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Treatments that lower urinary albumin excretion may slow progression of diabetic kidney disease (DKD) and improve clinical outcomes, even in the absence of hypertension. 1.1 Normotensive people with diabetes and macroalbuminuria should be treated with an ACE inhibitor or an ARB. 1.2 Treatment with an ACE inhibitor or an ARB may be considered in normotensive people with diabetes and microalbuminuria. This CPR addresses the evidence for treatment of normotensive patients who have diabetes and elevated albuminuria with ACE inhibitors and ARBs. The role of albuminuria change as a surrogate end point for clinical outcomes in the setting of DKD also is discussed. Relationships between glomerular structural lesions and the presence or absence of microalbuminuria in diabetes are not straightforward. Normotensive people with diabetes and macroalbuminuria should receive an ACE inhibitor or an ARB. In type 1 diabetes with macroalbuminuria, ACE inhibitors decrease albuminuria and reduce the risk of clinical outcomes regardless of the presence or absence of hypertension. In type 2 diabetes with macroalbuminuria, ARB treatment reduces the risk of clinical outcomes.
Overall, patients with diabetes, macroalbuminuria, and normal blood pressure rarely were included in the available studies. In normotensive people with diabetes and microalbuminuria, use of an ACE inhibitor or an ARB may be considered. Few studies have evaluated ACE inhibitors or ARBs for the treatment or prevention of microalbuminuria in normotensive people with type 1 diabetes. Because most people with type 2 diabetes and albuminuria have hypertension, few studies have evaluated normotensive people with type 2 diabetes and microalbuminuria. In the opinion of the Work Group, a change in albuminuria or transition between categories (normoalbuminuria, microalbuminuria, or macroalbuminuria) in normotensive people with diabetes is relatively weak evidence for change in status or prognosis of kidney disease.
Studies testing the hypothesis that albuminuria reduction predicts improved prognosis in DKD have been performed only as secondary analyses of studies of ARB treatment in people with type 2 diabetes and macroalbuminuria.210-212 In these studies, level of albuminuria reduction was a marker of decreased risk of adverse outcomes. Most studies that assessed the efficacy of ACE inhibitors or ARBs in people with diabetes and albuminuria were conducted in people with hypertension or in a mix of subjects with and without hypertension. In addition, in people with type 2 diabetes, microalbuminuria may represent early kidney injury or may be a manifestation of endothelial dysfunction and generalized vascular injury.
In normotensive people with diabetes and albuminuria, the target dose of ACE inhibitors or ARBs is unknown. Placing people with microalbuminuria and diabetes on therapy with an ACE inhibitor or ARB may lead to less attention to glycemic control. This item will be shipped through the Global Shipping Program and includes international tracking.
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All of the products MonotaRO Singapore offers are subject to Japanese local laws, regulations, and certification standards. Anemia is a serious medical condition in which blood is deficient in red blood cells (RBCs) and hemoglobin, leading to inadequate oxygen delivery to tissues and cells throughout the body. Untreated anemia is associated with chronic fatigue, increased risk of progression of multiple diseases, and death.
CKD is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body. Beyond the United States, according to a May 2013 article from The Lancet, projected worldwide population changes suggest that the potential number of cases of kidney disease, specifically end stage, will increase disproportionately in developing countries such as China and India, where the numbers of elderly people are expanding.
Injectable recombinant erythropoietin stimulating agents (rESAs), including epoetin alfa, epoetin beta, and darbepoetin alfa, are currently the standard of care for treating anemia in patients with CKD and must be administered intravenously or subcutaneously with iron supplements. Based on the reported revenues of companies that market and sell rESAs, we estimate that global sales of injectable rESAs were $7 billion in 2013, as compared to an estimated $12 billion in 2006.
In 2006, data on the risks of rESA use among these patients started to become available, forcing physicians to balance serious safety concerns against the efficacy of rESAs.
We also believe that an opportunity exists for a safer, well-tolerated alternative to replace injectable rESAs as the standard of care for anemia.
As a result of the safety concerns related to rESA use, patients have been forced to live with lower hemoglobin levels, higher rates of transfusions, and more intravenous (IV) iron use. A number of critical post-hoc analyses of the randomized controlled trials data have shifted attention from the role of normalized hemoglobin levels to the potential of dose-related toxicity of injectable rESAs in CKD patients as a contributing factor to the reported adverse cardiovascular outcomes.
