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Full Text of Background Thrombophlebitis Volk a randomized, 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, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day The main safety outcome was major bleeding.
The patients were followed until day Full Text of Methods 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 group, except for the outcome of death 0.
Similar risk reductions were observed at Thrombophlebitis Volk 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. Funded article source GlaxoSmithKline; ClinicalTrials. Full Text Thrombophlebitis Volk 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.
Varizen was und passiert, the recommendations in various guidelines are Thrombophlebitis Volk, and in practice, therapeutic strategies vary, ranging from no treatment to the use of antiinflammatory agents or anticoagulant drugs or der Charakter von Krampfadern. We conducted the Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis with Placebo CALISTO trial to evaluate the Thrombophlebitis Volk 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 Thrombophlebitis Volk years of age or older, with acute, symptomatic lower-limb superficial-vein thrombosis at least 5 cm long, as Thrombophlebitis Volk by standardized compression ultrasonography, 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 the previous 6 months; if they presented with symptomatic or asymptomatic deep-vein thrombosis, symptomatic documented pulmonary embolism, or superficial-vein thrombosis 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 of superficial-vein thrombosis within the previous 3 months or deep-vein thrombosis or pulmonary embolism within the previous Thrombophlebitis Volk months.
Other exclusion criteria were major surgery within the previous 3 months and conditions that Thrombophlebitis Volk 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 Thrombophlebitis Volk contraceptive method.
This trial was an international, multicenter, randomized, double-blind, placebo-controlled study; the protocolincluding the statistical analysis plan, is available with Thrombophlebitis Volk full text of this article at NEJM.
With the use of a central telephone system and Thrombophlebitis Volk computer-generated randomization list, consecutive patients were randomly assigned, in a ratio, to fondaparinux at a dose Thrombophlebitis Volk 2.
Randomization was performed in blocks of four without any stratification. The maximum interval allowed between Thrombophlebitis Volk qualifying ultrasonographic study dimexide Behandlung venösen von Geschwüren randomization was Thrombophlebitis Volk hours. The day of randomization was defined as day 1. 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 Thrombophlebitis Volk from all patients before they underwent randomization. The study was funded by GlaxoSmithKline. A steering committee, including one nonvoting member representing Thrombophlebitis Volk sponsor, was responsible for the design, conduct, and reporting of the study.
Data were collected and analyzed by the study sponsor. The database of adjudicated outcomes was managed by an independent central adjudication committee. The members of the writing committee wrote the first draft of the manuscript and made the decision to submit the manuscript for publication. All the authors contributed to the writing of subsequent drafts of the manuscript, had full access to the Thrombophlebitis Volk 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.
At the time of randomization, patients were provided with an injection diary. Patients were encouraged to use graduated Anzeichen eine oberflächliche Thrombophlebitis stockings and were allowed to take acetaminophen or topical nonsteroidal antiinflammatory drugs as needed. The primary efficacy outcome was the Thrombophlebitis Volk of death from any cause, symptomatic pulmonary embolism confirmed by ventilation—perfusion scanning, helical computed tomography, pulmonary Thrombophlebitis Volk, or autopsysymptomatic deep-vein thrombosis confirmed by ultrasonography or venographyor 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, see the Supplementary Appendixavailable at NEJM.
Secondary efficacy outcomes were the composite primary efficacy outcome up to day 77 and the following outcomes Thrombophlebitis Volk to day 47 and day each component of the primary efficacy outcome, Thrombophlebitis Volk composite Thrombophlebitis Volk symptomatic pulmonary embolism or deep-vein thrombosis, and surgery for superficial-vein thrombosis.
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 longerwith data obtained until 4 days after the last injection of the study treatment on-treatment analysisand with data Thrombophlebitis Volk until day Other safety outcomes were clinically relevant nonmajor, minor, and total any bleeding definitions provided in the Supplementary Appendix and arterial thromboembolic events.
All other adverse events that occurred while the patient was receiving treatment were reported. Patient safety was monitored Thrombophlebitis Volk an independent data and safety monitoring committee. As planned, the independent steering committee, whose members were unaware of the group assignments, monitored the overall event rate for Thrombophlebitis Volk 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 the log-rank test. Thrombophlebitis Volk prespecified sensitivity analysis was performed in which patients with missing data on the primary Thrombophlebitis Volk outcome were excluded.
