Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial

Hata, Kenichi; Kimura, Takahiro; Tsuzuki, Shunsuke; Ishii, Gen; Kido, Masahito; Yamamoto, Toshihiro; Sasaki, Hiroshi; Miki, Jun; Yamada, Hiroki; Furuta, Akira; Miki, Kenta; Egawa, Shin

doi:10.1111/iju.13189

Cited by 19 publications

(4 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These changes can lead to several postoperative complications, such as VTE and bleeding. It has been reported that VTE and bleeding at or greater than CD grade III after curative resection of primary colorectal cancer occurs at rates of 0 to 0.16% and 0.2 to 0.81%, respectively [22][23][24]. Compared with these data, in the present study, VTE and bleeding events more frequently occurred (Table 4).…”

Section: Discussioncontrasting

confidence: 44%

Impact of the preoperative prognostic nutritional index as a predictor for postoperative complications after resection of locally recurrent rectal cancer

Paku

Uemura

Kitakaze

et al. 2021

Preprint

View full text Add to dashboard Cite

Background Local recurrence is common after curative resections for rectal cancer. Surgical intervention is among the best treatment choices. However, achieving a negative resection margin often requires extensive pelvic organ resections; thus, the postoperative complication rate is quite high. Recent studies have reported that the inflammatory index could predict postoperative complications. This study aimed to validate the correlation between clinical factors, including inflammatory markers, and severe complications after surgery for local recurrent rectal cancer. Methods This retrospective study included 99 patients that underwent radical resections for local recurrences of rectal cancer. Postoperative complications were graded according to the Clavien-Dindo classification. Grades ≥ 3 were defined as severe complications. Risk factors for severe complications were identified with univariate and multivariate logistic regression models and assessed with receiver-operating characteristic curves. Results Severe postoperative complications occurred in 38 patients (38.4%). Analyses of correlations between inflammatory markers and severe postoperative complications revealed that the strongest correlation was found between the prognostic nutrition index and severe postoperative complications. The receiver-operating characteristic analysis showed that the optimal prognostic nutrition index cut-off value was 42.2 (sensitivity: 0.790, specificity: 0.508). In univariate and multivariate analyses, a prognostic nutrition index ≤ 44.2 (Odds ratio: 3.007, 95%CI:1.171–8.255, p = 0.02) and a blood loss ≥ 2850 mL (Odds ratio: 2.545, 95%CI: 1.044–6.367, p = 0.04) were associated with a significantly higher incidence of severe postoperative complications. Conclusions We found that a low preoperative prognostic nutrition index and excessive intraoperative blood loss were risk factors for severe complications after surgery for local recurrent rectal cancer.

show abstract

Section: Discussioncontrasting

confidence: 44%

Impact of the preoperative prognostic nutritional index as a predictor for postoperative complications after resection of locally recurrent rectal cancer

Paku

Uemura

Kitakaze

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…Moreover, there was no significant difference in the incidence of postoperative bleeding or other adverse events between the two groups. The results suggested that fondaparinux had good safety, supporting its prophylactic use after surgery for urinary malignancies ( Hata et al, 2016 ).…”

Section: Resultsmentioning

confidence: 92%

Unlocking the potential of fondaparinux: guideline for optimal usage and clinical suggestions (2023)