The significant safety risks associated with rESAs are outlined in a black-box warning in their prescribing information. In late 2009, Amgen announced the results from the Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy, or TREAT, its large, randomized, double-blind, placebo-controlled phase 3 study of patients with CKD (not requiring dialysis), anemia, and type 2 diabetes.
In January 2010, FDA officials published an editorial in the New England Journal of Medicine noting that a number of randomized trials, including TREAT, had attempted to show that using injectable rESAs to raise hemoglobin concentrations to higher targets improves clinical outcomes, but instead suggested the opposite.
In February 2010, the FDA required that injectable rESAs be prescribed and used under a REMS to ensure the safe use of the drugs.
In June 2011, the FDA cited increased risks of cardiovascular events as a basis for more conservative dosing guidelines for use of injectable rESAs in CKD patients and announced related changes to injectable rESA labeling.
We believe there is now substantial evidence to suggest that EPO level, not hemoglobin, is the cause of the safety issues in the above trials. We are developing our lead product candidate, vadadustat, to be a best-in-class hypoxia inducible factor-prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anemia secondary to CKD. The increasing incidence of diabetes in children, young adults, the elderly, and members of disadvantaged and transitional populations is responsible for an increasing incidence of DKD in these groups. 3.1 Screening and interventions for diabetes and CKD should focus on populations at greatest risk. 3.2 Although management of diabetes and CKD in special populations should follow the same principles as management in the majority population, there are special considerations in the treatment of children, adolescents, and the elderly. 3.3 Population-based interventions may be the most cost-effective means for addressing the burden of CKD in special populations. 3.4 Specialists in high-risk pregnancy and kidney disease should co-manage pregnancy in women with diabetes and CKD.
3.5 Treatment of DKD with RAS inhibitors before pregnancy may improve fetal and maternal outcomes, but these medicines should be discontinued as soon as a menstrual period is missed or after a positive pregnancy test. 3.6 Insulin should be used to control hyperglycemia if pharmacological therapy is necessary in pregnant women with diabetes and CKD.
This CPR addresses 4 distinct, but overlapping, groups with diabetes and CKD: children and adolescents, pregnant women, the elderly, and members of disadvantaged and transitional populations. In the United States, the burden of diabetes and CKD is borne disproportionately by ethnic and racial minorities.
This CPR describes the burden of diabetes and CKD in special populations and suggests strategies for improving care in these highly susceptible groups. The global burden of diabetes is expected to double between 2000 and 2030, with the greatest increases in prevalence occurring in the Middle East, sub-Saharan Africa, and India.19 Much of this increase will be driven by urbanization and the increase in the population older than 65 years. Special populations may demonstrate different patterns of comorbid conditions and a different course of CKD than the majority population. Higher rates of non-DKD in people with diabetes have been documented in Zuni Indians508 and Aborigines,509 emphasizing the importance of a careful diagnostic evaluation in patients with diabetes from high-risk groups. Children and adolescents should be referred to a registered dietitian experienced in managing diabetes and CKD in this age group.
Elderly people with diabetes and CKD often have a number of comorbidities, particularly CVD, as well as cognitive and functional impairments. The greater frequency of comorbid conditions in the elderly with diabetes is responsible for a greater prevalence of elevated albuminuria unrelated to DKD.
The presence of microalbuminuria in pregnant women with type 1 diabetes increases risks of adverse maternal and child outcomes, including preeclampsia and preterm delivery. Case-control and cohort studies involving more than 1,300 pregnant women with type 1 diabetes were reviewed to identify adverse maternal and child outcomes in pregnancies complicated by both diabetes and CKD (Table 52) and the predictors of these adverse outcomes (Table 53). Albuminuria in pregnant women with type 1 diabetes does not increase the risk of worsening of DKD unless kidney function also is impaired. Due to the increasing prevalence of type 2 diabetes in younger women, some may become pregnant after the development of kidney disease.


Recommendations regarding the medical management of hypertension, hyperglycemia, dyslipidemia, and nutrition in pregnant women with diabetes and CKD are outlined in Table 54. ACE inhibitors and ARBs should be stopped at the first indication of possible pregnancy in women with diabetes and CKD. Treatment of hypertension should follow the guidelines adopted by the American College of Obstetrics and Gynecology.533 Because antihypertensive therapy does not reduce the risk of preeclampsia and may cause potential harm to the fetus, hypertension should be treated cautiously. Insulin is the preferred pharmacological therapy for hyperglycemia in pregnant women with diabetes and CKD. Pharmacological treatment of lipid abnormalities during pregnancy is not currently recommended due to potential risks to the fetus.545 Nevertheless, maternal hypercholesterolemia is associated with the development of fetal atherosclerosis,546 so this recommendation may change as results of additional studies of statins and other agents during pregnancy become available.
