NEWS HIGHLIGHTSMedia Articles Related to Riastap (Fibrinogen Human)
AHA: Low Bleeding Rates Observed in Dabigatran Dose-Ranging Trial (CME/CE)
Source: MedPage Today Cardiovascular [2009.11.19]
ORLANDO (MedPage Today) -- The oral anticoagulant dabigatran did not appear to markedly increase major bleeding rates among post-MI patients who were already being treated with aspirin and clopidogrel (Plavix), researchers said here.
Xanodyne Announces FDA Approval Of Lysteda(TM) (Tranexamic Acid) For Treatment Of Women With Heavy Menstrual Bleeding
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.11.17]
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.
Alternative to Warfarin May Cut Risk of Bleeding
Source: MedicineNet Atrial Fibrillation Specialty [2009.11.16]
Title: Alternative to Warfarin May Cut Risk of Bleeding
Category: Health News
Created: 11/15/2009 4:10:00 PM
Last Editorial Review: 11/16/2009
FDA Approves Lysteda To Treat Heavy Menstrual Bleeding
Source: Endocrinology News From Medical News Today [2009.11.14]
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods.
Internal Bleeding
Source: MedicineNet Blood In Urine Specialty [2009.06.05]
Title: Internal Bleeding
Category: Diseases and Conditions
Created: 6/5/2009
Last Editorial Review: 6/5/2009
Published Studies Related to Riastap (Fibrinogen Human)
Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study. [2009.07]
It has been suggested that preoperative fibrinogen plasma concentration is independently associated to postoperative blood loss after cardiac surgery...
Role of fibrinogen-, factor VIII- and XIII-mediated clot propagation in gelatin haemodilution. [2009.07]
BACKGROUND: Gelatin solution impairs coagulation. The mechanism of coagulopathy is incompletely defined. The purpose of this study was to evaluate the capacity of single coagulation factors to reverse gelatin-promoted whole-blood coagulation disorders in vitro... CONCLUSIONS: Gelatin-induced whole-blood coagulation disorder in vitro is mainly dependent on the initial fibrinogen-fibrin interaction. The proposed mechanism might suggest not to reverse gelatin coagulopathy solely by fibrinogen administration. The administration of FFP, a mixture of different coagulation factors, reversed the gelatin-induced in vitro coagulopathy the best.
Antihypertensive pharmacogenetic effect of fibrinogen-beta variant -455G>A on cardiovascular disease, end-stage renal disease, and mortality: the GenHAT study. [2009.06]
OBJECTIVE: The FGB gene codes for fibrinogen-beta, a polypeptide of the coagulation factor fibrinogen, which is positively associated with cardiovascular diseases. Studies show that angiotensin-converting enzyme (ACE) inhibitors lower plasma fibrinogen concentrations, whereas diuretics and calcium-channel blockers do not. As carriers of the FGB-455 minor 'A' allele have higher levels of fibrinogen while ACE inhibitors lower it, we hypothesize that 'A' allele carriers benefit more from antihypertensive treatment with ACE inhibitors than calcium-channel blockers or diuretics, relative to 'GG' genotype individuals... CONCLUSION: There was evidence of pharmacogenetic effects of FGB-455 on stroke, ESRD, and mortality, suggesting that relative to those homozygous for the common allele, variant allele carriers of the FGB gene at position -455 have a better outcome if randomized to lisinopril than chlorthalidone (for mortality and ESRD) or amlodipine (for mortality and stroke). For the models in which a pharmacogenetic effect was observed, the outcome rates among 'GG' homozygotes were higher in those randomized to lisinopril versus amlodipine or chlorthalidone, whereas minor 'A' allele carriers had lower event rates when randomized to lisinopril versus the other medications.
Periodontal therapy reduces plasma levels of interleukin-6, C-reactive protein, and fibrinogen in patients with severe periodontitis and refractory arterial hypertension. [2009.05]
BACKGROUND: Recent epidemiologic studies suggest that inflammation is the link between periodontal diseases and cardiovascular complications. This study aimed to evaluate the effects of non-surgical periodontal treatment on plasma levels of inflammatory markers (interleukin [IL]-6, C-reactive protein [CRP], and fibrinogen) in patients with severe periodontitis and refractory arterial hypertension... CONCLUSION: Non-surgical periodontal therapy was effective in improving periodontal clinical data and in reducing the plasma levels of IL-6, CRP, and fibrinogen in hypertensive patients with severe periodontitis.
C-reactive protein and fibrinogen of bedridden older patients in a six-month vitamin D supplementation trial. [2009.05]
OBJECTIVE: To elucidate the association between vitamin D status, C-reactive protein (CRP) and fibrinogen. DESIGN: Secondary analysis of a randomised double-blind placebo controlled trial. SETTING: Four longterm care hospitals (1215 beds) in Helsinki, Finland. PARTICIPANTS: 218 long-term inpatients aged over 65 years. Intervention: Eligible patients (n = 218) were randomized to receive 0 IU/d, 400 IU/d, or 1200 IU/d cholecalciferol for six months... CONCLUSIONS: CRP concentrations are associated with bone turnover, but not with vitamin D status, and vitamin D supplementation has no major effect on CRP or fibrinogen concentrations in bedridden older patients.
Clinical Trials Related to Riastap (Fibrinogen Human)
Haemocomplettan® P During Aortic Replacement [Recruiting]
The primary purpose is to show that administration of Haemocomplettan® P significantly
reduces the amount of blood products needed during aortic surgery.
Fibrinogen Concentrate (Human) − Efficacy and Safety Study [Not yet recruiting]
This is a multinational, multicenter, prospective, open-label historically controlled Phase
IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate
(Human).
It is estimated that 150-300 patients in the U. S. suffer from afibrinogenemia. Substitution
with cryoprecipitate or alternative treatments have limited safety and efficacy.
The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen
Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma)
in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).
Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used
as a historical control.
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