Dosing patterns and costs of erythropoietic agents in patients with chronic kidney disease not on dialysis in managed care organizations

BACKGROUND: Epoetin alfa (EPO) and darbepoetin alfa (DARB) are erythropoietic agents indicated in the United States for the treatment of anemia in chronic kidney disease (CKD). OBJECTIVE: This study investigated dosing patterns and costs associated with the use of erythropoietic-stimulating therapy (EST) in patients with CKD not on dialysis who were newly starting EPO or DARB therapy in managed care organizations. METHODS: This was a retrospective analysis of medical claims data from >30 health plans for the period from July 2002 to February 2005. Patients were included if they were aged > or =18 years, had > or =1 claim for CKD within 90 days before the initiation of treatment, had newly started therapy with EPO or DARB, and had received > or =2 doses of treatment. If a patient was undergoing renal dialysis, data were censored 30 days before the first date of dialysis. Patients with a diagnosis of cancer or who had undergone chemotherapy were excluded from the analysis. The mean dosing interval was determined for both groups. Mean weekly doses and costs (using 2005 wholesale acquisition costs), weighted by the treatment duration, were calculated. The frequency of outpatient nephrologist visits was described and included in cost considerations. RESULTS: The study population consisted of 595 patients who received EPO and 260 who received DARB. The EPO group was significantly older than the DARB group (mean age, 63.5 vs 61.2 years, respectively; P = 0.020). The proportion of women was similar between the 2 groups (51.6% and 50.4%). Use of extended dosing (> or =q2wk) was common in both groups (63.2% and 90.8%). The weighted mean weekly dose was 11,536 U for EPO and 42.5 mug for DARB. The mean number of outpatient nephrologist visits during treatment was similar between the 2 groups (3.9 and 3.5). Mean weekly costs (EST drug cost plus cost of nephrologist visits) were significantly lower for EPO compared with DARB (159 dollars vs 205 dollars; P < 0.001). CONCLUSIONS: The majority of these CKD patients newly started on EST in managed care organizations received extended dosing regimens (> or =q2wk) of EPO or DARB. EPO treatment was associated with significantly lower mean weekly costs compared with DARB. The number of outpatient nephrology visits did not differ significantly between groups.     

慢性肾脏病的单中心横断面流行病学研究

目的 调查单中心肾内科门诊慢性肾脏病(CKD)患者的基础状况,判断CKD患者肾功能下降的危险因素.方法 对门诊就诊的CKD患者进行为期9个月的前瞻性横断面调查.结果 共有780例CKD病例入选.前4位CKD的病因分别为原发性肾小球疾病(59.0%),高血压肾病(7.6%),狼疮肾炎(6.4%),糖尿病肾病(6.3%).病例平均年龄41.9岁.CKD各期的分布为CKD 1期47.8%、2期18.7%、3期14.0%、4期8.1%、5期11.4%.多因素回归提示年龄、蛋白尿、高血压与CKD患者的肾功能下降独立相关.结论 目前针对中国CKD患者最大规模的单中心横断面调查,有助于确定CKD患者的基本状况,为进一步纵向随访奠定基础.     

慢性肾脏病患者血红蛋白变异度与肾功能进展关系的临床研究

目的评价在肾内科门诊规律随访的慢性肾脏疾病(CKD)患者的肾脏功能进展情况,及与血红蛋白变异度的相关情况。方法采用前瞻性队列研究设计,收集慢性肾脏病患者规律随访,定期抽取血样标本检测血红蛋白、肾功能等指标,建立数据库并应用统计软件对观察结果进行分析。结果共纳入197例患者,其中CKD 2期11例,3期125例,4期54例,5期7例。进入队列时基线年龄为62.3±10.6岁,基线肾小球滤过率(eGFR)为33.3±10.2 ml/(min·1.73 m2),随访18个月,72例(36.5%)患者的肾功能发生进展,与肾功能稳定组相比,肾功能进展组的血红蛋白变异度指标较高,差异有统计学意义(P<0.05)。结论慢性肾脏病患者的血红蛋白的变异度水平与肾功能进展有关,应对患者的血红蛋白波动增加关注。     

