetylcysteine ; or scavengers of reactive oxygen species 0.1 % DMSO or 1000 Units of superoxide dismutase ; was tested by adding these compounds at the indicated concentrations prior to incubation with inhibitors. Substrate protection was analyzed accordingly with 7-ethoxycoumarin 1 mM ; and 0.5 M clopidohrel or ticlopidine controls without inhibitors ; in the incubation mixture and determination of residual bupropion hydroxylase activity as described above. Substrate protection with the inhibitor paroxetin 50 M ; and 0.5 M coopidogrel or ticlopidine controls without inhibitors ; was analyzed accordingly after removal of paroxetine as CYP2B6 inhibitor by extensive dialysis as described below.
Order type with maximal rates of inactivation Kinact ; for clopid0grel and ticlopidine in microsomes recombinant CYP2B6 ; of 0.35 1.5 min 1 ; and 0.5 min 1 0.8 min 1 ; , respectively, and half-maximal inactivator concentrations KI ; were 0.5 M 1.1 M ; for clopidogrel and 0.2 M 0.8 M ; for ticlopidine. Inhibition was attenuated by the presence of alternative active site ligands but not by nucleophilic trapping agents or reactive oxygen scavengers, further supporting mechanism-based action. A chemical mechanism is discussed based on the known metabolic activation of clopidogrel and on the finding that hemoprotein integrity of recombinant CYP2B6 was not affected by irreversible inhibition. These results suggest the possibility of drug interactions between thienopyridine derivates and drug substrates of CYP2B6 and CYP2C19 and dexamethasone.
Routine use of the drug, called clopidogrel, either with aspirin or by itself would prevent 400, 000 second heart attacks and prolong hundreds of thousands of lives over a 25-year period compared with aspirin alone.
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Patients aged 60-65 years without risk factors should receive aspirin. Those younger than 60 years without risk factors may be given aspirin or be observed untreated. In view of the apparent increased risk of bleeding in the over 75's, the INR should be maintained at the lower end of the therapeutic range around 2-2.5. Patients classified as having lone AF should be assessed for the presence of risk factors, then treated accordingly. There is no benefit from adopting the low-intensity warfarin plus aspirin regimen or clopidogrel. After stroke or TIA Patients who have suffered and survived an acute stroke or transient ischaemic attack are at the highest risk of recurrent stroke and thromboembolism, approximately 12% per year In patients with AF and an acute stroke, imaging CT scan or MRI ; should be performed to exclude cerebral haemorrhage. in the absence of haemorrhage, anticoagulation therapy should begin after 2 weeks. in the presence of haemorrhage, anticoagulation therapy should not be given. in the presence of a large cerebral infarction, the initiation of anticoagulation therapy should be delayed. In patients with AF and an acute TIA, imaging CT scan or MRI ; should be performed to exclude recent cerebral infarction or haemorrhage and if absent, anticoagulation therapy should begin as soon as possible.
A group of dedicated activists went across to Europe to do demonstrations against all the Japanese HLS customers. All these companies have injunctions against SHAC in the UK, they dont however cover Europe! Day 1- Brussels We headed for our first demo against Yamanouchi Pharma. As soon as we told them why we were there their expressions changed. From every direction they came, people hanging off staircases, running in and out of offices. The police then turned up and after five minutes of kissing each other not us ; they decided to investigate what all the fuss was about and why 15 of them had been called out to for a few girls handing out leaflets and holding a banner. With a tight schedule ahead of us we headed towards our next target Glaverbel Asahi Glass ; . After the receptionist let us in and we informed her of why we were there, their expressions too changed. Funny that, there seemed to be some sort of pattern emerging here. The CEO Mr Ullsen appeared, the head of Glaverbel in Europe. We discussed with him for a while why it is urgent he looks at the evidence why they and Asahi need to sever ties with Huntingdon. We visited State Street too and tolterodine.