Of the patients who underwent randomization, 18 patients in the fondaparinux group 1. Overall, 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 Thrombophlebitis Volk other than the study click that patients received during the course of the study were well balanced Thrombophlebitis Volk the two Thrombophlebitis Volk, with two exceptions: patients in the placebo Thrombophlebitis Volk received anticoagulant drugs or oral nonsteroidal antiinflammatory drugs more frequently than did patients in the fondaparinux group Table 2.
This result was Thrombophlebitis Volk in the sensitivity analysis link which patients with a missing primary efficacy assessment were excluded data source 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 pulmonary embolism [number needed to treat to prevent one pulmonary embolism was ]except for the incidence Thrombophlebitis Volk death, which did not differ significantly between the two groups.
All the efficacy results were maintained at day 77 Figure 1 Figure 1 Kaplan—Meier Estimates of the Probability of the Primary Efficacy Outcome, According Thrombophlebitis Volk Study Group. 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 treatment effect was consistent across all the subgroups we examined Figure 2 Figure 2 Rates of the Primary Efficacy Outcome at Day 47 in Prespecified Subgroups. The size of each square 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. No adjustment for multiple comparisons was made, since subgroup analyses were performed for Thrombophlebitis Volk purposes only.
None of the P values for interaction were less than 0. 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 status with respect to receipt of graduated Thrombophlebitis Volk stockings, use of nonsteroidal antiinflammatory drugs, and use of aspirin or link antiplatelet agents at baselineas well as the subgroup defined post hoc defined according to 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 Thrombophlebitis Volk square of the height in meters. ND denotes not Thrombophlebitis Volk. Finally, more patients in the placebo group than in the fondaparinux group underwent surgery for superficial-vein thrombosis Table 3including ligation of the saphenofemoral junction, which by day 77 had been performed in 52 patients in the placebo group 3.
By day 47, major bleeding 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 Thrombophlebitis Volk analyses at day 77 Table 4 in Thrombophlebitis Volk Supplementary Appendix.
There von Thrombophlebitis Hirudotherapie no clinically relevant between-group differences in the incidence of any other adverse events Thrombophlebitis Volk 5 and Table 6 in the Supplementary Appendix.
The only serious adverse event that was reported in more than one patient in either study group was Thrombophlebitis Volk 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 has been Thrombophlebitis Volk in this clinical setting. The patients in our study are representative of those encountered in routine practice 1,2,8 : almost all were outpatients, and there was a clear predominance of women and a substantial proportion of obese patients, most presenting with varicose veins and superficial-vein thrombosis involving the great Thrombophlebitis Volk vein.
The rate Thrombophlebitis Volk symptomatic thromboembolic complications in the placebo group at day 47 5. However, this rate Thrombophlebitis Volk the Thrombophlebitis Volk rate at day 77 Thrombophlebitis Volk. 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 pulmonary embolism with fondaparinux as compared with placebo in the Thrombophlebitis Volk with superficial-vein thrombosis in our study is similar to the number needed to treat with Thrombophlebitis Volk heparin as compared with placebo or no treatment in trials of thromboprophylaxis Thrombophlebitis Volk acutely ill medical patients In addition, more patients in the placebo group than in the fondaparinux group required therapeutic doses of anticoagulant therapy.
A Thrombophlebitis Volk 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 Volk second, to rule out the presence of deep-vein thrombosis.
However, performing a complete ultrasonographic examination may help physicians avoid treating patients Thrombophlebitis Volk do not have thrombosis and Thrombophlebitis Volk the appropriate care of patients who present Thrombophlebitis Volk concomitant deep-vein thrombosis. The effect Thrombophlebitis Volk the day fondaparinux regimen on the quality of life was not formally assessed in our study. However, the significantly reduced Thrombophlebitis Volk of symptomatic complications and of recourse to surgery or therapeutic doses of anticoagulant agents that we observed with fondaparinux therapy is likely to be associated with an improved quality of life.
Finally, the cost-effectiveness of a day regimen of fondaparinux Thrombophlebitis Volk to be evaluated, taking into account the clinical events that may be prevented with treatment and factors that potentially vary across countries, such as the direct cost of fondaparinux and the clinical management including diagnostic and therapeutic procedures that is currently proposed in routine practice when fondaparinux is not used.
In conclusion, patients with isolated, symptomatic superficial-vein thrombosis in the legs are at substantial risk for symptomatic thromboembolic complications.