Improving efficiency and value in health care. Intravenous iron management for anaemia associated with chronic kidney disease: linking treatment to an outpatient clinic, optimizing service provision and patient choice

Rationale The National Service Framework advocates correction of anaemia in patients with chronic kidney disease (CKD). Oral iron is insufficient, while intravenous (IV) supplementation replenishes and maintains iron stores. In Yorkshire numerous peripheral clinics exist to reduce travel for patients, but patients must travel to the main unit for IV iron therapy. Therefore an outpatient service in tandem with a routine clinic for administration of IV CosmoFer was created. Purpose To evaluate the feasibility and benefits of IV iron therapy in the outpatient clinic during active patient review for CKD patients. Design A cross‐sectional study of patients attending for total dose IV iron (n = 57) at a peripheral clinic. Iron was administered and monitored according to protocol by one of the clinic nurses with medical staff available in the adjoining room. Haemoglobin, ferritin and renal function were recorded pre‐infusion and after 4–6 months. Results are given as medians/means ± standard error. Results A total of 76 IV infusions were carried out with no reported side effects or haemodynamic instability. Haemoglobin (median 10.9 vs. 11.3 g dL^?1, P = NS), creatinine and estimated glomerular filtration rate (eGFR) over the 6‐month period remained stable. Serum ferritin rose significantly [80.9 ± 6.2 vs. 186.4 ± 18.2 g L^?1 (P < 0.001)]. Hospital time saved 380 day case bed hours, doctor hours saved 76 hours, and patient hours saved 3 hours/patient. Cost savings for TDI CosmoFer in peripheral clinic versus in centre therapy and versus sucrose, respectively, for 76 treatments was £5749.40 and £46 320.80 respectively. Conclusion We have demonstrated, in a resource‐limited service, the feasibility and cost‐effectiveness of a management care pathway for patients with CKD, in a peripheral clinic, to receive total dose IV CosmoFer without disruption of a functioning renal clinic.     

Current chronic kidney disease practice patterns in the UK: a national survey

BACKGROUND: There is an increasing focus on improving the detection and management of patients with chronic kidney disease (CKD). Data on CKD prevalence based on population sampling are now available, but there are few data about CKD patients attending nephrology services or how such services are organized. AIM: To survey services for CKD patients nationally. METHODS: A pre-piloted questionnaire was sent to all 72 renal units in the UK, referring to the situation in June 2004. RESULTS: Seventy units (97%) responded. The median ratio of prevalent CKD patients/prevalent renal replacement therapy (RRT) patients in the 25 units with data was 3.7 (IQR 2.7-5.7) and the median ratio of CKD stage 4 and 5 patients/prevalent RRT patients was 0.6 (IQR 0.4-1.1). This gives an estimated 140 000 CKD patients under the care of UK nephrologists, with 23 000 at CKD stage 4 or 5 (excluding those on RRT). Very few units had a full complement of the recommended multi-skilled renal team. Counsellors and psychologist were the most common perceived shortages. Of 70 responding units, 50 (74%) were using low clearance clinics for management of advanced CKD patients. Elective dialysis access services often had long delays, with median waiting time for vascular access ranging between 1 and 36 weeks, and for Tenchkoff catheter, between 0 and 12 weeks. DISCUSSION: CKD patients are a significant workload for UK nephrologists. Current provision of service is variable, and services need to be re-designed to cope with the expected future increase of referral of CKD patients.     