Dietary protein intake should not be restricted during pregnancy in women with diabetes and CKD. Limitation of dietary protein in women with diabetes and CKD should be liberalized during pregnancy to ensure adequate nutrition for the fetus.
Pregnant women with diabetes and CKD stage 5 treated by kidney transplantation or dialysis should be managed according to the recommendations for earlier stages of CKD. Pregnant women with diabetes and CKD stage 5 (kidney transplantation or dialysis) have not been included in treatment studies.
Poor access to care and late referral for nephrological intervention are associated with poor outcomes in United States racial minorities.555 Improving outcomes for special populations will require not only changes in standards of clinical care, but also efforts to improve access to care for these high-risk groups. Addressing the increased burden of diabetes and CKD in developing countries where health resources are severely limited will require creativity and collaboration with public health professionals. However, most people with diabetes and albuminuria have hypertension; management of hypertension in these patients is reviewed in Guideline 3. RAS inhibition effectively reduces albuminuria progression and improves clinical outcomes in hypertensive patients with DKD, but relatively few studies, particularly of antihypertensive agents, have specifically recruited normotensive people with diabetes and elevated albuminuria.
In addition, intrapatient variability in albuminuria measurements is large, and there is controversy about the standardization of the measurement itself. A randomized controlled trial in people with type 1 diabetes and macroalbuminuria found that ACE inhibitors reduced the risk of the combined outcome of doubling of serum creatinine level, CKD stage 5, and death.168 A quarter of the participants were normotensive.
Therefore, evidence for ACE-inhibitor or ARB treatment in these patients was considered moderate to weak. Hazard Ratios for CVD and Heart Failure End Points as a Function of Percent Change in 6-month Albuminuria in the RENAAL trial. Observational analyses from the RENAAL trial found that the magnitude of albuminuria reduction predicted reduced risk of both CVD events and kidney end points (Fig 23 and Fig 24).
Interventions that reduce albuminuria or delay its increase may be promising as potential therapies for DKD. Hazard Ratios for Kidney End Points (Doubling of Serum Creatinine, CKD Stage 5, or Death) and CKD Stage 5 as a Function of Percent Change in 6-month Albuminuria in the RENAAL Trial.
Therefore, there are not abundant data to direct therapy for normotensive people with diabetes who have microalbuminuria or macroalbuminuria. In the absence of side effects or adverse events (eg, hyperkalemia), the Work Group recommends titration up to the maximum approved dose. The National Health and Nutrition Examination Survey (NHANES) 1999 to 2000 demonstrated that glycemic control has worsened in patients with diabetes and microalbuminuria, which may be caused by health care providers believing that RAS inhibition will reduce albuminuria and thus protect patients from clinical end points.484 The Work Group emphasizes the importance of glycemic control to prevent and treat albuminuria, as well as to reduce the overall risks of diabetes. Contact the seller- opens in a new window or tab and request a shipping method to your location.
You have read and agree to the Global Shipping Program terms and conditions - opens in a new window or tab. Import charges previously quoted are subject to change if you increase you maximum bid amount. Anemia has a number of potential causes, including nutritional deficiencies, iron deficiency, bone marrow disease, medications, and abnormalities in EPO production or sensitivity. This morbidity and mortality risk has been clearly shown in the CKD population, where in patients age 66 and older, anemic patients with mid-stage CKD (stage 3) have a 149% increase in cardiovascular events and patients with severe CKD (stage 4 and 5) have a 24% increase in cardiovascular events versus non-anemic patients in the same group, according to a paper published in 2006 in the peer-reviewed journal Blood. This damage can cause waste products to build up in the subject’s blood and can lead to other health problems, including cardiovascular disease, anemia, and bone disease. The prevalence and incidence of CKD is increasing in all segments of the US population, particularly in patients over 65, as shown below. This effect will be enhanced further if the trends of increasing hypertension and diabetes prevalence persist, competing causes of death—such as stroke and cardiovascular diseases—are reduced, and access to treatment improves.
Of these 2013 revenues, an estimated $3.5 billion were generated in the United States, the vast majority of which were for renal indications. The safety concerns with injectable rESA use include increased risk of cardiovascular disease as well as a potentially increased rate of tumor progression in patients with cancer.
