Peak and baseline concentrations of fondaparinux during prophylactic therapy

Phlebologie ◽  
2011 ◽  
Vol 40 (04) ◽  
pp. 187-194 ◽  
Author(s):  
R. Kanagendran ◽  
J. Scheuermann ◽  
H. Ackermann ◽  
R. Kaufmann ◽  
W.-H. Boehncke ◽  
...  
Keyword(s):  
Inverse Correlation ◽  
Life Time ◽  
High Rate ◽  
Secondary Outcome ◽  
Bleeding Events ◽  
Skin Reactions ◽  
Venous Thromboembolic Events ◽  
Baseline Concentrations ◽  
Allergic Skin ◽  
Baseline Levels

SummaryFondaparinux is widely approved for prophylaxis and treatment of venous thromboembolic events (VTE). However, its longer half-life time compared to heparins limits its peri-procedural use. Aim: To investigate 3h peak and 24h baseline concentrations of fondaparinux when administered for prophylaxis (1 x 2.5 mg qd). Secondary outcome measures: incidences of VTE, bleedings, HIT, allergic skin reactions, 30 days mortality. Patients, methods: Between 02/2010 and 03/2011, 3h peak and 24h baseline levels of fondaparinux were measured with a chromogenic anti-FXa method in 75 consecutive patients. Medical data were obtained from patients' records. Results: The 5% and 95% percentile of the 3h peak level were 0.20 μg/ml and 0.83 μg/ml (median: 0.53 μg/ml), and of the 24h baseline level 0.08 μg/ml and 0.53 μg/ml (median 0.21 μg/ml), respectively. An inverse correlation was found between fondaparinux levels and GFRs (rho=-0.617 (3h); rho=-0.648 (24h); p=0.01). Shorter (≤5 days) or longer (≥8 days) duration of prior fondaparinux exposure showed no significantly different 3h peak/24h baseline levels (p>0.6). One progressive thrombosis occurred but no major bleedings, HIT, allergic skin reactions or fatalities. Conclusions: After fondaparinux exposure, >75% of the patients still had relevant prophylactic 24h baseline levels. This did not coincide with a high rate of bleeding events. Due to the low patient number in this study undergoing surgery or interventions, it remains to be investigated whether or at which concentrations the bleeding risk is increased when baseline levels are within prophylactic ranges.

scholarly journals Comparison of Anti-factor Xa Levels in Female and Male Patients with Obesity After Enoxaparin Application for Thromboprophylaxis

2022 ◽  
Author(s):  
Jonas Wagner ◽  
Henrike Wruck ◽  
Anne Lautenbach ◽  
Philipp von Kroge ◽  
Stefan Wolter ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Factor Xa ◽  
Secondary Outcome ◽  
Bleeding Events ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Male Patients ◽  
Group 2 ◽  
Reasonable Choice ◽  
Complications After Bariatric Surgery

Abstract Purpose Venous thromboembolic events (VTEs) are common complications after bariatric surgery, and enoxaparin is commonly used to prevent VTEs. The risk for VTEs is sex-specific. Whether enoxaparin application results in similar anti-factor Xa activities (aFXa) in males and females with obesity remains to be determined. We investigated whether our dosage regimen of enoxaparin resulted in similar serum aFXa levels in female and male patients undergoing bariatric surgery. Materials and Methods We administered enoxaparin twice daily in patients undergoing bariatric surgery. Patients with a body mass index (BMI) > 60 kg/m2 (n = 11) received 60 mg enoxaparin (group 2), and patients with lower BMI (n = 86) received 40 mg per dose (group 1). Peak aFXa levels were measured 3 days after surgery. The primary outcome was the aFXa level. As a secondary outcome, we detected VTEs and major bleeding events and explored the possible influencing factors of aFXa. Results Women had higher aFXa than men, but after matching for anthropometric values, the two groups were similar (females: 0.17 ± 0.08 U/ml; males: 0.18 ± 0.08 U/ml). Linear regression revealed a moderate relationship between weight and aFXa levels. The 3-month follow-up was attended by 94.9%, at which one patient had pulmonary embolism. Conclusion Individual enoxaparin dosage regimens for men and women do not seem to be required. Weight-based dosing regimen seems to be a more reasonable choice. Graphical abstract

scholarly journals Benefit and Harm of Extended Dual Antiplatelet Therapy After PCI in high-risk TWILIGHT-like patients with acute coronary syndrome

