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Targeted Literature Review of the Burden of Illness in Patients With Chronic Kidney Disease and Type 2 Diabetes
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Objectives: Chronic kidney disease (CKD) is increasingly prevalent among patients with type 2 diabetes (T2D). CKD is associated with increased mortality rates, clinical and humanistic burden, and substantial health care costs in the T2D population. The objective of this review was to summarize the burden of illness among patients with CKD and T2D, including the profile of patients, incidence, prevalence, mortality, progression, diagnosis and screening rates, and cardiovascular (CV) events.
Methods: A targeted literature review of published studies was conducted using Embase; Medline; Medline In-Process Citations, Daily Update, and Epub Ahead of Print; Igaku Chuo Zasshi databases; and 7 websites. Methods recommended by the Cochrane collaboration handbook, the Centre for Reviews and Dissemination, and the Joanna Briggs Institute critical appraisal checklist were employed.
Results: A total of 1290 full-text articles were reviewed for eligibility and 73 were included in this analysis. Patient profiles indicated older age was associated with more severe disease and number of comorbidities. The definition of kidney disease varied between studies reporting incidence and prevalence, with reported values up to 37.0% and 43.5% for incidence and prevalence, respectively. CKD among patients with T2D contributed to higher mortality rates. Higher disease progression rates were associated with higher albuminuria and lower estimated glomerular filtration rate levels. The available literature suggested annual screening rates for CKD declined over time. CV events were reported to have a substantial effect on morbidity and resource use.
Conclusions: This review highlights the burden of CKD among patients with T2D and underscores a need for new treatment alternatives to reduce the burden of disease.
Am J Manag Care. 2021;27(suppl 8):S168-S177. https://doi.org/10.37765/ajmc.2021.88660
For author information and disclosures, see end of text
Introduction
The Kidney Disease Improving Global Outcomes 2011 reportdefines chronic kidney disease (CKD) as an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2 or a urinary albumin to creatinine ratio (UACR) of greater than 30mg/g.1 As the disease progresses, persistent albuminuria, hypertension, and deterioration of renal function are observed. CKD can be classified based on level of kidney function, or eGFR, and the amount of protein in the urine. The lower the eGFR level (G1-G5) and the higher the albuminuria (A1-A3), the more severe the disease. Therefore, CKD is characterized by a gradual loss of kidney function and the frequent cooccurrence of other complications, including cardiovascular (CV) events, kidney failure requiring renal replacement therapy, mortality, and poor quality of life for survivors.2,3
Kidney damage from diabetes is also called diabetic kidney disease (DKD) or diabetic nephropathy. 4 CKD is among the most severe complications of type 2 diabetes (T2D), making up the most significant contribution to the global CKD burden, with a heavy weight on the Western world.5 CKD occurs in 20% to 40% of patients with diabetes, and it can progress to end-stage renal disease (ESRD) that requires dialysis or kidney transplantation.6 Approximately 85% to 95% of all cases of diabetes are T2D, and diabetic nephropathy is the most frequent cause of ESRD in most countries.4 Moreover, among patients with diabetes, the presence of CKD markedly increases CV disease (CVD) risk.
Currently, treatment strategies focus on treating the underlying cause of kidney disease, controlling blood pressure, preventing CVD, slowing the progression of renal disease, and preventing death, creating an accumulation of patients with mid- to late-stage disease.7 Antihypertensive treatments that target the renin-angiotensin-aldosterone system (RAAS), such as angiotensin-converting-enzyme inhibitors (ACEIs) and angiotensin-receptor blockers (ARBs), have been shown to reduce proteinuria and delay disease progression.8-10
The current standard of care in the treatment of patients with CKD and T2D includes RAAS blockers; namely, ACEIs and ARBs in patients with hypertension and albuminuria,3,6 as well as sodium-glucose cotransporter-2 inhibitors, which are emerging treatment options based on results from recent clinical trials.11,12
Medical costs associated with CKD in T2D increase substantially as the disease progresses to a more severe stage.13 In 2017, total CKD in T2D-related expenditures in the US Medicare population were approximately $21.5 billion.14 Analysis of data collected in 2012 to 2017 revealed that patients with T2D and CKD at stage 4 or 5 had substantially higher medical costs compared with those with earlier stages of CKD. Each 1 mL/min/1.73m2 lower eGFR (starting from 30 mL/min/1.73m2) was associated with an increase of $1870 in all-cause total medical costs and $1805 of all-cause nondrug medical costs per patient.13 Data from 2016 and 2017 showed that annual mean medical costs per patient grew exponentially with increasing stages of CKD across all subgroups of patients with different comorbidities.15
In addition to the substantial economic burden, patients with CKD and T2D have a high burden of disease and remain at a high risk of associated complications. The objective of this review is to summarize the evidence available from studies that report the burden of illness among patients with CKD and T2D. This literature review aimed to present the evidence on the profile of patients, incidence, prevalence, mortality, progression, diagnosis and screening rates, and CV events among the specified populations.
