Unfractionated heparin infusion for treatment of venous thromboembolism based on actual body weight without dose capping

2019 ◽  
Vol 25 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Julia A Shlensky ◽  
Kristina M Thurber ◽  
John G O’Meara ◽  
Narith N Ou ◽  
Jennifer L Osborn ◽  
...  
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Actual Body ◽  
Unfractionated Heparin ◽  
Obese Group ◽  
Morbidly Obese ◽  
Actual Body Weight ◽  
Bleeding Events ◽  
Heparin Infusion ◽  
Significant Difference

Controversy exists regarding the use of dose capping of weight-based unfractionated heparin (UFH) infusions in obese and morbidly obese patients. The primary objective of this study was to compare time to first therapeutic activated partial thromboplastin time (aPTT) in hospitalized patients receiving UFH for acute venous thromboembolism (VTE) among three body mass index (BMI) cohorts: non-obese (< 30 kg/m2), obese (30–39.9 kg/m2), and morbidly obese (⩾ 40 kg/m2). In this single-center, retrospective cohort study, patients were included if they ⩾ 18 years of age, had a documented VTE, and were on an infusion of UFH for at least 24 hours. Weight-based UFH doses were calculated using actual body weight. A total of 423 patients met the inclusion criteria, with 230 (54.4%), 146 (34.5%), and 47 (11.1%) patients in the non-obese, obese, and morbidly obese cohorts, respectively. Median times to therapeutic aPTT were 16.4, 16.6, and 17.1 hours in each cohort. Within 24 hours, the cumulative incidence rates for therapeutic aPTT were 70.7% for the non-obese group, 69.9% for the obese group, and 61.7% for the morbidly obese group (obese vs non-obese: HR = 1.02, 95% CI: 0.82–1.26, p = 0.88; morbidly obese vs non-obese: HR = 0.87, 95% CI: 0.62–1.21, p = 0.41). There was no significant difference in major bleeding events between BMI groups (obese vs non-obese, p = 0.91; morbidly obese vs non-obese, p = 0.98). Based on our study, heparin dosing based on actual body weight without a dose cap is safe and effective.

scholarly journals Dosing and Pharmacokinetics of Polymyxin B in Patients with Renal Insufficiency

2016 ◽  
Vol 61 (1) ◽  
Author(s):  
Visanu Thamlikitkul ◽  
Yanina Dubrovskaya ◽  
Pooja Manchandani ◽  
Thundon Ngamprasertchai ◽  
Adhiratha Boonyasiri ◽  
...  
Keyword(s):  
Renal Function ◽  
Body Weight ◽  
Steady State ◽  
Renal Insufficiency ◽  
Actual Body ◽  
Normal Renal Function ◽  
Polymyxin B ◽  
Poor Correlation ◽  
Actual Body Weight ◽  
Significant Difference

ABSTRACT Polymyxin B remains the last-line treatment option for multidrug-resistant Gram-negative bacterial infections. Current U.S. Food and Drug Administration-approved prescribing information recommends that polymyxin B dosing should be adjusted according to the patient's renal function, despite studies that have shown poor correlation between creatinine and polymyxin B clearance. The objective of the present study was to determine whether steady-state polymyxin B exposures in patients with normal renal function were different from those in patients with renal insufficiency. Nineteen adult patients who received intravenous polymyxin B (1.5 to 2.5 mg/kg [actual body weight] daily) were included. To measure polymyxin B concentrations, serial blood samples were obtained from each patient after receiving polymyxin B for at least 48 h. The primary outcome was polymyxin B exposure at steady state, as reflected by the area under the concentration-time curve (AUC) over 24 h. Five patients had normal renal function (estimated creatinine clearance [CLCR] ≥ 80 ml/min) at baseline, whereas 14 had renal insufficiency (CLCR < 80 ml/min). The mean AUC of polymyxin B ± the standard deviation in the normal renal function cohort was 63.5 ± 16.6 mg·h/liter compared to 56.0 ± 17.5 mg·h/liter in the renal insufficiency cohort (P = 0.42). Adjusting the AUC for the daily dose (in mg/kg of actual body weight) did not result in a significant difference (28.6 ± 7.0 mg·h/liter versus 29.7 ± 11.2 mg·h/liter, P = 0.80). Polymyxin B exposures in patients with normal and impaired renal function after receiving standard dosing of polymyxin B were comparable. Polymyxin B dosing adjustment in patients with renal insufficiency should be reexamined.

