Does weight loss add value to blood pressure control among patients with diabetic kidney disease?

Obesity is an independent risk factor for development and progression of diabetic kidney disease (DKD). Whether weight loss provides any additional benefit beyond blood pressure (BP) control is unclear. To simulate a trial, we used the Archimedes model, a person-specific simulation model including detailed representations of physiology, diseases, and health care systems. Our population-based sample represented individuals diagnosed with type 2 diabetes and DKD drawn from 1999-2006 cohorts of NHANES. Simulations were generated to estimate costs and health outcomes across time for 3 treatment strategies: (1) standard of care (STD); (2) blood pressure control (BP); and (3) BP combined with 5% weight loss (BPWT). BP control represents 3.5%&6% reductions for those with SBP>130 and SBP>140, respectively. Over a 20y time horizon, discounted costs for the STD group were $165,261 with discounted quality adjusted life-years (QALYs) of 5.89. With BP estimated at$30/month, the incremental cost-effectiveness ratio (ICER) was $26,626/QALY compared to STD. With BPWT at$50/month, the ICER was $31,773 compared to STD. Even with varying intervention costs and durations (Figure), the ICERs remained favorable, especially for the BPWT group.In conclusion, weight loss in addition to BP control appears to provide favorable value, particularly over moderate time horizons

The epidemiology of chronic kidney disease in sub-Saharan Africa: a systematic review and meta-analysis

Background Amid rapid urbanisation, the HIV epidemic, and increasing rates of non-communicable diseases, people in sub-Saharan Africa are especially vulnerable to kidney disease. Little is known about the epidemiology of chronic kidney disease (CKD) in sub-Saharan Africa, so we did a systematic review and meta-analysis examining the epidemiology of the disease. Methods We searched Medline, Embase, and WHO Global Health Library databases for all articles published through March 29, 2012, and searched the reference lists of retrieved articles. We independently reviewed each study for quality. We used the inverse-variance random-eff ects method for meta-analyses of the medium-quality and highquality data and explored heterogeneity by comparing CKD burdens across countries, settings (urban or rural), comorbid disorders (hypertension, diabetes, HIV), CKD defi nitions, and time. Findings Overall, we included 90 studies from 96 sites in the review. Study quality was low, with only 18 (20%) medium-quality studies and three (3%) high-quality studies. We noted moderate heterogeneity between the mediumquality and high-quality studies (n=21; I²=47·11%, p<0·0009). Measurement of urine protein was the most common method of determining the presence of kidney disease (62 [69%] studies), but the Cockcroft-Gault formula (22 [24%] studies) and Modifi cation of Diet in Renal Disease formula (17 [19%] studies) were also used. Most of the studies were done in urban settings (83 [93%] studies) and after the year 2000 (57 [63%] studies), and we detected no signifi cant diff erence in the prevalence of CKD between urban (12·4%, 95% CI 11–14) and rural (16·5%, 13·8–19·6) settings (p=0·474). The overall prevalence of CKD from the 21 medium-quality and high-quality studies was 13·9% (95% CI 12·2–15·7). Interpretation In sub-Saharan Africa, CKD is a substantial health burden with risk factors that include communicable and non-communicable diseases. However, poor data quality limits inferences and draws attention to the need for more information and validated measures of kidney function especially in the context of the growing burden of noncommunicable diseases

Traditional Medicine Practices among Community Members with Diabetes Mellitus in Northern Tanzania: An ethnomedical Survey.

