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Improving Medication Safety and Cardiovascular Risk Factor Control to Mitigate Disparities in African-American Kidney Transplant Recipients: Design and Methods.

ABSTRACT: There is a lack of data analyzing the influence of cardiovascular disease (CVD) risk factor control on graft survival disparities in African-American kidney transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in African-Americans, leading to higher rates of renal failure and major acute cardiovascular events. However, with the exception of hypertension, there is no data demonstrating similar results within transplant recipients. Recent analyses conducted by our investigator group indicate that CVD risk factors, especially diabetes, are poorly controlled in African-American recipients, which likely impacts graft loss. This study protocol describes a prospective interventional clinical trial with the goal of demonstrating improved medication safety and CVD risk factor control in adult solitary kidney transplant recipients at least one-year post-transplant with a functioning graft. This is a prospective, interventional, 6-month, pharmacist-led and technology enabled study in adult kidney transplant recipients with the goal of improving CVD risk factor outcomes by improving medication safety and patient self-efficacy. This papers describes the issues related to racial disparities in transplant, the details of this intervention and how we expect this intervention to improve CVD risk factor control in kidney transplant recipients, particularly within African-Americans.

SUBMITTER: Cole AJ

PROVIDER: S-EPMC5844505 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Transplant Center Variability in Disparities for African-American Kidney Transplant Recipients.

Project description:BACKGROUND Disparities research has traditionally focused on patient-level variables to ascertain predominant risk factors driving differences in outcomes for African-American (AA) kidney transplant recipients. Our objectives were to determine the magnitude and impact of transplant center variability for graft outcome disparities. MATERIAL AND METHODS This was a retrospective cohort study analyzing 25 years of U.S. national transplant registry data at both the patient and center levels using univariate descriptive statistics and multivariable modeling. RESULTS A total of 257,024 recipients from 191 centers were analyzed; AAs represented 31.1% of recipients. After adjusting for baseline characteristics, AAs had 42% higher risk of graft loss (aHR 1.42, 95% CI 1.39 to 1.45; p<0.001). Center variability for graft outcome disparities in AAs was significant (race*center interaction term p<0.05), with the aHRs ranging from 0.5 to 4.9; 46% of centers demonstrated a non-statistically significant disparity (aHR p>0.05) and 25% of centers had a large AA disparity (aHR >1.75). In a more recent transplant time period (2000-14), overall racial disparities decreased but center-level disparities increased in variability. Center-level factors significantly associated with increasing disparity included higher acute rejection rates, fewer transplants per year, longer length of stay, lower use of calcineurin inhibitors (CNI), and lower living donor rates. CONCLUSIONS There is evidence of significant center-level variability in graft outcome disparities for AA kidney recipients. Further, there appears to be a number of center-level factors associated with this variability, including acute rejection rates, CNI use, number of transplants per year, and, in recent years, low living donor rates.

| S-EPMC6019128 | biostudies-literature

Genotype-guided tacrolimus dosing in African-American kidney transplant recipients.

Project description:Tacrolimus is dependent on CYP3A5 enzyme for metabolism. Expression of the CYP3A5 enzyme is controlled by several alleles including CYP3A5*1, CYP3A5*3, CYP3A5*6 and CYP3A5*7. African Americans (AAs) have on average higher tacrolimus dose requirements than Caucasians; however, some have requirements similar to Caucasians. Studies in AAs have primarily evaluated the CYP3A5*3 variant; however, there are other common nonfunctional variants in AAs (CYP3A5*6 and CYP3A5*7) that do not occur in Caucasians. These variants are associated with lower dose requirements and may explain why some AAs are metabolically similar to Caucasians. We created a tacrolimus clearance model in 354 AAs using a development and validation cohort. Time after transplant, steroid and antiviral use, age and CYP3A5*1, *3, *6 and *7 alleles were significant toward clearance. This study is the first to develop an AA-specific genotype-guided tacrolimus dosing model to personalize therapy.

| S-EPMC4909584 | biostudies-literature

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

Project description: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.

| S-EPMC6309248 | biostudies-literature

Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.

