Assessment of the prevalence of burnout and well-being in solid organ transplant pharmacists.

BACKGROUND: Solid organ transplant (SOT) pharmacist burnout and well-being has not been described. METHODS: A survey of SOT pharmacists was distributed to transplant pharmacy organization listservs. Burnout was assessed with the full 22 item Maslach Burnout Inventory Human Services Survey for Medical Personnel (MBI-HSS-MP) and well-being was assessed with the Mayo Well-Being Index (WBI). Logistic multivariate regression was constructed to identify risk factors for a composite burnout assessment. RESULTS: In total, 230 responses were included (estimated response rate 36.2%). Survey participants were predominantly Caucasian (80.4%), female (79.1%), married/partnered (67.4%), and were within the first 5 years of practice (32.2%) as clinical pharmacist/specialists (87%). According to the MBI-HSS-MP, 63% met criteria for burnout. Comparing the groups with or without burnout, low quality of life (40.4% vs. 9.5%; P<.001), extreme fatigue (52.1% vs. 19%; P<.001), and likelihood of leaving the job for reasons other than retirement (38.5% vs. 10.7%; P<.001) were more common. The incidence of SOT pharmacists with WBI scores ≥ 5 (decreased well-being) was 26.5%. Among clinical pharmacists, risk factors for burnout included > 10 h per week of clinical duties outside of transplant (OR 2.669, P = .021) and extreme fatigue (OR 3.473, P<.001). CONCLUSIONS: Pharmacist burnout in SOT practice was similar to that reported in various pharmacy specialties (53-61%), which impacts clinical workforce retention and personal well-being.

Important considerations for drugs, nutritional, and herbal supplements in pediatric solid organ transplant recipients.

Pediatric transplant recipients are on multiple prescription and non-prescription drugs. Many patients also use dietary, nutritional, and herbal supplements. This manuscript researched formulations of immunosuppressive drugs currently available and presents information on generic immunosuppressive drugs, commonly used non-prescription medications, dietary supplements, and herbal supplements. Immunosuppressive drugs are available in various formulations. Not all formulations are interchangeable. A number of FDA-approved generic formulations are available commercially in the United States. Generally generic formulations produce similar blood concentration vs time profiles compared to brand name products in adults and are considered to be bioequivalent. NSAID should be avoided in transplant patients due to potential drug interactions and increased risk associated with NSAID use; and appropriate doses of acetaminophen should be used for treatment of pain. Over-the-counter medications, such as guaifenesin and dextromethorphan, antihistamine medications, including diphenhydramine, loratadine, cetirizine, and fexofenadine, can be safely used in pediatric solid organ transplant population. Many safe and effective over-the-counter options exist for stool softening and as laxative. Diarrhea can lead to an increase in calcineurin inhibitor levels. Food can alter the absorption of immunosuppressive drugs. Several herbal products can alter immune status of the patients or alter the blood concentration of immunosuppressive drugs or may produce renal or hepatic toxicities and should be avoided in pediatric transplant recipients. It is important to educate pediatric transplant recipients and their families about not only immunosuppressive drug therapy but also about non-prescription drugs, dietary, and herbal supplement use.

A seven-helix protein constitutes stress granules crucial for regulating translation during human-to-mosquito transmission of Plasmodium falciparum.

The complex life-cycle of the human malaria parasite Plasmodium falciparum requires a high degree of tight coordination allowing the parasite to adapt to changing environments. One of the major challenges for the parasite is the human-to-mosquito transmission, which starts with the differentiation of blood stage parasites into the transmissible gametocytes, followed by the rapid conversion of the gametocytes into gametes, once they are taken up by the blood-feeding Anopheles vector. In order to pre-adapt to this change of host, the gametocytes store transcripts in stress granules that encode proteins needed for parasite development in the mosquito. Here we report on a novel stress granule component, the seven-helix protein 7-Helix-1. The protein, a homolog of the human stress response regulator LanC-like 2, accumulates in stress granules of female gametocytes and interacts with ribonucleoproteins, such as CITH, DOZI, and PABP1. Malaria parasites lacking 7-Helix-1 are significantly impaired in female gametogenesis and thus transmission to the mosquito. Lack of 7-Helix-1 further leads to a deregulation of components required for protein synthesis. Consistently, inhibitors of translation could mimic the 7-Helix-1 loss-of-function phenotype. 7-Helix-1 forms a complex with the RNA-binding protein Puf2, a translational regulator of the female-specific antigen Pfs25, as well as with pfs25-coding mRNA. In accord, gametocytes deficient of 7-Helix-1 exhibit impaired Pfs25 synthesis. Our data demonstrate that 7-Helix-1 constitutes stress granules crucial for regulating the synthesis of proteins needed for life-cycle progression of Plasmodium in the mosquito vector.

