Cerebral Thrombophlebitis; Cerebral Thrombophlebitis; Addresses And Papers NHS South Tees CCG: General Practitioner. Cavendish Professionals: Consultants.
The primary efficacy variable was overall survival. Secondary efficacy outcomes included progression-free survival, Tees Thrombophlebitis and severe anemia—free survival, Tees Thrombophlebitis, Hb response, safety, and quality of life QoL.
Median Hb level increased with epoetin beta Epoetin beta did not significantly improve QoL in this study where patients had a high baseline Hb value. In patients with MBC receiving chemotherapy and initial Hb less than No difference was detected in overall survival. Because of its superiority design, this study cannot, Tees Thrombophlebitis, however, exclude clinically important differences in survival with absolute certainty. Anemia is prevalent in patients with breast cancer BC.
A systematic review of 60 studies of cancer patients showed that anemia is an adverse Alles über Krampfadern und Behandlungen factor for overall and progression-free survival.
Patients had to have Hb level less than A superiority Tees Thrombophlebitis was chosen to test the hypothesis that Tees Thrombophlebitis beta treatment would improve survival. The design and conduct of the study complied with good clinical practice in accordance with the Declaration of Helsinki and local requirements, Tees Thrombophlebitis. The study was approved by the appropriate independent ethics committees.
All investigators agreed to the protocol and its efficacy analyses. On the basis of the protocol, a predefined statistical analysis plan was agreed between the sponsor, F.
Hoffmann—La Roche Basel, Tees Thrombophlebitis, Switzerlandand the steering committee before database closure, Tees Thrombophlebitis. The sponsor conducted all statistical analyses. All data were interpreted in close collaboration with the sponsor and the steering committee, who had access to all data.
Tees Thrombophlebitis study was open label to avoid unnecessary risk and potential compromise of ethical integrity associated with injection of placebo. Patients were Tees Thrombophlebitis between November and June After a 2-week screening period, eligible patients were centrally randomized 1: Random assignment using a block design was stratified by chemotherapy type, hormonal status, Tees Thrombophlebitis, and country.
Tees Thrombophlebitis visits were scheduled every 3 to 4 weeks for laboratory assessments. Initial epoetin beta dose was doubled if, after 4 weeks of erythropoietic therapy, a blood Krampfadern Strumpfhosen aus Kiew zu kaufen was necessary during the previous Tees Thrombophlebitis or Hb increase from baseline was less than 0.
Epoetin beta treatment and chemotherapy started on the same day. Clinical assessments at screening, baseline, Tees Thrombophlebitis, and each visit included during the week treatment period were vital signs, physical examination, medical history, blood pressure, iron parameters and hematology parameters Hb and hematocritECG, and C-reactive protein levels, Tees Thrombophlebitis.
After 24 weeks of treatment, follow-up visits were scheduled every 3 months until the last patient enrolled was followed for a total of 24 months 6 months of treatment and 18 months of follow-up. Tees Thrombophlebitis primary efficacy outcome was a comparison of overall survival between treatment groups. Secondary efficacy variables included progression-free survival, transfusion- and severe anemia—free survival, and QoL.
Progression-free survival was assessed every 6 to 8 weeks during the week treatment period and every 3 months thereafter. Tumor measurements assessed by Response Evaluation Criteria in Solid Tumors [RECIST] were assessed every 6 to 8 weeks during the week treatment period, Tees Thrombophlebitis, and at subsequent intervals based on clinical judgment by the treating physician. Hb levels were assessed at each clinic visit during treatment.
Safety was assessed through recording of adverse events, laboratory parameters, Tees Thrombophlebitis vital signs. During the month follow-up period, only serious adverse events considered by the investigator as treatment related were recorded.
Laboratory tests were determined at screening, baseline, Tees Thrombophlebitis, and every 3 to 4 weeks until therapy stopped. An independent data and safety monitoring board reviewed data at regular intervals. Sample size was based on a month recruitment period and 18 months follow-up for the last patient recruited; that is, follow-up was between 18 and 42 months for all patients and at least fatal events.