Parameters is restricted. Already in the original description of the lasso the connection to Bayesian statistics was stated: The L1 penalty is equivalent to putting independent prior Laplace distributions on the parameters. Because of the special nature of this penalty, a subset of the parameters are shrunk to exactly zero. This is appealing in the context of ADR monitoring since it gives a natural signalling threshold at zero, although, admittedly, it is not altogether obvious that lasso logistic regression should be superior to e.g. ridge logistic regression in this application. It might be clarifying to think of the LLR as a multivariate extension of the Bayesian measures of disproportionality, e.g. the IC, which in turn are based on the non-Bayesian measures of disproportionality. However, this extension does not only bring advantages but also possible limitations, such as the need for model assumptions and presumably heavier computational load. The sheer complexity of the method is also an issue since it might be difficult to interpret the models produced. The aim of the project is to: 1. implement the method of LLR on the WHO drug safety database 2. investigate the properties of the LLR in ADR monitoring to see if this method is practically useful and 3. to attempt to characterize when the LLR is most and least likely to be beneficial in ADR monitoring.
Medication for a period of Featured Trials continued ; twelve months. Study Snapshot PLATO Study patients Patient Condition: Acute Coronary Syndrome ACS ; Official Title: A Randomized, Double-Blind, Parallel Group, will be seen at Phase 3, Efficacy and Safety Study of AZD6140 VHIF one month Compared With Clopidogrel for Prevention of post procedure, Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes ACS ; and then every Intervention: Drug: AZD6140, Clopidogrel three months until Study Phase: Phase III study completion. Study Design: Treatment, Randomized, Double-Blind, Active Patients will Control, Parallel Assignment, Safety Efficacy Study undergo repeat Expected Enrollment: 18, 000 study patients physical exams, Victoria Enrollment: 0 patients blood samples, Principal Investigator: W. Peter Klinke, M.D. Co-Investigator: Anthony Della Siega, M.D. and an ECG. Knowledge Gained AZD6140 is a reversible, oral ADP receptor antagonist acting via the P2Y12 receptor, which can effectively block ADP mediated platelet activation and aggregation. AZD6140 will be compared with clopidogrel to determine which drug, when either is used in.
Aspirin 75mg dispersible tablets Aspirin in high-risk groups can lower the risk of subsequent vascular events post-MI, NNT 28; previous stroke, NNT 28 ; .1 A dose of 75mg is recommended for chronic use.2 No extra benefit is gained from increasing the dose plus minimising the dose to 75mg reduces the risk of upper GI bleeding.2, 3 Using enteric coated or modified release formulations do not reduce the risk of GI bleeding but it may reduce the incidence of dyspepsia.4 Dipyridamole modified release 200mg The ESPS-2 study demonstrated that MR-dipyridamole 200mg twice daily ; plus aspirin 25mg twice daily ; was more effective than aspirin or MR-dipyridamole in the secondary prevention of ischaemic stroke, NNT 34.5 Bleeding episodes were significantly more frequent in the MR-dipyridamole plus aspirin 8.7% ; and the aspirin alone 8.2% ; groups compared with the dipyridamole alone 4.7% ; and placebo 4.2% ; .5, 6 A systematic review identified no clear benefit of standard release dipyridamole for the prevention of serious vascular events when prescribed alone, or in combination with aspirin, to patients with vascular disease.7 Therefore, standard release dipyridamole tablets or suspension should not be prescribed. NICE recommend that the combination of MR dipyridamole and aspirin be used in patients who have had an ischaemic stroke or a TIA for a period of 2 years from the most recent event. Thereafter, or if dipyridamole is not tolerated, current evidence suggests that for the best risk: benefit, preventative therapy should revert to low dose aspirin.8 Clopidogrel 75mg tablets In the CAPRIE study n 19, 185 ; clopidogrel 75mg was only marginally more effective than aspirin 325mg NNT 196 over 1 year ; in the reducing the risk of suffering from a stroke, MI or CV death.9 