scholarly journals Monitoring Tacrolimus Trough Concentrations During the First Year After Kidney Transplantation: A National Retrospective Cohort Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Sarah S. Alghanem ◽  
Moetaza M. Soliman ◽  
Ali A. Alibrahim ◽  
Osama Gheith ◽  
Ahmed S. Kenawy ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Side Effects ◽  
Trough Concentration ◽  
De Novo ◽  
Target Range ◽  
First Year ◽  
Trough Concentrations ◽  
Multifaceted Interventions ◽  
Hospital Protocol

Background: There is a lack of data in the literature on the evaluation of tacrolimus (TAC) dosage regimen and monitoring after kidney transplantation (KT) in Kuwait. The aim of the present study was to evaluate TAC dosing in relation to the hospital protocol, the achievement of target TAC trough concentration (C0), the prevalence of TAC side effects (SEs), namely, posttransplant diabetes mellitus (PTDM), denovo hypertension (HTN), and dyslipidemia, and factors associated with the occurrence of these SEs among KT recipients.Methods: A retrospective study was conducted among 298 KT recipients receiving TAC during the first year of PT. Descriptive and multivariate logistic regression analyses were used.Results: The initial TAC dosing as per the local hospital protocol was prescribed for 28.2% of patients. The proportion of patients who had C0 levels within the target range increased from 31.5 to 60.3% during week 1 through week 52. Among patients who did not have HTN, DM, or dyslipidemia before using TAC, 78.6, 35.2, and 51.9% of them were prescribed antihypertensive, antidiabetic, and antilipidemic medications during the follow-up period. Age of ≥40 years was significantly associated with the development of de novo HTN, dyslipidemia, and PTDM (p < 0.05). High TAC trough concentration/daily dose (C0/D) ratio was significantly associated with the development of PTDM (p < 0.05).Conclusion: Less than two-fifths of patients achieved target TAC C0 levels during the first month of PT. Side effects were more common in older patients. These findings warrant efforts to implement targeted multifaceted interventions to improve TAC prescribing and monitoring after KT.

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals P1761SIDE EFFECTS OF MTOR INHIBITORS DEPEND ON THE BASELINE METABOLIC STATUS OF KIDNEY TRANSPLANT RECIPIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
David Cucchiari ◽  
Alicia Molina-Andujar ◽  
Enrique Montagud-Marrahi ◽  
Jordi Rovira ◽  
Fritz Diekmann
Keyword(s):  
Kidney Transplantation ◽  
Side Effects ◽  
Kidney Transplant ◽  
De Novo ◽  
Mtor Inhibitors ◽  
Metabolic Status ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract Background and Aims Biologically, the cellular activity of the mTOR complexes depends on the balance between the catabolic and the anabolic inputs. Hence, we hypothesized that the metabolic side effects of mTOR inhibitors (mTORi) in kidney transplantation depend on the baseline metabolic status of the patient. Method The analysis included all the patients that have been transplanted in our Center between June 2013 to December 2016, completed one year of follow-up and did not change medication during the first year after kidney transplantation (per-protocol population, n=298). Outcomes chosen include de novo diabetes, 1-year difference from baseline in glycated hemoglobin (HbA1c), triglycerides and total cholesterol. Kidney transplant recipients were treated either with an mTORi (either Sirolimus or Everolimus, n=134) or Mycophenolic Acid (MPA, n=164). Both drugs were always accompanied by tacrolimus and steroids. Patients were stratified according to the treatment received (mTORi versus MPA) and the baseline metabolic status (diabetes mellitus type 2 and obesity). Differences among groups were analyzed with exact Fisher test and ANOVA test with LSD post-hoc analysis. Results We observed a strong difference for 1-year change in HbA1c depending on the baseline metabolic status of the patients (P&lt;0.001 between groups, Figure 1a). The worst results were observed for patients with baseline diabetes. Among these, obese patients treated with mTORi had the higher increase in HbA1c (3.04 ± 1.18% from baseline, P&lt;0.01 with all groups at post-hoc analysis). De-novo diabetes was more frequent in patients taking mTORi (23.4 vs. 13.1%), albeit not significantly (P=0.100) and without differences taking into account obesity as a covariate. Triglycerides increased substantially in patients without baseline diabetes and treated with mTORi (P&lt;0.05). Surprisingly, in diabetic patients no differences were observed in triglycerides between mTORi and MPA groups (Figure 1b). There were no differences in the increase in total cholesterol among groups (P=0.155) (Figure 1c). Conclusion We observed that the 1-year increase in HbA1c and triglycerides attributable to mTORi after kidney transplantation depends on the baseline metabolic status of the patients. We propose that the metabolic side effects of mTORi depend on the balance between anabolic and catabolic inputs of every kidney transplant recipient.

