scholarly journals DUAL ANTIPLATELET THERAPY IN THE REAL CLINICAL PRACTICE

2014 ◽  
Vol 10 (5) ◽  
pp. 500-504
Author(s):  
G. N. Guseva ◽  
T. V. Pavlova ◽  
I. L. Voronova ◽  
S. M. Chohlunov
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. 


Author(s):  
Andrew M Goldsweig ◽  
Paul Chan ◽  
Fengming Tang ◽  
Margaret Fang ◽  
David J Cohen ◽  
...  

Introduction: The CHARISMA trial for chronic cardiovascular disease (CVD) and the ACTIVE-W trial for atrial fibrillation (AF) demonstrated benefits of dual antiplatelet therapy with aspirin and clopidogrel (A+C) versus aspirin alone. We hypothesized that these trials caused increased prescription of A+C in clinical practice. Methods: We queried the ACC's PINNACLE Program for patients meeting inclusion criteria of the CHARISMA trial (CVD defined as CAD, angina, stroke/TIA, or PVD; excluded AF or PCI patients) or the ACTIVE-W trial (chronic AF, not prescribed warfarin). We determined the proportion of patients prescribed A+C therapy by quarter 9/08-12/09. A Poisson model was established for A+C prescription by patient-quarter. Results: We identified 80,583 patients meeting CHARISMA criteria and 20,245 patients meeting ACTIVE-W criteria. Prescription of A+C therapy for CVD patients meeting CHARISMA criteria increased during the study period from 15.3% to 25.1% (p<0.001). Prescription of A+C therapy for AF patients meeting ACTIVE-W criteria increased from 3.0% to 4.0% (p=0.029). In both groups, most of the increase occurred after Q2 2009, when ACTIVE-W was published. In the Poisson model, after adjustment for age, sex, and insurance status, the increased prescription rate ratios were 1.0736 (1.0644-1.0829, p<0.0001) for CVD patients and 1.0390 (0.9927-1.0875, p=0.1001) for AF patients; after separate adjustment for comorbidities, the rate ratios were 1.0811 (1.0719-1.0903, p<0.0001) and 1.0747 (1.0238-1.1232, p=0.0014) respectively. Conclusion: Following CHARISMA and ACTIVE-W, clinicians have increased prescription of AsC therapy for patients with CVD or AF.


Heart ◽  
2018 ◽  
Vol 104 (19) ◽  
pp. 1555-1556 ◽  
Author(s):  
Eunice N C Onwordi ◽  
William AE Parker ◽  
Robert F Storey

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