Abstract:
:In 2016, biosimilar enoxaparin (Inhixa®, Techdow) was introduced in European markets with the same indications as branded enoxaparin (Clexane®, Sanofi). Its use is constantly increasing in clinical practice, however, little information from post-marketing clinical trials is available on its safety and effectiveness. We conducted an observational, retrospective study to assess the safety and effectiveness of Inhixa in preventing venous thromboembolism (VTE) in medically ill patients and in patients undergoing major abdominal surgery. We then compared our results with the incidence of symptomatic VTE and bleeding events during treatment with Clexane by pooling the results of clinical studies carried out in the same settings. We enrolled 381 patients, 189 admitted to a Medical Department and 192 to a Surgical Department from two single institutions. The incidence of major bleeding events was 1.8% globally (95% IC 0.7-3.8), 1.6% in medical patients (95% IC 0.3-4.6) and 2.1% in surgical patients (95% IC 0.6-5.3). VTE rate was 0.5% in the whole population (95% IC 0.1-1.9) and 0.5% (95% IC 0.01-2.9) in each group, respectively. The pooled estimate of the incidence of major bleeding with Clexane was 0.5% (IC 95%: 0.2-1.1) in medical patients and 2.6% (IC 95% 1.3-5.1) in surgical patients. The incidence of thrombotic events was 0.6% (IC 95%: 0.2-1.8) and 0.7% (CI95% 0.3-1.6), respectively. The incidence of bleeding and thrombosis in medical and surgical patients receiving Inhixa was low suggesting biosimilar enoxaparin is a valid alternative to branded enoxaparin.
journal_name
Intern Emerg Medjournal_title
Internal and emergency medicineauthors
Fantoni C,Bertù L,Faioni EM,Froiio C,Mariani N,Ageno Wdoi
10.1007/s11739-020-02536-4subject
Has Abstractpub_date
2020-10-27 00:00:00eissn
1828-0447issn
1970-9366pii
10.1007/s11739-020-02536-4pub_type
杂志文章abstract::Cardiovascular disease and cancer incidence and prevalence have risen over the past few decades to become the leading causes of death. On the one hand, cancer patients will be treated with cardiotoxic chemotherapies; on the other, cardiovascular patients will receive a new diagnosis of cancer and will have to face tre...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-014-1064-9
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abstract::Despite its rarity, infliximab-related hepatitis constitutes a cutting edge and challenging problem. In December 2004, a drug warning was issued by the Food and Drug Administration to alert healthcare professionals to the risk of hepatotoxicity in course of infliximab therapy. Subsequently, several reports of probable...
journal_title:Internal and emergency medicine
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abstract::Cirrhosis is characterized by a complex coagulation defect leading to the prolongation of the prothrombin and activated partial thromboplastin times (PT and APTT). Arbitrary PT cut-off values are still used as a yardstick to guide treatment with fresh-frozen plasma (FFP) or other pro-coagulant agents in patients under...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-011-0528-4
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journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-017-1697-6
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journal_title:Internal and emergency medicine
pub_type: 杂志文章,评审
doi:10.1007/s11739-012-0804-y
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abstract::Prescription of non-vitamin K antagonist oral anticoagulants (NOACs) requires an assessment of renal function (RF) and the Cockcroft-Gault (CG) equation is traditionally recommended. The objective of the study was to evaluate the potential changes in NOACs management using different equations for estimating RF. In a p...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-018-1857-3
更新日期:2018-10-01 00:00:00
abstract::Over the past 50 years, the prevalence of Helicobacter pylori infection has fallen as standards of living improved. The changes in the prevalence of infection and its manifestations (peptic ulcer disease and gastric mucosal lesions) were investigated in a large cohort of Sardinians undergoing upper endoscopy for dyspe...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-015-1218-4
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abstract::Nowadays, amiodarone is the most commonly used antidysrhythmic drug in clinical practice. It is highly effective in the management of recurrent ventricular dysrhythmias, paroxysmal supraventricular dysrhythmias, including atrial fibrillation and flutter, and in the maintenance of sinus rhythm after electrical cardiove...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-014-1140-1
更新日期:2014-12-01 00:00:00
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journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-011-0553-3
更新日期:2011-06-01 00:00:00
abstract::Upper extremities deep venous thrombosis (UEDVT) is a rare condition. According to the literature, approximately 4-10% of all cases of venous thrombosis may involve the subclavian, axillary or brachial veins. In the last few decades, the incidence of UEDVT has increased because of more frequent use of central venous c...
journal_title:Internal and emergency medicine
pub_type: 杂志文章,评审
doi:10.1007/s11739-009-0320-x
更新日期:2010-04-01 00:00:00
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journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-019-02271-5
更新日期:2020-09-01 00:00:00
abstract::Serum potassium homeostasis play an important role in myocardial function, but the impact of serum potassium levels on long-term mortality has not been well evaluated. In the current study, we investigated patients with acute coronary syndrome (ACS) and analyzed the relationship between admission serum potassium level...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-015-1253-1
更新日期:2015-12-01 00:00:00
abstract::The term splanchnic vein thrombosis encompasses Budd-Chiari syndrome (BCS), extrahepatic portal vein obstruction (EHPVO), and mesenteric vein thrombosis; the simultaneous involvement of additional regions is frequent, and clinical presentations and risk factors may be shared. The annual incidence of BCS and isolated m...