Impact of a multidisciplinary multimodal opioid minimization initiative in kidney transplant recipients.

Opioid use after kidney transplant has been shown to be a risk factor for chronic opioid use, which leads to an increased risk of mortality. The purpose of this study was to evaluate the early impact of a multimodal pain regimen and education quality improvement program on opioid use after kidney transplant 2 months after implementation. This was a retrospective, single-center analysis of post-operative opioid use, comparing the average daily Morphine milligram equivalents (MME) of the patients who received education on opioids and a multimodal pain regimen (preoperative TAP/QL block, scheduled APAP and gabapentin) compared to a historical control group. Despite having no differences in pre-transplant opioid exposure, daily and overall inpatient opioid utilization was significantly reduced in the multimodal pain protocol cohort (38.6 vs 8.0 MME/day; P < .001); 5% of patients in the multimodal pain protocol cohort were discharged with an opioid prescription, compared to 96% of controls (P < .001). Our early results demonstrate that a multimodal pain protocol can effectively and dramatically reduce short-term opioid utilization in kidney transplant recipients.

Hospital admissions and emergency department visits among kidney transplant recipients.

Reducing acute care utilization is a means of improving long-term patient outcomes. We sought to assess high inpatient (IP) admission and standalone emergency department (ED) utilization within a 9-month period post-kidney transplantation and to identify mutable factors to reduce utilization. In this ten-year retrospective study, 1599 adult kidney transplant recipients were identified. A previous transplant, graft loss, or death within 3 months post-transplantation excluded 319 patients. Comprehensive resource utilization data were obtained from a statewide database. Those with ≥2 IP admissions or standalone ED visits 4-12 months post-transplantation were classified as high utilizers. Multivariable logistic regression models were used for examining associations of predictors with high IP or ED utilization. Of 1280 kidney recipients, 209 and 183 were categorized as IP and ED high utilizers, respectively. Factors significantly associated with high IP utilization included valvular disease, body mass index ≥35, and IP or ED use <3 months post-transplantation; while factors associated with high ED utilization included IP or ED use <3 months post-transplantation, younger age, female, smoker, congestive heart failure, depression, and IP or ED use 1 year pre-transplantation. Inpatient and standalone ED utilization within a 9-month period after kidney transplantation is high and associated with sociodemographic factors, mutable comorbidities, and healthcare utilization.

Protocol-based nurse coordinator management of ambulatory tacrolimus dosing in de novo renal transplant recipients-A single-center experience with a large African American population.

INTRODUCTION: Transplant nurse (RN) coordinators review tacrolimus levels frequently and would be capable of making dose adjustments autonomously if not limited by their license. Collaborative practice agreements could be an answer; thus, the aim of this evaluation was to determine if an RN-driven protocol could be used safely and effectively to manage tacrolimus in ambulatory kidney transplant (KTX) recipients. METHODS: This was a retrospective review of all solitary adult KTX recipients between August 1, 2016, and July 29, 2017. The primary objective was to evaluate protocol adherence and frequency of use, and secondary objectives were to evaluate the utility of the protocol both overall and based on ethnicity. RESULTS: A total of 173 patients were included in the evaluation (59% African American [AA], 41% non-African American [non-AA). RN coordinators followed the protocol for 75% of tacrolimus adjustments; however, they only responded to 27% of the overall levels. There was no difference in 180-day tacrolimus-associated readmission (15% AA vs 5% non-AA, P = .06), biopsy-proven acute rejection (4% AA vs 7% non-AA, P = .363), or hyperkalemia (34% AA vs 32% non-AA, P = .87) between groups. CONCLUSIONS: Transplant nurse coordinators are capable of accurately following a protocol for tacrolimus dosage adjustment in a large, racially diverse kidney transplant center.

The impact of time-varying clinical surrogates on disparities in African-American kidney transplant recipients - a retrospective longitudinal cohort study.