Obesity Does Not Alter the Pharmacokinetics of Drotrecogin Alfa (Activated) in Severe Sepsis

2005 ◽  
Vol 39 (2) ◽  
pp. 262-267 ◽  
Author(s):  
Howard Levy ◽  
David Small ◽  
Darell E Heiselman ◽  
Richard Riker ◽  
Jay Steingrub ◽  
...  
Keyword(s):  
Body Weight ◽  
Severe Sepsis ◽  
Actual Body ◽  
Drotrecogin Alfa ◽  
Phase Iii ◽  
Actual Body Weight ◽  
Open Label ◽  
Risk Of Death ◽  
Drotrecogin Alfa Activated ◽  
Significant Difference

BACKGROUND: Drotrecogin alfa (activated) [DrotAA] is approved for the reduction of mortality in adults with severe sepsis (sepsis with acute organ dysfunction) and high risk of death. Patients whose actual body weight was >135 kg were excluded from the Phase III PROWESS trial. OBJECTIVE: To compare exposure to DrotAA in patients with severe sepsis weighing >135 kg with those weighing ⩽135 kg in an open-label, Phase IV trial, and quantify the elimination half-life (t1/2) of DrotAA in these patients. METHODS: PROWESS inclusion/exclusion criteria were used, except that patients >135 kg were enrolled. Blood samples were collected for steady-state plasma concentration (Css) analysis of activated protein C once each day and for t1/2 analysis after infusion. Weight-normalized clearance (Clp) and t1/2 estimates for DrotAA were calculated and compared between weight groups. RESULTS: Patient weight range was 59–227 kg. There were 32 patients ⩽135 kg and 20 patients >135 kg enrolled. Median Clp was 0.45 L/h/kg (interquartile range [IQR] 0.37–0.54) for patients ⩽135 kg and 0.42 L/h/kg (IQR 0.33–0.54) for patients >135 kg (p = 0.692). Median estimates of Css were 51.9 ng/mL (IQR 43.4–62.0) and 56.5 ng/mL (IQR 44.9–71.1; p = 0.570). In patients ⩽135 kg, DrotAA had a median t1/2 of 16.7 minutes (IQR 13.9–20.0) compared with 16.0 minutes (IQR 12.9–19.8) in patients >135 kg (p = 0.767), for a composite median t1/2 of 16.3 minutes (IQR 14.2–18.8). CONCLUSIONS: There is no statistically significant difference in Css concentrations or t1/2 of DrotAA between patients weighing ⩽135 kg and >135 kg. DrotAA should be dosed by actual body weight.

Edoxaban Versus Enoxaparin for the Prevention of Venous Thromboembolism: Pooled Analysis of Venous Thromboembolism and Bleeding From STARS E-3 and STARS J-V

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 208-208 ◽  
Author(s):  
Takeshi Fuji ◽  
Satoru Fujita ◽  
Shintaro Tachibana ◽  
Yohko Kawai
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Subgroup Analysis ◽  
Factor Xa ◽  
Pooled Analysis ◽  
Bleeding Events ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Patient Subgroups

