RESUMEN
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.
Asunto(s)
Anticoagulantes/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Enoxaparina/uso terapéutico , Pacientes Internos , Tromboembolia Venosa/prevención & control , Anciano , Femenino , Humanos , Italia , Masculino , Estudios RetrospectivosRESUMEN
Over the last years, direct oral anticoagulants (DOACs) have radically changed and simplified the therapeutic approach and management of patients on anticoagulant therapy. For these patients, international guidelines recommend to set up a regular follow-up (every 1-6 months) to re-enforce education, to ensure adequate adherence and persistence to treatment. In real-life setting, the application of the suggested follow-up regimens and incidence rates of thrombotic and bleeding complications related to the intensity of follow-up strategies has not been described. We conducted a multicentre, retrospective study at 4 Italian Thrombosis Centres to describe follow-up strategies of patients on DOACs treatment and to assess the incidence of bleeding and thrombotic complications. We enrolled 534 patients, with median follow-up 24 months: 52.1% had < 3 visits/year (group 1), while 47.9% required ≥ 3 visits/year (group 2). Mean age and gender were similar between the 2 groups, while severe anaemia (4.4% and 1.2%, p 0.03) and creatinine clearance < 50 mL/min were more common in group 2 (26.8% and 17.8%, p 0.02). The incidence of thromboembolic events was 3.9% in group 2 and 1.1% in group 1 (p 0.03). Major bleeding rates were non-significantly higher in group 2, whereas non-major bleeding rates occurred significantly more frequently in group 2 (26.6% and 18.7%, respectively, p 0.03). A tailored follow-up program is of critical importance to correctly manage patients on DOACs. A less intense follow-up management is feasible and safe for a substantial proportion of patients, provided they are carefully identified at specialized centres.
Asunto(s)
Anticoagulantes/administración & dosificación , Continuidad de la Atención al Paciente , Administración Oral , Anciano , Anciano de 80 o más Años , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tromboembolia/epidemiologíaRESUMEN
In recent years, several studies have consistently described the chronobiologic aspects of many cardiovascular diseases. Several studies have also assessed the circadian and circannual patterns of occurrence and mortality of deep vein thrombosis and pulmonary embolism, but the results have been less univocal. Different mechanisms have been proposed to explain these possible patterns, including oscillation of coagulation proteins, the role of meteorologic parameters, and air pollution. This article summarizes the available evidence on chronobiologic aspects of venous thromboembolism and discusses the casual mechanism.
Asunto(s)
Ritmo Circadiano/fisiología , Estaciones del Año , Tromboembolia Venosa/fisiopatología , HumanosRESUMEN
The international guidelines recommend the use of direct oral anticoagulants (DOACs) over vitamin K antagonists for anticoagulation long-term therapy in patients diagnosed with venous thromboembolism (VTE), and for stroke prevention in patients with non-valvular atrial fibrillation (AF). Efficacy and safety of DOACS have been extensively evaluated in large phase III trials. According to the product label, dose reductions of DOACs are recommended for patients with AF and renal impairment, low body weight and concomitant use of interfering medications. Except for Edoxaban, dose reductions of DOACs are not recommended in patients with VTE based on the same indications for AF patients. The aim of this article is to discuss the indication of a lower DOAC dose in some patients with VTE. Observational studies and randomized control trials (RCTs) show that patients with AF are usually older, more often have chronic diseases, and more often are treated with several concomitant medications, potentially increasing their haemorrhagic risk. Furthermore, many VTE patients need a shorter period of anticoagulation therapy than AF patients. In real-life studies, VTE patients treated with inappropriate DOAC doses present a higher rate of VTE recurrence, and the same risk of bleeding compared to those treated with the correct dose. In light of this evidence, the use of lower DOAC dose in patients with VTE does not appear reasonable and may be potentially dangerous.