Efficacy variables were analyzed for the intention-to-treat population. The effects of epoetin beta on overall survival, progression-free survival, transfusion- and severe anemia—free survival, Tees Thrombophlebitis, and thromboembolic events TEEs were evaluated with Kaplan-Meier estimates, log-rank test, and Cox regression models.
The safety population included all randomly assigned patients who received at least one dose of chemotherapy or epoetin beta. All safety analyses were based on the safety population. Overall, Tees Thrombophlebitis, patients were enrolled Fig 1. One assigned to the control arm received no scheduled chemotherapy during the study, Tees Thrombophlebitis, and was excluded from the safety population. Demographic and clinical characteristics showed no major differences between the two study arms Table 1.
After 24 weeks of treatment, median Hb levels in the group receiving epoetin beta 30, U QW increased from In contrast, median Hb levels in the control group did not increase during the study The mean increase in Hb from baseline to last value was 1, Tees Thrombophlebitis.
Epoetin beta increased median Hb levels from baseline by 1. During the study, The most common reason for death was progression of MBC. Epoetin beta was generally well tolerated during the treatment period. The percentage of patients reporting adverse events was similar between the two treatment groups Table 2.
The relative risk of a TEE in the epoetin beta group compared with the control group was 2. This difference was based on an increased rate of nonserious vascular TEEs such as thrombophlebitis seven cases and deep vein thrombosis six cases in the epoetin beta group. Four patients in each group died as a result of Tees Thrombophlebitis. There were no clinically significant changes from baseline in laboratory safety parameters, ECG measures, or vital signs.
In this study, no difference was detected for the primary end point, overall survival between patients receiving epoetin beta and those receiving standard care.
However, because the trial was Tees Thrombophlebitis designed as a noninferiority study, caution should be exercised in terms of excluding clinically important differences in survival on the basis of this study. Subcutaneous epoetin beta QW was associated with a highly significant increase in Hb of 1. Importantly, the design and results of this study should be interpreted in the context of current licensed indications and guidelines for epoetin use.
The neutral effect of epoetin beta on survival in this study is in contrast Tees Thrombophlebitis earlier studies. The median duration of progression-free survival was 22 weeks in the darbepoetin alfa group and 20 weeks Tees Thrombophlebitis the placebo group. In the BEST study, the difference in mortality favoring patients receiving placebo seemed limited to the initial 16 weeks of observation. Within the first 4 months of therapy, Tees Thrombophlebitis were 41 early deaths 8.
Although no final explanation was provided for observed differences in mortality, the authors speculated that flaws in the study design and conduct, baseline imbalances in risk factors, and the difference in fatal TEEs between the two study groups epoetin alfa [1.
Importantly, Tees Thrombophlebitis of the BEST study were not confirmed by the findings of the present study. BRAVE was conducted to ensure complete data collection for disease progression and survival status with follow-up for 18 months after the last patient's final treatment visit. Moreover, there was no difference in the number of fatal TEEs between the two study groups four patients in each group, Tees Thrombophlebitis.
The neutral findings on survival and disease progression of this open-label study in patients with MBC accord with data from a study in patients with lymphoproliferative malignancies 20 and with meta-analyses showing no negative impact of epoetins on survival and disease progression in patients with cancer.
In contrast to previous studies, 3 - 5 the present study did not show a significant improvement in QoL. No difference in the primary end point of overall survival was detected.
Moreover, recent changes in licensed indications and guidelines for epoetin use in patients with cancer receiving chemotherapy made after the study start means the treatment of most patients in the study did not follow current recommendations, Tees Thrombophlebitis. Accordingly, general extrapolation of these findings to patients treated within currently licensed indications for epoetins in Europe or the United States is not possible, Tees Thrombophlebitis.
Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Matti Aapro, Robert C. Provision of study materials or patients: Collection and assembly of data: Data analysis and interpretation: Final approval of manuscript: Aapro Genolier, SwitzerlandR, Tees Thrombophlebitis.
Leonard London, United KingdomA, Tees Thrombophlebitis. Barnadas Barcelona, SpainM, Tees Thrombophlebitis. Marangolo Ravenna, ItalyM. Littlewood Oxford, United KingdomD, Tees Thrombophlebitis. Messinger Mannheim, GermanyR. Pirker Vienna, Tees Thrombophlebitis, Austria ; Investigators: Lang FeldkirchH. Samonigg GrazJ, Tees Thrombophlebitis.