The percentage of patients on dialysis in the United States receiving IV iron has increased from 50% in 1999 to 71% in 2011, which is consistent with the general trend of increasing IV iron.
These results were surprising at the time and contradicted the extensive body of data from observational studies that showed reduced mortality and improved health outcomes to be associated with higher hemoglobin levels.
The strongest correlation of adverse outcomes in the post-hoc analyses has been to the level of the rESA dose, not the hemoglobin level achieved.
This warning arose from numerous events highlighting the safety concerns of injectable rESAs and the responses by the FDA, as highlighted below. As part of the REMS, a medication guide explaining the risks and benefits of injectable rESAs must be provided to all patients receiving injectable rESAs for all indications, and the FDA imposed reporting and monitoring obligations on the manufacturers to ensure compliance. The collective preclinical and clinical data support a critical rethinking on the best approach to treating anemia, the appropriate and safe hemoglobin target, and the right time to initiate treatment for these patients. Implementation and evaluation of population-based interventions should take into account the heterogeneity of the populations at risk.
The latter group is made up predominantly, but not exclusively, of people from less-developed countries undergoing economic and social change and by racial and ethnic minorities in developed countries. Worldwide, populations of developing countries appear to be at greatest risk of developing diabetes and CKD during the next several decades.
Maternal and fetal outcomes among pregnant women with type 1 diabetes and CKD also are described. Countries with the highest numbers of estimated cases of diabetes in 2000 and projections for 2030 are shown in Table 50.
In populations with decreased access to care, when care is often received only late in the course of disease, the cause of kidney disease may be attributed, by default, to the most common cause in that group (eg, hypertension in African Americans510 and type 2 diabetes in American Indians) without adequate investigation. Estimated Number of Adults with Diabetes by Age Group and Year for the Developed and Developing Countries and for the World. Also, children and adolescents are more likely to revert from microalbuminuria to normoalbuminuria than adults (see Guideline 1). Statins are preferred for elevated LDL-C levels, and atorvastatin has received FDA approval for use in children and adolescents with familial hypercholesterolemia. For those who are obese, weight loss strategies should include both increased physical activity and a well-balanced diet. Therefore, the benefits of intensive risk factor management should be considered judiciously in light of these increased risks. Macroalbuminuria further increases these risks and also may increase risk of perinatal mortality. Clinically significant worsening of kidney disease is apparent only in women who already have increased baseline levels of serum creatinine and albuminuria. In the absence of data regarding pregnancy in women with type 2 diabetes and CKD, it is the opinion of the Work Group that they should be managed according to the same principles as women with type 1 diabetes and CKD because their risks are likely to be at least as great as in women with type 1 diabetes.
Based on extensive experience, methyldopa has long been considered the drug of choice by many experts. However, until such studies are available, it is the opinion of the Work Group that statins and other lipid-lowering therapies should be discontinued after a missed menstrual period or a positive pregnancy test result in women with diabetes and CKD. Therefore, in the opinion of the Work Group, strategies for the management of hyperglycemia, hypertension, and dyslipidemia may be extrapolated from the recommendations for women with earlier stages of CKD. Although there is a greater body of evidence that evaluates ACE inhibitors in type 1 diabetes and ARBs in type 2 diabetes (Table 44 to Table 46), the Work Group views their relative benefits as interchangeable for early and late stages of DKD. Many studies in people with diabetes and microalbuminuria or macroalbuminuria have targeted stabilization or reduction in albuminuria levels as surrogate end points for progression of kidney disease. For all these reasons, the Work Group concluded that the evidence for using albuminuria as a surrogate marker for clinical outcomes was not sufficiently strong to merit a guideline statement.
There was no significant difference in the treatment effect between the normotensive and hypertensive individuals.
Nevertheless, based on this limited evidence, the Work Group recommends treatment with an ACE inhibitor or an ARB in this group of patients. The Heart Outcomes Prevention Evaluation (HOPE) trial found that ramipril reduced the risk of the combined end point of myocardial infarction, stroke, or death due to CVD in people with type 2 diabetes.
211,212 Similarly, an analysis from the IDNT found that degree of proteinuria reduction corresponded to decreased kidney end points (Fig 25). However, in the opinion of the Work Group, there currently is insufficient evidence to assume that lowering albuminuria levels will necessarily lead to improvements in clinical outcomes, such as progression to CKD stage 5, CVD events, or death.


