A Comparison of Efficacy Between Recombinant Activated Factor VII (ARYOSEVEN TM) and NOVOSEVEN® in Patients with Hereditary FVIII Deficiency with Inhibitor

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4299-4299 ◽  
Author(s):  
Mohammad Faranoush ◽  
Hassan Abolghassemi ◽  
Gh Toogeh ◽  
Mehran Karimi ◽  
Peyman Eshghi ◽  
...  

Abstract Introduction: Concentrated factor VIII replacement therapy in severe hemophilia prevents disabling arthropathy, life-threatening bleeding, improves health related quality of life and increase life expectancy. Patients with neutralizing antibodies (inhibitors) did not respond to usual doses of FVIII and they need higher doses of FVIII or bypassing agents (eg. rFVIIa, FEIBA) to control bleeding. The aim of this study was to compare the efficacy of a new biosimilar recombinant factor VIIa (Aryoseven ™) with Novoseven® in controlling bleeding episodes in hemophilia A patients with inhibitors. Methods: A randomized double blind clinical trial study was conducted in eight comprehensive hemophilia care centers in Iran. We randomized 66 male patients in two groups, with 4 consecutive block randomization when bleeding occurred. All patients entered the study with only one bleed. Informed consent signed by all patients or their parents. Group A (31 patients, 47%) received Aryoseven ™ and group B (35 patients, 53%) received Novoseven®. rFVIIa dosage was 90 -120 μg/kg intravenously every 2 hours. Results: During the study 66 patients (All male) were enrolled in two arms. The mean age was 20.5±10.9 years. Comparison of baseline data between the two showed no significant difference. The distributions of these variables were similar between the two groups. Other factors, such as vital signs, coagulation tests, liver, renal function tests, and blood count were not significantly different between the two groups. Median plasma level of FVII clotting activity (FVII: C) in group A and B was 103.8±38.4 IU/ dl and 98.6±26.7 IU/dl before injection respectively. Median plasma level of FVIII inhibitor in group A and B was 15.0 BU (IQR: 8.8-58.0) and 19.0 BU (IQR: 11.0-31.0). The average time from onset of bleeding to start treatment were 1246± 1104 and 2301 ± 1693 minutes (p = 0.311) in group A and B respectively. This study results showed that increased levels of factor VII were comparable between two groups after rFVIIa injection. A comparison of the Kavakli global response scores after injection and the treatment success rate in terms of achieving to score 6 or higher showed that both groups were comparable in treatment success rates. The global treatment response rate was 96.8% in group A and 91.4% in group B. Administration of either Aryoseven™ or Novoseven® had comparable effect on controlling pain and joint mobility. Reported side effects were minor (headache, nausea, and rash) and occurred in similar frequency. Discussion: The present study showed increased FVII levels and clinical efficacy in the control of the bleeding episodes in Hemophilia A patients with inhibitor for both drugs. Some similarities exist between our findings and the previous clinical trials designed for Novoseven®. In other studies, the treatment success rate by using the global response scoring system has been 70% -86% by different rFVIIa dosage regimen, in our study was above 90% in both treatment groups. In most studies, it was reported more than 90% achieving to cessation of bleeding at 9 hours after first injection of rFVIIa as response time which was also similar to our study. Conclusion: This study showed non-inferiority of Aryoseven ™ compared to Novoseven® in cessation of bleeding episodes in hemophilia A patients with inhibitor. There was no evidence of significant difference between the efficacy and safety of two drugs. There were no clinically meaningful differences between the biosimilar product and the original product in terms of the safety, purity, and efficacy. Biosimilar rFVIIa is effective in treatment of acute joint bleeding in patients with inhibitor in comparison to Novoseven®. Disclosures Mehrvar: Aryogen Zist Darou: Employment. Khoein:Aryogen Zist Darou: Employment. Kaymar:Aryogen Zist Darou: Employment. Mahbodi:Aryogen Zist Darou: Employment. Vaziri:Aryogen Zist Darou: Employment.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3181-3181
Author(s):  
Tom Knudsen ◽  
Peter Johansen ◽  
Jill Reckless ◽  
Shraddha Desai ◽  
Grant E. Blouse