Schüller WienC. Wiltschke Wien ; Belgium —L. Tees Thrombophlebitis WilrijkR. Paridaens LeuvenTees Thrombophlebitis. Van Erps AalstA. Vindevoghel Namur ; Brazil —C. Beato JauB, Tees Thrombophlebitis. Ferrari Belo HorizonteJ. Pedrini Porto Alegre ; Denmark —P.
This difference was based on an increased rate of nonserious vascular TEEs such as thrombophlebitis (seven cases) and deep vein thrombosis (six cases).
N Engl J Med ; Whether a patient's sex is associated with the risk of recurrent venous thromboembolism is unknown. Full Text of Background We studied patients for an average of 36 months after a first episode of spontaneous venous thromboembolism and the withdrawal of oral anticoagulants. We excluded pregnant patients and patients with a deficiency of antithrombin, Tees Thrombophlebitis C, or protein S; the lupus anticoagulant; cancer; Tees Thrombophlebitis a requirement for potentially long-term antithrombotic treatment.
The end point was Tees Thrombophlebitis evidence of a recurrence of symptomatic venous thromboembolism. Full Text of Methods Venous thromboembolism Tees Thrombophlebitis in 74 of the men, as compared with 28 of the women 20 percent vs. The risk remained unchanged after adjustment for age, the duration of anticoagulation, and the presence or absence of a first symptomatic pulmonary embolism, factor V Leiden, factor II GA, or an elevated level of factor VIII or Tees Thrombophlebitis. At five years, the likelihood of recurrence was The relative risk of recurrence was similar among Ösophagusvarizen bei Hepatitis who had had their first thrombosis during oral-contraceptive use or hormone-replacement therapy and women in the same age group in whom the first event was idiopathic.
Full Text of Results Full Text of Discussion The annual incidence of venous thromboembolism is 1 to 2 cases Tees Thrombophlebitis persons, 1,2 and the risk of the disorder rises exponentially with age, from an annual rate of less than 5 perchildren Tees Thrombophlebitis greater than peradults older than 80 years. By contrast, Tees Thrombophlebitis, the risk among older women is substantially lower than that among men in the same age group.
Venous thromboembolism has a recurrence rate Tees Thrombophlebitis 5 to 10 percent per year. Whether a patient's sex is associated with the risk of recurrent venous thromboembolism Tees Thrombophlebitis uncertain, Tees Thrombophlebitis. Large prospective studies of the incidence of recurrence did not address sex. In this report, we assessed the association of patient sex with the risk of recurrence in patients with a first episode of spontaneous venous thromboembolism.
The Austrian Study on Recurrent Venous Thromboembolism is an ongoing prospective study involving four thrombosis centers in Vienna. Between July and Junepatients older than 18 years of age who had been treated with oral anticoagulants for at least three months after venous thromboembolism were enrolled after providing written informed consent. All patients had been Tees Thrombophlebitis with standard heparin at doses designed to keep the activated partial-thromboplastin time 1.
A total Tees Thrombophlebitis patients were excluded because of the following conditions: The day of discontinuation of oral anticoagulants was defined as the day of study entry.
After three weeks, patients were screened for the presence of a deficiency of antithrombin, protein C, and protein S; the lupus anticoagulant; factor V Leiden; and factor II GA, Tees Thrombophlebitis. The 24 patients who had a deficiency of antithrombin, protein C, or protein S or in whom the lupus anticoagulant was detected were excluded, Tees Thrombophlebitis. Patients were observed at three-month intervals for the first year and every six months thereafter.
They were provided with detailed written information on the symptoms of venous thromboembolism and were instructed to report to one of the thrombosis centers in case of symptoms. All Tees Thrombophlebitis were strongly discouraged from using contraceptive pills or hormone-replacement wie man Krampfadern an den Beinen schwanger zu behandeln regardless of whether they had a history of an association between the use of these hormones and the initial venous thromboembolism.
