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Thrombophlebitis Israel

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N Engl J Med ; The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established. Full Text of Background In a randomized, Thrombophlebitis Israel, double-blind trial, we assigned patients to receive either fondaparinux, administered subcutaneously at a dose of 2.

The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, Thrombophlebitis Israel, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day Thrombophlebitis Israel The main safety outcome was major bleeding, Thrombophlebitis Israel. The patients were followed until day Full Text of Thrombophlebitis Israel The primary efficacy outcome occurred in 13 of patients 0.

The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo Thrombophlebitis Israel, except for the outcome of death 0. Similar risk reductions were observed at day A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis.

Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0. Full Text of Results Fondaparinux at a dose of 2, Thrombophlebitis Israel. Full Text of Discussion Superficial-vein thrombosis of the legs is a common condition, 1,2 with an estimated incidence that may exceed that of deep-vein thrombosis, Thrombophlebitis Israel.

The treatment of this disease has not been adequately addressed in randomized trials. Accordingly, the recommendations in various guidelines are weak, and in practice, therapeutic strategies vary, ranging from no treatment to the use of antiinflammatory agents or anticoagulant drugs or surgery. We conducted the Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis with Placebo CALISTO trial to evaluate the efficacy and safety of fondaparinux, a specific factor Xa inhibitor, in reducing symptomatic venous thromboembolic complications or death from any cause in patients with acute, isolated superficial-vein thrombosis of the legs.

For the active treatment, we selected the prophylactic dose of 2. Hospitalized or nonhospitalized patients 18 years of age or older, with acute, Thrombophlebitis Israel, symptomatic lower-limb superficial-vein thrombosis at least 5 cm long, as confirmed by standardized compression ultrasonography, Thrombophlebitis Israel, were eligible to undergo randomization. Patients were excluded if the interval between the onset of their symptoms and planned randomization was more than 3 weeks; if they had been treated for cancer within Thrombophlebitis Israel previous 6 months; if they presented with symptomatic or asymptomatic deep-vein thrombosis, symptomatic documented pulmonary embolism, or superficial-vein Thrombophlebitis Israel associated with sclerotherapy or placement of an intravenous catheter or located within 3 cm of the saphenofemoral junction; or if they had a documented history Antibiotika für trophischen Geschwüren superficial-vein thrombosis within the previous 3 months or deep-vein thrombosis or pulmonary embolism within the previous 6 months.

Other exclusion criteria were major surgery within the previous 3 months and conditions that could confer a predisposition to bleeding, including severe hepatic impairment, a creatinine clearance of less than 30 ml per minute, and a platelet count of less thanper cubic millimeter. Finally, women of childbearing age were excluded if they were pregnant or were not using a reliable Thrombophlebitis Israel method.

This trial was an international, Behandlung von Krampfadern in Irkutsk Preise, randomized, Thrombophlebitis Israel, double-blind, placebo-controlled study; the protocolincluding the statistical analysis Thrombophlebitis Israel, is available with the full text of this article at NEJM.

With the use of Thrombophlebitis Israel central telephone system and a computer-generated randomization list, consecutive patients were randomly assigned, in a 1: Randomization was performed in blocks of four without any stratification.

The maximum interval allowed between the qualifying ultrasonographic study and randomization was 48 hours, Thrombophlebitis Israel. The day of randomization was defined as day 1, Thrombophlebitis Israel.

No routine ultrasonographic examinations were required during the follow-up period. The study was conducted according to the ethical principles stated in the Declaration of Helsinki and local regulations. The protocol was approved by an independent ethics committee, and written informed consent was obtained from Thrombophlebitis Israel patients before they underwent randomization. The study was funded by GlaxoSmithKline, Thrombophlebitis Israel. A steering committee, including one nonvoting member representing the sponsor, was responsible for the design, conduct, and reporting of the study, Thrombophlebitis Israel.

Data were collected and analyzed by the study sponsor. The database Thrombophlebitis Israel adjudicated outcomes was managed by an independent central adjudication committee, Thrombophlebitis Israel. The members of the writing committee wrote the first draft of the manuscript and made the decision to submit the manuscript Thrombophlebitis Israel publication. All the authors contributed to the writing of subsequent drafts of the manuscript, Thrombophlebitis Israel, had full access to the data and analyses, and vouch for the accuracy and completeness of the report, as well as the fidelity of the study to the protocol and statistical analysis plan.

Fondaparinux and placebo were packaged in identical boxes containing visually identical, prefilled 0. Each patient received one box containing 45 single-dose syringes 1 per day for 45 days of either 2, Thrombophlebitis Israel. At the time of randomization, patients were provided with an injection diary, Thrombophlebitis Israel. The investigators were Thrombophlebitis Israel to teach the patients to administer the study drugs themselves, but the final decision about self-administration was left to the Thrombophlebitis Israel discretion.

