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Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients
Abolghasemi H, Panahi Y, Ahmadinejad M, Toogeh G, Karimi M, Eghbali A, Mirbehbahani NB, Dehdezi BK, Badiee Z, Hoorfar H, et al
Journal of Pharmacopuncture.. 2018;21((2)):76-81.
Abstract
Objective: This study compared the safety and efficacy of Safacto versus xyntha in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received Safacto and 16 patients received Xyntha for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in Safacto and Xyntha were 1.96+/-0.5 IU/dl and 1.63+/-0.5 IU/dl and increased to 88.84+/-25.2 IU/dl and 100.09+/-17.8 IU/dl, respectively (P<0.001). Pain score and range of motion improvement were 9.3+/-0.9 and 8.7+/-0.1 in Safacto (P=0.17); and 9.4+/-0.8 and 8.8+/-0.3 in Xyntha (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that Safacto has a favorable efficacy and safety profile.
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2.
A randomized trial of factor VIII and neutralizing antibodies in hemophilia A
Peyvandi F, Mannucci PM, Garagiola I, El-Beshlawy A, Elalfy M, Ramanan V, Eshghi P, Hanagavadi S, Varadarajan R, Karimi M, et al
The New England Journal of Medicine. 2016;374((21)):2054-64.
Abstract
BACKGROUND The development of neutralizing anti-factor VIII alloantibodies (inhibitors) in patients with severe hemophilia A may depend on the concentrate used for replacement therapy. METHODS We conducted a randomized trial to assess the incidence of factor VIII inhibitors among patients treated with plasma-derived factor VIII containing von Willebrand factor or recombinant factor VIII. Patients who met the eligibility criteria (male sex, age <6 years, severe hemophilia A, and no previous treatment with any factor VIII concentrate or only minimal treatment with blood components) were included from 42 sites. RESULTS Of 303 patients screened, 264 underwent randomization and 251 were analyzed. Inhibitors developed in 76 patients, 50 of whom had high-titer inhibitors (≥5 Bethesda units). Inhibitors developed in 29 of the 125 patients treated with plasma-derived factor VIII (20 patients had high-titer inhibitors) and in 47 of the 126 patients treated with recombinant factor VIII (30 patients had high-titer inhibitors). The cumulative incidence of all inhibitors was 26.8% (95% confidence interval [CI], 18.4 to 35.2) with plasma-derived factor VIII and 44.5% (95% CI, 34.7 to 54.3) with recombinant factor VIII; the cumulative incidence of high-titer inhibitors was 18.6% (95% CI, 11.2 to 26.0) and 28.4% (95% CI, 19.6 to 37.2), respectively. In Cox regression models for the primary end point of all inhibitors, recombinant factor VIII was associated with an 87% higher incidence than plasma-derived factor VIII (hazard ratio, 1.87; 95% CI, 1.17 to 2.96). This association did not change in multivariable analysis. For high-titer inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98). When the analysis was restricted to recombinant factor VIII products other than second-generation full-length recombinant factor VIII, effect estimates remained similar for all inhibitors (hazard ratio, 1.98; 95% CI, 0.99 to 3.97) and high-titer inhibitors (hazard ratio, 2.59; 95% CI, 1.11 to 6.00). CONCLUSIONS Patients treated with plasma-derived factor VIII containing von Willebrand factor had a lower incidence of inhibitors than those treated with recombinant factor VIII. (Funded by the Angelo Bianchi Bonomi Foundation and others; ClinicalTrials.gov number, NCT01064284; EudraCT number, 2009-011186-88.).
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3.
A comparison of efficacy between recombinant activated factor VII (Aryoseven) and Novoseven in patients with hereditary FVIII deficiency with inhibitor
Faranoush M, Abolghasemi H, Mahboudi F, Toogeh G, Karimi M, Eshghi P, Managhchi M, Hoorfar H, Dehdezi BK, Mehrvar A, et al
Clinical & Applied Thrombosis/Hemostasis. 2016;22((2)):184-90.
Abstract
INTRODUCTION This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors. METHODS Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 mug/kg intravenously every 2 hours. RESULTS Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 +/- 1104 minutes and in group B was 2301 +/- 1693 minutes (P = .311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable. CONCLUSION Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia.Copyright © The Author(s) 2014.
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Source of factor VIII replacement (PLASMATIC OR RECOMBINANT) and incidence of inhibitory alloantibodies in previously untreated patients with severe hemophilia a: the multicenter randomized sippet study
Peyvandi F, Mannucci PM, Garagiola I, Elalfy M, El-Beshlawy A, Ramanan MV, Eshghi P, Hanagavadi S, Varadarajan R, Karimi M, et al
Blood. 2015;126((23)): Abstract No. 5.