However, the consensus of the Work Group was that the benefits of ACE inhibitors and ARBs for reducing albuminuria and delaying kidney disease progression are likely to be similar among most people with diabetes and albuminuria, regardless of their blood pressure level. Given the uncertainty regarding the presence of kidney disease in subjects with microalbuminuria and the lack of clinical end points in trials of patients with diabetes and microalbuminuria, the Work Group's recommendations for use of ACE inhibitors and ARBs in normotensive people with diabetes and microalbuminuria are less strong than in those with macroalbuminuria. If you reside in an EU member state besides UK, import VAT on this purchase is not recoverable. Please check with your country's customs office to determine what these additional costs will be prior to bidding or buying. Erythropoietin (EPO), a hormonal factor primarily produced in the kidneys and liver, binds to and activates the EPO receptor on these precursor cells. Common causes of anemia due to inadequate EPO production include chronic kidney disease (CKD), age, heart failure, inflammatory diseases, cancer, and other critical illnesses.
Similarly, compared to non-anemic patients, anemia increases the mortality rate by 199% in mid-stage CKD, and 59% in severe CKD.
As CKD progresses, the combined effect of decreased RBC production from lower EPO signaling, increased rate of RBC destruction, and reduced iron availability to the bone marrow results in the increased prevalence and severity of anemia.
CKD patients are classified by the degree of their loss of kidney function as measured by the glomerular filtration rate, or GFR, and albuminuria, the protein levels in urine. Risk factors for the development of CKD include underlying disease (hypertension, diabetes, and cardiovascular disease), lifestyle factors (tobacco use and inactivity), family history, aging, and prenatal factors (maternal diabetes mellitus, low birth weight, and small-for-gestational-age status).
We believe that the decline in market revenue since 2007 is a direct result of these increased safety concerns, as well as reimbursement pressures. Following this change in labeling, the use of injectable rESAs in cancer patients has declined significantly.
Study results reportedly failed to show benefit compared to the control group with regard to composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) and composite of time to all-cause mortality or chronic renal replacement. The FDA also required Amgen to conduct additional clinical trials to explore dosing strategies to minimize hemoglobin variability, rates of change, and excursions.
In pregnant women, the presence of diabetes and CKD may adversely affect the health of both the mother and her offspring. Early intervention in these high-risk populations provides the best opportunity for reducing the morbidity and mortality associated with diabetes and CKD.
However, few studies have evaluated the benefit of treating pregnant women who have diabetes and CKD with interventions aimed at decreasing the risk of maternal and fetal adverse outcomes, and none of these studies included women with type 2 diabetes or with CKD stage 5 treated by either kidney transplantation or dialysis. Development of diabetes during the childbearing years also will increase, primarily in the developing countries (Fig 27). Nonetheless, those children and adolescents with diabetes and CKD pose a number of unique concerns. As per Guideline 5, high-protein diets (>20% of calories) should be avoided in children and adolescents with diabetes and CKD.
Because hypoglycemia and hypotension are particular concerns, less intensive goals should be considered based on individual circumstances.
Microalbuminuria increases risks of preeclampsia and preterm delivery up to 8 times.520, 521 Macroalbuminuria further increases these risks to more than 30 times522-524 (Table 52). Women and adolescent girls with childbearing potential who are treated with lipid-lowering therapies should be counseled about these risks. The scope of the evidence review did not include specific management of CKD stage 5 in pregnancy.
Accordingly, the Work Group assumes, as in Guideline 3, that a class effect exists across these agents, although several individual agents of each class have not been tested with clinical end points in kidney disease. Studies evaluating interventions aimed at reducing albuminuria primarily used ACE inhibitors and ARBs. In turn, this conclusion influenced the Work Group's interpretation of the strength of the evidence for use of ACE inhibitors or ARBs in diabetic patients who are normotensive and have either macroalbuminuria or microalbuminuria. 210 These findings raise the hypothesis that albuminuria reduction per se has beneficial effects.
Conversely, the failure to reduce albuminuria does not preclude a beneficial clinical effect on DKD from a potential intervention. The activation of the EPO receptor stimulates these cells to divide, differentiate into RBCs that contain hemoglobin, and mobilize into circulation. Successful treatment of anemia significantly improves patients’ quality of life, especially with respect to vitality, fatigue, and physical function. CKD affects more than 30 million people in the United States, and the prevalence of anemia is associated with the severity of CKD in this population. Despite the increased use of iron and rate of transfusions, patients are subject to safety risks related to these alternative treatments to injectable rESAs. Children79 and elderly people496 who are members of these populations appear to be at particularly high risk of morbidity associated with DKD.
