scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

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. 

Information technology in the evaluation of RWD / RWE (Real-World Data / Real-World Evidence)

2021 ◽  
Author(s):  
OV Zhukova ◽  
AL Khokholov
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Clinical Practice ◽  
Clinical Efficacy ◽  
Real World ◽  
Information Technologies ◽  
Real World Data ◽  
Real World Evidence ◽  
Software Modules ◽  
Real Clinical Practice

The features of evaluating data from real clinical practice are discussed. Approaches to material processing for decision support in medicine and health care are also given. The development of standardized methods of analysis with the possibility of obtaining a unified indicator for assessing data from routine clinical practice, combined with the development of information technology is the direction of development of the concept of result-oriented health care. The classification of information technologies used in medicine and public health is presented. The main characteristics and functioning features of the developed software modules for automated data evaluation of real clinical practice are presented: a program for the distribution of drugs on the levels of clinical efficacy, a program to assess the effectiveness of therapy for the specified period; a program to determine the interval of clinical efficacy of drugs.

Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study

2017 ◽  
Vol 29 (4) ◽  
pp. 245-251 ◽  
Author(s):  
Alberto Russi ◽  
Vera Damuzzo ◽  
Marco Chiumente ◽  
Jacopo Pigozzo ◽  
Marco Cesca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Real World ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Multicenter Observational Study

The real-world benefit of novel androgen receptor-targeting agents (ARTA) before and after docetaxel in CRPC with bone metastases in Japan: A subanalysis of the PROSTAT-BSI, a prospective observational study before and after approval of novel ARTAs.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 43-43
Author(s):  
Atsushi Mizokami ◽  
Rie Fukuda ◽  
Taiki Kamijima ◽  
Kouji Izumi ◽  
Yoshifumi Kadono ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Hormonal Therapy ◽  
Real World ◽  
Prospective Observational Study ◽  
Favorable Effect ◽  
The Real ◽  
Significant Difference ◽  
Before And After ◽  
Psa Progression

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.

scholarly journals Efficacy and safety of the target-specific oral anticoagulants for stroke prevention in atrial fibrillation: the real-life evidence

2016 ◽  
Vol 8 (2) ◽  
pp. 67-75 ◽  
Author(s):  
Vincenzo Russo ◽  
Anna Rago ◽  
Riccardo Proietti ◽  
Federica Di Meo ◽  
Andrea Antonio Papa ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Real World ◽  
Stroke Prevention ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Thromboembolic Stroke ◽  
The Real ◽  
Concise Review ◽  
Real World Setting

The aim of our article is to provide a concise review for clinicians entailing the main studies that evaluated the efficacy and safety of target-specific oral anticoagulants (TSOAs) for thromboembolic stroke prevention in the real-world setting. Atrial fibrillation (AF) is one of the most common supraventricular arrhythmias that requires anticoagulation therapy to prevent stroke and systemic embolism. TSOAs, dabigatran, apixaban and rivaroxaban have become available as an alternative to warfarin anticoagulation in nonvalvular atrial fibrillation (NVAF). Randomized clinical trials showed non-inferior or superior results in efficacy and safety of the TSOAs compared with warfarin for stroke prevention in NVAF patients. For this reason, the 2012 update to the European Society of Cardiology guidelines for the management of AF recommends TSOAs as broadly preferable to vitamin K antagonists (VKAs) in the vast majority of patients with NVAF [Camm et al. 2012]. Although the clinical trial results and the guideline’s indications, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. Recently, a large number of studies testing the efficacy and the safety of TSOAs in clinical practice have been published. The aim of our article is to provide a concise review for clinicians, outlining the main studies that evaluated the efficacy and safety of TSOAs for thromboembolic stroke prevention in the real-world setting.

scholarly journals Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice

2021 ◽  
Vol 5 (4) ◽  
pp. 196-199
Author(s):  
M.V. Khruslov ◽  
◽  
A.S. Sorokina ◽  
Yu.A. Sapel'nikova ◽  
T.V. Vavilova ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Clinical Efficacy ◽  
Real World ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
Daily Group ◽  
Thrombotic Complications

Aim: to assess the efficacy and safety of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AFib) in real-world clinical practice. Patients and Methods: this non-interventional prospective study enrolled 356 patients aged 50-75 years with AFib and creatinine clearance ≥50 ml/min. All patients were divided into three age-matched groups based on DOACs prescribed. Group 1 patients (n=120) received rivaroxaban 20 mg daily. Group 2 patients (n=112) received dabigatran etexilate 150 mg twice daily. Group 3 patients (n=124) received apixaban 5 mg twice daily. The groups were comparable in comorbidities and the risks of thrombotic and hemorrhagic complications. Followup was 2 years after starting treatment. Thrombotic complications, massive bleedings, and death for any reason were considered end-points. Results: no significant differences in the rate of cardiogenic thrombotic complications between the groups were reported. In patients who received apixaban, fewer bleeding complications were diagnosed (insignificant differences). Conclusions: the efficacy and safety of DOACs in patients over 50 years are similar. KEYWORDS: atrial fibrillation, oral anticoagulants, thrombotic complications, infarction, stroke, bleedings. FOR CITATION: Khruslov M.V., Sorokina A.S., Sapel'nikova Yu.A., Vavilova T.V. Clinical efficacy and safety of direct oral anticoagulants in patients with atrial fibrillation in real-world clinical practice. Russian Medical Inquiry. 2021;5(4):196–199 (in Russ.). DOI: 10.32364/2587-6821-2021-5-4-196-199.