An improved understanding of the impact of clinical surrogates on disparities in African-American (AA) kidney transplantation (KTX) is needed. We conducted a 10-year retrospective longitudinal cohort study of electronically abstracted clinical data assessing the impact of surrogates on disparities in KTX. Clinical surrogates were assessed by posttransplant year (1, 2, 3 or 4) and defined as acute rejection (Banff ≥1A), mean SBP >140 mmHg, tacrolimus variability (CV) >40%, mean glucose >160 mg/dl and mean hemoglobin <10 g/dl. We utilized landmark methodology to minimize immortal time bias and logistic and survival regression to assess outcomes; 1610 KTX were assessed (54.2% AAs), with 1000, 468, 368 and 303 included in the year 1, 2, 3 and 4 complete case analyses, respectively. AAs had significantly higher odds of developing a clinical surrogate, which increased in posttransplant years three and four [OR year 1 1.99 (1.38-2.88), year 2 1.77 (1.20-2.62), year 3 2.35 (1.49-3.71), year 4 2.85 (1.72-4.70)]. Adjusting for the five clinical surrogates in survival models explained a significant portion of the higher risks of graft loss in AAs in post-transplant years three and four. Results suggest focusing efforts on improving late clinical surrogate management within AAs may help mitigate racial disparities in KTX.

Development and future deployment of a 5 years allograft survival model for kidney transplantation.

AIM: Identifying kidney transplant patients at highest risk for graft loss prior to loss may allow for effective interventions to improve 5 years survival. METHODS: We performed a 10 years retrospective cohort study of adult kidney transplant recipients (n = 1747). We acquired data from electronic health records, United Network of Organ Sharing, social determinants of health, natural language processing data extraction, and real-time capture of dynamically evolving clinical data obtained within 1 year of transplant; from which we developed a 5 years graft survival model. RESULTS: Total of 1439 met eligibility; 265 (18.4%) of them experienced graft loss by 5 years. Graft loss patients were characterized by: older age, being African-American, diabetic, unemployed, smokers, having marginal donor kidneys and cardiovascular comorbidities. Predictive dynamic variables included: low mean blood pressure, higher pulse pressures, higher heart rate, anaemia, lower estimated glomerular filtration rate peak, increased tacrolimus variability, rejection and readmissions. This Big Data analysis generated a 5 years graft loss model with an 82% predictive capacity, versus 66% using baseline United Network of Organ Sharing data alone. CONCLUSION: Our analysis yielded a 5 years graft loss model demonstrating superior predictive capacity compared with United Network of Organ Sharing data alone, allowing post-transplant individualized risk-assessed care prior to transitioning back to community care.

Renal Function Variability: An Independent Risk Factor for Graft Loss and Death following Kidney Transplantation.

BACKGROUND: Several studies have been performed to evaluate surrogate markers of long-term allograft function in renal transplant recipients. These include serum creatinine, estimated glomerular filtration rate (eGFR), slope of eGFR, and more recently eGFR variability. The aim of this study was to measure eGFR slope while assessing the variability of this slope and if high variability occurring at any time post-transplant was predictive of poorer long-term outcomes in a large cohort of kidney transplant recipients. METHODS: Adult solitary kidney transplant recipients transplanted between July 1, 2005 and July 31, 2015 were included. The primary outcome was time to graft loss, defined as return to chronic dialysis, retransplant, or death. Secondary outcomes were death-censored graft loss and acute allograft rejection. Cox regression was utilized for primary and secondary outcomes. Multivariate logistic regression was used to determine baseline factors predictive of high eGFR variability. RESULTS: A total of 1,543 patients were included in the analysis. The percentage of patients who experienced an eGFR coefficient of variation of <30% was 79.6% (1,229/1,543), while 20.4% (314/1,543) patients had high eGFR variability (≥30%). Patients with high eGFR variability tended to be younger, African-American and female. Those with higher eGFR variability, accounting for confounding and other eGFR measures (peak and slope), had significantly lower overall patient and graft survival. CONCLUSION: This study provides a novel analysis of the utility of eGFR variability in a large cohort. The clinical use of the slope of eGFR and eGFR variability may aid in predicting long-term graft outcomes and facilitate early patient discussions to change the trajectory of allograft function.

A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients.