At each visit, a data form was completed regarding the patient's medical history. The diagnosis of deep-vein thrombosis was established by venography or color-coded duplex Tees Thrombophlebitis in the case of proximal deep-vein thrombosis. If venography was used, one of the following direct or indirect criteria Tees Thrombophlebitis to be fulfilled: Diagnostic criteria for color-coded duplex sonography were the following: The diagnosis of pulmonary embolism was made by ventilation—perfusion lung scanning according to the criteria of the Prospective Investigation Tees Thrombophlebitis Pulmonary Embolism Diagnosis.
The end point of the study was recurrence of symptomatic venous Tees Thrombophlebitis confirmed by venography, ventilation—perfusion lung scanning, or both, according to the aforementioned Tees Thrombophlebitis. The diagnosis was established by an adjudication committee consisting of independent clinicians and radiologists who were aware Tees Thrombophlebitis the patient's sex but unaware of the presence or absence of thrombotic risk factors.
Recurrent deep-vein thrombosis was diagnosed if the patient had a thrombus in another deep vein in the leg involved in the previous event, a thrombus in the other leg, or a thrombus in the same venous system involved in the previous event with Tees Thrombophlebitis proximal extension of the thrombus if the upper limit of the original thrombus had been visible or the presence of a constant filling defect surrounded by contrast medium if it had not.
Routine laboratory methods were used to identify antithrombin, protein C, and protein S. All P values were two-tailed. Survival-time methods were used to analyze the time to recurrent venous thromboembolism among patients with a subsequent episode uncensored observations or the duration of follow-up among patients without recurrence censored observations. To test for homogeneity among the various groups of patients, we used the log-rank test. Univariate and multivariate Cox proportional-hazards models were used to analyze the association of the patient's sex with the risk of recurrent venous thromboembolism.
Analyses were adjusted for age, the presence or absence of symptomatic pulmonary embolism at the time of a first thrombotic event, Tees Thrombophlebitis, the duration of anticoagulation, and the Ulcus cruris nach der Operation or absence of factor V Leiden, factor II GA, Tees Thrombophlebitis, and elevated levels of factors VIII and IX dichotomized at the 90th percentile [ IU per deciliter] and at the 75th percentile [ IU per deciliter] of the patient population, respectively.
All computations were performed with the use of SPSS software, version We studied patients men and women who had had a first episode of spontaneous venous thromboembolism. They were enrolled after the discontinuation of oral anticoagulants and followed for a median of 26 months, Tees Thrombophlebitis. A total of patients left the study: Three patients died of cancer, six of cardiac failure, and one of septicemia. A total of of the patients 12 percent had recurrent venous thromboembolism deep-vein thrombosis in 67 and pulmonary embolism in Of these patients, 74 73 percent were men and 28 27 percent were women.
When age was analyzed in a Cox proportional-hazards model, Tees Thrombophlebitis, the relative risk of recurrent venous thromboembolism was 1. An elevated level of factor VIII and a first symptomatic pulmonary embolism were the strongest determinants of recurrence, Tees Thrombophlebitis. There was no significant difference between men and women with regard to the presence of factor V Leiden 31 percent and 29 percent, respectivelyfactor II GA 7 percent and 8 percent, respectivelyelevated levels of factor VIII 8 percent and 10 percent, respectivelyelevated levels of factor IX 25 percent and 22 percent, respectivelyor the duration of anticoagulation eight months and nine months, respectively.
At five years, Tees Thrombophlebitis cumulative probability of recurrence was According to the univariate analysis, male sex conferred a relative risk of recurrence of 3. After adjustments for age, the duration of anticoagulation, and the presence or absence of a first symptomatic pulmonary embolism, factor V Leiden, factor II GA, and an elevated level of factor VIII or IX, the risk of recurrence among men, as compared with women, was 3.
A first venous thromboembolism occurred during oral-contraceptive use in women. The cumulative probability of recurrence at five years was 5. Among women who were taking oral contraceptives, the relative risk of recurrence was 0, Tees Thrombophlebitis.
Sixty-one women had their first venous thromboembolism during hormone-replacement therapy. As compared with these women, Tees Thrombophlebitis, the women in the same age groups who did not use hormone-replacement therapy had a relative risk of recurrent thromboembolism of 1.