Abstract Abstract 208 Introduction: Edoxaban is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Two randomized, double-blind, double-dummy, phase 3 studies (STARS E-3 and STARS J-V) have been conducted to evaluate the efficacy and safety of edoxaban compared with enoxaparin for the prevention of venous thromboembolism (VTE) after total knee (TKA) or hip arthroplasty (THA). The objective of this pooled analysis was to investigate the effects of edoxaban on VTE and bleeding in key subgroups. Methods: Patients (N=1326) undergoing TKA or THA in Japan and Taiwan were randomized to receive oral edoxaban 30 mg once daily (qd) or subcutaneous enoxaparin 2000 IU twice daily (bid, equivalent to 20 mg bid) for 11–14 days. Edoxaban was initiated 6–24 hours after surgery and enoxaparin was initiated 24–36 hours after surgery, which is the standard of care in Japan. The primary efficacy outcome was the composite of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). The principal safety outcome was the incidence of major and clinically relevant nonmajor (CRNM) bleeding. Results: A total of 1307 patients received at least 1 dose of edoxaban or enoxaparin. There were no clinically relevant differences in baseline characteristics between the treatment groups. The mean age was 68 years and mean body weight was 58.8 kg. Over 70% of patients received physiotherapy (intermittent pneumatic compression, elastic stocking). Overall, edoxaban significantly reduced the incidence of the composite of symptomatic and asymptomatic DVT and PE compared with enoxaparin (5.1% vs 10.7%, P<0.001). Subgroup analysis showed that edoxaban numerically reduced the incidence of the composite efficacy endpoint regardless of age or body weight. The effect was statistically significant in patients <75 years of age and in those <70 kg. Edoxaban was also significantly more effective than enoxaparin in the presence or absence of concomitant physiotherapy. The incidence of major and CRNM bleeding events was 4.6% vs 3.7% in the edoxaban and enoxaparin groups, respectively (P=0.427). Subgroup analysis of major and CRNM bleeding indicated no significant difference between edoxaban and enoxaparin in any of the patient subgroups evaluated, based on age, weight, or creatinine clearance. Conclusion: Edoxaban 30 mg qd is superior to enoxaparin 20 mg bid in the prevention of VTE events following TKA and THA without a statistically significant increase in bleeding in important patient subgroups likely to receive this treatment. Disclosures: Fuji: Daiichi Sankyo: Consultancy; Astellas: Consultancy; Showa Ikakogyo: Consultancy; Bayer: Consultancy. Fujita:Astellas: Consultancy; GlaxoSmithKline: Consultancy; Daiichi Sankyo: Consultancy; Bayer: Consultancy. Tachibana:Daiichi Sankyo: Consultancy. Kawai:Daiichi Sankyo: Consultancy; Toyama Chemical: Consultancy; Bayer: Consultancy.

Toxicity and effectiveness of carboplatin in obese or overweight patients

2018 ◽  
Vol 25 (6) ◽  
pp. 1328-1335 ◽  
Author(s):  
Cristina Grueso Cuesta ◽  
Jaime E Poquet Jornet ◽  
Juan M Gasent Blesa ◽  
Antonio Valdivia Perez ◽  
Francisco J Carrera Hueso ◽  
...  
Keyword(s):  
Overall Survival ◽  
Body Weight ◽  
Actual Body ◽  
Response Rate ◽  
Progression Free Survival ◽  
Normal Weight ◽  
Actual Body Weight ◽  
Free Survival ◽  
Significant Difference ◽  
Dose Reductions

Objective To evaluate the efficiency and toxicity of carboplatin using actual body weight in obese/overweight patients using the Calvert formula with Cockcroft–Gault for CrCl estimation. Methods We evaluated the association of BMI in regards to efficiency and toxicity in a retrospective cohort study of patients who started treatment with carboplatin between 2012 and 2013. Cohorts included obese/overweight patients and normal-weight patients. Efficiency was measured by overall survival, progression-free survival and response rate. Toxicity was measured by the proportion of dose reductions and delays of chemotherapy cycles. We utilized a bivariate and multivariate analysis. Results Eighty-six patients were included in the study (50% obese/overweight). There was not a statistically significant difference in effectiveness and toxicity between the two groups in BMI. In the multivariate analysis, BMI not was associated with overall survival (hazard ratio: 0.95, 95% CI: 0.54–1.66, p = 0.849), progression-free survival (hazard ratio: 0.91; 95% CI: 0.54–1.54; p = 0.732), cycle delays (odds ratio (OR): 1.47, 95% CI: 0.80–2.69, p = 0.218) or carboplatin dose reductions (OR: 0.87, 95% CI: 0.35–2.15, p = 0.760). Response rate was 53.5% in both groups. Conclusions In our study, obese and overweight cancer patients did not show a statistically significant difference in terms of effectiveness and toxicity compared to normal-weight cancer patients who were treated with carboplatin using their actual body weight with the Calvert formula and Cockcroft–Gault for CrCl estimation. Therefore, it was appropriate to use the actual body weight for our patients.

scholarly journals Daptomycin Dosing Based on Ideal Body Weight versus Actual Body Weight: Comparison of Clinical Outcomes

2013 ◽  
Vol 58 (1) ◽  
pp. 88-93 ◽  
Author(s):  
Jennifer K. Ng ◽  
Lucas T Schulz ◽  
Warren E. Rose ◽  
Barry C. Fox ◽  
David R. Andes ◽  
...  
Keyword(s):  
Body Weight ◽  
Actual Body ◽  
Clinical Success ◽  
Infection Type ◽  
Ideal Body Weight ◽  
Actual Body Weight ◽  
Success Rates ◽  
Content Type ◽  
Significant Difference ◽  
Ideal Body