Yin,

Han,

Wang

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

Background: Thromboembolic disease is associated with a high rate of disability or death and gravely jeopardizes people’s health and places considerable financial pressure on society. The primary treatment for thromboembolic illness is anticoagulant medication. Fondaparinux, a parenteral anticoagulant medicine, is still used but is confusing due to its disparate domestic and international indications and lack of knowledge about its usage. Its off-label drug usage in therapeutic settings and irrational drug use are also common.Objective: The aim of this guideline is to enhance the judicious clinical application of fondaparinux by consolidating the findings of evidence-based research on the drug and offering superior clinical suggestions.Methods: Seventeen clinical questions were developed by 37 clinical pharmacy experts, and recommendations were formulated under the supervision of three methodologists. Through methodical literature searches and the use of recommendation, assessment, development and evaluation grading techniques, we gathered evidence.Results: This guideline culminated in 17 recommendations, including the use of fondaparinux for venous thromboembolism (VTE) prevention and treatment, perioperative surgical prophylaxis, specific diseases, special populations, bleeding and overdose management. For different types of VTE, we recommend first assessing thrombotic risk in hospitalized patients and then administering the drug according to the patient’s body mass. In surgical patients in the perioperative period, fondaparinux may be used for VTE prophylaxis, but postoperative use usually requires confirmation that adequate hemostasis has been achieved. Fondaparinux may be used for anticoagulation prophylaxis in patients hospitalized for oncological purposes, in patients with atrial fibrillation (AF) after resuscitation, in patients with cirrhosis combined with portal vein thrombosis (PVT), in patients with antiphospholipid syndrome (APS), and in patients with inflammatory bowel disease (IBD). Fondaparinux should be used with caution in special populations, such as pregnant female patients with a history of heparin-induced thrombocytopenia (HIT) or platelet counts less than 50 × 109/L, pregnant patients with a prethrombotic state (PTS) combined with recurrent spontaneous abortion (RSA), and children. For bleeding caused by fondaparinux, dialysis may partially remove the drug.Conclusion: The purpose of this guideline is to provide all healthcare providers with high-quality recommendations for the clinical use of fondaparinux and to improve the rational use of the drug in clinical practice. Currently, there is a lack of a dedicated antidote for the management of fondaparinux. The clinical investigation of activated prothrombin complex concentrate (APCC) or recombinant activated factor VII (rFⅦa) as potential reversal agents is still pending. This critical gap necessitates heightened scrutiny and research emphasis, potentially constituting a novel avenue for future inquiries into fondaparinux sodium. A meticulous examination of adverse events and safety profiles associated with the utilization of fondaparinux sodium will contribute significantly to a more comprehensive understanding of its inherent risks and benefits within the clinical milieu.

show abstract

“…While for several years the standard therapy of LMWH has been in use, the trend has been changing towards factor Xa inhibitors (fondaparinux) because of their selectivity in action [9]. Fondaparinux was the first approved drug among factor Xa inhibitors [10] and is a synthetic pentasaccharide that selectively binds to antithrombin, making it rapidly inhibit factor Xa, a key enzyme in the coagulation pathway [9][10][11][12][13][14][15][16][17][18]. Pharmacokinetic analysis suggested that fondaparinux has rapid and complete absorption and a longer half-life, resulting in 24-h coverage without crossreacting with heparin-induced antibodies, and no need for monitoring of platelet counts [9][10][11][12][13][14][15].…”

Section: Introductionmentioning

confidence: 99%

“…Several trials have shown the benefit-risk ratio of fondaparinux over enoxaparin in preventing VTE in various patient profiles. Much of the evidence was either generated from randomized or specific cohort studies, under controlled clinical conditions [4,6,[12][13][14][15]18]. Hence, it is important to re-evaluate the performance of fondaparinux under uncontrolled clinical conditions such as real-world settings.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study

Ramakrishna

Gupta

Pai

et al. 2021

Drugs - Real World Outcomes

View full text Add to dashboard Cite

Background Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. Objective To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. Methods Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. Results The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). Conclusions The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.

show abstract

Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial

Abstract: Fondaparinux is non-inferior to low molecular weight heparin with respect to risk of bleeding. The favorable safety profile of fondparinux supports its prophylactic use as an alternative to low molecular weight heparin after surgery for urological malignancy.

Cited by 19 publications

References 27 publications

Impact of the preoperative prognostic nutritional index as a predictor for postoperative complications after resection of locally recurrent rectal cancer

Impact of the preoperative prognostic nutritional index as a predictor for postoperative complications after resection of locally recurrent rectal cancer

Unlocking the potential of fondaparinux: guideline for optimal usage and clinical suggestions (2023)

Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study

Contact Info

Product

Resources

About