scholarly journals Strategies for control achievement in the real clinical practice settings. The data of ARROW-ACT study

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.

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. 


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 43-43
Author(s):  
Atsushi Mizokami ◽  
Rie Fukuda ◽  
Taiki Kamijima ◽  
Kouji Izumi ◽  
Yoshifumi Kadono ◽  
...  

43 Background: ARTAs (enzalutamide and abiraterone) have been approved for relapse of prostate cancer in Japan since 2014. However, the efficacy of ARTAs for overall survival (OS) has not yet been proven in Japanese real-world clinical practice. Bone Scan Index (BSI), amount of bone metastasis in a unit of %, has become available for bone scintigraphy using software of BONENAVI (EXINIbone) in Japan. To confirm the benefit of BSI, we conducted a prospective observational study from 2012 to 2017 on mHSPC and mCRPC prior to docetaxel (presented at ASCO-GU 2020). Then we conducted this subanalysis to investigate the real-world benefit of ARTAs on OS before and after docetaxel. Methods: Patients enrolled as the mHSPC (N = 148) and mCRPC (N = 99) groups in the PROSTAT-BSI registry over a 3-year observation period were analyzed with or without ARTAs or flutamide. Patients were evaluated for PSA progression, BSI progression, and OS during hormonal therapy or chemotherapy. Results: In the mHSPC group, 123 patients were treated with combined androgen blockade (androgen deprivation + 80 mg bicalutamide) as an initial hormonal therapy. Thirty-seven patients were treated with flutamide after PSA progression. Thirty-seven patients were also treated with ARTAs as 2nd or later. Docetaxel was used in 25 patients. There was no significant difference in PSA (median: 265.5 and 248.0 ng/mL; P = 0.877) and BSI (median: 1.28% and 1.68%; P = 0.131) between the ARTA (-) and ARTA (+) groups at the start of hormonal therapy, respectively. Despite a median PSA-PFS disadvantage of 16 months in the ARTA (+) group compared to the ARTA (-) group (median: 8.9 and 25.2 months), OS of both groups were comparable (3-year survival rate: 84.0% and 75.7%; HR [95% CI]:0.556 [0.238-1.299], P = 0.232), respectively, indicating favorable effect of ARTA on OS. Furthermore, OS tended to be more extended in patients who received flutamide prior to ARTAs (N = 21) (HR [95% CI]:0.3175 [0.050-2.026], P = 0.225). In the mCRPC group, 8 patients who used ARTA prior to docetaxel were excluded from this analysis. ARTAs were used to treat relapse after docetaxel in 44 patients. Cabazitaxel was used in 14 patients. There was no significant difference in PSA (median: 16.8 and 26.8 ng/mL; P = 0.240) and BSI (median: 2.43% and 1.48%; P = 0.105) between the ARTA (-) and ARTA (+) groups at the start of docetaxel, respectively. There was no significant difference in PSA-PFS between the ARTA (-) and ARTA (+) groups (median PSA-PFS: 4.3 months and 7.0 months; P = 0.999), but OS was significantly better in the ARTA (+) group in the ARTA (-) group (median OS: 28.9 months vs 21.1 months; HR [95% CI]: 0.484 [0.264-0.888]; P = 0.019). Conclusions: This subanalysis demonstrates the benefit of ARTAs for OS before and after docetaxel in clinical practice.


Author(s):  
Л.И. Малинова ◽  
Н.Ф. Пучиньян ◽  
Н.В. Фурман ◽  
П.В. Долотовская ◽  
Т.П. Денисова ◽  
...  

Цель исследования: оценить частоту встречаемости тромбоцитопении (ТП) в реальной практике врача-кардиолога и характеризовать ее в зависимости от тяжести состояния пациента (варианта оказания специализированной кардиологической помощи). Материалы и методы: Проведено многолетнее ретроспективное обсервационное исследование на базе крупного кардиологического центра, оказывающего специализированную кардиологическую помощь как в плановом, так и в экстренном порядке, а также в условиях консультационно-поликлинического отделения. Анализировались данные 31430 пациентов. Под ТП понималось патологическое состояние, характеризующееся снижением количества тромбоцитов, циркулирующих в периферической крови, < 150×109/л. Результаты: У 2,69% пациентов кардиологического профиля был выявлен уровень тромбоцитов в периферической крови < 150×109/л. Среди пациентов, госпитализированных по неотложным и экстренным показаниям, частота ТП составила 9,41%. У пациентов, нуждающихся в экстренной и неотложной кардиологической помощи, ТП была более тяжелая (LQ 7×103/мм3; p = 0,012), сопровождалась анемией (гемоглобин LQ 13 г/л; р = 0,003) и лейкоцитозом (лейкоциты UQ 16,3×103/мм3; р = 0,000). Нарастание степени тяжести ТП у больных, госпитализированных в экстренном порядке, было ассоциировано со значимым снижением степени тромбоцитарного анизоцитоза — PDW = 8,7 [6,6; 12,4]% (p = 0,001) и минимальными изменениями размера тромбоцитов (MPV). Заключение: В реальной клинической практике тромбоцитопения выявляется у 2,7% пациентов кардиологического профиля, частота ее встречаемости увеличивается с нарастанием тяжести клинического состояния больных. Установлены цитоморфологические различия тромбоцитопении у пациентов кардиологического профиля в зависимости от тяжести состояния. Полученные данные свидетельствуют об угнетении тромбоцитопоэза в качестве ведущего механизма снижения количества тромбоцитов у кардиологических пациентов с тромбоцитопенией, госпитализированных в ургентном порядке. Objectives: to evaluate the frequency of thrombocytopenia in the real cardiological clinical practice, and to characterize it according to the severity of the patient’s condition. Patients/Methods: A long-term retrospective observational study was performed in the large cardiological center providing specialized cardiological care: planned and emergency hospitalizations as well as outpatient consultation. We analyzed data from 31,430 patients. Thrombocytopenia (TP) was considered as a pathological condition characterized by abnormally low levels of platelets < 150×109/L. Results: Platelets levels < 150×109/L were detected in 2.69% of patients with cardiovascular disorders. Among critically ill patients the incidence of TP was 9.41%. In patients requiring urgent admission to intensive cardiovascular care unit (ICU), TP was more severe (LQ 7×103/mm3; p = 0.012) and accompanied by anemia (hemoglobin LQ 13 g/L; p = 0.003) and leukocytosis (leukocytes UQ 16.3×103/mm3; p = 0.000). An increase in the severity of TP in patients admitted to ICU was associated with a significant decrease of platelet anisocytosis — PDW = 8.7 [6.6; 12.4]% (p = 0.001) and minimal changes in platelet volume (MPV). Conclusions: In real clinical practice, thrombocytopenia was detected in 2.7% of patients with cardiovascular disorders; and its frequency increased with worsening of the patients’ clinical state. Thrombocytopenia characterized by cytomorphological differences according to the clinical severity in cardiovascular patients. Received data suggest an inhibition of platelet production as a leading mechanism for platelet count reducing in critically ill patients with cardiovascular disorders.


Author(s):  
Joaquín Rodríguez Sánchez ◽  
Hugo Uchima Koecklin ◽  
Lucía González López ◽  
Miriam Cuatrecasas ◽  
Eva de la Santa Belda ◽  
...  

Author(s):  
Francesca Corzani ◽  
Carolina Cecchetti ◽  
Claudia Oriolo ◽  
Paola Altieri ◽  
Annamaria Perri ◽  
...  

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