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DDIs significantly contribute to the onset of ADRs in older adults and intervention programmes, e.g., the employment of a computerized system, may reduce the burden of iatrogenic illnesses in the elderly.
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Pharmacogenetics is the science about how germ line mutations affect the response to drugs, and the role of single nucleotide polymorphisms in cytochrome P450 (CYP) genes has been particularly well studied during the last 25 years. The current knowledge about CYP2C9, VKORC1 and warfarin, CYP2C19 and clopidogrel, CYP2D6 and tamoxifen and CYP3A5 and tacrolimus is summarized, and it is concluded that genotyping before treatment seems to be of little practical use for all four drugs. The same applies to simvastatin and SLCOB1 and metformin and OCT1 transporter polymorphisms.
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A search of literature published between 2004 and 2014 was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 13 studies were eligible for inclusion.
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Use of low-dose aspirin (LDA) is increasing with guideline recommendation for stroke prevention. The risk of gastrointestinal symptoms and bleeding with aspirin is dose-dependent, but still increases even at low doses. The principal treatment for NSAIDs-induced ulcer is discontinuation of NSAIDs use. However, discontinuation of LDA administration in stroke patients can increase the risk of stroke recurrence. Therefore, use of LDA cannot easily be discontinued. In patients who experience gastric intolerance to aspirin, options are to reduce the dose of aspirin to the minimum effective dose; to change to dispersable or enteric-coated preparations; to add concomitant gastro-protective drugs such as antacids, misoprostol, proton pump inhibitors, or H2-receptor antagonists; or to change to another antithrombotic agent: clopidogrel, cilostazol or warfarin if appropriate.
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Decades after the introduction of oral anti-coagulants namely the vitamin K antagonist (VKA) Warfarin and antiplatelet agents such as Aspirin and Plavix, new classes of direct, small molecule, novel oral anti-coagulant medications and antiplatelet P2Y12 receptor inhibitors have recently become available. For the novel oral anticoagulants (NOAC), these agents can be separated by direct thrombin inhibitors such as Dabigatran and direct Factor Xa inhibitors such as Rivaroxaban and Apixaban. For next generation antiplatelet agents such as Ticagrelor and Prasugrel, these new P2Y12 receptor inhibitors form the cornerstone of therapy for patients with acute coronary syndrome (ACS) or undergoing percutaneous interventions. These novel oral antithrombotics are revolutionizing the field of stroke prevention, atrial fibrillation (AF), the management of venous thromboembolism (VTE) and treatment of ACS. This article reviews the current research developed in order to identify therapeutic effects and establish net clinical benefits of these new oral antithrombotics.
The established cell-based system for coexpression of VKORC1 and factor IX uses FIX activity as an indicator of carboxylation efficiency. This system reflects the warfarin resistance status of VKORC1 mutations from anticoagulant resistant rodents more closely than the traditional DTT-driven enzyme assay. All mutations studied were also predicted to be involved in the reaction mechanism.
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Unfractionated heparin, low molecular weight heparin, and warfarin are often used for patients at high risk of thromboembolism and are associated with increased risk of major and even life threatening hemorrhages. They are in use for a long time and have treatment strategies in place in an event of life threatening intracranial hemorrhage. The advent of newer anticoagulants, direct thrombin inhibitors (dabigatran) and two factor Xa inhibitors (rivaroxaban and apixaban), has increased the options of anticoagulation for patients with atrial fibrillation and venous thrombosis, but at the same time, in the absence of an antidote, they have created a great challenge for treating physicians to manage intracranial bleeding related to these agents. In this paper, we will briefly summarize the state of knowledge regarding the risk of anticoagulation-related ICH, and review basic concepts on anticoagulation reversal and the general management of patients with this complication.
