Abstract:
BACKGROUND AND OBJECTIVE:The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact® (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico. METHODS:This was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact® infusion. RESULTS:Information from 40 subjects was analyzed; 43% were women (n = 17), mean age was 39.05 ± 26.8 years (range 0-91 years). The medical specialties included in this analysis were cardiac surgery - 52.5% of the cases, gynecology/obstetrics - 17.5%, general surgery and orthopedics - 12.5% each, and hematology and neurosurgery - 2.5%, respectively. Mean plasma fibrinogen levels before and after Clottafact® infusion were 2.58 g/L and 4.02 g/L; p = 0.001, respectively. The mean Clottafact® dose was 2.20 ± 0.77 g. One patient presented SUSARs (dry mouth and dysgeusia) with drug administration, which ceased after treatment discontinuation. CONCLUSIONS:In this real-life post-marketing study, the safety profile of Clottafact® was very similar to previous reports. Thus, Clottafact® shows a favorable safety profile in clinical practice.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Colin-Bracamontes I,Pérez-Calatayud ÁA,Carrillo-Esper R,Rodríguez-Ayala E,Padilla-Molina M,Posadas-Nava A,Olvera-Vázquez S,Hernández-Salgado Ldoi
10.1007/s40261-020-00906-6subject
Has Abstractpub_date
2020-05-01 00:00:00pages
485-491issue
5eissn
1173-2563issn
1179-1918pii
10.1007/s40261-020-00906-6journal_volume
40pub_type
杂志文章abstract:BACKGROUND:Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β2-adrenoceptor agonist that has been approved in the EU for the treatment of chronic obstructive pulmonary disease (COPD). Ethnic differences may influence the pharmacokinetics and pharmacodynamics of a drug, and it is therefore important to com...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11586520-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-tre...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-018-0742-1
更新日期:2019-04-01 00:00:00
abstract:BACKGROUND:Urinary tract infection (UTI) is a leading cause of morbidity in the female population, with high levels of prevalence and recurrence within 6 months. OBJECTIVES:Our objective was to estimate annual costs and health resource utilization by women with UTIs, and the impact on quality of life (QoL) due to lowe...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0069-x
更新日期:2013-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:As compared with individual tablets, saxagliptin/metformin extended-release (XR) fixed-dose combination (FDC) tablets offer potential for increased patient compliance with the convenience of once-daily dosing. Two bioequivalence studies assessed the fed-state bioequivalence of saxagliptin/metf...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11590290-000000000-00000
更新日期:2011-01-01 00:00:00
abstract::The superior vena cava (SVC) syndrome occurs when obstruction of this vessel interrupts venous return of blood from the head, upper extremities and thorax to the right atrium. Most cases of SVC syndrome result from neoplasia, especially from lung cancer, but other non-cancer-associated causes may include fibrosis caus...
journal_title:Clinical drug investigation
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更新日期:2007-01-01 00:00:00
abstract::This review focuses on previously unpublished clinical and pharmacokinetic data with the diclofenac epolamine (diclofenac hydroxyethylpyrrolidine) patch supporting the hypothesis of a topical effect of this formulation. Previous studies have shown that 1 or 2 weeks of treatment with diclofenac epolamine provides pain ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/0044011-200929010-00001
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929050-00001
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abstract:BACKGROUND:Aliskiren is the first oral direct renin inhibitor to be approved for the treatment of hypertension. The pharmacokinetic and pharmacodynamic profile of aliskiren has been extensively characterized in Caucasian individuals; however, drug disposition, treatment response and tolerability can vary among ethnic g...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533050-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::The efficacy and tolerability of fluticasone aqueous nasal spray, 200µg once daily for 21 days, was compared with cetirizine, 10mg once daily for 21 days, in a multicentre, randomised, double-blind, double-dummy, parallel group study. 237 evaluable patients aged 12 years and above, with seasonal allergic rhinitis (def...