Project description:IntroductionHealth disparities in African-American (AA) kidney transplant recipients compared with non-AA recipients are well established. Cardiovascular disease (CVD) risk control is a significant mediator of this disparity.ObjectiveTo assess the efficacy of improved medication safety, CVD risk control, and racial disparities in kidney transplant recipients.MethodsProspective, pharmacist-led, technology-aided, 6-month interventional clinical trial. A total of 60 kidney recipients with diabetes and hypertension were enrolled. Patients had to be at least one-year post transplant with stable graft function. Primary outcome measured included hypertension, diabetes, and lipid control using intent-to-treat analyses, with differences assessed between AA and non-AA recipients.ResultsThe participants mean age was 59 years, with 42% being female and 68% being AA. Overall, patients demonstrated improvements in blood pressure <140/90 mmHg (baseline 50% vs. end of study 68%, p=0.054) and hemoglobin A1c <7% (baseline 33% vs. end of study 47%, p=0.061). AAs demonstrated a significant reduction from baseline in systolic blood pressure (-0.86 mmHg per month, p=0.026), which was not evident in non-AAs (-0.13 mmHg per month, p=0.865). Mean HgbA1c decreased from baseline in the overall group (-0.12% per month, p=0.003), which was similar within AAs (-0.11% per month, p=0.004) and non-AAs (-0.14% per month, p=0.029). There were no changes in low-density lipoproteins, triglycerides, or high-density lipoproteins over the course of the study. Medication errors were significantly reduced and self-reported medication adherence significantly improved over the course of the study.ConclusionThese results demonstrate the potential efficacy of a pharmacist-led, technology-aided, educational intervention in improving medication safety, diabetes, and hypertension and reducing racial disparities in AA kidney transplant recipients. (ClinicalTrials.gov NCT02763943).

| S-EPMC6350824 | biostudies-literature

Outcome disparities between African Americans and Caucasians in contemporary kidney transplant recipients.

Project description:BackgroundRacial disparities in African-American (AA) kidney transplant have persisted for nearly 40 years, with limited data available on the scope of this issue in the contemporary era of transplantation.MethodsDescriptive retrospective cohort study of US registry data including adult solitary kidney transplants between Jan 1, 2005 to Dec 31, 2009.Results60,695 recipients were included; 41,426 Caucasians (68%) and 19,269 AAs (32%). At baseline, AAs were younger, had lower college graduation rates, were more likely to be receiving public health insurance and have diabetes. At one-year post-transplant, AAs had 62% higher risk of graft loss (RR 1.62, 95% CI 1.50-1.75) which increased to 93% at five years (RR 1.93, 95% CI 1.85-2.01). Adjusted risk of graft loss, accounting for baseline characteristics, was 60% higher in AAs (HR 1.61 [1.52-1.69]). AAs had significantly higher risk of acute rejection and delayed graft function.ConclusionAAs continue to experience disproportionately high rates of graft loss within the contemporary era of transplant, which are related to a convergence of an array of socioeconomic and biologic risk factors.

| S-EPMC5373991 | biostudies-literature

Donor Risk Index for African American liver transplant recipients with hepatitis C virus.

Project description:UnlabelledAfrican American (AA) liver transplant (LT) recipients with hepatitis C virus (HCV) have higher rates of graft loss than other racial/ethnic groups. The Donor Risk Index (DRI) predicts graft loss but is neither race- nor disease-specific and may not be optimal for assessing donor risk for AA HCV-positive LT recipients. We developed a DRI for AA with HCV with the goal of enhancing graft loss predictions. All U.S. HCV-positive adult AA first deceased donor LTs surviving ≥30 days from March 2002 to December 2009 were included. A total of 1,766 AA LT recipients were followed for median 2.8 (interquartile range [IQR] 1.3-4.9) years. Independent predictors of graft loss were donor age (40-49 years: hazard ratio [HR] 1.54; 50-59 years: HR 1.80; 60+ years: HR 2.34, P < 0.001), non-AA donor (HR 1.66, P < 0.001), and cold ischemia time (CIT) (HR 1.03 per hour >8 hours, P = 0.03). Importantly, the negative effect of increasing donor age on graft and patient survival among AAs was attenuated by receipt of an AA donor. A new donor risk model for AA (AADRI-C) consisting of donor age, race, and CIT yielded 1-year, 3-year, and 5-year predicted graft survival rates of 91%, 77%, and 68% for AADRI <1.60; 86%, 67%, and 55% for AADRI 1.60-2.44; and 78%, 53%, and 39% for AADRI >2.44. In the validation dataset, AADRI-C correctly reclassified 27% of patients (net reclassification improvement P = 0.04) compared to the original DRI.ConclusionAADRI-C identifies grafts at higher risk of failure and this information is useful for risk-benefit discussions with recipients. Use of AA donors allows consideration of older donors.

| S-EPMC4561529 | biostudies-literature

Impact of Cardiovascular Risk Factors on Graft Outcome Disparities in Black Kidney Transplant Recipients.