Long Term Follow Up of De Novo Use of mTOR Inhibitors (mTORi) After Kidney Transplantation.

2014 ◽  
Vol 98 ◽  
pp. 543-544 ◽  
Author(s):  
M. Paula ◽  
P. Hannun ◽  
C. Felipe ◽  
A. Ferreira ◽  
M. Cristelli ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
De Novo ◽  
Mtor Inhibitors ◽  
Long Term Follow Up

Management of antiangiogenics’ renovascular safety in ovarian cancer subgroup and intermediate results of the MARS study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5067-5067
Author(s):  
Vincent Launay-Vacher ◽  
Nicolas Janus ◽  
Joseph Gligorov ◽  
Frédéric Selle ◽  
Francois Goldwasser ◽  
...  
Keyword(s):  
Renal Function ◽  
Side Effects ◽  
Clinical Setting ◽  
De Novo ◽  
Treatment Withdrawal ◽  
French Society ◽  
Anti Vegf ◽  
Vegf Pathway ◽  
Grade 3

5067 Background: Anti-VEGF drugs (AVD) are widely used in cancer patients (pts). Hypertension (HTN) and proteinuria (Pu) are class-side-effects of AVD, related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Methods: Hypertension (HTN) and proteinuria (Pu) are class-side-effects of anti-VEGF drugs (AVD), related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Results: Among 77 OC pts been included, 38 completed the study to date (1-year follow-up (f/u)). Median age at inclusion (introduction of the AVD) was 62 years. Diabetes and HTN prevalences were 5.2% and 7.9%, respectively. Baseline renal assessment retrieved: Pu 13.2%, Hu 7.9%, mean aMDRD 80.9 ml/min/1.73m2 and 3 pts with aMDRD<60. The incidence of de novo Pu during f/u was 36.4% (Table). All pts with Pu at inclusion improved, except one. Among pts with de novo Pu, 58.3% afterwards improved/normalized. No Grade 3/4 Pu has been reported (at inclusion or during f/u) and no Hu. 17.1% developed HTN. In addition, a mean renal function decrease of -2.7 ml/min/1.73m2/year was observed and 4 pts had aMDRD<60 at the end of f/u. 36.4% had grade 1 SCr increase (median increase of 15.9%) No thrombotic micro-angiopathy (TMA) has been reported. Conclusions: The results of the MARS subgroup of OC pts shows that 1) TMA remains rare, 2) Pu develops in 36.4% of the pts, however with no Grade 3/4, 3) less than 20% developed HTN, and 4) renal function was not especially impaired. Furthermore, in case of a renovascular effect, investigators followed the recommendations from the French Society of Nephrology (Halimi JM et Al. Nephrol Ther 2008) and no treatment withdrawal for unmanageable renovascular toxicity occurred. [Table: see text]

Results of the MARS study on the management of antiangiogenics’ renovascular safety in breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e12504-e12504
Author(s):  
Joseph Gligorov ◽  
Nicolas Janus ◽  
Catherine Daniel ◽  
Philippe Beuzeboc ◽  
Isabelle Ray-Coquard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Renal Function ◽  
Side Effects ◽  
Prospective Observational Study ◽  
De Novo ◽  
Treatment Withdrawal ◽  
French Society ◽  
Vegf Pathway ◽  
Grade 3