journal_title:Internal and emergency medicine
pub_type: 杂志文章,评审
doi:10.1007/s11739-010-0413-6
更新日期:2010-12-01 00:00:00
abstract::This study aimed to compare the diagnostic accuracy of heart, lung and inferior vena cava (IVC) ultrasonography modalities, alone and combined, for possible added accuracy in diagnosing acute decompensated heart failure (ADHF), in a group of patients with the final diagnosis of ADHF based on plasma level of B-type nat...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-019-02233-x
更新日期:2020-04-01 00:00:00
abstract::The most relevant manifestation of coronavirus disease 2019 (COVID-19) is interstitial pneumonia. Several lung ultrasound (US) protocols for pneumonia diagnosis are used in clinical practice, but none has been proposed for COVID-19 patients' screening in the emergency department. We adopted a simplified 6-scan lung US...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-020-02596-6
更新日期:2021-01-11 00:00:00
abstract::Patients with chronic obstructive pulmonary disease (COPD) have an increased cardiovascular morbidity and mortality. Flow-mediated (FMD) and nitrate-mediated dilatation (NMD) are considered non-invasive methods to assess endothelial function and surrogate markers of subclinical atherosclerosis. We performed a systemat...
journal_title:Internal and emergency medicine
pub_type: 杂志文章,评审
doi:10.1007/s11739-017-1690-0
更新日期:2017-09-01 00:00:00
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journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-018-1808-z
更新日期:2018-06-01 00:00:00
abstract::The objective of this study was to prospectively assess the prevalence, predictors and prognostic significance of microalbuminuria in a large cohort of consecutive acute cardiac patients, admitted to an intensive cardiac care unit from 1 January 2008 to 30 June 2009. In 815 acute cardiac patients, microalbuminuria is ...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-011-0619-2
更新日期:2013-06-01 00:00:00
abstract::Extreme hypomagnesemia (hypoMg) can be encountered in many situations, but little data currently exist. Our aim is to describe the epidemiological, clinical, etiological characteristics, and the biological abnormalities of consecutive inpatients with extreme hypomagnesemia. In our observational monocentric study, betw...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-018-1898-7
更新日期:2018-12-01 00:00:00
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pub_type: 杂志文章
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更新日期:2017-12-01 00:00:00
abstract::Septic arthritis (SA) is commonly associated with Staphylococcal or Streptococcal infections. Overtime, there has been a global increase in the distribution of antimicrobial resistance within both Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative bacteria such as exten...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-019-02244-8
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journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-012-0880-z
更新日期:2013-03-01 00:00:00
abstract:OBJECTIVE:Postprandial lipemia is generally studied after a test meal that provides most of the calories as fat and that does not reflect the common food intake. We investigated postprandial changes in serum triglycerides (TG) and in high-density lipoprotein (HDL) concentration and composition after a regular meal poor...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/BF02934762
更新日期:2006-01-01 00:00:00
abstract::Predictors of short-term readmission after ischemic stroke have been previously identified, but few studies analyzed predictors of long-term readmission, namely early imaging findings and treatment with intravenous thrombolysis (IVT). To characterize predictors of hospital readmission during the first year after hospi...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-016-1519-2
更新日期:2017-02-01 00:00:00
abstract::The recent position paper of the European Society of Cardiology (ESC) on cardiovascular toxicity of cancer treatments has attracted considerable interest by healthcare professionals, since it is the first concrete help in the difficult task of monitoring and approaching cardiovascular side effects of anticancer treatm...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-017-1755-0
更新日期:2018-01-01 00:00:00
abstract::Rapid diagnostic tools for Helicobacter pylori are important in endoscopy. To assess the accuracy of a new 5-min rapid urease test (UFT300, ABS Cernusco, sul Naviglio, Italy) compared with the 1-h Pyloritek (Serim Laboratories, Elkhart, IN) and the 24-h CLO test (Kimberly-Clark Ballard Medical Products, Roswell, GA), ...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-009-0344-2
更新日期:2010-02-01 00:00:00
abstract::Coronavirus disease 2019 (COVID-19) is an emerging infectious disease which has had a rapid surge in cases and deaths since it is first documented in Wuhan, China, in December 2019. COVID-19 is caused by the Betacoronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 uses angiotensin-conve...
journal_title:Internal and emergency medicine
pub_type: 杂志文章,评审
doi:10.1007/s11739-020-02616-5
更新日期:2021-01-16 00:00:00
abstract::In chronic heart failure (CHF) due to systemic cardiovascular disease, obese patients have better survival. Bodyweight versus survival was analyzed post hoc in subjects with limited scleroderma (SSc) and isolated pulmonary artery hypertension (PAH), i.e. with CHF due to pulmonary vascular disease. Rheumatologists refe...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-016-1446-2
更新日期:2016-10-01 00:00:00
abstract::SCODIAC was a pilot study which revealed an increasing use of SGLT2i in 123 outpatients affected with Heart Failure (HF) and Type 2 Diabetes Mellitus. SCODIAC-II study, the second phase of the program, has been carried out to determine diagnostic and therapeutic pathways in a larger group of patients and to verify whe...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-020-02528-4
更新日期:2020-10-17 00:00:00
abstract::We evaluated the effect of body mass index (BMI) on intubation success rates and complications during emergency airway management. We retrospectively analyzed an airway registry at an academic medical center. The primary outcomes were the incidence of difficult intubation and complication rates, stratified by BMI. We ...
journal_title:Internal and emergency medicine
pub_type: 杂志文章
doi:10.1007/s11739-012-0874-x
更新日期:2013-02-01 00:00:00