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
HY Wang ◽  
R Zhang ◽  
ZX Cai ◽  
KF Dou
Keyword(s):  
Acute Coronary Syndrome ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Cardiovascular Death ◽  
Secondary Outcome ◽  
Short Term ◽  
Bleeding Events ◽  
Coronary Syndrome

Abstract Funding Acknowledgements Type of funding sources: None. Background Recent emphasis on reduced duration and/or intensity of antiplatelet therapy following PCI irrespective of indication for PCI may fail to account for the substantial risk of subsequent nontarget lesion events in acute coronary syndrome (ACS) patients. This study sought to investigate the benefits and risks of extended-term (>12-month) DAPT as compared with short-term DAPT in high-risk "TWILIGHT-like" ACS patients undergoing PCI. Methods All consecutive patients fulfilling the "TWILIGHT-like" criteria undergoing PCI from January 2013 to December 2013 were identified from the prospective Fuwai PCI Registry. High-risk "TWILIGHT-like" patients were defined by at least 1 clinical and 1 angiographic feature based on TWILIGHT trial selection criteria. The present analysis evaluated 4,875 high-risk "TWILIGHT-like" patients with ACS who were event-free at 12 months after PCI. The primary outcome was the composite of all-cause death, myocardial infarction (MI), or stroke at 30 months while BARC type 2, 3, or 5 bleeding was key secondary outcome. Results Extended DAPT compared with shorter DAPT reduced the composite outcome of all-cause death, MI, or stroke by 63% (1.5% vs. 3.8%; HRadj: 0.374, 95% CI: 0.256 to 0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007 to 0.362) and that for MI 0.45 (0.153 to 1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9% vs. 1.3%; HRadj: 0.668 [0.379 to 1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly in patients treated with DAPT > 12-month or DAPT ≤ 12-month. The effect of long-term DAPT on primary and key secondary outcome across the proportion of ACS patients with 1-3, 4-5, or 6-9 risk factors showed a consistent manner (Pinteraction > 0.05). Conclusion Among high-risk "TWILIGHT-like" patients with ACS after PCI, long-term DAPT reduced ischemic events without increasing clinically meaningful bleeding events as compared with short-term DAPT, suggesting that extended DAPT might be considered in the treatment of ACS patients who present with a particularly higher risk for thrombotic complications. Abstract Figure.

scholarly journals Conservative Management of Medication-Related Osteonecrosis of the Jaws (MRONJ): A Retrospective Cohort Study

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 195
Author(s):  
Elena M. Varoni ◽  
Niccolò Lombardi ◽  
Giulio Villa ◽  
Alberto Pispero ◽  
Andrea Sardella ◽  
...  
Keyword(s):  
Conservative Management ◽  
Prognostic Score ◽  
Clinical History ◽  
Osteonecrosis Of The Jaw ◽  
Pharmacological Therapy ◽  
Complete Healing ◽  
High Rate ◽  
Secondary Outcome ◽  
Severe Side Effect

Background: Medication-related osteonecrosis of the jaw (MRONJ) is a severe side effect of bisphosphonates and anti-resorptive drugs prescribed for treatment of severe osteoporosis, Paget’s disease, and bone malignancies. The aim of this study was to evaluate the clinical outcome of a combined pharmacological and surgical management strategy on patients affected by MRONJ. Materials and methods: Medical records of patients with MRONJ were retrospectively examined to collect clinical history data. Conservative management included an initial pharmacological phase with antibiotics and antiseptic agents, followed by surgical intervention to remove bone sequestrum. Primary outcomes were healing from MRONJ at short term (1 month after surgery) and at longer term (3 months after surgery). Secondary outcome was assessment of recurrences at longer-term follow-up. Results: Thirty-five patients were included in the study with mean follow-up of 23.86 ± 18.14 months. Seven cases showed spontaneous exfoliation of necrotic bone during pharmacological therapy, which in one case did not require any further intervention. At 1-month posttreatment, 31 out of 35 (88.5%) patients showed complete healing. The 25 patients who were followed for at least 3 months revealed a healing rate of 92% (23/25). Recurrences occurred in 7 patients out 23 who showed the long-term healing, after a mean period of 7.29 ± 3.45 months. The prognostic score (University of Connecticut Osteonecrosis Numerical Scale—UCONNS) was significantly higher (p = 0.01) in patients with poor healing as compared to complete healing, both at 1 and 3 months posttreatment. Conclusions: A MRONJ treatment approach based on a combined pharmacological and surgical treatment strategy showed a high rate of healing and few recurrences.

scholarly journals Allergic Skin Reactions to Anticonvulsant Medications in Patients Receiving Cranial Radiation Therapy