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A Comparison Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Congenital Factor VII Deficiency
Faranoush M, Abolghasemi H, Toogeh G, Karimi M, Eshghi P, Managhchi M, Hoorfar H, Dehdezi BK, Mehrvar A, Khoeiny B, et al
Clinical & Applied Thrombosis/Hemostasis. 2015;21((8)):724-8.
Abstract
In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 mug/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVIIcoagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy. Copyright © The Author(s) 2014.
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Comparing efficacy of three methods of tranexamic acid administration in reducing hemoglobin drop following total knee arthroplasty
Sarzaeem MM, Razi M, Kazemian G, Moghaddam ME, Rasi AM, Karimi M
Journal of Arthroplasty. 2014;29((8):):1521-4.
Abstract
The ideal method of providing tranexamic acid (TXA) for decreasing hemoglobin drop after TKA is still controversial. In this clinical trial, 200 patients were randomly allocated to four groups. In group 1, 500mg TXA was administered intravenously. In group 2, the joint irrigated with 3g of TXA in 100cc of saline. In group 3, 1.5g of TXA was injected through the drain. Group 4 did not take TXA. Albeit all methods had a statistical effect on hemoglobin drop, drainage and number of transfused units when compared to controls, but intravenous injection of TXA seems to be much more effective in terms of reducing hemoglobin drop and transfused units; and what's more TXA injection by drain is more effective regarding to reducing postoperative drainage. Copyright 2014 Elsevier Inc. All rights reserved.
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7.
A comparison of efficacy between recombinant activated factor VII (ARYOSEVEN TM) and NOVOSEVEN® in patients with hereditary FVIII deficiency with inhibitor
Faranoush M, Abolghassemi H, Toogeh G, Karimi M, Eshghi P, Managhchi M, Hoorfar H, Keikhaei DB, Mehrvar B, Khoein B, et al
Blood. 2014;124((21)): Abstract No. 4299
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Comparision of recombinant coagulation factor VII (ARYOSEVEN) with NOVOSEVEN in patients with FVIII & IX deficiency with an inhibitor
Faranoush M, Hassan A, Karimi M, Toogeh G, Eshghi P, Managchi MR, Hamid H, Kamyar K, Heshmat R, Baghaiepour MR
Journal of Thrombosis and Haemostasis. 2013;11((S2):):568. Abstract No. PB 1.50-6.
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The comparison of efficacy between recombinant activated factor VII (ARYOSEVEN) and NOVOSEVEN in patients with congenital factor VII deficiency
Faranoush M, Hassan A, Toogeh G, Karimi M, Eshghi P, Managchi MR, Hamid H, Kamyar K, Heshmat R, Keykhahi B
Journal of Thrombosis and Haemostasis. 2013;11((S2):):1198. Abstract No. PO 481.
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10.
Neuroprotective effects of erythropoietin in acute ischemic stroke
Asadi B, Askari GR, Khorvash F, Bagherpur A, Mehrabi F, Karimi M, Ghasemi M, Najjaran A
International Journal of Preventive Medicine. 2013;4((Suppl 2):):S306-12.
Abstract
BACKGROUND Ischemic brain strokes consisttwo-thirdsof strokesand their complications bear a lot of disability for patient and society. In this study, we seek for effect of Erythropoietin on ischemic brain stroke's outcomes according to National Institutes of Health Stroke Scale (NIHSS) changes. METHODS This study is a RCT (randomized clinical trial). All patients with focal neurologic deficit with primary suspicion of brain stroke undergone neuroimaging evaluations. After confirmation of new ischemic brain stroke, the patients with inclusion criteria'srandomized into two groups of cases and controls. NIHSS was defined for each patient and all patients received a routine treatment protocol. Erythropoietin 16,000 IU as a bolus intravenous dose was given to case patients as soon as neuroimaging study confirmed new ischemic stroke and continued as 8000 IU each 12 h up to total dose of 56,000 IU during 3 days. Patients re-evaluated at days 14 and 28 and NIHSS was assessed by another neurologist blinded to patient's group. Finally, NIHSS changes of both groups compared with each other's. RESULTS Evaluations revealed that in days14 and 28 during follow-up, Erythropoietin was effective in NIHSS (P= 0.0001). This effect was of value in level of consciousness Commands (P= 0.024), facial palsy (P= 0.003), motor arm (P= 0.0001), motor leg (P= 0.0001), sensory (P= 0.009), and best language (P= 0.023). CONCLUSIONS Administration of high-dose erythropoietin in first 24 h can be effective on reduction of ischemic stroke complication. A larger scale clinical trial is warranted.