e12504 Background: Anti-VEGF drugs (AVD) are widely used in cancer patients (pts). Hypertension (HTN) and proteinuria (Pu) are class-side-effects of AVD, related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Methods: This multicentric, prospective, observational study evaluated the renovascular safety of AVD in pts naive from any AVD, conducted in 7 centres in France, from 2009 to 2012, with a follow-up (f/u) of 1 year. Data collected included: gender, age, serum creatinine (SCr), diabetes, HTN, hematuria (Hu) and dipstick Pu, at baseline and at each visit. Results: 1,124 pts were included; 402 breast cancer (BC) pts received bevacizumab. Median age at inclusion was 55 years. Visceral, bone and cerebral metastasis frequencies were 74.7, 5.1 and 2.5%, respectively. HTN prevalences: 12.4%. Baseline renal assessment retrieved: Pu 23.9%, Hu 16.2%, mean aMDRD 96.4 ml/min/1.73m2 and 14 pts with aMDRD<60. The incidence of de novo Pu and HTN during f/u was 61.7 and 16.8% (Table). 69.7 % of pts with Pu at inclusion improved or remained stable. Among pts with de novo Pu, 75.7% afterwards improved/normalized. No grade 4 Pu has been reported. Renal function remained stable with a mean aMDRD of 96.2 at the end of f/u. 7.4% had grade 2-3 SCr increase (no grade 3-4). No thrombotic micro-angiopathy (TMA) was reported. Conclusions: These results on the renovascular safety of bevacizumab in BC patients showed that 1) TMA is rare, 2) Grade 3 Pu developed in 4.6% of pts, with no grade 4, 3) less than 17% developed HTN, and 4) aMDRD was stable. Furthermore, in case of a renovascular effect, investigators followed the recommendations from the French Society of Nephrology (Halimi JM. Nephrol Ther 2008) and no treatment withdrawal for unmanageable renovascular toxicity occurred. [Table: see text]

scholarly journals De-novo malignancies after kidney transplantation: A long-term observational study

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242805
Author(s):  
Felix A. Fröhlich ◽  
Fabian Halleck ◽  
Lukas Lehner ◽  
Eva V. Schrezenmeier ◽  
Marcel Naik ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
De Novo ◽  
Small Sample ◽  
Unknown Primary ◽  
Control Group ◽  
Long Term Outcome ◽  
Specific Mortality ◽  
Cancer Specific Mortality

Background De-novo malignancies after kidney transplantation represent one major cause for mortality after transplantation. However, most of the studies are limited due to small sample size, short follow-up or lack of information about cancer specific mortality. Methods This long-term retrospective analysis included all adult patients with complete follow-up that underwent kidney transplantation between 1995 and 2016 at our centre. All patients with diagnosis of malignancy excluding non-melanoma skin cancer (NMSC) were identified and a matched control group was assigned to the kidney transplant recipients with post-transplant malignancies. Results 1417 patients matched the inclusion criteria. 179 malignancies posttransplant were diagnosed in 154 patients (n = 21 with two, n = 2 patients with three different malignancies). Mean age at cancer diagnosis was 60.3±13.3 years. Overall incidence of de-novo malignancies except NMSC was 1% per year posttransplant. Renal cell carcinoma was the most common entity (n = 49, incidence 4.20 per 1000 patient years; cancer specific mortality 12%), followed by cancer of the gastro-intestinal tract (n = 30, 2.57; 50%), urinary system (n = 24, 2.06; 13%), respiratory system (n = 18, 1.54; 89%), female reproductive system (n = 15, 1.29; 13%), posttransplant lymphoproliferative disorders and haematological tumours (n = 14, 1.20; 21%), cancers of unknown primary (n = 7, 0.60 100%) and others (n = 22, 1.89; 27%). Male sex, re-transplantation and time on dialysis were associated with de-novo malignancies after transplantation. Conclusion De-novo malignancies continue to be a serious problem after kidney transplantation. To improve long-term outcome after Kidney transplantation, prevention and cancer screening should be more tailored and intensified.

scholarly journals P1634TIME-UPDATED SERUM CALCIUM AND PHOSPHATE ARE ASSOCIATED WITH GRAFT AND PATIENT OUTCOMES AFTER KIDNEY TRANSPLANTATION