ABSTRACTDaptomycin use at our institution changed to ideal body weight dosing based on a published analysis of pharmacokinetic-pharmacodynamic efficacy target attainment, bacterial ecology, and a desire to reduce drug toxicity. The current study compared outcomes between actual body weight and ideal body weight dosing of daptomycin before and after this intervention. In the evaluable group, 69 patients received doses based on actual body weight and 48 patients received doses based on ideal body weight. Patients were treated for documentedEnterococcusspecies,Staphylococcus aureus, or coagulase-negativeStaphylococcusinfections, including bloodstream, intraabdominal, skin and soft tissue, urinary, and bone. There was no statistically significant difference in clinical success between the groups (88.9% for actual body weight compared to 89.1% for ideal body weight,P= 0.97). After we adjusted for gender, age, body mass index, concomitant 3-hydroxy-3-methylglutaryl–coenzyme A reductase inhibitors, infection type, and organism type, clinical success rates remained similar between groups (adjusted odds ratio of 0.68 in favor of actual body weight, 95% confidence interval [CI] of 0.13 to 3.55). Microbiological outcomes, length of stay, mortality, and adverse effects were also similar between groups. Further studies are warranted to confirm that ideal body weight dosing provides similar outcomes to actual body weight dosing for all patients and types of infections and organisms.

scholarly journals Comparison of heparin dosing based on actual body weight in non-obese, obese and morbidly obese critically ill patients

2013 ◽  
Vol 3 (3) ◽  
pp. 195 ◽  
Author(s):  
AnthonyT Gerlach ◽  
Jerilynn Folino ◽  
CharlesH Cook ◽  
BenjaminN Morris ◽  
ClaireV Murphy ◽  
...  
Keyword(s):  
Body Weight ◽  
Actual Body ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Morbidly Obese ◽  
Actual Body Weight

Impact of Weight-Band Dosing of Tinzaparin for Venous Thromboembolism Prophylaxis on Persistent Wound Drainage in Adult Patients Undergoing Hip and Knee Arthroplasty

2021 ◽  
pp. 106002802110242
Author(s):  
Cassandra Cooper ◽  
Ouida Antle ◽  
Jennifer Lowerison ◽  
Deonne Dersch-Mills ◽  
Ashley Kenny
Keyword(s):  
Body Weight ◽  
Venous Thromboembolism ◽  
Knee Arthroplasty ◽  
Total Joint Arthroplasty ◽  
Joint Arthroplasty ◽  
Thromboembolism Prophylaxis ◽  
Wound Drainage ◽  
Increased Risk ◽  
Significant Difference ◽  
The Impact

Background: Persistent wound drainage and venous thromboembolism (VTE) are potential complications of total joint arthroplasty, and these risks can be challenging to balance in clinical practice. Anecdotal observation has suggested that following joint arthroplasty, persistent wound drainage occurs more frequently with higher body weight and higher doses of tinzaparin when compared with lower body weight and lower doses of tinzaparin. Objective: The overall purpose of this study was to describe the impact of a tinzaparin weight-band dosing table for VTE prophylaxis on wound healing, thrombosis, and bleeding outcomes in patients undergoing total joint arthroplasty. Methods: This retrospective chart review included patients who underwent total hip or knee arthroplasty and received tinzaparin for thromboprophylaxis per their weight-banding category. The primary outcome was the incidence of persistent wound drainage. Secondary outcomes include the occurrence of VTE and clinically important bleeding during hospital admission. Results: A total of 231 patients were included in the analysis. There was no significant difference in persistent wound drainage between the 3 weight categories, and there were no differences in rates of VTE or clinically important bleeding. Concurrent use of low-dose acetylsalicylic acid was associated with a 3-fold increased risk of persistent wound drainage (risk ratio = 3.35; 95% CI = 2.14-5.24; P = 0.00003). Conclusion and Relevance: In joint arthroplasty patients, we observed no significant difference in rates of persistent wound drainage between various weight categories receiving different weight-banded doses of tinzaparin. Our results do not suggest that the current weight-band dosing table for tinzaparin needs to be adjusted to optimize patient outcomes.

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