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1.
Article | IMSEAR | ID: sea-216211

ABSTRACT

Purpose: To evaluate efficacy for an on-demand treatment of acute bleeding events, pharmacokinetics, safety, and tolerability of HemoRel-A® in severe hemophilia A. Methods: A total of 44 male subjects with severe hemophilia A with an annualized bleed rate of 12 while on-demand treatment with factor VIII (FVIII) were enrolled in the study and received HemoRel-A® for bleed treatment. The efficacy of HemoRel-A® was evaluated based on a four-point scale (excellent, good, moderate, or none). Six-point pharmacokinetic (PK) assessment was performed following a single dose of 50 IU/kg in 12 subjects after a 7-day wash-out period. Safety evaluations were performed at each visit and inhibitor testing was performed in all patients at screening and end of study. Results: Forty-four male subjects received at least a single dose of the study medication and were included in the intent-to-treat (ITT) analysis and safety outcome. In 23 (7.52%) out of the 306 bleeding events, HemoRel-A® efficacy was rated as excellent, in 272 (88.89 %) bleeds it was rated as good, and in 11 (3.68%) bleeding events it was rated as moderate. No failure of efficacy was noted in any of the bleeding events. Thus overall out of 306 bleeding events, 295 (96.41%) showed excellent or good efficacy. Pharmacokinetic assessment based on plasma FVIII activity measured by the chromogenic assay in 12 patients showed comparative results similar to FVIII preparations. A total of 12 adverse events (AEs) were reported in this study. There was no inhibitor development in this previously treated patients (PTP) cohort. Conclusion: HemoRel-A® was established to be efficacious and safe in the treatment of acute bleeding events in subjects with severe hemophilia A.

2.
Indian Heart J ; 2022 Feb; 74(1): 51-55
Article | IMSEAR | ID: sea-220954

ABSTRACT

Background: Covid-19 is multi-system viral infection caused by SARS-CoV-2 virus. Apart from having acute severe respiratory illness causing high mortality, the disease also has a variety of cardiovascular manifestations contributing to morbidity as well as mortality. Cardiac dysfunction and myocarditis are well established complications of Covid-19 as evident in multiple studies after the Covid-19 pandemic. However it is not sufficiently studied in Indian patients either by Echocardiography or by any other imaging modalities like cardiac magnetic resonance imaging (MRI). Methodology: In this study, we analysed the severity of Left ventricular(LV) dysfunction in Covid-19 survivors. A total of 100 consecutive patients of Covid-19 after one month of discharge who had no underlying cardiovascular diseases underwent echocardiography and global longitudinal strain (GLS) imaging. This study cohort included patients with mild 42 (42%),moderate 46(46%) and severe 12(12%) Covid-19 disease as defined by computerised tomography (CT) severity score. Result: We observed that total 36(36%) patients had reduced ejection fraction(EF) which included 11 patients having EF <40% and remaining 25(25%) having EF 40e50% (p<0.002). Also 22 (22%) patients had abnormal global longitudinal strain (GLS) values with normal ejection fraction which is suggestive of subclinical myocarditis. We observed LV dysfunction in 7(19.5%) patients who had severe Covid-19 while mild to moderate LV dysfunction observed in 29(80.5%) non critical patients. Conclusion: In conclusion our study demonstrates that myocardial dysfunction is common in covid-19 regardless of disease severity. 2D-echocardiography with GLS is likely to detect early LV dysfunction among these patients.

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