{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T13:59:44Z","timestamp":1790863184507,"version":"4.1.0"},"reference-count":13,"publisher":"FapUNIFESP (SciELO)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Rev. Assoc. Med. Bras."],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:p> Objectives: to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study. Methods: patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons. Results: DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg\/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 \u00b1 35.4% and 67.5 \u00b1 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous, 40 mg\/day). Mean percentages of anti-factor Xa levels within the target ranges were 77.9 \u00b1 30.9% and 77.8 \u00b1 32.9%, respectively (p = .009 for non-inferiority). There were no cases of VTE or major bleeding events in any subgroup. Conclusion: generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity, as well as similar clinical efficacy and safety outcomes.<\/jats:p>","DOI":"10.1590\/1806-9282.61.01.044","type":"journal-article","created":{"date-parts":[[2015,4,16]],"date-time":"2015-04-16T17:39:41Z","timestamp":1429205981000},"page":"44-50","source":"Crossref","is-referenced-by-count":6,"title":["Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis"],"prefix":"10.1590","volume":"61","author":[{"given":"Ivan Benaduce","family":"Casella","sequence":"first","affiliation":[{"name":"University of S\u00e3o Paulo,  Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Puech-Le\u00e3o","sequence":"additional","affiliation":[{"name":"USP,  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Intensiva"},{"issue":"2","key":"ref11","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1046\/j.1365-2141.1999.01153.x","article-title":"Occurrence of thrombosis and haemorrhage, relationship with anti-Xa, anti-IIa activities, and D-dimer plasma levels in patients receiving a low molecular weight heparin, enoxaparin or tinzaparin, to prevent deep vein thrombosis after hip surgery","volume":"104","author":"Bara L","year":"1999","journal-title":"Br J Haematol"},{"issue":"6","key":"ref12","first-page":"727","article-title":"Differences of venous thromboembolic risks in vascular general and trauma surgery patients","volume":"48","author":"Mommertz G","year":"2007","journal-title":"J Cardiovasc Surg (Torino)"},{"issue":"6","key":"ref13","doi-asserted-by":"crossref","first-page":"1514","DOI":"10.1016\/j.jvs.2008.07.055","article-title":"Incidence of ipsilateral postoperative deep venous thrombosis in the amputated lower extremity of patients with peripheral obstructive arterial disease","volume":"48","author":"Matielo MF","year":"2008","journal-title":"J Vasc Surg"}],"container-title":["Revista da Associa\u00e7\u00e3o M\u00e9dica Brasileira"],"original-title":[],"link":[{"URL":"http:\/\/www.scielo.br\/pdf\/ramb\/v61n1\/0104-4230-ramb-61-01-0044.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2017,5,22]],"date-time":"2017-05-22T22:58:45Z","timestamp":1495493925000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.scielo.br\/scielo.php?script=sci_arttext&pid=S0104-42302015000100014&lng=en&tlng=en"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,2]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2015,2]]}},"alternative-id":["S0104-42302015000100014"],"URL":"https:\/\/doi.org\/10.1590\/1806-9282.61.01.044","relation":{},"ISSN":["0104-4230"],"issn-type":[{"value":"0104-4230","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,2]]}}}