Diabetes is a growing burden in sub-Saharan Africa where traditional medicines (TMs) remain a primary form of healthcare in many settings. In Tanzania, TMs are frequently used to treat non-communicable diseases, yet little is known about TM practices for non-communicable diseases like diabetes. Between December 2013 and June 2014, we assessed TM practices, including types, frequencies, reasons, and modes, among randomly selected community members. To further characterize TMs relevant for the local treatment of diabetes, we also conducted focus groups and semi-structured interviews with key informants. We enrolled 481 adults of whom 45 (9.4 %) had diabetes. The prevalence of TM use among individuals with diabetes was 77.1 % (95 % CI 58.5-89.0 %), and the prevalence of using TMs and biomedicines concurrently was 37.6 % (95 % CI 20.5-58.4 %). Many were using TMs specifically to treat diabetes (40.3 %; 95 % CI 20.5-63.9), and individuals with diabetes reported seeking healthcare from traditional healers, elders, family, friends, and herbal vendors. We identified several plant-based TMs used toward diabetes care: Moringa oleifera, Cymbopogon citrullus, Hagenia abyssinica, Aloe vera, Clausena anisata, Cajanus cajan, Artimisia afra, and Persea americana. TMs were commonly used for diabetes care in northern Tanzania. Individuals with diabetes sought healthcare advice from many sources, and several individuals used TMs and biomedicines together. The TMs commonly used by individuals with diabetes in northern Tanzania have a wide range of effects, and understanding them will more effectively shape biomedical practitices and public health policies that are patient-centered and sensitive to TM preferences

Knowledge, Attitudes, and Practices Associated with Chronic Kidney Disease in Northern Tanzania: A Community-Based Study.

Non-communicable diseases (NCDs) are a leading cause of death among adults in sub-Saharan Africa, and chronic kidney disease (CKD) is a growing public health threat. Understanding knowledge, attitudes, and practices associated with NCDs is vital to informing optimal policy and public health responses in the region, but few community-based assessments have been performed for CKD. To address this gap, we conducted a cross-sectional survey of adults in northern Tanzania using a validated instrument. Between January and June 2014, we administered a structured survey to a random sample of adults from urban and rural communities. The validated instrument consisted of 25 items designed to measure knowledge, attitudes, and practices associated with kidney disease. Participants were also screened for CKD, diabetes, hypertension, and human immunodeficiency virus. We enrolled 606 participants from 431 urban and rural households. Knowledge of the etiologies, symptoms, and treatments for kidney disease was low (mean score 3.28 out of 10; 95% CI 2.94, 3.63). There were no significant differences by CKD status. Living in an urban setting and level of education had the strongest independent associations with knowledge score. Attitudes were characterized by frequent concern about the health (27.3%; 20.2, 36.0%), economic (73.1%; 68.2, 77.5%), and social impact (25.4%; 18.6, 33.6%) of kidney disease. Practices included the use of traditional healers (15.2%; 9.1, 24.5%) and traditional medicines (33.8%; 25.0, 43.9%) for treatment of kidney disease as well as a willingness to engage with mobile-phone technology in CKD care (94.3%; 90.1, 96.8%). Community-based adults in northern Tanzania have limited knowledge of kidney disease. However, there is a modest knowledge base upon which to build public health programs to expand awareness and understanding of CKD, but these programs must also consider the variety of means by which adults in this population meet their healthcare needs. Finally, our assessment of local attitudes suggested that such public health efforts would be well-received

Comparison of outcomes for veterans receiving dialysis care from VA and non-VA providers

Abstract Background Demand for dialysis treatment exceeds its supply within the Veterans Health Administration (VA), requiring VA to outsource dialysis care by purchasing private sector dialysis for veterans on a fee-for-service basis. It is unclear whether outcomes are similar for veterans receiving dialysis from VA versus non-VA providers. We assessed the extent of chronic dialysis treatment utilization and differences in all-cause hospitalizations and mortality between veterans receiving dialysis from VA versus VA-outsourced providers. Methods We constructed a retrospective cohort of veterans in 2 VA regions who received chronic dialysis treatment financed by VA between January 2007 and December 2008. From VA administrative data, we identified veterans who received outpatient dialysis in (1) VA, (2) VA-outsourced settings, or (3) both (“dual”) settings. In adjusted analyses, we used two-part and logistic regression to examine associations between dialysis setting and all-cause hospitalization and mortality one-year from veterans’ baseline dialysis date. Results Of 1,388 veterans, 27% received dialysis exclusively in VA, 47% in VA-outsourced settings, and 25% in dual settings. Overall, half (48%) were hospitalized and 12% died. In adjusted analysis, veterans in VA-outsourced settings incurred fewer hospitalizations and shorter hospital stays than users of VA due to favorable selection. Dual-system dialysis patients had lower one-year mortality than veterans receiving VA dialysis. Conclusions VA expenditures for “buying” outsourced dialysis are high and increasing relative to “making” dialysis treatment within its own system. Outcomes comparisons inform future make-or-buy decisions and suggest the need for VA to consider veterans’ access to care, long-term VA savings, and optimal patient outcomes in its placement decisions for dialysis services