Anaemia is common and predicts mortality in diabetic nephropathy

BACKGROUND: Diabetes is the single largest cause of chronic renal failure, accounting for 18% of patients on renal replacement therapy in the UK. AIM: To investigate the chronic kidney disease stage at which patients with diabetic nephropathy are referred to renal services, determine the prevalence of anaemia in patients with diabetic nephropathy, examine patient outcome and identity prognostic factors. DESIGN: Retrospective review. METHODS: Patients with diabetic nephropathy referred to our renal services between 1989 and 2004 were identified from electronic records. Estimated glomerular filtration rate (calculated using the MDRD formula) and haemoglobin at referral were collected. Times to renal replacement therapy and death were noted. RESULTS: We identified 508 patients. At referral, mean eGFR was 34 ml/min/1.73 m(2) and 48% of patients were at CKD stages 4 and 5. Mean haemoglobin was 11.7 g/dl; 21% had a haemoglobin <10 g/dl at referral. Median survival was 37.9 months (95%CI 33.2-42.6); median survival independent of renal replacement therapy (RRT) was 21 months (95%CI 17.8-24.6). Of patients starting RRT, 38% did so within 1 year of referral. Older age (RR 1.02, 95%CI 1.01-1.04) and lower haemoglobin (RR 0.9, 95%CI 0.85-0.99) at referral predicted death on multivariate analysis. DISCUSSION: At referral to renal services, almost 50% of patients with diabetic nephropathy were at CKD stages 4 and 5. Anaemia was common and predicted mortality. All diabetic patients from CKD stage 3 should be screened for anaemia. We believe that patients with diabetic nephropathy should be discussed with renal services when they reach CKD stage 3 with evidence of progression of renal disease.     

The value of a specialist lipid clinic

Aims: To establish the value of the first 3 years of a cardiovascular risk factor clinic in tackling the major risk factors for cardiovascular disease (CVD). Methods: A database review of all 339 patients referred to the clinic. Results: Blood pressure levels in the hypertensive patients were significantly reduced and 9% of the smokers managed to quit for 12 months, half of them subsequently relapsing. Ninety‐eight oral glucose tolerance tests were performed and 40% were abnormal yielding 10 patients with hitherto unsuspected diabetes and 29 with impaired glucose tolerance. Sixty‐four of the 97 referrals of patients in the primary prevention group (no evidence of CVD) were found to have calculated Framingham coronary heart disease risk estimates of < 15% per decade, the lowest being 0.3%. Lipid levels were significantly reduced in both the hypercholesterolaemic (n = 290) and hypertriglyceridaemic (n = 49) patient groups through the use of more potent statins, extensive use of combination therapy and appropriate use of fibrates and omega‐3 fish oil supplements. The annual drug cost per patient treated only increased from £310.72 to £398.08, yet there was a 3.5‐fold increase in the number of patients achieving the General Medical Services 2 target of a total cholesterol < 5 mmol/l and a 4.5‐fold increase in patients achieving the Joint British Societies 2 target of a low‐density lipoprotein (LDL) cholesterol < 2 mmol/l. Conclusion: The need for a specialist clinic was demonstrated by the 66% of primary prevention referrals who did not meet the current NICE treatment threshold. Additionally, the clinic was able to diagnose and treat 39 patients with undiagnosed diabetes mellitus/impaired glucose tolerance and 12 with hypothyroidism. LDL cholesterol was reduced overall by 36% implying a greater than one‐third reduction in future cardiovascular events before the improvements in blood pressure control and smoking cessation are included and this was achieved at marginal extra cost to the mean drug bill at referral.     

Economic burden of chronic kidney disease

Objectives To define the cost of care and evaluate interventions associated with improving outcomes and delaying the progression of chronic kidney disease (CKD). Methods Using the PubMed database, a systematic review of the literature was conducted describing (i) the cost of care associated with treating earlier stages of CKD, and (ii) the role of early referral, erythropoiesis‐stimulating proteins and anti‐hypertensive agents in improving clinical outcomes and reducing the cost of CKD. Results The higher costs associated with treatment of the CKD population are largely due to higher rates and duration of comorbidity‐driven hospitalizations. Studies suggest that early referral to a nephrologist, use of erythropoiesis‐stimulating proteins and anti‐hypertensive agents may be associated with better outcomes and lower costs. In some instances, however, higher target haemoglobin levels could have harmful effects in CKD patients. Conclusion The substantial costs incurred during earlier stages of CKD increase markedly during the transition to renal replacement and remain elevated thereafter. An increase in awareness among health care providers may result in more timely interventions. More proactive management, in turn, can lead to improved clinical and economic outcomes through the slowing of disease progression and prevention of comorbidities.     