Abstract Background: FVIII deficient knock-out (F8 -/-) rats mimic the bleeding incidents seen in severe human hemophilia A (HA). Subcutaneous (SQ) marzeptacog alfa activated (MarzAA), a novel, engineered recombinant activated coagulation Factor VII (rFVIIa) has been shown to effectively treat episodic bleeding in a pilot experiment in HA rats. This study evaluated the effect of single SQ doses of MarzAA and a single intravenous (IV) dose of rFVIIa on episodic bleeding in F8 -/- rats. Moreover, it compared the effect of SQ MarzAA and IV rFVIIa directly. Methods: Animals were allocated to treatment with either SQ vehicle, SQ MarzAA (60, 180 or 385 µg/kg) or IV rFVIIa (NovoSeven ®) (580 µg/kg) immediately after the bleeding was diagnosed. Doses were based on allometric scaling from humans (Nair AB and Jacob S. J Basic Clin Pharm 2016; 7: 27-31). The primary endpoint of the study was clinical efficacy as rated by a well-defined 4-point scale (Excellent, Good, Fair or Poor), and the efficacy assessment was either treatment success (Excellent or Good) or treatment failure (Fair or Poor) at the 24-hour timepoint. All personnel handling or assessing animals were blinded to the treatment status of each animal except those dosing animals who knew the route of administration. Results: A total of 86 F8 -/- rats was enrolled in the study. Of these, 61 rats presented treatment eligible bleeds between 3 and 10 weeks of age. No statistically significant difference in bleeding severity score were found across groups on diagnosis. As assessed by the clinical outcome at 24 hours, all three SQ MarzAA dose groups exhibited a statistically significant effect on treatment response when compared to SQ vehicle treatment (Figure 1). Conversely, no statistically significant effect could be identified when the single IV rFVIIa 580 µg/kg dose group was compared to vehicle. The overall treatment success rates at 24 hours were: SQ vehicle: 8%, SQ MarzAA 60 µg/kg: 58%, SQ MarzAA 180 µg/kg: 67%, SQ MarzAA 385 µg/kg: 85%, and IV rFVIIa 580 µg/kg: 33%. When compared directly using allometric scaling of clinical doses, SQ MarzAA at 385 µg/kg exhibited a statistically superior effect compared to IV rFVIIa at 580 µg/kg (p=0.0154, Fischer's exact test). Conclusion: Single doses of SQ MarzAA were effective in treating episodic bleeding in HA rats and statistically distinguishable from vehicle at all dose levels tested. When clinically relevant doses were compared directly to rFVIIa, SQ MarzAA compared favorably to IV rFVIIa. Taken together, these data provide robust nonclinical evidence that a single dose of SQ MarzAA may be successful in treating episodic bleeding when administered after bleeding has started. Figure 1 Figure 1. Disclosures Knudsen: Catalyst Biosciences: Current Employment, Current holder of individual stocks in a privately-held company. Blouse: Catalyst Biosciences: Current Employment.


2021 ◽  
Vol 17 (1) ◽  
pp. 69-74
Author(s):  
Harendra Kumar Jha ◽  
Tapan Kumar Dhali ◽  
Ritu Amatya

Introduction: Many treatments have been attempted in pityriasis versicolor with different reports of success. No direct comparative study between Ketoconazole 400 mg single dose against Ketoconazole 200 mg od for 5 days have been made earlier. The aim of this study was to study and compare the therapeutic efficacy of oral ketoconazole 400 mg single dose with oral ketoconazole 200 mg once daily for 5 days in pityriasis versicolor. Methods: This was a randomized controlled trial. Patients were randomized to receive either ketoconazole 400 mg single dose (group A) or ketoconazole 200 mg daily for 5 days (group B). Altogether 80 patients were taken, 40 in each group. Patients were assessed after 8 weeks and both clinical and mycological evaluation was done. The treatment success (mycological cure) was defined by a negative KOH at 8 weeks post treatment. Chi-square test was used to identify the significance of the variables. Results: The mycological cure at 8 weeks was 46% in group A and 74% in group B and the result was significant. No significant adverse event was noted in any of the groups. Conclusions: There was significant difference in the treatment outcome in both the groups. Ketoconazole 200 mg daily for 5 days had superior efficacy than ketoconazole 400 mg single dose. There was no significant difference in the adverse events.   Key words: Ketoconazole, Pityriasis versicolor


2019 ◽  
Vol 1 (4) ◽  
pp. 133-139
Author(s):  
Yasser Hamdy ◽  
Mohammed Mahmoud Mostafa ◽  
Ahmed Elminshawy