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Willemijn Van der Plas ◽  
António W Gomes-Neto ◽  
Stefan P Berger ◽  
Schelto Kruijff ◽  
Stephan Bakker ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Patient Outcomes ◽  
Serum Calcium ◽  
First Year ◽  
Regression Analyses ◽  
Phosphate Homeostasis ◽  
Post Transplant ◽  
Increased Risk ◽  
The Relationship

Abstract Background and Aims Disturbances in calcium-phosphate homeostasis are common after kidney transplantation. The clinical implications of changes in calcium-phosphate homeostasis after transplantation are unclear. The aim of this study was to assess the relationship between time-updated serum calcium and phosphate levels and subsequent graft and patient outcomes. Method Kidney transplant recipients with ≥2 serum calcium and phosphate measurements were included from a large single-center cohort; only first transplants were considered. Patients with graft failure &lt;3 months were excluded, as were measurements obtained when eGFR was &lt;15 mL/min/1.73m2 or during intensive care unit admission. Normocalcemia was defined as (albumin-corrected) calcium between 2.20 and 2.60 mmol/L (8.8-10.4 mg/dL), and normophosphatemia as 0.70-1.50 mmol/L (2.17-4.64 mg/dL). Time-updated multivariable Cox regression analyses and time-updated restricted cubic splines analyses were performed to assess the relationship between post-KTx serum corrected calcium and phosphate levels and mortality and death-censored graft failure (DCGF). Final models were adjusted for recipient age, sex, BMI, eGFR, proteinuria, systolic BP (all time-updated), antihypertensive drug use, recipient CMV status, donor age, sex, and status (living or post-mortal), cold and warm ischemia times, HLA mismatches, primary kidney disease, and serum phosphate (in calcium analyses) or corrected calcium (in phosphate analyses). Results A total of 2,769 patients with 138,496 serum corrected calcium and phosphate levels post-KTx were included (median [IQR] 43 [31-61] measurements per patient). Mean age was 47 ± 14 yrs, 42.3% was female, and 19% underwent a pre-emptive transplantation. Hypercalcemia was more common in the first year (15%) and declined to ∼5% during long-term follow-up; hypocalcemia occurred in ∼10% throughout. Hypophosphatemia (24.3%) and hyperphosphatemia (15.5%) were particularly common during the first 30 days post-transplant, and stabilized at ∼10% and ∼5% after the first year. During median follow-up of 16.3 (8.7 – 25.2) years, 477 patients (17.2%) developed DCGF and 1050 (37.9%) patients died. In multivariable regression analyses, post-transplant hypocalcaemia was associated with an increased risk of DCGF (fully adjusted hazard ratio [HR] 2.01 [95% CI 1.61-2.50], P&lt;0.0001; Figure 1A), but not mortality (HR 1.06 [95% CI 0.88-1.27], P=0.55; Figure 1B). Post-transplant hypercalcaemia was associated with an increased risk of mortality (HR 1.77 [95% CI 1.44-2.17], P&lt;0.0001), but not DCGF (HR 0.79 [95% CI 0.48-1.32], P=0.37). Patients with post-KTx hyperphosphatemia were at increased risk of both DCGF (HR 37.12 [95% CI 30.33-45.42], P&lt;0.0001; Figure 1C) and mortality (HR 3.17 [95% CI 1.65-3.86], P&lt;0.0001; Figure 1D). Patients with hypophosphataemia had a lower risk of developing DCGF (HR 0.48 [95% CI 0.28-0.81], P&lt;0.01), but not mortality (HR 0.92 [95% CI 0.72-1.18], P=0.42). Similar results were obtained in sensitivity analyses in a subgroup with parathyroid hormone data available (N=1,412) or after exclusion of the highest and lowest 0.5% of calcium or phosphate levels. Conclusion Post-transplant hypocalcaemia and hyperphosphatemia are associated with an increased risk of DCGF, while hypophosphataemia was linked with a lower DCGF risk. Hypercalcaemia and hyperphosphataemia were associated with an increased mortality risk. These findings underline the relevance of keeping calcium and phosphate within normal range after kidney transplantation.

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