Project description:Although outcome inequalities for non-Hispanic black (NHB) kidney transplant recipients are well documented, there is paucity in data assessing the impact of cardiovascular disease (CVD) risk factors on this disparity in kidney transplantation. This was a longitudinal study of a national cohort of veteran kidney recipients transplanted between January 2001 and December 2007. Data included baseline characteristics acquired through the United States Renal Data System linked to detailed clinical follow-up information acquired through the Veterans Affairs electronic health records. Analyses were conducted using sequential multivariable modeling (Cox regression), incorporating blocks of variables into iterative nested models; 3139 patients were included (2095 non-Hispanic whites [66.7%] and 1044 NHBs [33.3%]). NHBs had a higher prevalence of hypertension (100% versus 99%; P<0.01) and post-transplant diabetes mellitus (59% versus 53%; P<0.01) with reduced control of hypertension (blood pressure <140/90 60% versus 69%; P<0.01), diabetes mellitus (A1c <7%, 35% versus 47%; P<0.01), and low-density lipoprotein (<100 mg/dL, 55% versus 61%; P<0.01). Adherence to medications used to manage CVD risk was significantly lower in NHBs. In the fully adjusted models, the independent risk of graft loss in NHBs was substantially reduced (unadjusted hazard ratio, 2.00 versus adjusted hazard ratio, 1.49). CVD risk factors and control reduced the influence of NHB race by 9% to 18%. Similar trends were noted for mortality, and estimates were robust across in sensitivity analyses. These results demonstrate that NHB kidney transplant recipients have significantly higher rates of CVD risk factors and reduced CVD risk control. These issues are likely partly related to medication nonadherence and meaningfully contribute to racial disparities for graft outcomes.

| S-EPMC4982810 | biostudies-literature

Equity in Genomics: A Brief Report on Cardiovascular Health Disparities in African American Adults.

Project description:BackgroundAfrican Americans are more likely to die from cardiovascular disease (CVD) than all other populations in the United States. Although technological advances have supported rapid growth in applying genetics/genomics to address CVD, most research has been conducted among European Americans. The lack of African American representation in genomic samples has limited progress in equitably applying precision medicine tools, which will widen CVD disparities if not remedied.PurposeThis report summarizes the genetic/genomic advances that inform precision health and the implications for cardiovascular disparities in African American adults. We provide nurse scientists recommendations for becoming leaders in developing precision health tools that promote population health equity.ConclusionsGenomics will continue to drive advances in CVD prevention and management, and equitable progress is imperative. Nursing should leverage the public's trust and its widespread presence in clinical and community settings to prevent the worsening of CVD disparities among African Americans.

| S-EPMC7775264 | biostudies-literature

Genomewide Association Study of Tacrolimus Concentrations in African American Kidney Transplant Recipients Identifies Multiple CYP3A5 Alleles.

Project description:We previously reported that tacrolimus (TAC) trough blood concentrations for African American (AA) kidney allograft recipients were lower than those observed in white patients. Subtherapeutic TAC troughs may be associated with acute rejection (AR) and AR-associated allograft failure. This variation in TAC troughs is due, in part, to differences in the frequency of the cytochrome P450 CYP3A5*3 allele (rs776746, expresses nonfunctional enzyme) between white and AA recipients; however, even after accounting for this variant, variability in AA-associated troughs is significant. We conducted a genomewide association study of TAC troughs in AA kidney allograft recipients to search for additional genetic variation. We identified two additional CYP3A5 variants in AA recipients independently associated with TAC troughs: CYP3A5*6 (rs10264272) and CYP3A5*7 (rs41303343). All three variants and clinical factors account for 53.9% of the observed variance in troughs, with 19.8% of the variance coming from demographic and clinical factors including recipient age, glomerular filtration rate, anticytomegalovirus drug use, simultaneous pancreas-kidney transplant and antibody induction. There was no evidence of common genetic variants in AA recipients significantly influencing TAC troughs aside from the CYP3A gene. These results reveal that additional and possibly rare functional variants exist that account for the additional variation.

| S-EPMC4733408 | biostudies-literature

The APOL1 genotype of African American kidney transplant recipients does not impact 5-year allograft survival.

Project description:Apolipoprotein L-1 (APOL1) gene variants are associated with end-stage renal disease in African Americans (AAs). Here we investigate the impact of recipient APOL1 gene distributions on kidney allograft outcomes. We conducted a retrospective analysis of 119 AA kidney transplant recipients, and found that 58 (48.7%) carried two APOL1 kidney disease risk variants. Contrary to the association seen in native kidney disease, there is no difference in allograft survival at 5-year posttransplant for recipients with high-risk APOL1 genotypes. Thus, we were able to conclude that APOL1 genotypes do not increase risk of allograft loss after kidney transplantations, and carrying 2 APOL1 risk alleles should not be an impediment to transplantation.

| S-EPMC3387301 | biostudies-literature

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