Background: Functional tricuspid valve regurgitation secondary to left-sided valve disease is common. DeVega repair is simple, but residual regurgitation with subsequent impairment of the right ventricular function is a concern. This study aims to compare tricuspid valve repair using DeVega vs. ring annuloplasty and their impact on the right ventricle in the early postoperative period and after six months. Methods: This is a prospective cohort study of 51 patients with rheumatic heart disease who underwent tricuspid valve repair for secondary severe tricuspid regurgitation. Patients were divided into two groups: group A; DeVega repair (n=34) and group B; ring annuloplasty repair (n=17). Patients were assessed clinically and by echocardiography before discharge and after six months for the degree of tricuspid regurgitation, right ventricular diameter and tricuspid annular plane systolic excursion (TAPSE). Results: Preoperative echocardiographic assessment showed no difference in left ventricular end-systolic diameter, end-diastolic diameter, ejection fraction and right ventricular diameter, however; group A had significantly better preoperative right ventricular function measured by TAPSE (1.96 ± 0.27 vs1.75 ± 0.31 cm; p=0.02). Group B had significantly longer cardiopulmonary bypass time (127.65 ± 13.56 vs. 111.74 ± 18.74 minutes; p= 0.003) and ischemic time (99.06 ± 11.80 vs. 87.15 ± 16.01 minutes; p= 0.009). Pre-discharge, there was no statistically significant difference in the degree of tricuspid regurgitation, but the right ventricular diameter was significantly lower in group B (2.66 ± 0.41 and 2.40 ± 0.48 cm; p=0.049). After six months of follow up, the degree of tricuspid regurgitation (p= 0.029) and the right ventricular diameter were significantly lower in the ring annuloplasty group (2.56 ± 0.39 and 2.29 ± 0.44 cm; p=0.029). Although there was a statistically significant difference in preoperative TAPSE, this difference disappeared after six months. Conclusion: Both DeVega and ring annuloplasty techniques were effective in the early postoperative period, ring annuloplasty was associated with lesser residual regurgitation and better right ventricular remodeling in severe functional tricuspid regurgitation than DeVega procedure after 6-months of follow up.


2020 ◽  
Vol 35 (3) ◽  
Author(s):  
Tayyaba Gul Malik ◽  
Hina Nadeem ◽  
Eiman Ayesha ◽  
Rabail Alam

Objective: To study the effect of short-term use of oral contraceptive pills on intra-ocular pressures of women of childbearing age.   Methods: It was a comparative observational study, conducted at Arif memorial teaching hospital and Allied hospital Faisalabad for a period of six months. Hundred female subjects were divided into two groups of 50 each. Group A, included females, who had been taking oral contraceptive pills (OCP) for more than 6 months and less than 36 months. Group B, included 50 age-matched controls, who had never used OCP. Ophthalmic and systemic history was taken. Careful Slit lamp examination was performed and intraocular pressures (IOP) were measured using Goldman Applanation tonometer. Fundus examination was done to rule out any posterior segment disease. After collection of data, we analyzed and compared the intra ocular pressures between the two groups by using ANOVA in SPSS version 21.   Results: Average duration of using OCP was 14.9 months. There was no significant difference of Cup to Disc ratios between the two groups (p= 0.109). However, significant difference was noted between the IOP of OCP group and controls. (p=0.000). Conclusion: OCP significantly increase IOP even when used for short time period.


Author(s):  
Rajendra Joshi ◽  
N. B. Mashetti ◽  
Rakesh Kumar Gujar

Dushta Vrana is a common and frequently encountered problem faced in surgical practice. The presence of Dushta Vrana worsens the condition of the patient with different complications and may become fatal. Local factors on wound like slough, infection and foreign body, affect the normal process of healing. A healthy wound in a normal body heals earlier with a minimum scar as compared to a contaminated wound. Therefore in this study all the efforts are made to make a Dushta Vrana into a Shuddha Vrana. Once the Vrana becomes Shuddha, Ropana of the Vrana will start. The objective of the study was to evaluate the clinical efficacy of Jatyadi Taila and Jatyadi Ghrita in Dushta Vrana. Clinically diagnosed 60 Patients of Dushta Vrana were randomly divided into two groups, each consisting of 30 Patients. Group A were treated with the Jatyadi Taila and Group B was treated by Jatyadi Ghrita. The results observed was based on the relief obtained on the subjective and objective parameters taken for consideration for this study viz, size of ulcer, discharge, smell, pain, burning sensation, itching and granulation were found significant (P Lass Than 0.05). On the basis of assessment criteria and overall result of treatment, the patients of Jatyadi Taila group showed better results when compared to Jatyadi Ghrita group. Even though statistically there is no much significant difference between the two groups, but by seeing the effect on individual parameters (subjective and objective) and over all response, Jatyadi Taila seems to be effective when compared to Jatyadi Ghrita. It is having more Ropana qualities when compared to Shodhana.