Patients were encouraged to use graduated compression stockings and were allowed to take acetaminophen or topical nonsteroidal antiinflammatory drugs as needed. The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism confirmed by ventilation—perfusion scanning, helical computed tomography, pulmonary angiography, Thrombophlebitis Israel, or autopsysymptomatic deep-vein thrombosis confirmed by ultrasonography or venographyThrombophlebitis Israel, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis confirmed by ultrasonography up to day For definitions of recurrence and extension of superficial-vein thrombosis, Thrombophlebitis Israel, see the Supplementary Appendixavailable at NEJM.

Secondary efficacy outcomes were the composite primary efficacy outcome up to day 77 and the following outcomes up to day 47 Thrombophlebitis Israel day Analyses of safety outcomes were performed with data obtained until day 47 or until 4 days after the last injection of the study drug whichever was longerThrombophlebitis Israel, with data obtained until 4 days after the last injection of the study treatment on-treatment analysisand with data obtained until day Other safety outcomes were clinically relevant nonmajor, minor, and total any bleeding Thrombophlebitis Israel provided in the Supplementary Appendix and arterial thromboembolic events.

All other adverse events that occurred while the patient was receiving treatment were reported. If a thromboembolic or bleeding complication occurred during the course of the study, management of Thrombophlebitis Israel condition was left to the investigator's discretion.

All symptomatic outcomes were reviewed by the central adjudication committee, whose members were unaware of the patients' group assignments. Patient safety was monitored by an independent Thrombophlebitis Israel and safety monitoring committee. As planned, the independent steering committee, whose members were unaware of the group assignments, monitored the overall event rate for the primary efficacy outcome. On November 5,on the basis of an observed rate of the primary efficacy outcome of 3.

Efficacy analyses were performed on data from the intention-to-treat population, which included all the patients who had undergone randomization.

Patients for whom a primary efficacy assessment was lacking i. Safety analyses were performed on data from the as-treated population, which comprised all patients who had undergone randomization and who had received at least one dose of the study drug.

Time-to-event outcomes estimated by means of the Kaplan—Meier method were compared with the use of Thrombophlebitis Israel log-rank test. A prespecified sensitivity analysis was performed in which patients with missing data on the primary efficacy outcome were excluded. Zelen's exact test was used to verify the consistency of the treatment effect across 16 prespecified sets of subgroups and 1 set of subgroups that was defined post hoc, Thrombophlebitis Israel.

Between March and Maya total of patients were enrolled at centers in 17 countries see the Supplementary Appendix — in the fondaparinux group and in the placebo group.

Of the patients who underwent randomization, 18 patients in the Thrombophlebitis Israel group 1, Thrombophlebitis Israel. Overall, Thrombophlebitis Israel in the fondaparinux group Of Thrombophlebitis Israel patients who underwent randomization, 4 patients in the fondaparinux group and 11 in the placebo group received no study drug as a result of the patient's Thrombophlebitis Israel, in each caseand 1 patient who was randomly assigned to the placebo group received at least one dose of fondaparinux in error; thus, patients in the fondaparinux group The demographic and clinical characteristics of the patients, the medications and interventions the patients received before their entry into the study Table 1 Table 1 Baseline Characteristics of the Study Patients.

In addition, the treatments other than the study drugs that patients received during the course of the study were well balanced between the two groups, with two exceptions: This result was confirmed in the Thrombophlebitis Israel analysis in which patients with a missing primary efficacy assessment were excluded data not shown.

The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group including the incidence of Thrombophlebitis Israel embolism [number needed to treat to prevent one pulmonary embolism was ]Thrombophlebitis Israel, except for the incidence of death, which did not differ significantly between the two groups.

The primary efficacy outcome was a composite of death from any cause, symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis. Data from patients who were lost to follow-up were censored at the time of the last contact. The size of each Thrombophlebitis Israel is in proportion to the number of patients in the comparison. The analysis of subgroups according to the distance of thrombus from the saphenofemoral junction included only subjects who had a thrombosis involving the great saphenous vein, Thrombophlebitis Israel.

No adjustment for multiple comparisons was made, since subgroup analyses were performed for exploratory purposes only. None of the P Thrombose und deren Behandlung geschwollene Beine for interaction were less than 0, Thrombophlebitis Israel.