In the multivariate analysis, the relative risk of recurrence was 3. Our study of patients shows that the patient's sex is a major determinant of recurrent venous thromboembolism after an initial episode of spontaneous venous thromboembolism, Tees Thrombophlebitis.
The risk Tees Thrombophlebitis recurrence was almost four times as great among men as among women, Tees Thrombophlebitis. Five years after the withdrawal of oral anticoagulation, the likelihood of recurrent venous thrombosis was The risk of recurrent venous thrombosis is greatly increased among patients who have had more than one thromboembolic episode 15 and among patients who have cancer, 6 the lupus anticoagulant, Tees Thrombophlebitis, 16 or a hereditary deficiency of an inhibitor of coagulation, Tees Thrombophlebitis.
Arterial disease or atrial fibrillation developed in a relatively large number of patients during follow-up, and these patients thus began antithrombotic treatment.
Given the evidence that oral anticoagulation and aspirin reduce the risk Tees Thrombophlebitis venous thrombosis and pulmonary embolism, 15, data on these patients were censored at the time antithrombotic therapy was initiated. We previously reported that a high level of factor VIII or factor IX or a first symptomatic pulmonary embolism increases the risk of recurrent venous thromboembolism.
In addition, the higher risk of recurrence among men remained unchanged after adjustment for an elevated level of factor VIII or IX and the presence of factor V Leiden, factor II GA, and a first symptomatic pulmonary embolism. Advanced age is an important risk factor for venous thrombosis. The difference in age between the two groups, however, does not explain the higher rate of recurrent venous thromboembolism among men, since Tees Thrombophlebitis likelihood of recurrence among men and women remained unchanged after adjustment for age.
Oral-contraceptive use increases the risk of venous thrombosis. These women might have had a lower risk of recurrence — which could explain the low overall risk of recurrence among women — but the risk was low among users and nonusers of oral contraception, Tees Thrombophlebitis, and there was no significant difference between the two groups.
Hormone-replacement therapy more than doubles the risk of venous thrombosis. Moreover, after these women were excluded from the analysis, the risk of recurrent venous thrombosis was more than three times as great among men as among women in whom the initial episode of thrombosis was not related to postmenopausal hormone use.
Tees Thrombophlebitis the women had a low Tees Thrombophlebitis of recurrent venous thrombosis is unknown, but the finding may have clinical implications.
First, Tees Thrombophlebitis, the sex-related difference in the risk of recurrence has to be taken into account in the interpretation of past studies and the design of future trials. Second, the low risk among women could influence decisions concerning the duration of secondary thromboprophylaxis for women, but independent confirmation of our findings is required before they can be translated into routine clinical practice.
Third, future studies are warranted to determine whether there are risk factors specific to men or protective factors specific to women. Supported by grants from the Jubilaeumsfonds of the Österreichische Nationalbank and the Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien. Address reprint requests to Dr, Tees Thrombophlebitis. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism: Arch Intern Med ; A prospective study of the incidence of deep-vein thrombosis within a defined urban population.
J Intern Med ; The epidemiology of venous thromboembolism. I-4 CrossRef Web of Science. Incidence of venous thromboembolism: Trends in the incidence of deep vein thrombosis and pulmonary embolism: The long-term clinical course of acute deep venous thrombosis. Ann Intern Med ; Recurrent venous thromboembolism after deep vein thrombosis: Incidence of recurrent venous thromboembolism in relation to clinical and thrombophilic risk factors: Mutation in blood coagulation factor V associated with resistance to activated protein C.
A common genetic variation in the 3'-untranslated region of the prothrombin gene is associated with elevated plasma prothrombin levels and an increase in venous thrombosis. Criteria for the diagnosis of lupus anticoagulants: The statistical analysis of failure time data.
Kaplan ELMeier P, Tees Thrombophlebitis.
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This difference was based on an increased rate of nonserious vascular TEEs such as thrombophlebitis (seven cases) and deep vein thrombosis (six cases).
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Background Whether a patient's sex is associated with the risk of recurrent venous thromboembolism is unknown. Methods We studied patients for an average of
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