Accordingly, specialists in diabetes and kidney disease with experience in these age groups should be involved in their care.
However, low-protein diets (<10% of calories) also should be avoided because of concerns about providing adequate nutrition for growth and development and because proof of efficacy is lacking in this age group.
Drug therapies for hyperglycemia, hypertension, and dyslipidemia can be used as in other patients with diabetes and CKD.
Macroalbuminuria also appears to increase the risk of preterm birth, small-for-gestational-age infants, and perinatal mortality independent of preeclampsia525-527 Furthermore, higher HbA1c in the first trimester of pregnancy increases the risk of major malformations (Table 53).528 Therefore, women with diabetes and CKD who are pregnant should be monitored and treated as high-risk patients. This assumption is based on consistency among studies with agents of either class and it reflects the opinion of the Work Group. Therefore, the evidence ratings in CPR 1 were downgraded from those given for corresponding statements in the KDOQI™ Guidelines on Hypertension and Antihypertensive Agents in CKD. In type 1 diabetes, withdrawal of ACE inhibition caused a rapid increase in albuminuria,208 and in type 2 diabetes, discontinuation of irbesartan in the IRMA-2 study prompted a rapid return to pretreatment levels of albuminuria in patients receiving the lower dose of irbesartan and a partial return to pretreatment levels in those receiving the higher dose of irbesartan.209 Third, few normotensive patients with diabetes and microalbuminuria have been enrolled in clinical trials of treatments for kidney disease. However, an alternative possibility is that albuminuria reduction is a marker for patients with less severe kidney and vascular disease. Hemoglobin is an iron-containing protein in RBCs that transports oxygen to, and carbon dioxide from, the tissues of the body.
In addition, patients whose anemia has been successfully treated have demonstrated lower mortality rates, less frequent hospitalization, and decreases in cardiovascular morbidity. The risks of transfusions include the development of antibodies to foreign antigens, transmission of blood-borne pathogens, impairment of venous access in patients with CKD (nondialysis), and iron overload with chronic transfusion.
Finally, among a subgroup of patients with a history of cancer at baseline, a statistically significant increase in deaths from cancer was observed in the Aranesp-treated patients compared to placebo-treated patients.
Moreover, the number of young women with diabetes who become pregnant and already have kidney disease is increasing, yet little is known about the effect of diabetes and CKD on these women or on their offspring. Data regarding treatment of hyperglycemia, hypertension, and dyslipidemia in children with diabetes and adolescents with CKD are almost nonexistent. However, drugs should be started at low doses and carefully titrated to monitor for responses and side effects.
In the opinion of the Work Group, pregnant women with diabetes and CKD should be co-managed by specialists in high-risk pregnancies and kidney disease. However, some data suggest that atenolol early in pregnancy may cause fetal growth retardation. The demonstrated benefits of RAS inhibition for reducing and stabilizing albuminuria were noted, yet in the absence of studies with clinical end points, the Work Group found this evidence insufficient to justify a higher rating. A strategy of targeting treatment of albuminuria, in addition to blood pressure and other risk factors, has not been tested prospectively in patients with diabetes. The risks of IV iron include hypersensitivity reactions, such as fatal anaphylactic-type reactions.
However, therapeutic lifestyle changes (diet, exercise, and weight loss, when appropriate) are prudent for each of these risk factors.
Long-acting calcium channel blockers or hydralazine also are considered reasonable add-on therapy.
In the opinion of the Work Group, treatment goals for glycemia in type 1 diabetes and CKD should follow the American Diabetes Association (ADA) Standards of Care for children and adolescents (Table 51).174 Given the greater risk of hypoglycemia in those with decreased kidney function, treatment goals must be carefully individualized. Diuretics usually are avoided in pregnancy, particularly when there are concerns about preeclampsia. However, if a pregnant woman with chronic hypertension has been treated with a diuretic before conception, it is not necessary to discontinue the therapy as long as there are no signs of preeclampsia. Cautions regarding the use of other oral agents in children and adolescents with diabetes and CKD are the same as those described for adults (Guideline 2, Table 22), with the exception that TZDs should not be used because of concerns about liver toxicity due to the experience with troglitazone.




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