Essentials The optimal dosing strategy of rivaroxaban for patients at the extremes of body weight is not known.A pharmacokinetic study was conducted based in real‐world patients in a London teaching hospital.In the cohort of patients studied, weight on its own did not impact significantly on rivaroxaban pharmacokinetics.A larger study with patients in the weight categories of interest from the real‐world population is required to further clarify the situation. BackgroundThere is concern amongst clinicians that the fixed dosing strategy of rivaroxaban for the treatment of venous thromboembolism (VTE) might not be optimal in those patients under or overweight.ObjectiveTo develop a pharmacokinetic model for rivaroxaban, based on real‐world patients, specifically focusing on the impact of patients’ body weight on rivaroxaban pharmacokinetics.Patients/methodsOne hundred and one patients prescribed rivaroxaban prophylactic or treatment doses for the prevention or treatment of VTE were recruited at a London teaching hospital. Subjects had up to 3 rivaroxaban concentrations measured during a single dosing period (trough, 1 and 3 hours post dose). Population pharmacokinetic analyses was conducted to develop a rivaroxaban model, which was subsequently evaluated.ResultsA one‐compartment model with between‐subject variability on rivaroxaban clearance and volume of distribution, with a combined (additive and proportional) error model, best fitted the data. Following a full covariate analysis, creatinine clearance on rivaroxaban clearance was found to be the significant covariate impacting on the pharmacokinetic profile of rivaroxaban in the dataset.ConclusionsOur results suggest that the most important covariate impacting on rivaroxaban pharmacokinetics is creatinine clearance and the weight alone has little effect. These findings are in line with previous studies for rivaroxaban. Larger datasets, from real‐world patients who are followed longitudinally, should be conducted to provide front‐line clinicians with further reassurance when prescribing rivaroxaban for the acute management of VTE.
We describe the use of Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) in the investigation and diagnosis of Charcot neuroarthropathy (CN) in patients with a hot swollen foot but normal radiographs and clinical suspicion of CN, usually termed Stage 0. This was a retrospective cohort review of 46 diabetes patients who underwent 3 phase bone scintigraphy with “High Resolution” SPECT/CT. The imaging demonstrated that Stage 0 Charcot foot has a distinct bone pathology, which can be classified into three groups: (1) fractures on Computed Tomography (CT) with accompanying focal uptake of tracer on SPECT, (2) bony abnormalities apart from fracture on CT with focal uptake of tracer on SPECT, and (3) normal CT but focal bony uptake of tracer on SPECT. The CT component of SPECT/CT detected bony fractures in 59% of patients. Early treatment with below knee cast and follow-up for 24 months showed only 4 patients who developed Stage 1 Eichenholtz Charcot foot. Our findings support the use of 3 phase bone scintigraphy with SPECT/CT in the characterization and early diagnosis of CN. Stage 0 Charcot foot has a distinct bone pathology which requires urgent treatment to prevent progression to Stage 1 Eichenholtz Charcot foot. If SPECT/CT is unavailable, CT alone will detect bone fracture in 59% patients.
The "diabetic foot attack" is one of the most devastating presentations of diabetic foot disease, typically presenting as an acutely inflamed foot with rapidly progressive skin and tissue necrosis, at times associated with significant systemic symptoms. Without intervention, it may escalate over hours to limb-threatening proportions and poses a high amputation risk. There are only best practice approaches but no international protocols to guide management. Immediate recognition of a typical infected diabetic foot attack, predominated by severe infection, with prompt surgical intervention to debride all infected tissue alongside broad-spectrum antibiotic therapy is vital to ensure both limb and patient survival. Postoperative access to multidisciplinary and advanced wound care therapies is also necessary. More subtle forms exist: these include the ischemic diabetic foot attack and, possibly, in a contemporary categorization, acute Charcot neuroarthropathy. To emphasize the importance of timely action especially in the infected and ischemic diabetic foot attack, we revisit the concept of "time is tissue" and draw parallels with advances in acute myocardial infarction and stroke care. At the moment, international protocols to guide management of severe diabetic foot presentations do not specifically use the term. However, we believe that it may help increase awareness of the urgent actions required in some situations.
We report the outcomes of 20 patients (12 men, 8 women, 21 feet) with Charcot neuro-arthropathy who underwent correction of deformities of the ankle and hindfoot using retrograde intramedullary nail arthrodesis. The mean age of the patients was 62.6 years (46 to 83); their mean BMI was 32.7 (15 to 47) and their median American Society of Anaesthetists score was 3 (2 to 4). All presented with severe deformities and 15 had chronic ulceration. All were treated with reconstructive surgery and seven underwent simultaneous midfoot fusion using a bolt, locking plate or a combination of both. At a mean follow-up of 26 months (8 to 54), limb salvage was achieved in all patients and 12 patients (80%) with ulceration achieved healing and all but one patient regained independent mobilisation. There was failure of fixation with a broken nail requiring revision surgery in one patient. Migration of distal locking screws occurred only when standard screws had been used but not with hydroxyapatite-coated screws. The mean American Academy of Orthopaedic Surgeons Foot and Ankle (AAOS-FAO) score improved from 50.7 (17 to 88) to 65.2 (22 to 88), (p = 0.015). The mean Short Form (SF)-36 Health Survey Physical Component Score improved from 25.2 (16.4 to 42.8) to 29.8 (17.7 to 44.2), (p = 0.003) and the mean Euroqol EQ‑5D‑5L score improved from 0.63 (0.51 to 0.78) to 0.67 (0.57 to 0.84), (p = 0.012). Single-stage correction of deformity using an intramedullary hindfoot arthrodesis nail is a good form of treatment for patients with severe Charcot hindfoot deformity, ulceration and instability provided a multidisciplinary care plan is delivered.
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