Author(s):  
Patil Aniket ◽  
Dindore Pallavi ◽  
Arbar Aziz ◽  
Kadam Avinash ◽  
Saroch Vikas

The quest for excellence in mental and physical health is not new. We find various references and formulations in Ayurvedic classics meant for promoting mental and physical health of a child. Suvarna Prashan is one of the formulations explained in age old Ayurvedic classic Kashyap Samhita. This formulation is very widely used now days as a memory and immune booster for children. But there is very little systematic documented study which can be used to evaluate the efficacy of the formulation. Suvarna Bhasma was prepared in Ayurved Rasayani Pharmacy, Pune. Madhu and Ghrita were collected from KLE Ayurveda Pharmacy, Belgaum. Suvarna Bindu Prashan was prepared in KLE Ayurved pharmacy, Belgaum. It contains Suvarna Bhasma, Ghrita and Madhu. Twenty apparently healthy male and female children with age group of three to four years were ready to sign inform consent form were selected into two groups each. Subjects in Group A received Suvarna Bindu Prashan where as Group B (Control group) did not receive any treatment. Both the groups were observed for six months. Children in Suvarna Bindu Prashan group showed significant reduction in the scores of eating habits, behavior, mood, temperament and scores of event of illness. However there was no significant difference in the score of sleeping habit. There was significant increase in IQ percentage.


Author(s):  
Mohamed I. Refaat ◽  
Amr K. Elsamman ◽  
Adham Rabea ◽  
Mohamed I. A. Hewaidy

Abstract Background The quest for better patient outcomes is driving to the development of minimally invasive spine surgical techniques. There are several evidences on the use of microsurgical decompression surgery for degenerative lumbar spine stenosis; however, few of these studies compared their outcomes with the traditional laminectomy technique. Objectives The aim of our study was to compare outcomes following microsurgical decompression via unilateral laminotomy for bilateral decompression (ULBD) of the spinal canal to the standard open laminectomy for cases with lumbar spinal stenosis. Subjects and methods Cases were divided in two groups. Group (A) cases were operated by conventional full laminectomy; Group (B) cases were operated by (ULBD) technique. Results from both groups were compared regarding duration of surgery, blood loss, perioperative complication, and postoperative outcome and patient satisfaction. Results There was no statistically significant difference between both groups regarding the improvement of visual pain analogue, while improvement of neurogenic claudication outcome score was significant in group (B) than group (A). Seventy-three percent of group (A) cases and 80% of group (B) stated that surgery met their expectations and were satisfied from the outcome. Conclusion Comparing ULBD with traditional laminectomy showed the efficacy of the minimally invasive technique in obtaining good surgical outcome and patient satisfaction. There was no statistically significant difference between both groups regarding the occurrence of complications The ULBD technique was found to respect the posterior spinal integrity and musculature, accompanied with less blood loss, shorter hospital stays, and shorter recovery periods than the open laminectomy technique.


Obesity Facts ◽  
2021 ◽  
pp. 1-9
Author(s):  
Serdar Sahin ◽  
Havva Sezer ◽  
Ebru Cicek ◽  
Yeliz Yagız Ozogul ◽  
Murat Yildirim ◽  
...  