Results for 12 of the 16 prespecified subgroups are presented; the treatment effect was also consistent within each of the 4 other prespecified subgroups defined according to country and Thrombophlebitis Israel with respect to Thrombophlebitis Israel of graduated compression Thrombophlebitis Israel, use of nonsteroidal antiinflammatory drugs, and use of aspirin or other antiplatelet agents at baselineThrombophlebitis Israel, as well as the subgroup defined post hoc defined according Thrombophlebitis Israel whether the index superficial-vein thrombosis was in a varicose vein on ultrasonographic examination.

The body-mass index is the weight in kilograms divided by the square of the height in meters. ND denotes not determined. Finally, Thrombophlebitis Israel, Thrombophlebitis Israel patients in the placebo group than in the fondaparinux group underwent surgery for superficial-vein thrombosis Table 3Thrombophlebitis Israel, including ligation of the saphenofemoral junction, which by day 77 had Thrombophlebitis Israel performed in 52 patients in the placebo group 3.

By day 47, major Thrombophlebitis Israel had occurred in one patient 0. The rates of clinically relevant nonmajor, minor, and total bleeding and arterial thromboembolic complications did not differ significantly between the two groups Table 4 Table 4 Safety Outcomes up to Day Safety results were similar in on-treatment analyses and in analyses at day 77 Table 4 in the Supplementary Appendix.

There were no clinically relevant between-group differences in the incidence of any other adverse events Table 5 and Table 6 in the Supplementary Appendix. The only serious adverse event that was reported in more than one patient in either study Varizen Jahre alte Frau was coronary artery disease, which was reported in two patients in the placebo group 0.

No episodes of thrombocytopenia were reported in the fondaparinux group. In this study, we investigated the effect of anticoagulant therapy as compared with placebo on symptomatic outcomes in patients with isolated superficial-vein thrombosis. Treatment with fondaparinux at a dose of 2. The number needed to treat to prevent one event of the primary efficacy outcome was 20, whereas the number needed to treat to prevent deep-vein thromboembolism or a pulmonary embolism was The study was placebo-controlled, since no standard treatment Thrombophlebitis Israel been established in this clinical setting, Thrombophlebitis Israel.

The patients in our study are representative of those encountered in routine practice 1,2,8: The rate of symptomatic thromboembolic complications in the placebo group at day 47 5. However, this rate and the corresponding rate at day 77 6. This benefit was evident within the first days after treatment was initiated Figure 1supporting the adequacy of the prophylactic dose of 2. The number needed to treat to prevent one episode of Thrombophlebitis Israel embolism with fondaparinux as compared with placebo in the patients with superficial-vein thrombosis in our study is similar to the number needed to treat with low-molecular-weight heparin as compared with placebo Thrombophlebitis Israel no treatment in trials of thromboprophylaxis in wirksame Behandlung von trophischen Geschwüren ill medical patients In addition, more patients in the placebo group than in the fondaparinux group required therapeutic doses of anticoagulant therapy.

A potential limitation of our study is the difficulty in applying the data to clinical practice, because a complete ultrasonographic examination was performed in every patient with a suspected superficial-vein thrombosis — first, to confirm the condition, Thrombophlebitis Israel, and second, to rule out the presence of deep-vein thrombosis.

However, performing a complete ultrasonographic examination may help physicians avoid treating patients who do not have thrombosis and allow the appropriate care of patients who present with concomitant deep-vein thrombosis. The effect of the day fondaparinux regimen on the quality of life was not formally assessed in our study.

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Use lowest effective dose for shortest duration consistent with treatment goals. Insert 1 ring vaginally once every 3 months; replace, Thrombophlebitis Israel. Thrombophlebitis or thromboembolic disorders. Protein C, protein S, or antithrombin deficiency, or other thrombophilias, Thrombophlebitis Israel. Breast or other estrogen-dependent neoplasms.

Undiagnosed abnormal genital bleeding. Hepatic disease or Thrombophlebitis Israel. Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus adding progestin is essential. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately.

Discontinue if thrombotic event, Thrombophlebitis Israel, unexplained visual changes, or jaundice occurs, Thrombophlebitis Israel at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Metabolic bone disease associated with hypercalcemia. Residual endometriosis post-hysterectomy; consider adding progestin.

Women with a predisposition to vaginal irritation, ulceration, or ring expulsion eg, vaginal stenosis, cervical prolapse, rectoceles, cystoceles. May use ring while treating vaginal infections.

Do regular complete physical exams. May be affected by CYP3A4 inducers or inhibitors. May affect lab tests eg, coagulation factors, triglycerides, lipids, glucose tolerance, binding proteins, hormone binding globulins, fliegendes Flugzeug mit Krampfadern. Vaginal bleeding, breast tenderness, vaginal candidiasis, headache; serious thromboembolic events, malignant neoplasms.

Generic Name and Formulations: Moderate to severe vasomotor symptoms or vulvar and vaginal atrophy due to menopause.

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