Late referral of patients with chronic kidney disease: no time to waste

The prevalence of patients with chronic kidney disease (CKD) in the US population is approximately 11%, and because of the increase in life expectancy and in diabetic nephropathy incidence, an exponential increase is predicted for the next decades. During the past decade, evidence that the progression of CKD can be attenuated by a multifactorial therapeutic approach has been increasing. However, a substantial percentage of patients with CKD will have progression to CKD stage V (ie, need for renal replacement therapy). Late referral of these patients (ie, <1 to 6 months before the start of renal replacement therapy) has been shown to be associated with higher mortality, morbidity, and costs. However, up to 64% of patients with CKD are still referred late. This review presents the available data on the epidemiology, causes, and consequences of late patient referral. Furthermore, it offers information to prevent late referral, improve CKD patient care, and change clinical practice.     

慢性肾脏病患者门诊治疗依从性调查及影响因素分析

目的探讨慢性肾脏病患者门诊治疗依从性及其影响因素。方法采用问卷调查的方法采集了96例门诊治疗的慢性肾脏疾病患者的资料,采用前瞻性研究方法了解慢性肾脏病患者的依从性及影响用药依从性的因素,并观察其预后及转归。结果慢性肾脏病门诊治疗的患者依从性普遍偏低,56%的患者依从性差,23%的患者依从性好。依从性好的患者随访6月后,好转或稳定为86.4%,恶化或死亡为13.6%;而依从性差的患者随访6月后好转或稳定为52.2%,恶化或死亡为48.0%。患者依从性与患者年龄、受教育程度、经济收入、治疗状况等有关。结论慢性肾脏病患者门诊治疗依从性普遍偏低,与多种因素有关,其依从性与其预后有关系。因此对患者给予合理有效的指导,可能对延缓慢性肾衰的进展具有重要的现实意义。     

Disorders of calcium metabolism

Hypocalcaemia not associated with hypoalbuminaemia or 25(OH)-Vitamin D deficiency is rare and should be referred to a specialist clinic. 25(OH)-Vitamin D deficiency can often be treated safely by GPs, unless it is associated with renal impairment and secondary hyperparathyroidism, in which case a nephrology referral is required. An endocrine referral is required if deficiency is associated with pregnancy, co-existent primary hyperparathyroidism or the patient is receiving warfarin. The key role of the GP in managing hypercalcaemia is to distinguish between malignant and parathyroid causes in order to make the appropriate specialist referral (oncology, endocrine or renal). Severe hypercalcaemia (greater than 3.5 mmol/L or hypercalcaemia with dehydration, abdominal pain or reduced consciousness is a medical emergency.     

Identification, management and referral of adults with chronic kidney disease: concise guidelines

Chronic kidney disease (CKD) is often thought to be a relatively rare condition requiring specialist care. However, early CKD is common and referral of all patients would completely overwhelm existing specialist services. The purpose of this concise guidance is to inform general physicians and general practitioners about the identification and management of CKD, and who to refer for specialist care.     

Quality of chronic kidney disease management in primary care: a retrospective study

Background: Early detection and appropriate management of chronic kidney disease (CKD) in primary care are essential to reduce morbidity and mortality. Aim: To assess the quality of care (QoC) of CKD in primary healthcare in relation to patient and practice characteristics in order to tailor improvement strategies. Design and setting: Retrospective study using data between 2008 and 2011 from 47 general practices (207 469 patients of whom 162 562 were adults). Method: CKD management of patients under the care of their general practitioner (GP) was qualified using indicators derived from the Dutch interdisciplinary CKD guideline for primary care and nephrology and included (1) monitoring of renal function, albuminuria, blood pressure, and glucose, (2) monitoring of metabolic parameters, and alongside the guideline: (3) recognition of CKD. The outcome indicator was (4) achieving blood pressure targets. Multilevel logistic regression analysis was applied to identify associated patient and practice characteristics. Results: Kidney function or albuminuria data were available for 59 728 adult patients; 9288 patients had CKD, of whom 8794 were under GP care. Monitoring of disease progression was complete in 42% of CKD patients, monitoring of metabolic parameters in 2%, and blood pressure target was reached in 43.1%. GPs documented CKD in 31.4% of CKD patients. High QoC was strongly associated with diabetes, and to a lesser extent with hypertension and male sex. Conclusion: Room for improvement was found in all aspects of CKD management. As QoC was higher in patients who received structured diabetes care, future CKD care may profit from more structured primary care management, e.g. according to the chronic care model.