BACKGROUND: There is a lack of conclusive evidence to suggest if calcineurin inhibitor (CNI) withdrawal or minimization with sirolimus is the best strategy for African Americans. METHODS: This was a randomized, prospective, open-label, pilot study comparing the two mammalian target of rapamycin (mTOR) transition strategies in adult African Americans between six and 24 wk post-transplant. The primary outcome was a comparison of the eGFR at one yr after conversion. RESULTS: Forty patients were randomized and analyzed in an intent-to-treat fashion. Median day of transition was day 96 (withdrawal) and 68 (minimization). Patients in the CNI-withdrawal group (n = 23) had significantly higher eGFR at one yr compared to the CNI-minimization group (n = 17, 73 vs. 56 mL/min, p = 0.03), as well as a significantly larger increase in eGFR from baseline (12 vs. 5 mL/min, p = 0.03). There were no differences in infections, acute rejection, death, or graft loss. Both regimens were constrained by disproportionately high discontinuation rates despite modest toxicity profiles. CONCLUSION: In spite of considerable withdrawal rate across both study arms, African American kidney transplant recipients who underwent early transition to a sirolimus-based CNI-withdrawal regimen had significantly better graft function at one yr compared to those transitioned to a sirolimus-based CNI-minimization regimen. Clinicaltrials.gov identifier: NCT01005706.

Predicting and preventing readmissions in kidney transplant recipients.

A lack of research exploring post-transplant process optimization to reduce readmissions and increasing readmission rates at our center from 2009 to 2013 led to this study, aimed at assessing the effect of patient and process factors on 30-d readmission rates after kidney transplantation. This was a retrospective case-control study in adult kidney transplant recipients. Univariate and multivariate analyses were utilized to assess patient and process determinants of 30-d readmissions. 384 patients were included; 30-d readmissions were significantly associated with graft loss and death (p = 0.001). Diabetes (p = 0.049), pharmacist identification of poor understanding or adherence, and prolonged time on hemodialysis prior to transplant were associated with an increased risk of 30-d readmissions. After controlling for risk factors, readmission rates were only independently predicted by pharmacist identification of patient lack of understanding or adherence regarding post-transplant medications and dialysis exposure for more than three yr (OR 2.3, 95% CI 1.10-4.71, p = 0.026 and OR 2.1, 95% CI 1.22, 3.70, respectively), both of which were significantly modified by history of diabetes. Thirty-d readmissions are attributable to both patient and process-level factors. These data suggest that a lack of post-transplant medication knowledge in high-risk patients drives early hospital readmission.

Incidence, risk factors, and outcomes of opportunistic infections in pediatric renal transplant recipients.

OIs present significant risks to patients following solid organ transplantation. The purpose of this study was to identify risk factors for the development of OIs after kidney transplantation in pediatric patients and to evaluate the impact of OIs on outcomes in this patient population. A single-center retrospective longitudinal cohort analysis including pediatric patients 21 yr of age or younger transplanted from July 1999 to June 2013 at an academic medical center was conducted. Patients were excluded if they received multi-organ transplant. A total of 175 patients were included in the study. Patients who developed OIs were more likely to be female and younger at the time of transplant. A six-factor risk model for OI development was developed. Death, disease recurrence, and PTLD development were similar between groups but trended toward increased incidence in the OI group. Incidence of rejection was significantly higher in the OI group (p = 0.04). Patients who developed OIs had several important risk factors, including younger age, EBV-negative serostatus, CMV donor (+)/recipient (-), biopsy-proven acute rejection, ANC <1000, MMF dose >500 mg/m(2), and any infection. Incidence of rejection was higher in the OI group, but rate of graft loss was not statistically different.

Depression, Resource Utilization, and Outcomes Following Liver Transplant.

CONTEXT: There is evidence that depression after liver transplant (LTX) is associated with increased morbidity and mortality; however, the effect of depression treatment on LTX outcomes has not been well established. OBJECTIVE/SETTING/DESIGN: This single-center, longitudinal cohort study aimed to determine whether depression treatment influences outcomes after LTX. Depression diagnosis was based on medical history and documentation from psychosocial providers. PATIENTS/INTERVENTION/MAIN OUTCOME MEASURES: Patients were studied from October 2010 to June 2013 and separated into 3 groups for analysis: no depression, adequately treated depression, and inadequately treated depression. Adequacy of depression treatment was determined using the Antidepressant Treatment History Form. RESULTS: Of the 161 patients included in the analysis, 103 did not have depression, 24 had adequately treated depression, and 34 had inadequately treated depression. Baseline demographics were similar between the groups. Patients with inadequately treated depression had significantly more encounters with a health-care provider (P = .03). Graft loss tended to be higher in these patients (27% in the inadequately treated group, 17% in the adequately treated, and 14% in the no depression group, P = .25). The adequately treated group was more likely than the inadequately treated group to be on antidepressants at 30 days post-LTX (P = .001). The inadequately treated group was more likely to be on a sleep aid 30 days post-LTX (P = .01). CONCLUSION: Inadequately treated depression led to increased health-care resource utilization. Patients with adequately treated depression had similar outcomes as those with no depression. Use of sleep aids early post-LTX may be a surrogate indicator of inadequately treated depression.

Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients.

BACKGROUND: One primary purpose of transplant is to improve quality of life (QOL) in renal transplant recipients (RTRs) ≥ 50 yr of age, where death with a functioning graft limits life years gained. We aimed to determine the impact of induction therapy, with its subsequent effects on rejection, infection, and readmissions, on QOL. METHODS: Subanalysis of patients ≥ 50 yr of age that participated in a single-center, prospective, risk-stratified, randomized, open-label study. Two hundred RTRs ≥ 50 yr of age. INTERVENTIONS: All patients received either rabbit antithymocyte globulin (rATG) or interleukin 2 receptor antagonists (IL-2RA) in addition to tacrolimus (FK), mycophenolate mofetil (MMF), and corticosteroids in a randomized fashion. Outcome analyses included safety, efficacy, and QOL. RESULTS: Results reported 1 yr post-transplant. Of 111 patients ≥ 50 yr old, 48 received IL-2RA and 63 received rATG. Baseline characteristics were similar between groups. Patients that received rATG had a trend toward lower acute rejection rates, fewer readmissions, and fewer supratherapeutic tacrolimus troughs, with similar rates of infections. QOL analysis demonstrated patients that received rATG were significantly more likely to have improvements in physical and social functioning after transplant. CONCLUSIONS: Contrary to the common practice, T-cell depletion in recipients ≥ 50 yr of age may be beneficial.

Cardiovascular risk factors contribute to disparities in graft outcomes in African American renal transplant recipients: a retrospective analysis.

Data examining cardiovascular (CV) risk factors in renal transplant recipients (RTRs) and their contribution to the disparity in graft survival between African American (AA) patients and non-AAs is limited. A single-center, retrospective analysis of 1003 adult RTRs from January 1, 2000 to May 1, 2008 to inspect the impact of race on post-transplant CV events, treatment of CV risk factors and their independent influence on graft outcomes was performed. AAs experienced a higher incidence of late graft loss, with 1- and 5-year graft survival rates of 93% and 76% vs 95% and 84% in the non-AA group, respectively. AA patients had a higher prevalence of hypertension (HTN) and diabetes mellitus (DM) and demonstrated reduced control of DM post-transplant (AA 74% vs non-AA 82%, p = 0.053). Multivariate analysis for graft survival indicated acute rejection, delayed graft function (DGF) and incidence of CV events were significant risk factors for graft failure, while the use of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) and 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were protective. In conclusion, after controlling for CV risk factors and events, race did not have an independent effect on outcomes, suggesting CV risk factors and events contribute to this disparity. Clinical summary. AAs experienced a higher rate of graft failure and CV events; after adjusting for multiple immunological and CV risk factors, race no longer remained an independent risk factor for post-transplant CV events or graft failure; although disparities in post-transplant outcomes remain, race alone does not account for the disparity; the racial disparity is due to the higher incidence of DGF and acute rejection, as well as traditional CV risk factors, including HTN and DM.

Optimizing finite resources: Pharmacist chart reviews in an outpatient kidney transplant clinic.

OBJECTIVE: To determine if a pharmacist-executed comprehensive chart review could serve as sufficient substitution for direct participation during outpatient clinic visits in the postdischarge follow-up treatment of kidney transplant recipients. DESIGN: Retrospective, longitudinal, cross-sectional study. SETTING: Acute and chronic transplant clinics at the Medical University of South Carolina, Charleston, SC. PARTICIPANTS: 219 individual kidney transplant recipients. MAIN OUTCOME MEASURES: Effectiveness of chart review assessments (with written notes) as compared with in-clinic assessments (with verbal communication with transplant providers followed by documentation by pharmacists). An independent transplant provider graded pharmacist recommendations by severity. All recommendations were compared with the provider's plan to determine if the recommendations were incorporated. RESULTS: During the 3-month study period, 170 pharmacist chart reviews were written and 175 clinic visits involved direct pharmacist participation. Providers accepted a greater percentage of recommendations that were delivered directly compared with recommendations presented via a note in the patient folder following chart review (92% vs. 28%, respectively; P <0.0001). Directly provided recommendations were also associated with higher severity scores. CONCLUSION: The results of this study suggest that comprehensive chart review by pharmacists prior to patient clinic visits may not be as effective as in-person consultation in communicating recommendations to providers. Further research is needed in similar clinic settings.