Geographic and Temporal Trends in Peritoneal Dialysis Services in the United States Between 1995 and 2003

Peritoneal dialysis (PD) is the preferred dialysis modality for many end-stage renal disease (ESRD) patients in the US. However, in sharp contrast to the high rates of PD use in other industrialized countries, utilization of PD in the US is low and declining. PD availability is a necessary condition for PD utilization; however, little is known about the availability and geographic distribution of PD services. This study describes trends in the regional supply of PD services among dialysis facilities between 1995 and 2003

Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure–Response Relationships in Renal Transplant Patients

Sirolimus, an immunosuppressant agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants is necessary to optimize the care of patients and set standards for bioequivalence evaluation of sirolimus products. However, the therapeutic index for sirolimus has been inconsistently defined, potentially due to inconsistencies in sirolimus exposure-response relationships

Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism A Randomized Clinical Trial

Importance Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. Objective To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet. Design, Setting, and Participants A randomized, double-blind, double-dummy active clinical trial was conducted comparing IV etelcalcetide vs oral placebo and oral cinacalcet vs IV placebo in 683 patients receiving hemodialysis with serum parathyroid hormone (PTH) concentrations higher than 500 pg/mL on active therapy at 164 sites in the United States, Canada, Europe, Russia, and New Zealand. Patients were enrolled from August 2013 to May 2014, with end of follow-up in January 2015. Interventions Etelcalcetide intravenously and oral placebo (n = 340) or oral cinacalcet and IV placebo (n = 343) for 26 weeks. The IV study drug was administered 3 times weekly with hemodialysis; the oral study drug was administered daily. Main Outcomes and Measures The primary efficacy end point was noninferiority of etelcalcetide at achieving more than a 30% reduction from baseline in mean predialysis PTH concentrations during weeks 20-27 (noninferiority margin, 12.0%). Secondary end points included superiority in achieving biochemical end points (>50% and >30% reduction in PTH) and self-reported nausea or vomiting. Results The mean (SD) age of the trial participants was 54.7 (14.1) years and 56.2% were men. Etelcalcetide was noninferior to cinacalcet on the primary end point. The estimated difference in proportions of patients achieving reduction in PTH concentrations of more than 30% between the 198 of 343 patients (57.7%) randomized to receive cinacalcet and the 232 of 340 patients (68.2%) randomized to receive etelcalcetide was −10.5% (95% CI, −17.5% to −3.5%, P for noninferiority, <.001; P for superiority, .004). One hundred seventy-eight patients (52.4%) randomized to etelcalcetide achieved more than 50% reduction in PTH concentrations compared with 138 patients (40.2%) randomized to cinacalcet (P = .001; difference in proportions, 12.2%; 95% CI, 4.7% to 19.5%). The most common adverse effect was decreased blood calcium (68.9% vs 59.8%). Conclusions and Relevance Among patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism, the use of etelcalcetide was not inferior to cinacalcet in reducing serum PTH concentrations over 26 weeks; it also met superiority criteria. Further studies are needed to assess clinical outcomes as well as longer-term efficacy and safety

Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism

Importance Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease. Objective To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis. Design, Setting, and Participants Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism. Trial A was conducted in 508 patients at 111 sites in the United States, Canada, Europe, Israel, Russia, and Australia from March 12, 2013, to June 12, 2014; trial B was conducted in 515 patients at 97 sites in the same countries from March 12, 2013, to May 12, 2014. Interventions Intravenous administration of etelcalcetide (n = 503) or placebo (n = 513) after each hemodialysis session for 26 weeks. Main Outcomes and Measures The primary efficacy end point was the proportion of patients achieving greater than 30% reduction from baseline in mean PTH during weeks 20-27. A secondary efficacy end point was the proportion of patients achieving mean PTH of 300 pg/mL or lower. Results The mean age of the 1023 patients was 58.2 (SD, 14.4) years and 60.4% were men. Mean PTH concentrations at baseline and during weeks 20-27 were 849 and 384 pg/mL vs 820 and 897 pg/mL in the etelcalcetide and placebo groups, respectively, in trial A; corresponding values were 845 and 363 pg/mL vs 852 and 960 pg/mL in trial B. Patients randomized to etelcalcetide were significantly more likely to achieve the primary efficacy end point: in trial A, 188 of 254 (74.0%) vs 21 of 254 (8.3%; P < .001), for a difference in proportions of 65.7% (95% CI, 59.4%-72.1%) and in trial B, 192 of 255 (75.3%) vs 25 of 260 (9.6%; P < .001), for a difference in proportions of 65.7% (95% CI, 59.3%-72.1%). Patients randomized to etelcalcetide were significantly more likely to achieve a PTH level of 300 pg/mL or lower: in trial A, 126 of 254 (49.6%) vs 13 of 254 (5.1%; P < .001), for a difference in proportions of 44.5% (95% CI, 37.8%-51.2%) and in trial B, 136 of 255 (53.3%) vs 12 of 260 (4.6%; P < .001), for a difference in proportions of 48.7% (95% CI, 42.1%-55.4%). In trials A and B, respectively, patients receiving etelcalcetide had more muscle spasms (12.0% and 11.1% vs 7.1% and 6.2% with placebo), nausea (12.4% and 9.1% vs 5.1% and 7.3%), and vomiting (10.4% and 7.5% vs 7.1% and 3.1%). Conclusions and Relevance Among patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism, use of etelcalcetide compared with placebo resulted in greater reduction in serum PTH over 26 weeks. Further studies are needed to assess clinical outcomes as well as longer-term efficacy and safety

Special Feature CKD as a Model for Improving Chronic Disease Care through Electronic Health Records

Abstract Electronic health records have the potential to improve the care of patients with chronic medical conditions. CKD provides a unique opportunity to show this potential: the disease is common in the United States, there is significant room to improve CKD detection and management, CKD and its related conditions are defined primarily by objective laboratory data, CKD care requires collaboration by a diverse team of health care professionals, and improved access to CKD-related data would enable identification of a group of patients at high risk for multiple adverse outcomes. However, to realize the potential for improvement in CKD-related care, electronic health records will need to provide optimal functionality for providers and patients and interoperability across multiple health care settings. The goal of the National Kidney Disease Education Program Health Information Technology Working Group is to enable and support the widespread interoperability of data related to kidney health among health care software applications to optimize CKD detection and management. Over the course of the last 2 years, group members met to identify general strategies for using electronic health records to improve care for patients with CKD. This paper discusses these strategies and provides general goals for appropriate incorporation of CKD-related data into electronic health records and corresponding design features that may facilitate (1) optimal care of individual patients with CKD through improved access to clinical information and decision support, (2) clinical quality improvement through enhanced population management capabilities, (3) CKD surveillance to improve public health through wider availability of population-level CKD data, and (4) research to improve CKD management practices through efficiencies in study recruitment and data collection. Although these strategies may be most effectively applied in the setting of CKD, because it is primarily defined by laboratory abnormalities and therefore, an ideal computable electronic health record phenotype, they may also apply to other chronic diseases