Epilepsia ◽  
1999 ◽  
Vol 40 (3) ◽  
pp. 341-344 ◽  
Author(s):  
Harvey J. Mamon ◽  
Patrick Y. Wen ◽  
Anne C. Burns ◽  
Jay S. Loeffler
Keyword(s):  
Radiation Therapy ◽  
Skin Reactions ◽  
Cranial Radiation ◽  
Allergic Skin

Abstract 15502: Clinical Outcomes in Patients Undergoing Non-cardiac Surgery Within 1 Year of Pci

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Davide Cao ◽  
Matthew A Levin ◽  
Samantha Sartori ◽  
Anastasios Roumeliotis ◽  
Rishi Chandiramani ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Antiplatelet Therapy ◽  
Care Center ◽  
Tertiary Care ◽  
Coronary Intervention ◽  
Secondary Outcome ◽  
Cardiac Events ◽  
Bleeding Events ◽  
Target Vessel Revascularization ◽  
Increased Risk

Introduction: Perioperative cardiovascular events are an important cause of morbidity and mortality associated with non-cardiac surgery (NCS), especially in patients with recent percutaneous coronary intervention (PCI) who require dual antiplatelet therapy. Objective: To illustrate the types and timing of different noncardiac surgeries occurring within 1 year of PCI, and to evaluate the risk of thrombotic and bleeding events according to perioperative antiplatelet management. Methods: All patients undergoing NCS within 1 year of PCI at a tertiary-care center between 2011 and 2018 were included. The primary outcome was major adverse cardiac events (MACE; composite of death, myocardial infarction, stent thrombosis or target vessel revascularization). The key secondary outcome was major bleeding, defined as ≥2 units of blood transfusion. All outcomes were evaluated at 30 days after NCS. Results: A total of 1092 NCS (corresponding to 747 patients) were included and classified by surgical risk (low: 50.9%, intermediate: 38.4%, high: 10.7%) and priority (elective: 88.5%, urgent/emergent: 11.5%). High-risk and urgent/emergent surgeries tended to occur earlier post-PCI compared to low-risk and elective ones ( Figure-A ). The incidence of MACE and bleeding was time-dependent, with an increased risk in surgeries occurring in the first 6 months post-PCI ( Figure-B ). Perioperative antiplatelet cessation occurred in 487 (44.6%) NCS and was more likely for intermediate-risk procedures and after 6 months of PCI. There was no significant association between antiplatelet cessation and cardiac events. Conclusions: Among patients undergoing NCS within 1 year of PCI, the perioperative risk of MACE is inversely related to time from PCI. Preoperative interruption of antiplatelet therapy was observed in less than half of all cases and was not associated with an increased risk of cardiac events.

scholarly journals Vascular Complications in Patients with Hepatocellular Carcinoma Treated with Sorafenib

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2961 ◽  
Author(s):  
Katharina Pomej ◽  
Bernhard Scheiner ◽  
Dabin Park ◽  
David Bauer ◽  
Lorenz Balcar ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Cardiovascular Risk ◽  
Treatment Option ◽  
Multivariable Analysis ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Increased Risk ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic

VEGF(R)-targeted therapies are associated with an increased risk of thromboembolism and bleeding, which might be pronounced in patients with increased cardiovascular risk. Nevertheless, sorafenib represents an important treatment option in patients with hepatocellular carcinoma (HCC). We retrospectively investigated the risk of arterial/venous thromboembolic and bleeding events in 252 patients treated with sorafenib for HCC between 05/2006 and 03/2020 at the Medical University of Vienna. Cardiovascular risk was assessed using Framingham score. Eight patients (3.2%) experienced 11 arterial/venous thromboembolic events. Only two patients (0.8%) developed arterial thromboembolism even though cardiovascular risk was low, intermediate, and high in 15 (8.7%), 104 (60%), and 54 (31.2%) of 173 assessable patients. Median overall survival (OS) was shorter in the high risk vs. low/intermediate risk group 7.4 (95% CI: 3.4–11.3) vs. 10.0 (95% CI: 6.8–13.2 months) and independently associated with OS in multivariable analysis HR: 1.53 (95% CI: 1.07–2.19; p = 0.019). Forty-eight (19%) patients experienced a bleeding, most commonly gastrointestinal bleeding (14%) followed by epistaxis (4.7%). Advanced liver dysfunction was not associated with an increased incidence of bleeding/venous thromboembolism. Sorafenib represents a safe treatment option even in patients with increased cardiovascular risk. Bleeding complications were comparable with previous reports, even though patients with more advanced liver disease were included.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

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