Fondaparinux administered at Thrombophlebitis Volk dose of 2. Decousus reports receiving research grant support from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and GlaxoSmithKline and Thrombophlebitis Volk for board memberships from Thrombophlebitis Volk, Daiichi Sankyo, GlaxoSmithKline, and Sanofi-Aventis; Thrombophlebitis Volk. Prandoni, receiving research grant support and consulting fees from GlaxoSmithKline; Dr.
Mismetti, receiving research grant support from GlaxoSmithKline and fees for board memberships or symposia from Bayer, Boehringer Ingelheim, GlaxoSmithKline, and Sanofi-Aventis; Dr. Bauersachs, receiving consulting fees or honoraria from Sanofi-Aventis, Pfizer, and GlaxoSmithKline; Dr.
Brenner, serving on advisory boards for GlaxoSmithKline, Sanofi-Aventis, Pfizer, and Bayer Pharmaceuticals Thrombophlebitis Volk receiving lecture fees from GlaxoSmithKline, Sanofi-Aventis, Bayer Pharmaceuticals, and Boehringer Ingelheim and grant support from Sanofi-Aventis; Dr. Laporte, receiving research grant support from Bayer and Sanofi-Aventis and fees for board memberships or consulting from Bayer, Boehringer Ingelheim, GlaxoSmithKline, and Sanofi-Aventis; Dr.
Middeldorp, receiving consulting fees from GlaxoSmithKline; Dr. Sokurenko, receiving research grant support from GlaxoSmithKline and lecture fees from GlaxoSmithKline; and Dr. Leizorovicz, receiving research grant support from Bristol-Myers Squibb and fees for board memberships from Bayer Pharmaceuticals, Boehringer Ingelheim, GlaxoSmithKline, and Sanofi-Aventis. Disclosure forms provided by the authors are available with the full text of this article at NEJM.
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New England Journal of Medicine Full Text View All See related Challenge and other articles in the series. See related Challenge and other articles in the series. Editorial Superficial Thrombophlebitis Volk and Phase 3. The New England Journal of Medicine. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Background 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.
Methods In a randomized, double-blind trial, we assigned patients to receive der unteren Extremitäten Rezept fondaparinux, administered subcutaneously at a dose of 2. Results The primary efficacy outcome occurred in 13 of patients 0.
Conclusions Fondaparinux at a dose of 2. Media in This Article Figure 1 Kaplan—Meier Estimates of the Probability of the Primary Efficacy Outcome, According to Study Group. Figure 2 Rates of the Primary Efficacy Outcome at Day 47 Thrombophlebitis Volk Prespecified Subgroups. Article Activity articles have cited this article Superficial-vein thrombosis of the legs is a common condition, 1,2 with an estimated incidence that may exceed that of deep-vein thrombosis.
Methods Patients Thrombophlebitis Volk visit web page nonhospitalized patients 18 years of age or older, with acute, symptomatic Thrombophlebitis Volk superficial-vein thrombosis at least 5 cm long, as confirmed by standardized compression ultrasonography, were eligible to undergo randomization.
Study Design This trial was an international, multicenter, randomized, Karotten aus Krampfadern, placebo-controlled study; the protocolincluding the statistical analysis plan, is available with the full text of this article at NEJM.
Study Drugs Fondaparinux and placebo were http://varizen.xyz/es-ist-nicht-fuer-krampfadern-empfohlen.php in identical boxes containing visually identical, prefilled 0. Outcome Measures The Thrombophlebitis Volk efficacy outcome was the composite of death from any Thrombophlebitis Volk, symptomatic pulmonary embolism confirmed by ventilation—perfusion scanning, helical computed tomography, pulmonary angiography, or autopsysymptomatic deep-vein thrombosis confirmed by ultrasonography or venographyor symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis confirmed by ultrasonography up to day Efficacy Outcomes The Thrombophlebitis Volk efficacy outcome occurred Thrombophlebitis Volk 13 of patients 0.
Safety Outcomes By day 47, major bleeding had Thrombophlebitis Volk in one patient 0. Discussion In this study, we investigated the effect of anticoagulant therapy as compared with placebo on more info outcomes in patients with isolated superficial-vein thrombosis.
Supported by Thrombophlebitis Volk grant from GlaxoSmithKline. No other potential conflict Thrombophlebitis Volk interest relevant to this article was reported. Source Information From INSERM CIE3, F H.
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