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The current mainstay of the treatment and secondary thromboprophylaxis of thrombotic antiphospholipid syndrome (APS) is anticoagulation with warfarin or other vitamin K antagonists (VKAs). In addition to their well-known limitations, VKAs are often problematic in APS patients because of the variable sensitivity of thromboplastins to lupus anticoagulant. As a result, the international normalized ratio may not accurately reflect the intensity of anticoagulation. Direct oral anticoagulants (DOACs) are established as therapeutic alternatives to VKAs for a wide range of indications, including the treatment and secondary prevention of venous thromboembolism. Definition of the role of DOACs in the treatment of thrombotic APS is emerging with the results of recent and ongoing clinical studies. This review focuses on the current situation with regard to DOACs for secondary thromboprophylaxis in APS and issues pertinent to DOAC use in APS patients, as well as potential future directions.
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Novel oral anticoagulants (NOACs) expand the treatment options for patients with atrial fibrillation (AF). Their benefits need to be weighed against the risk-benefit ratio in real-world elderly patients, prompting this cost-effectiveness study of NOACs (apixaban, dabigatran, edoxaban and rivaroxaban), warfarin and aspirin for stroke prevention in AF.
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A total of 205 patients had 364 prescriptions for warfarin and antibiotics concomitantly, and there was a significant interaction between antibiotic and time (F(15, 358) = 1.9; P = 0.0221). Antibiotics with a significant increase in INR were amoxicillin (P = 0.0019), azithromycin (P < 0.0001), ciprofloxacin (P = 0.002), levofloxacin (P < 0.0001) and moxifloxacin (P < 0.0001). There was a significant association between type of antibiotic and secondary outcomes of overanticoagulation.
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Between January 2007 and January 2011, 28 consecutive patients (85.7% male, mean age 67.1 ± 9.1 years) with LAF underwent video-assisted bilateral RF ablation. Fourteen patients (50%) had paroxysmal, five (17.8%) persistent, and nine (32.2%) long-persistent LAF. All patients were followed-up according to the Heart Rhythm Society/ European Heart Rhythm Association/European Cardiac Arrhythmia Society (HRS/EHRA/ECA) and success/failure was reported as suggested by Society of Thoracic Surgeon (STS) guidelines. Mean follow-up was 27.8 ± 8.6 months.
The international normalized ratio (INR) was developed to assess adequacy of Coumadin dosing. Its use has been generalized to guide fresh frozen plasma (FFP) therapy in stable patients. Thrombelastography (TEG) is a whole-blood assay measuring the viscoelastic properties of the clot in near real time. This study hypothesized that INR does not reflect coagulopathy and should not be used to guide FFP therapy in stable trauma and surgical patients.
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Drug interaction between Warfarin and psychiatric agents may have important therapeutic effects for patients undergoing cardiac surgery. We present a case of a patient in whom concurrent treatment with Warfarin and valproic acid resulted in supratherapeutic international normalized ratio values. A discussion of the possible mechanisms for this interaction as well as a review of interactions between Warfarin and other psychiatric medications is the subject of this case report.
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A 33-year-old male with hereditary deficiency of antithrombin III (AT III) was diagnosed with annuloaortic ectasia and scheduled for the aortic root replacement. As perioperative anticoagulation, AT III was administered to have its activity≥70% in addition to heparin. During the operation with cardiopulmonary bypass, 3,000 IU of AT III concentrate was infused, and there was no hemorrhagic complication. After the operation low-molecular-weight heparin was used instead of unfractionated heparin to avoid bleeding. However, renal infarction occurred on postoperative day 11. Heparin was continuously given in combination with 1,500 IU/day of AT III concentrate until oral warfarin reached within therapeutic range. The patient recovered without further sequelae. Cardiac surgery might be safely performed in patients with AT III deficiency by replenishing AT III concentrate to keep its activity higher than 80%.
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Our patient developed acute bilateral PE despite receiving long-term anticoagulation with dabigatran. While it is possible that patient-specific factors resulted in reduced dabigatran exposure and efficacy, conclusions cannot be made.