Clinical and Financial Impact of Pharmacist Involvement in Discharge Medication Reconciliation at an Academic Medical Center: A Prospective Pilot Study.

BACKGROUND: Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources. OBJECTIVE: This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process. METHODS: Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission. RESULTS: During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance. CONCLUSION: Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution.

Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation.

OBJECTIVE: The aim of this study was to determine the safety and efficacy of induction with rabbit antithymocyte globulin (RATG) compared with interleukin-2 receptor antagonists in a racially diverse kidney transplant patient population under modern immunosuppression. BACKGROUND: The optimal induction therapy in patients at risk for rejection, particularly black recipients, in the modern era of immunosuppression with flow cytometry-based cross-matching is unclear. METHODS: This was a prospective, risk-stratified, randomized, single-center, open-label study of 200 consecutively enrolled patients in a large academic teaching center. Patients were randomized to receive either daclizumab or basiliximab versus RATG for induction in combination with tacrolimus, mycophenolate mofetil, and corticosteroids. Patients were stratified between groups to ensure equal numbers of black, retransplants, high panel reactive antibodies (PRAs) (>20%), and prolonged cold ischemic times (>24 hours) in each group. Primary outcome measure is treatment efficacy defined as the incidence of biopsy-proven acute rejection and estimated creatinine clearance. Patients were followed up for 12 months. Renal transplant recipients were included if they were adult (≥18 years old) and received an allograft from a deceased, living unrelated, or nonhuman leukocyte antigen identical living-related donor. RESULTS: A total of 200 patients (n = 98 in the interleukin-2 receptor antagonists, and n = 102 in the RATG) were enrolled from February 2009 through July 2011. One-year acute rejection rates were low and similar between groups (10% in the interleukin-2 receptor antagonist group vs 6% in the RATG group; P = 0.30). Creatinine clearance was also similar between groups (interleukin-2 receptor antagonist group 56 ± 20 mL/min per 1.73 m2 vs RATG group 55 ± 22 mL/min per 1.73 m2; P = 0.73). Subanalysis of recipient race revealed that in blacks only RATG was protective against 6- and 12-month acute rejection, without an increased risk of infection. Induction did not affect rejection rates according to recipient calculated PRAs; however, RATG was associated with an increased risk of BK virus in low-PRA patients. CONCLUSIONS AND RELEVANCE: RATG induction provides improved protection against early acute rejection in black renal transplant recipients, whereas sensitized patients do not seem to demonstrate a similar benefit from this therapy. This study is registered at Clinicaltrials.gov (NCT00859131).

The impact of diabetes mellitus and glycemic control on clinical outcomes following liver transplant for hepatitis C.

Hepatitis C is the leading indication for liver transplantation in the USA and recurrence is universal. The impact of preexisting diabetes, new-onset diabetes after transplant (NODAT), and glycemic control on fibrosis progression has not been studied. This retrospective longitudinal cohort study included adult liver recipients with hepatitis C transplanted between 2000 and 2011. Patients were divided into three groups: preexisting diabetes (n = 41), NODAT (n = 59), and no diabetes (n = 103). Patients with preexisting diabetes (70%) or NODAT (59%) were more likely to develop hepatitis C recurrence (≥stage 1 fibrosis), as compared to non-diabetics (36%, p = 0.006). There was also a trend toward a higher incidence of at least Stage 2 fibrosis (36% and 48% vs. 23%, respectively; p = 0.063). Patients with tight glycemic control had a lower rate of Stage 2 fibrosis development (78% vs. 60%, p = 0.027), while those with good control (<150 mg/dL) also had lower rates of Stage 2 fibrosis (84% vs. 62%, p = 0.004). Multivariable analysis verified a decreased rate of recurrence for patients with blood glucose <138 mg/dL (p = 0.021), after controlling for confounders. These results demonstrate that diabetes is strongly associated with an increased risk of hepatitis C virus-related fibrosis development and glycemic control may reduce the risk and severity of recurrence.