Navegando por Palavras-chave "Warfarin"
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- ItemAcesso aberto (Open Access)Custos relacionados a anticoagulação oral em pacientes com fibrilação atrial não valvar(Universidade Federal de São Paulo (UNIFESP), 2021) Guerrero, Andressa Zulmira Avila [UNIFESP]; Paola, Angelo Amato Vincenzo De [UNIFESP]; Universidade Federal de São PauloBackground: atrial fibrillation is a public health problem with a fivefold increased risk of stroke or death. Analyzing costs is important when introducing new therapies and must be recalculated in special situations, such as the novel coronavirus pandemic of 2020. Objective: This study aimed to evaluate the costs and quality of life related to anticoagulant therapy of atrial fibrillation during 1 year, in patients treated in a public university hospital. Methods: Patient costs were those related to the anticoagulation and calculated by the average monthly costs of warfarin or direct oral anticoagulants. Patient non-medical costs (eg., food and transportation) were calculated from data obtained by questionnaires. The Brazilian SF-6D was used to measure the quality of life.P-values< 0.05 were considered statistically significant. Results: The study population consisted of 90 patients, 45 in each arm (warfarin vs direct oral anticoagulants). Costs were 20% higher in the direct oral anticoagulants group ($55,532.62 vs $46,385.88), most being related to drug price ($23,497.16 vs $1,903.27). Hospital costs were higher in the warfarin group ($31,088.41 vs $24,604.74) and related to outpatient visits. Additionally, nonmedical costs were almost 2 times higher in the warfarin group ($13,394.20 vs $7,430.72). Costs equivalence can be reached with 0.61x/DOACs drug prices. There were no significant group differences in the quality of life. Conclusions: Direct oral anticoagulants group costs were higher than warfarin group. However, reducing 40% of the drug price may be feasible to incorporate direct oral anticoagulants into the Brazilian public health system.
- ItemAcesso aberto (Open Access)Design and rationale for the WARFA trial: a randomized controlled cross-over trial testing the therapeutic equivalence of branded and generic warfarin in atrial fibrillation patients in Brazil(Biomed Central Ltd, 2017) Freitas, Carolina Gomes [UNIFESP]; Walsh, Michael; Atallah, Alvaro Nagib [UNIFESP]Background: Warfarin is a commonly used anticoagulant. Whether a given dose of the different formulations of Brazilian warfarin will result in the same effect on the international normalized ratio (INR) is uncertain. The aim of the WARFA trial is to determine whether the branded and two generic warfarins available in Brazil differ in their effect on the INR. Methods: WARFA is a cross-over RCT comparing three warfarins. The formulations tested are the branded Marevan (R) (Uniao Quimica/Farmoquimica) and two generic warfarin (manufactured respectively by Uniao Quimica Farmaceutica Nacional and Laboratorio Teuto Brasileiro). All of them were manufactured in Brazil, are available in all settings of the Brazilian healthcare system and were purchased from retail drugstores. Eligible participants had atrial fibrillation or flutter, had been using warfarin for at least 2 months with a therapeutic range of 2.0-3.0 and had low variability in INR results during the 1st period of the trial. Our primary outcome, for which we have an equality hypothesis, is the difference between warfarins in the mean absolute difference between two INR results, obtained after three and 4 weeks with each drug. Our secondary outcomes, that will be tested for inequality (except for the mean INR, which will be tested for equality), include the difference in the warfarin dose, and time in therapeutic range. Clinical events and adherence were also recorded and will be reported. Discussion: To our knowledge, WARFA will be the first comparison of the more readily applicable INR results between branded and generic warfarins in Brazil. WARFA is important because warfarins are commonly switched between in the course of a chronic treatment in Brazil. Final results of WARFA are expected in May 2017. Trial registration: ClinicalTrials.gov NCT02017197. Registered 11 December 2013.
- ItemSomente MetadadadosEquivalência Terapêutica Entre A Varfarina Sódica De Referência E As Genéricas Em Pacientes Adultos Com Fibrilação Atrial No Brasil: Ensaio Clínico Randomizado Do Tipo Crossover(Universidade Federal de São Paulo (UNIFESP), 2017-09-28) Freitas, Carolina Gomes [UNIFESP]; Atallah, Alvaro Nagib [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Objective: Assess whether there is therapeutic equivalence between the branded and generic warfarin sodium available in Brazil. Methods: Randomized crossover equivalence trial (record NCT02017197, 11 December 2013, at ClinicalTrials.gov). We compared the 5 mg warfarin tablets of the brand Marevan (Farmoquímica, Rio de Janeiro/RJ) with the two generic formulations available in Brazil, manufactured by União Química Farmacêutica Nacional (Brasília/DF) and Laboratório Teuto Brasileiro (Anápolis/GO); all drugs were purchased from retail drugstores. During the period of August 2014 and March 2016 we recruited patients from an anticoagulation clinic at a public university hospital in São Paulo/SP. The included patients were adults with atrial fibrillation or atrial flutter, for whom warfarin, in the INR therapeutic range of 2.0 to 3.0, was indicated (CHA2DS2VASc ≥ 1). Subjects could not have any exclusion criteria and also needed: to be on warfarin for at least 2 months; to sign the Consent Term; to demonstrate low variability in INR results in the first period of the study. Outcome assessers were blinded to treatments; patients, however, were not. The primary endpoint, the difference between warfarins in the INR variability, and the secondary outcome, the difference in the mean INR, were tested for equivalence with a ± 0.49 margin. Other variables assessed were the mean weekly dose needed for anticoagulation, the time in the therapeutic range (TTR), the frequence of clinical events and adherence to treatments. Warfarin weekly dose, INR and clinical events were assessed in the 3rd and 4th weeks of each period; the TTR was based on these INR results. We used a multilevel mixed-effects linear regression model with patients as random intercepts and sequences, periods, carry-over and treatments as fixed effects. We planned a two-staged analysis, including all variables in the model and testing them for significance at the 5% level in the 1st stage. If statistical significance was not shown for the sequence, period, and carry-over variables, they would be removed from the model. Otherwise, the assumptions for performing a crossover study would have been violated and thus the analysis would be performed with only the data from the 1st period of the study. Results: 100 patients were randomized to the three formulations. Compared to Marevan, União Química (UQ) warfarin has proved equivalent in the outcomes of INR variability (+0.09; 95% CI -0.29 to +0.46, P = 0.644) and mean INR (-0.05; 95% CI -0.41 to +0.30, P = 0.764). Analyzes of both outcomes were inconclusive for Teuto (T) warfarin, either compared to Marevan (respectively +0.29; 95% CI -0.09 to +0.68, P=0.134 and +0.23; 95% CI -0.12 to +0.59 (P=0.198) or to UQ warfarin (+0.20; 95% CI -0.16 to +0.57, P=0.266 e +0.29; 95% CI -0.06 to +0.64, P=0.102). Conclusion: We attested the equivalence of the results, in terms of variability and mean INR, obtained by the branded (Marevan) and the generic UQ warfarin. Further data are needed for a definitive answer regarding generic T warfarin.
