The Anticoagulation Treatment of Venous Thromboembolism: from Randomized Clinical Studies to the Data from the Real Clinical Practice

Flebologiia ◽  
2016 ◽  
Vol 10 (2) ◽  
pp. 106
Author(s):  
E. I. Seliverstov ◽  
I. S. Lebedev ◽  
S. G. Leont’ev
2014 ◽  
Vol 10 (5) ◽  
pp. 500-504
Author(s):  
G. N. Guseva ◽  
T. V. Pavlova ◽  
I. L. Voronova ◽  
S. M. Chohlunov

2021 ◽  
Vol 17 (3) ◽  
pp. 376-385
Author(s):  
K. V. Lobastov ◽  
A. R. Navasardyan ◽  
I. V. Schastlivtsev

Aim. To assess the duration of the anticoagulant treatment of venous thromboembolism (VTE) in various categories of patients in real clinical practice through survey of practitioners, as well as correspondence of the duration with current clinical guidelines.Material and methods. Data obtained from electronic survey of practicing surgeons as part of a commercial brand assessment (Brand Adoption Monitor) was studied. Survey was carried out by the "Validata” analytical agency at the request and with the financial support of Bayer. Inpatient and outpatient vascular surgeons, as well as general outpatient surgeons were invited to complete the electronic questionnaire. The number of interviewed specialists was 100: 50 inpatient vascular surgeons and 50 outpatient specialists, among whom the share of vascular surgeons (phlebologists, angi-ologists) was about 20%. The study was completed in 20 cities of Russia with a population of at least 200,000 people from all federal districts except the North Caucasus and the Republic of Crimea. The selection criteria for participants were: work experience in the specialty ≥3 years, work experience at the current organization >6 months, ≥5 patients with VTE during in the last month.Results. In total, 104 doctors were surveyed during the period from December 11, 2019 to January 20, 2020, of which 50 were inpatient vascular surgeons and 54 were from outpatient setting. According to the survey of vascular surgeons in hospitals, 75% (6 [5;10]) of patients were hospitalized with a primary episode of VTE and 25% (2 [1;4]) with a recurrent thrombotic event. In an outpatient surgeon, 27.5% (3 [2;5]) of patients were treated in an outpatient setting without hospitalization, 34.7% (3 [2;5]) came to an appointment immediately after discharge from the hospital and 38.8% (2 [1;4]) were a repeat visit regarding a previous VTE. Most often, surgeons observed episodes of clinically unprovoked VTE in 27.3% of cases, thrombotic events provoked by major transient risk factors were 12.2%, event provoked by small transient risk factors were 13.3% and events provoked by small persistent risk factors were 12.6%, while cancer-associated thrombosis represented 13.5%. Most surgeons chose to prescribe anticoagulant therapy beyond 3 months. About half of the specialists prescribed therapy for a year or longer for cancer-associated thrombosis and recurrent VTE. When treating the first episode of clinically unprovoked VTE, about half of the respondents chose anticoagulation for a period of 3 to 6 months. About 60% of specialists prescribed anticoagulant therapy for a period of 3 to 6 months to patients with minor transient or persistent risk factors and patients with VTE provoked by major transient risk factor (trauma or surgery).Conclusion. Correspondence of the duration of anticoagulant therapy in real clinical practice with the international clinical guidelines varies within 450% range and, on average, does not exceed 30%. This discrepancy was both in situations when the duration of therapy was lower than recommended, but also in situations when treatment extension would not have been recommended.


2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 


2009 ◽  
Vol 8 (4) ◽  
pp. 75-81
Author(s):  
Ye. S. Kulikov

At multicenter prospective observational study conducted in 19 centers in Russia under common protocol (n = 543) was demonstrated that in the context of real clinical practice the use of a step-up treatment regime and long-term dosing in a stable volume leads to control achievement in 73,3 and 69,4% cases respectively.


2013 ◽  
Vol   (1) ◽  
pp. 44 ◽  
Author(s):  
Elena Spartakovna Zholobova ◽  
O Yu Konopelko ◽  
O S Rozvadovskaya ◽  
V Ya Elyashevich ◽  
M N Nikolayeva

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