• Key points

• Quality of care for chronic kidney disease patients in primary care can be improved.

• In comparison with guideline advice, adequate monitoring of disease progression was observed in 42%, of metabolic parameters in 2%, correct recognition of impaired renal function in 31%, and reaching blood pressure targets in 43% of chronic kidney disease patients.

• Quality of care was higher in patients with diabetes.

• Chronic kidney disease management may be improved by developing strategies similar to diabetes care.

     

三种CKD-EPI公式在女性慢性肾病人群中估算肾小球滤过率的比较

目的评价在我国女性慢性肾病(CKD)患者人群中3种CKD-EPI公式计算肾小球滤过率估算值(eGFR)的性能。方法将2010年1月至2015年1月在江苏省中医院肾内科住院的女性CKD患者75例纳入本研究,收集患者的一般资料、血清肌酐(Cr)水平、血清胱抑素C(CycC)水平和99 mTc-DTPA肾动态显像资料。以99 mTc-DTPA肾动态显像法所测肾小球滤过率(GFR)为金标准,用3种CKD-EPI公式(EPI_(Scr)、EPI_(CysC)和EPI_(Scr-CysC))估算eGFR,比较3种公式的偏倚、准确性和95%一致性范围。结果整体公式性能比较,偏倚方面三种公式绝对偏倚比较差异无统计学意义(P0.05);准确度方面:相对偏倚在±30%范围内百分率,CKD-EPICysC与CKD-EPI_(Scr)公式间比较差异有统计学意义(66.67%vs.56.00%,P0.05);一致性方面:BlandAltman散点图显示,CKD-EPI_(Scr-CysC)、CKD-EPI_(Scr)、CKD-EPI_(CysC)公式的95%一致性范围分别为(-33.0%,36.1%)、(-38.4%,35.7%)和(-33.7%,36.6%)。CKD早期,偏倚和准确度方面三个公式比较差异无统计学意义(P0.05),一致性方面:CKDEPI_(Scr-CysC)、CKD-EPI_(Scr)和CKD-EPI_(CysC)公式的95%一致性范围分别为(-33.5%,36.9%)、(-39.0%,36.4%)和(-34.3%,37.5%)。结论尽管CKD-EPI_(Scr-CysC)公式在评估中表现最为优秀,但三种CKD-EPI公式性能差异并不十分明显,在临床实际中仍需综合考虑。     

Palliative care in advanced kidney disease: a nurse-led joint renal and specialist palliative care clinic

The National Service Framework for Renal Services Part 2 identifies quality requirements for end-of-life care for individuals with kidney failure, recognizing the potential to forge closer relationships between renal and specialist palliative care providers. This article describes a pilot project set up by two Clinical Nurse Specialists, one working in hospice specialist palliative care and the other in renal palliative care within an acute trust. The purpose of the pilot was to work in collaboration to run a streamlined nurse-led clinic that would meet the palliative care needs of chronic kidney disease (CKD) Stage 5 patients and their carers. To achieve this the clinic would have to provide optimal symptom management, empower patients to make their own choices, and support them with advance care planning underpinned by the End of Life Care Strategy. The partnership also aimed to promote service improvement and practice development using transference of knowledge, skills, and expertise. Initial informal feedback, including a very small patient survey, suggests that the clinic was well received by patients, carers, and other health professionals. The clinic is ongoing and deserves more formal evaluation to encourage future service development.     

The benefits of IV iron therapy in treating anemia in patients with renal disease and comorbid cardiovascular disease.