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
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Treatment Regime ◽  
The Real ◽  
Multicenter Prospective Observational Study ◽  
Real Clinical Practice

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.

Clinical Trials in Schizophrenia with Results for the Real World

CNS Spectrums ◽  
2006 ◽  
Vol 11 (S7) ◽  
pp. 9-13 ◽  
Author(s):  
Diana O. Perkins
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Real World ◽  
Clinical Decision Making ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Clinical Decision ◽  
Clinical Practices ◽  
Treatment Protocols ◽  
The Real

AbstractMost clinical data for antipsychotics come from studies designed to test the efficacy and safety of the drugs under ideal conditions, in limited subgroups of patients. In contrast, practical clinical trials (PCTs) are designed to test the effectiveness of different treatment options under conditions that more accurately reflect actual clinical practice. Consequently, PCTs are able to provide information that can be utilized by healthcare providers and other decision makers. Characteristics of PCTs include a clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest relevant effects, randomization to protect against bias, uncertainty regarding the outcome of treatment, assessment and treatment protocols that enact best clinical practices, simple and relevant outcomes, and limited subject and investigator burden. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) research program is an example of a PCT. The CATIE study illustrates how PCTs, when properly designed, might be helpful in informing clinical decision making. Because the CATIE study was designed to reflect the effectiveness of antipsychotics under naturalistic clinical conditions, its results should have particular applicability to the arena of clinical practice. This article provides a discussion of the differences between efficacy and effectiveness studies. In assessing the practical utility of results from the CATIE study, much can be learned on how to shape future studies of effectiveness so as to better generate data that are applicable to the “real world.”

Short-Term Evaluation of the Real-World Efficacy and Safety of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis: A Canadian Multicenter Retrospective Cohort Study

2020 ◽  
Vol 24 (5) ◽  
pp. 468-473
Author(s):  
Christine E. Jo ◽  
Jorge R. Georgakopoulos ◽  
Matthew Ladda ◽  
Arvin Ighani ◽  
Asfandyar Mufti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Clinical Practice ◽  
Real World ◽  
Treatment Options ◽  
The United States ◽  
Severe Atopic Dermatitis ◽  
Efficacy And Safety ◽  
Long Term Treatment ◽  
Tertiary Hospitals

Background Systemic therapy for atopic dermatitis (AD) has been challenging with limited safe and efficacious long-term treatment options. In 2017, dupilumab was approved in the United States, Europe, and Canada as the first targeted therapy for patients with moderate-to-severe AD. Despite promising efficacy and safety results in clinical trials, our understanding of dupilumab in clinical practice remains limited with few studies outside clinical trials in literature. Objective The aim of this study is to evaluate the efficacy and safety of dupilumab in clinical practice and discuss any differences in results between clinical trials and real-world results. Methods A retrospective chart review was conducted of consecutive patients receiving dupilumab treatment at two tertiary hospitals in Toronto, Canada, between December 2017 and May 2019. The primary efficacy endpoint was measured by Investigator’s Global Assessment (IGA) score of 0/1 at 16 weeks and all adverse events (AEs) experienced by patients were recorded. Results Of the 93 patients included in the study, 51 (55%) reached IGA 0/1 and 38 (41%) experienced ≥1 AE. There were no severe AEs or discontinuation prior to 16 weeks due to an AE. Conclusions These findings suggest a higher IGA-based efficacy profile with no newly identified safety concerns in patients treated with dupilumab at two tertiary hospitals in Toronto, Canada, compared to those in randomized controlled trials.

scholarly journals DABIGATRAN AND IDARUZIZUMAB. NEW OPPORTUNITIES FOR IMPROVING PATIENT SAFETY

2019 ◽  
pp. 53-61
Author(s):  
N. A. Novikova ◽  
A. N. Volovchenko ◽  
D. A. Parfenov
Keyword(s):  
Monoclonal Antibody ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Oral Anticoagulants ◽  
Medication Use ◽  
Antibody Fragment ◽  
Efficacy And Safety ◽  
Reversal Agent ◽  
Reversal Agents ◽  
Real Clinical Practice

The widespread use of new oral anticoagulants in clinical practice requires improving the safety of medication use, i.e. the use of specific reversal agents, if necessary. Idarucizumab, a humanied monoclonal antibody fragment, is the first reversal agent authorized in our country that binds to dabigatran. Its efficacy and safety have been validated in several clinical trials, and its use gains experience in real clinical practice.

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