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Antiphospholipid Syndrome (APS), a thrombophilic condition, is being increasingly recognised as an important cause of recurrent pregnancy loss, preeclampsia and possible infertility. It could occur as a primary condition or it may be secondary to connective tissue diseases, infections or malignancies. Though recurrent pregnancy loss is a common feature ofAPS, there are other presentations attributable to thrombosis. The mechanism of thrombosis is still not completely understood but there are various suggested mechanisms. Presence of anti-cardiolipin antibodies (aCL) and lupus anticoagulant (LAC) are diagnostic. Management is variously with heparin, aspirin and warfarin, although other treatment modalities are being deployed. A high index of suspicion is needed for this otherwise treatable condition. Management is ideally best done by an obstetrician and a rheumatologist.
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Despite the proven effectiveness of antithrombotic therapy for atrial fibrillation (AF), the treatment remains suboptimal. The aim of this study was to implement and evaluate a system to improve the appropriate use of antithrombotics for stroke prevention in AF utilizing a clinical pharmacist as a stroke risk assessor.
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Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. Although once considered a nuisance arrhythmia, recent clinical trial evidence suggests that the presence of AF is an important independent predictor of mortality and morbidity. The primary goals of AF treatment are relief of symptoms and prevention of stroke. The value of anticoagulation with warfarin has been proven unequivocally. Control of ventricular rate with atrioventricular nodal blocking agents-the so-called rate control strategy-is least cumbersome and sometimes the best approach. By contrast, efforts to restore and maintain sinus rhythm using antiarrhythmic drugs-the rhythm control approach-although tedious, may be ideal in patients who are young or highly symptomatic and in those with new-onset AF. The relative merits of both treatment strategies are discussed in this article, emphasizing the excellent clinical trial data that support each.
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Although numerous studies have demonstrated that a significant portion of warfarin dosing variability can be explained by genetic polymorphisms, few prospective studies have been conducted that examine the integration of this information in practical dosing situations. Those that have, have shown that using pharmacogenomic information improves initial dosing estimates and decreases the need for frequent clinic visits and laboratory testing. Data showing a reduction in serious bleeding events is sparse. Cost-effectiveness analyses have generally shown a small but positive effect with pharmacogenomic testing in patients receiving warfarin.
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TMG administration is associated with coagulopathy. Using an INR screening protocol and an aggressive transfusion protocol, bleeding complications associated with coagulopathy can be avoided in this higher-risk group.
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clinicaltrials.gov Identifier: NCT00222638.
Rates for efficacy and safety clinical events for warfarin were estimated as the weighted averages from the RE-LY, ROCKET-AF and ARISTOTLE trials, and event rates for NOACs were determined by applying trial hazard ratios or relative risk ratios to such weighted averages. Incremental medical costs to a US health payer of an AF patient experiencing a clinical event during 1 year following the event were obtained from published literature and inflation adjusted to 2010 cost levels. Medical costs, excluding drug costs, were evaluated and compared for each NOAC vs warfarin. Sensitivity analyses were conducted to determine the influence of variations in clinical event rates and incremental costs on the medical cost reduction.
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This article describes prospective alpha allocation and balanced alpha allocation for the design of the COAG trial.
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The study included 8,040 VTE patients identified as being at high risk of recurrence (mean age 61 years, 59.4% male), of whom 76.9% were not compliant with warfarin therapy based on PDC, and 51.5% discontinued therapy. Among those with at least 2 warfarin prescriptions (n = 7612), 34.1% of high-risk patients were not compliant with warfarin therapy between the first and last refills based on MPR. Kaplan-Meier curves showed that patients who were compliant or continued warfarin therapy were less likely to experience a VTE event (all P less than 0.05). Noncompliant patients had a 3 times greater risk of VTE recurrence than compliant patients, based on PDC (hazard ratio [HR] = 3.01, 95% confidence interval [CI]: 1.28-4.97). Among the subpopulation who filled at least 2 warfarin prescriptions, noncompliant patients (based on MPR) were also found to be more likely to have recurrent VTE events, compared with compliant patients (HR = 1.60, 95% CI: 1.18-2.16). Patients who discontinued warfarin were more likely to have recurrent VTE events compared with patients who did not discontinue on warfarin treatment (HR = 1.48, 95% CI: 1.09-2.01).