Aspirin and clopidogrel were equally well tolerated. The only statistically significant differences between groups for severe adverse events were for skin rash clopidogrel 0.26%, aspirin 0.10%, NNH 625 ; and GI bleeding clopidogrel 0.49%, aspirin 0.71%, NNH 455 ; . In a RCT of 320 patients on aspirin who had a healed ulcer, clopidogrel was compared with aspirin and esomeprazole to prevent recurrent ulcer bleeding over 12 months.10 The incidence of recurrent bleeding was 8.6% with clopidogrel and 0.7% with aspirin + esomeprazole NNH 13 ; . For patients with a history of bleeding peptic ulcer who must take an antiplatelet, aspirin 75mg daily + omeprazole 20mg twice daily would appear to be a safer option than clopidogrel. NICE recommends that clopidogrel alone should be used for the secondary prevention of occlusive vascular events in patients who are intolerant of low dose aspirin. Aspirin intolerance is defined by NICE as proven hypersensitivity a systematic review reported 21% of adult asthma sufferers had aspirin hypersensitivity ; 11 or a history of severe dyspepsia induced by low-dose aspirin.8 There is no evidence to support the use of clopidogrel instead of aspirin for patients who suffer from recurrent strokes. Clopidogrel plus aspirin only licensed for ACS ; In the CURE study the combination of aspirin 75mg and clopidogrel 75mg in patients with Acute Coronary Syndrome without ST-segment elevation ; reduced the absolute risk of cardiovascular death, non-fatal MI, or stroke by 2.1% NNT 48 ; compared to aspirin alone.12 The risk of bleeds was higher in the combination group vs the control group: minor bleeds NNH 37, major bleeds NNH 100. Two vascular events will be prevented but one patient will suffer a major bleed. In MATCH there was no benefit of combination treatment over clopidogrel alone in reducing the risk of ischaemic events after stroke or TIA. However, the risk of serious gastrointestinal bleeds was significantly increased with the combination.13 NICE recommend the use of clopidogrel + aspirin 75mg for the management of patients with non-STsegment-elevation ACS who are at moderate to high risk of MI or death. Treatment should continue for 12 months after the most recent acute episode of ACS, after which the treatment should revert to aspirin 75mg.14 Post PCI follow discharge advice from tertiary centre on duration of clopidogrel and aspirin. As a general rule bare metal stents require 4 weeks and drug eluting stents require 12 months unless in the setting of an ACS when 12 months is required.
Table 1. Primary End Point Analysis of the Management of Atherothrombosis With Clopidogrel in High-Risk Patients Trial.
G.A. O'Driscoll et al VID, RGB a William Dawson Scholarship GO'D a Fonds de la Recherche en Sant du Qubec-Fonds Qubecois de la Recherche sur la Nature et les Technologies-Sant Doctoral Fellowship LD a KM Hunter Doctoral Research Award from the Canadian Institutes of Health Research A-LVH and a Scottish Rite Charitable Foundation of Canada Graduate Student Award LD and cloxacillin.
1. Moussa I, Oetgen M, Roubin G, Colombo A, Wang X, Iyer S, Maida R, Collins M, Kreps E, Moses JW. Effectiveness of clopidogrel and aspirin versus ticlopidine and aspirin in preventing stent thrombosis after coronary stent implantation. Circulation 1999; 99: 2364 Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358: 527533. Steinhubl SR, Berger PB, Mann JT III, Fry ET, DeLago A, Wilmer C, Topol EJ. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002; 288: 24112420. Kandzari DE, Berger PB, Kastrati A, Steinhubl SR, Mehilli J, Dotzer F, Ten Berg JM, Neumann FJ, Bollwein H, Dirschinger J, Schomig A. Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization. J Coll Cardiol 2004; 44: 21332136. Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 Antiplatelet Therapy for Re.
Additional effects other than inhibiting CD40L expression, we also treated CD40-KO NeuT mice to evaluate any effects of clopidogrel other than inhibition of CD40L expression and therefore of CD40 triggering. Results show that clopidogrel had no significant effect on tumor growth in CD40-KO NeuT mice Fig. 5, E and F ; , indicating that, in our tumor system, its effect is mainly through the inhibition of platelet CD40L.
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