journal_title:Clinical drug investigation
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:In England, the uptake of direct oral anticoagulants (DOACs) for stroke prevention in atrial fibrillation has been slow and varied across different Clinical Commissioning Groups (CCGs). This study aimed to profile the prescribing of oral anticoagulants for stroke prevention in patients with atr...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00763-y
更新日期:2019-04-01 00:00:00
abstract::This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-017-0519-y
更新日期:2017-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Little is known about the effects of the calcium channel antagonist manidipine when it is added as a third drug in non-controlled hypertensive patients with diabetes mellitus receiving dual antihypertensive therapy. The aim of this study was to evaluate the response in terms of blood pressure (...
journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.2165/11587400-000000000-00000
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE AND DESIGN:There is comparatively little information on asthma management in China. A multicentre, randomised, open-label, parallel-group, 6-week treatment study was conducted to evaluate the efficacy and safety of salmeterol/fluticasone propionate combination treatment in Chinese adult asthmatic patients. S...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424100-00004
更新日期:2004-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11595860-000000000-00000
更新日期:2012-02-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200020020-00003
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:First-line bevacizumab-based therapy has been shown to improve outcomes in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The recent international phase IV SAiL study (a Study of Avastin [bevacizumab] in combination with platinum-containing chemotherapy in patients with...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-012-0001-9
更新日期:2012-11-01 00:00:00
abstract::HMG-CoA reductase inhibitors (statins) are highly effective drugs for prevention of cardiovascular events in high-risk patients. Due to the widespread prescription of these agents, special attention should be given to their rare adverse effects when these may have severe outcomes. Here, we report two cases of localize...
journal_title:Clinical drug investigation
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journal_title:Clinical drug investigation
pub_type: 杂志文章,meta分析
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更新日期:2018-08-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626100-00003
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200727060-00003
更新日期:2007-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
doi:10.1007/s40261-020-00965-9
更新日期:2020-11-01 00:00:00
abstract::Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall,...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0492-5
更新日期:2017-04-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-016-0463-2
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:Elderly patients are more susceptible to Clostridium difficile infections (CDIs). Despite existing guidelines, there is no specific treatment for CDI in geriatrics. Vancomycin is commonly used in the treatment of CDI. Teicoplanin is an alternative glycopeptide which recently received marketing authorization ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-017-0524-1
更新日期:2017-07-01 00:00:00
abstract:BACKGROUND AND AIM:Gastro-oesophageal reflux disease is a common medical problem that places a significant financial burden on outpatient pharmaceutical expenditure. A substantial proportion of this expenditure can be attributed to the use of proton pump inhibitors (PPIs). The aim of this analysis was to evaluate the c...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525050-00005
更新日期:2005-01-01 00:00:00
abstract::Sublingual buprenorphine [Subutex(R)] is used to treat opioid dependence. However, illicit intravenous (IV) injection of buprenorphine is a widespread problem. This survey investigated the IV misuse of buprenorphine among patients receiving drug replacement therapy at the Drug Addiction Centre in Udine, Italy. All pat...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/11536020-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Despite the availability of effective pain treatments, there are numerous barriers to effective management resulting in a large proportion of patients not achieving optimal pain control. Chronic pain is inadequately treated because of a combination of cultural, societal, educational, political and religious constraint...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11630040-000000000-00000
更新日期:2012-02-22 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Recently the PatenT (Prevalence, awareness, treatment and control of hypertension in Turkey) study showed that while the prevalence of hypertension in Turkey is high, effective control of BP is infrequently achieved. This study investigated the efficacy and safety of quinapril (as monotherapy o...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200727090-00003
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Phenylephrine HCl 10 mg has been used as a nasal decongestant for over 50 years, yet only limited pharmacokinetic and metabolic data are available. The purpose of this study was to evaluate single-dose pharmacokinetics and safety of phenylephrine HCl 10, 20, and 30 mg and to assess cardiovascu...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0311-9
更新日期:2015-09-01 00:00:00