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A total of 2836 flights carried over 2500 units of thawed plasma throughout the study period. During this time, 16 patients received prehospital plasma resuscitation, five of who were on warfarin with a concurrent TBI. The median Injury Severity Score was 17 (8.5-27.5) with a median Glasgow Coma Score of 13 (8-15) and a mortality rate of 40%. A median of 2 (1.5-2.0) units of thawed plasma and 0 (0-0) units of RBCs were transfused en route. The pretransfusion point-of-care international normalized ratio improved from 3.1 (2.3-4.0) to 1.9 (1.3-3.6) upon trauma center admission (serum sample). One hundred percent of the transported, but unused, thawed plasma underwent subsequent transfusion prior to expiration.
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Warfarin is the most frequently prescribed anticoagulant for the long-term treatment in the clinic. Recent studies have shown that polymorphic alleles within the CYP2C9, VKORC1, and CYP4F2 genes are related to the warfarin dosage requirement. In this study, a novel non-synonymous mutation (1009C>A) in CYP2C9 was detected in a warfarin-hypersensitive patient, while the other two candidate genes were both found to be homozygous for the wild-type alleles. The newly identified point mutation results in an amino acid substitution at position 337 of the CYP2C9 protein (P337T) and has been designated as the novel allele CYP2C9*58. When expressed in insect cell microsomes, the relative intrinsic clearance values of the CYP2C9.58 variant for tolbutamide and losartan were quite similar to those of the typical defective variant CYP2C9.3, whereas the clearance value of CYP2C9.58 for diclofenac was slightly higher than that of another typical defective variant CYP2C9.2. These data suggested that when compared with wild-type CYP2C9.1, the enzymatic activity of the novel allelic variant has been greatly reduced by the 1009C>A mutation. If patients carrying this allele take drugs metabolized by CYP2C9, their metabolic rate might be slower than that of wild-type allele carriers and thus much more attention should be paid to their clinical care.
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For the nephrologist and surgeon, maintaining vascular access is a significant challenge in hemodialysis (HD), because the portal is vulnerable to infection, stenosis, and thrombus. Vascular access options for HD include the placement of arteriovenous (AV) fistulas, AV grafts, and double-lumen, cuffed central vein catheters. Catheter use is generally associated with higher rates of infection and could compromise the adequacy of HD. Primary AV fistulas, which are generally recommended and provide excellent HD access, are not always the ideal choice for certain patients, such as the elderly or patients with diabetes mellitus. AV grafts allow for a large surface area available for cannulation, and thrombosed grafts have longer patency rates after revision than do revised fistulas. Although both AV fistulas and AV grafts are vulnerable to thrombosis and/or stenosis, surveillance and techniques such as Doppler ultrasound and intravascular ultrasound can minimize such complications. In addition, pharmacotherapeutic options are being studied to determine whether these complications can be prevented. Studies using a variety of pharmacologic agents have been conducted to determine whether stenosis and graft thrombosis can be prevented and have produced varying results. The use of warfarin can result in significant bleeding, but agents such as fish oil and angiotensin-converting enzyme inhibitors have shown some effect in increasing the patency in AV grafts and fistulas. Additional randomized trials with at least 1 or 2 yrs of follow-up are necessary to assess the long-term use of these pharmacotherapies.
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Intracerebral hemorrhage (ICH) is the most feared complication associated with vitamin K antagonists (VKAs). We performed a retrospective study on the clinicoradiologic characteristics that influence its outcome.