<b><i>Introduction:</i></b> The aim of this was to describe the predictors of mortality related to COVID-19 infection and to evaluate the association between overweight, obesity, and clinical outcomes of COVID-19. <b><i>Methods:</i></b> We included the patients &#x3e;18 years of age, with at least one positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction. Patients were grouped according to body mass index values as normal weight &#x3c;25 kg/m<sup>2</sup> (Group A), overweight from 25 to &#x3c;30 kg/m<sup>2</sup> (Group B), Class I obesity 30 to &#x3c;35 kg/m<sup>2</sup> (Group C), and ≥35 kg/m<sup>2</sup> (Group D). Mortality, clinical outcomes, laboratory parameters, and comorbidities were compared among 4 groups. <b><i>Results:</i></b> There was no significant difference among study groups in terms of mortality. Noninvasive mechanical ventilation requirement was higher in group B and D than group A, while it was higher in Group D than Group C (Group B vs. Group A [<i>p</i> = 0.017], Group D vs. Group A [<i>p</i> = 0.001], and Group D vs. Group C [<i>p</i> = 0.016]). Lung involvement was less common in Group A, and presence of hypoxia was more common in Group D (Group B vs. Group A [<i>p</i> = 0.025], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> = 0.006], and Group D vs. Group C [<i>p</i> = 0.014]). The hospitalization rate was lower in Group A than in the other groups; in addition, patients in Group D have the highest rate of hospitalization (Group B vs. Group A [<i>p</i> &#x3c; 0.001], Group C vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group A [<i>p</i> &#x3c; 0.001], Group D vs. Group B [<i>p</i> &#x3c; 0.001], and Group D vs. Group C [<i>p</i> = 0.010]). <b><i>Conclusion:</i></b> COVID-19 patients with overweight and obesity presented with more severe clinical findings. Health-care providers should take into account that people living with overweight and obesity are at higher risk for COVID-19 and its complications.


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ben Xu ◽  
Si-da Cheng ◽  
Yi-ji Peng ◽  
Qian Zhang

Abstract Background To compare the functional and oncological outcomes between innovative “three-port” and traditional “four-port” laparoscopic radical prostatectomy (LRP) in patients with prostate cancer (PCa). Methods We retrospectively collected the data of PCa patients treated at our institutions from June 2012 to May 2016. According to the inclusion criteria, a total of 234 patients were included in the study, including 112 in group A (four-port) and 122 in group B (three-port). The perioperatively surgical characteristics, functional and oncological outcomes were compared between groups. Results There were no statistical differences in the baseline parameters between these two groups. Compared with group A, the operative time (OT) and estimated blood loss (EBL) were significantly less in group B. On follow-up, the rate of positive surgical margin (PSM), prostate specific antigen (PSA) biochemical recurrence and continence after LRP did not show any statistically significant difference between the groups. An identical conclusion was also received in comparison of overall survival (OS) and biochemical recurrence-free survival (BRFS) between both groups. Conclusions Innovative “three-port” LRP can significantly shorten the OT and reduce the EBL compared with the traditional “four-port” LRP. Meanwhile, it does not increase the rate of PSM and PSA biochemical recurrence. “Three-port” LRP could be popularized in the future in view of its superior surgical technique, considerably better functional outcomes and remarkable oncological control.


2021 ◽  
Vol 15 ◽  
pp. 175346662110042
Author(s):  
Xiaoke Shang ◽  
Yanggan Wang

Aims: The study aimed to compare and analyze the outcomes of high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV) in the treatment of patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation. Methods: A total 120 patients with AHRF were enrolled into this study. These patients underwent tracheal intubation and mechanical ventilation. They were organized into two groups according to the score of Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II); group A: APACHE II score <12; group B: 12⩽ APACHE II score <24. Group A had 72 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (36 patients in each subgroup). Group B had 48 patients and patients given HFNC were randomly assigned to subgroup I while patients given NPPV were assigned to subgroup II (24 patients in each subgroup). General information, respiratory parameters, endpoint event, and comorbidities of adverse effect were compared and analyzed between the two subgroups. Results: The incidence of abdominal distension was significantly higher in patients treated with NPPV than in those treated with HFNC in group A (19.44% versus 0, p = 0.005) and group B (25% versus 0, p = 0.009). There was no significant difference between the HFNC- and NPPV-treated patients in blood pH, oxygenation index, partial pressure of carbon dioxide, respiratory rate, and blood lactic acid concentration in either group ( p > 0.05). Occurrence rate of re-intubation within 72 h of extubation was slightly, but not significantly, higher in NPPV-treated patients ( p > 0.05). Conclusion: There was no significant difference between HFNC and NPPV in preventing respiratory failure in patients with AHRF with an APACHE II score <24 after extubation. However, HFNC was superior to NPPV with less incidence of abdominal distension. The reviews of this paper are available via the supplemental material section.


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