Fondaparinux for the treatment of superficial-vein thrombosis in the legs.
Details
Serval ID
serval:BIB_CF5B25B979C9
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Fondaparinux for the treatment of superficial-vein thrombosis in the legs.
Journal
New England Journal of Medicine
Working group(s)
CALISTO Study Group
Contributor(s)
Décousus H., Leizorovicz A., Bauersachs R., Brenner B., Laporte S., Middeldorp S., Mismetti P., Prandoni P., Richard-Lordereau I., Décousus H., Leizorovicz A., Prandoni P., Richard-Lordereau I., Décousus H., Leizorovicz A., Bauersachs R., Boda Z., Brenner B., Laporte S., Matyas L., Middeldorp S., Mismetti P., Prandoni P., Sokurenko G., Schulman S., Cucherat M., Ford I., Monreal M., Mismetti P., Becker F., Bost V., Girard P., Becker F., Constans J., Gauthier E., Seymour L., Froloshki B., Stober P., Borthwick L., Jaques D., Trelfa A., Allende-Echevarrietta P., Kensit S., Kovacs I., Laursen E., Dramov A., Chlumsky J., Maasalu K., Quere I., Bauersachs R., Kiskinis D., Boda Z., Hoffman R., Piovella F., Krievins D., Middeldorp S., Krievins D., Oszkinis G., Sokurenko G., Stvrtinova V., Lozano Sanchez F., Mazzolai L., Myschalov V., Sokurenko G., Popovich V., Baluev M., Burov Y., Mikulskaya E., Chirkova V., Shvalb P., Kalinin R., Kachinskiy A., Apartsin K., Shulikovskaya I., Chizhova E., Subbotin Y., Shulgina L., Ignatenko P., Antropova N., Solomatin A., Nosko V., Zhukov B., Melnikov M., Zubareva N., Gusev V., Mineev D., Plechev V., Oleynik B., Khafizov A., Barbarash O., Lonchakova I., Berns S., Dubrovskiy A., Mikhaylov D., Mosin S., Chumakov A., Smirnov G., Krasavin V., Suplotova L., Ivanov E., Klushina T., Chernyatina M., Belikov L., Gladchenko M., Khmelniker S., Peshkov A., Shanigin A., Voskanyan Y., Golubov E., Shnukov R., Esipenko V., Neverko I., Ivanov A., Lenskaya L., Hvashevskiy A., Kotelnikov M., Apurin S., Zonova E., Nimaev V., Rogalev K., Butorin S., Sabelnikov V., Prokopets A., Nikiforov Y., Chernyakov A., Kon E., Guskova A., Katelnitskiy I., Belentsov S., Rodoman G., Ershova O., Soroka V., Mátyás L., Szentesi S., Simon G., Hajdu L., Varga M., Mogán I., Darabos G., Simó G., Ungár D., Bende B., Nyíri B., Boda Z., Rázsó K., Oláh Z., Halmos F., Gergely M., Somogyi Z., Kollár L., Menyhei G., Benkö L., Szentpéteri I., Simon J., Szegedi J., Murányi A., Frank J., Schoenen B., Grossgloss T., Mueller-Buehl U., Eggeling T., Eggeling S., Mietaschk A., von Bilderling P., Kurzbach J., Pfister R., Buechner L., Schoen N., Schoen B., Kaehler W., Schnieder HG., Enderle J., Muenter KC., Schulte-Huermann D., Ruetten A., Ante D., von Nettelbladt EF. , Zollman C., Kamphausen U., Keilhau DA., Brado B., Pourhassan S., Boss S., Noppeney T., Betzl G., Herman G., Tsantilas D., Gudz I., Voloshyna M., Syerna A., Nikulnikov P., Danylets A., Guch A., Skupyy O., Tatarin A., Kravchenko I., Shtutin O., Rodin Y., Konovalova K., Sergeev O., Socolov A., Harbarlak S., Mylytsya M., Mylytsya K., Grigorjeva M., Shershneva O., Myshalov V., Chernyak V., Nykonenko O., Velygotskyy M., Bobrov O., Sofronkov N., Feshchenko Y., Kobza I., Rusyn V., Guenneguez H., Ouvry P., Di Maio A., Diamand JM., Quéré I., Brisot D., Martin M., Bressollette L., Louis P., Boveda S., Delsart D., Faisse P., Elias A., Aquilanti S., Gris JC., Jurus C., Quémeneur T., Leandri C., Saby JC., Lance G., Giannoukas A., Saleptsis V., Koutsias S., Kiskinis D., Saratzis N., Giannopoulos A., Katsamouris A., Kostas T., Tsetis D., Lazarides M., Filis K., Gerasimidis T., Papacharalambous G., Tsoupanos S., Krievins D., Gedins M., Kisis K., Zelobovskis J., Nokikovs N., Smolakova V., Zvirgzdins V., Ivanova P., Udris I., Bugán V., Komová J., Dzupina A., Horvát P., Bojdova E., Lasan I., Lasanová Z., Jascur J., Vacula I., Dostálová K., Andreozzi G., Camporese G., Verlato F., Davì G., Lessiani G., Pesavento R., Minotto I., Piovella F., Siragusa S., Parisi R., Imberti D., Prisco D., Lozano Vilardell P., Merino O., Acín García F., Cañibano C., Marinello Roura J., Alvarez Fernández J., Trujillo Santos J., Blanes Mompo J., Giménez Gaibar A., Izquierdo Lamoca L., Moreno Palomares J., Sánchez Gutiérrez A., Martínez Fernández S., Vaquero C., Muñoz Alvarez D., Cairols Castellote M., Grozdinski L., Dramov A., Oszkinis G., Gabriel M., Slowiński M., Dorobisz A., Milnerowicz A., Jawień A., Dereziński T., Strugala C., Chlumsky J., Jirka V., Skalicka L., Hirmerova J., Krcova E., Stanek F., Krivankova M., Kaha E., Aru A., Maasalu K., Kamphuisen P., Gaastra M., Gerdes V., Damsté HS., ten Cate H., Valentijn R., Jeanneret C., Mazzolai L., Banyai M., Hayoz D., Kalka C., Willenberg T., Lugassy G., Lishner M., Hussein O.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
2010
Volume
363
Number
13
Pages
1222-1232
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. 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 47. The main safety outcome was major bleeding. The patients were followed until day 77.
RESULTS: The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). 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 (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. 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 0.7% with fondaparinux and 1.1% with placebo.
CONCLUSIONS: Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.)
METHODS: In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. 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 47. The main safety outcome was major bleeding. The patients were followed until day 77.
RESULTS: The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). 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 (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. 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 0.7% with fondaparinux and 1.1% with placebo.
CONCLUSIONS: Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.)
Keywords
Acute Disease, Anticoagulants/administration & dosage, Anticoagulants/adverse effects, Double-Blind Method, Female, Hemorrhage/chemically induced, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Polysaccharides/administration & dosage, Polysaccharides/adverse effects, Pulmonary Embolism/epidemiology, Pulmonary Embolism/prevention & control, Recurrence, Risk, Treatment Outcome, Venous Thrombosis/complications, Venous Thrombosis/drug therapy
Pubmed
Web of science
Create date
15/02/2011 12:09
Last modification date
20/08/2019 15:49
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