It is important for nephrology nurses to understand the relationship that exists between renal disease, cardiac disease, and anemia. Even mild cases of chronic kidney disease (CKD) have been associated with an increase in adverse cardiovascular outcomes. And anemia, which can result from both CKD and congestive heart failure, has been shown to exacerbate the adverse consequences of these conditions. An early, aggressive correction of anemia in patients with CKD can be implemented to break this cycle and stop disease progression. Studies have shown that anemia correction improves both cardiac and renal function and can result in increased hemoglobin levels, decreased number of hospital days, and improved quality of life. An effective strategy for managing anemia in patients with renal disease and comorbid cardiovascular disease includes the administration of both recombinant human erythropoietin and intravenous iron. In addition, the nephrology nurse plays an integral role in managing anemia and improving outcomes in these patients. Therefore, the nephrology nurse should have an increased awareness of the link between anemia and renal/cardiac disease as well as available treatment options.     

Can intensive treatment alter the progress of established diabetic nephropathy to end-stage renal failure?

Diabetic nephropathy is now the leading cause of end-stage renal disease in the Western world, and is associated with a higher patient morbidity and mortality than other causes of renal failure, largely because of associated cardiovascular disease. Numerous studies have elucidated the factors which influence its onset and progression. The St Vincent Declaration in 1994 proposed standards for the appropriate management of patients with diabetic nephropathy. We assessed whether referral to a nephrology clinic attempting to apply these standards influenced the progression of diabetic nephropathy. The results show a significant improvement in blood pressure, glycosylated haemoglobin and serum cholesterol following referral. There was a significant reduction in the rate of decline of renal function following referral in 39% of patients. With the possible exception of diabetic control there were no significant differences in the management of those that did and did not show improvement. The results show that with intensive out-patient clinic monitoring it is possible to improve the quality of patient care, and that even in established diabetic nephropathy it is possible to slow the rate of progression to end-stage renal failure.     

Assessment for chronic kidney disease service in high-risk patients at community health clinics

BACKGROUND: Chronic kidney disease (CKD) poses significant public health concerns. Early identification and interventions can help prevent or slow progression to end-stage renal disease. OBJECTIVE: To characterize CKD in high-risk indigent patients in a primary care setting and evaluate opportunities for pharmacists to work collaboratively with physicians to improve medication use and CKD patient outcomes. METHODS: Medical records of 200 patients with diabetes mellitus and/or hypertension were reviewed by the clinical pharmacist. Estimated glomerular filtration rate (creatinine clearance [Cl(cr)]) and urinalysis were used to identify and stage CKD according to published guidelines. Glycosylated hemoglobin concentrations and blood pressures were recorded. The pharmacist evaluated medications for possible drug-related problems (DRPs), made therapeutic recommendations, and evaluated the acceptance rate by physicians. RESULTS: One hundred nineteen patients met inclusion criteria, and a total of 68.9% met CKD criteria: stage 1, 16.0%; stage 2, 20.2%; stage 3, 25.2%; stage 4, 1.7%; stage 5, 0.8%; and not stageable, 5.0%. A total of 381 DRPs were identified, averaging 3.2 (1.7) per patient (range 0-11). The number of DRPs correlated with Cl(cr) (r = -0.25; p = 0.007). Therapeutic recommendations included change of drug, dose and/or interval adjustment of the current drug, discontinuation of nonsteroidal antiinflammatory drugs, additional laboratory monitoring, meeting goal blood pressure and glycosylated hemoglobin, adding renoprotective drug and/or low-dose aspirin, and nephrologist referral. Fewer than half (40.9%) of the recommendations were accepted or accepted with modifications, and an approximately equal percentage were not accepted by the physicians. CONCLUSIONS: CKD prevalence was high among the patients evaluated here. New guidelines are available to assist in managing CKD ambulatory patients. Pharmacist collaboration with physicians may optimize CKD screening in high-risk patients and improve medication usage.     

Online mentoring: ANNAConnections.

As the number of patients with chronic kidney disease (CKD) rises exponentially, there is an increased demand for nephrology nurses with expertise in all areas of practice. At this time of a serious nursing shortage, professional associations are needful of members able to assume leadership positions and prepare the organizations for the future. Novices to nursing, to nephrology or to leadership present a challenge to all areas of practice, from CKD clinics to dialysis units to transplant units, and to the maintenance and growth of professional associations. The purpose of this article is to introduce an innovative mentoring program that allows facilitation of the growth and development of nephrology nurses from novice to expert in multiple areas of career or leadership development.