- ItemAcesso aberto (Open Access)Hematoma intramural duodenal como complicação de terapia anticoagulante com Warfarin: relato de caso e revisão da literatura(Colégio Brasileiro de Radiologia e Diagnóstico por Imagem, 2004-12-01) Faria, Juliano [UNIFESP]; Pessoa, Roberta; Hudson, Marcelo; Vitoi, Sílvio; Villela, Ovídio; Torres, José; Paula, Mara Delgado; Bemvindo, Aloísio; Universidade Federal de São Paulo (UNIFESP); Hospital Márcio Cunha Serviço de Diagnóstico por Imagem; Colégio Brasileiro de Radiologia e Diagnóstico por Imagem; Hospital Márcio Cunha Serviço de Terapia IntensivaWe report a case of a patient receiving chronic oral anticoagulant therapy with Warfarin who presented with acute intestinal obstruction. Computed tomography showed intramural duodenal hematoma. Treatment was conservative with correction of the coagulation parameters and observation. This case exemplifies the usefulness of conservative therapy and computed tomography in patients with acute small bowel obstruction receiving anticoagulant therapy.
- ItemAcesso aberto (Open Access)Perioperative management of anticoagulant users scheduled for glaucoma surgery: a survey among the Brazilian Glaucoma Society members(Conselho Brasileiro de Oftalmologia, 2013-12-01) Balbino, Marcos; Boin, Plinio [UNIFESP]; Prata, Tiago dos Santos [UNIFESP]; University of São Paulo Department of Anesthesiology; Hospital Medicina dos Olhos; Universidade Federal de São Paulo (UNIFESP)PURPOSE: To investigate and describe, among the members of the Brazilian Glaucoma Society (BGS), the practices regarding the perioperative management of anticoagulants (warfarin and aspirin) use in patients scheduled for glaucoma surgery. METHODS: The active members of the Brazilian Glaucoma Society answered a questionnaire evaluating different aspects of their current perioperative management of glaucomatous patients taking warfarin or aspirin. RESULTS: A total of 52 participants returned a complete questionnaire. Warfarin or aspirin was routinely interrupted prior to glaucoma surgery by 82.7% of the respondents. The majority of the surgeons who discontinued these medications reported doing so 7 days prior to surgery and resumed their use the day after the procedure. Almost half of our interviewees reported hemorrhagic complications that could be related to anticoagulant therapy. A large number of the surgeons (86.5%) preferred a particular surgical technique for anticoagulated patients; however, most of them (88.5%) do not change the anesthetic planning in such patients. Finally, the majority of the participants (90.4%) refer their anticoagulated patients to a preoperative appointment with a cardiologist or a general practitioner before the surgery. CONCLUSIONS: The majority of Brazilian Glaucoma Society members participating in this study interrupt either warfarin or aspirin prior to glaucoma surgery. Although there is scant information available in the literature to offer definitive guidance, most participants from the Brazilian Glaucoma Society seem to share the same opinion when it comes to perioperative management of anticoagulant users.
- ItemAcesso aberto (Open Access)Risco de interações medicamentosas em pacientes com câncer e recebendo cuidados de suporte exclusivo(Universidade Federal de São Paulo (UNIFESP), 2009-11-25) Riechelmann, Rachel Simões Pimenta [UNIFESP]; Giglio, Auro del [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Background: Drug-drug interactions (DDIs) comprise an important problem in medical oncology practice. We systematically reviewed the frequency of DDIs in oncology. Methods: We searched PubMed for eligible articles and online databases abstracts of major oncology meetings. Results: Eight studies reported on the frequency of DDIs: six evaluated the frequency of potential DDIs while 2 studies reported on real DDIs, i.e. interactions that had clinical consequences. Studies of potential DDIs found that approximately one third of patients are exposed to dangerous drug doublets, with the most common ones involving warfarin and anticonvulsants. One study of real DDIs found that 2% of hospitalized cancer patients had a DDI as the cause of admission. Conclusion: Drug interactions comprise an important issue in oncology, with approximately one third of ambulatory cancer patients being at risk of DDIs. Data are limited on the clinical consequences of drug interactions among cancer patients.