Safety and effectiveness of biosimilar enoxaparin (Inhixa) for the prevention of thromboembolism in medical and surgical
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Safety and effectiveness of biosimilar enoxaparin (Inhixa) for the prevention of thromboembolism in medical and surgical inpatients Chiara Fantoni1 · Lorenza Bertù2 · Elena Maria Faioni3,5 · Caterina Froiio4 · Nicolò Mariani5 · Walter Ageno2 Received: 27 June 2020 / Accepted: 10 October 2020 © Società Italiana di Medicina Interna (SIMI) 2020
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 postmarketing 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. Keywords Inhixa · Enoxaparin · Biosimilar · LMWH · Prevention
Introduction Patients undergoing general surgery and hospitalized acutely ill medical patients are at increased risk of venous thromboembolism (VTE) [1, 2]. Several randomized clinical trials have demonstrated the efficacy and safety of low-molecularweight heparin (LMWH) in preventing VTE in this setting and, based on these findings [3, 4], international guidelines
* Chiara Fantoni [email protected] 1
Department of Medicine, Maggiore Hospital, Bologna, Italy
2
Department of Medicine and Surgery, University of Insubria, Varese, Italy
3
Department of Health Sciences, University of Milan, Milan, Italy
4
University of Milan, Milan, Italy
5
ASST Santi Paolo E Carlo, Milan, Italy
recommend their use as first choice in patients with high thrombotic risk and acceptable bleeding risk [5, 6]. Over the last years, several biosimilar LMWHs have become available worldwide, and their use in clinical practice is constantly increasing. According to a recent position paper of the European Medicines Agency (EMA), the therapeutic eq
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