Methods
There is no defined standard or accepted methodology for conducting a targeted literature review; therefore, the initial stages of this review (ie, literature searching study selection, data extraction, and risk of bias assessment) followed methods recommended by the Cochrane collaboration handbook16 and the Centre for Reviews and Dissemination17 to reduce the risk of bias and errors.
The search was performed in Embase, Medline, Medline In-Process Citations, Daily Update and Epub Ahead of Print, and Igaku Chuo Zasshi databases. Additionally, websites of the National Health Service, National Institute for Clinical Excellence, Guidelines International Network, National Guidelines Clearinghouse, FDA, European Medicines Agency, and Haute Autorité de santéwere searched. Abstracts and full texts were screened by 2 independent reviewers to select relevant articles based on the inclusion criteria.
The review focused on the largest studies and the most recently published study results at the time of the literature review (March 2021). Studies were selected to cover all countries of interest (Canada, China, France, Germany, Italy, Japan, Spain, United Kingdom [UK], and United States). Studies with limited applicability due to highly selected population (eg, veterans; a single sex) and studies reporting minimal data were also excluded.
Data from included studies were extracted using templates created in Excel. One reviewer extracted the data while another validated the accuracy of the extracted information. A quality assessment was undertaken by using the Joanna Briggs Institute critical appraisal checklist for studies reporting prevalence data.18
Results
After removing duplicate studies, 20,878 records were identified, which were subjected to title and abstract screening. Of these, 1290 were selected to be checked at the full-paper stage. After the full-paper screening, 1217 additional records were excluded. Overall, after the study selection process and reference checking, 73 studies were included in the present targeted literature review. The study selection process is depicted in the Figure. The list of studies included in the review, along with reported variables, are presented in Table 1.19-125
Profiles of Patients With CKD and T2D
The demographic and comorbidity profiles of patients with CKD and T2D were presented in 9 studies, providing adequate descriptions of eGFR and albuminuria.19-26 Older age was associated with more severe disease and frequent comorbidities. Additional details regarding patient profiles are presented in Table 2.19-26,35
Diagnosis and Screening Rates
There was a general lack of information about the rates of screening for and diagnosis of CKD in patients with T2D. No studies about rates of diagnosis were identified, and 3 studies reported information about screening rates.27-29 The results of a UK study indicated that in the T2D population, annual screening rates decline over time, with a rate of 75.6% at 1 year after the start of the diabetic treatment, stabilizing at around 57% after 5 years.28 However, a study from Germany revealed that only 15.3% of patients underwent eGFR testing at least once in 2016.27
Incidence
The definition of kidney disease associated with T2D varied among studies that reported incidence rates. When defined as the presence of an urine albumin test indicating microalbuminuria or macroalbuminuria or as a diagnosis of ESRD, dialysis, or renal replacement therapy, the 1-, 3-, and 5-year incidence of developing diabetic nephropathy were estimated at 5.3%, 12.3%, and 14.7%, respectively (data from United States).30 Similar results were obtained in a study that was conducted in China. Throughout a median follow-up period of 7.2 years, 19.7% of patients developed CKD, defined as stage 3 and above based on eGFR level; the incidence rate ranged from 21.5 to 54.4 per 1000 person-years, depending on the level of glycated hemoglobin (A1C).31 During a 4-year follow-up in another study, 37% of patients developed DKD (defined as diabetes with albuminuria, low eGFR, or both), 16% developed low glomerular filtration rate, and 27% developed albuminuria; of note, all patients had hypertension at baseline.32 Lower incident rates of CKD defined similarly were reported in a study in the UK (The Health Improvement Network), in which the incidence rate ranged from 4.23 to 14.39 per 1000 patient-years.33
According to data from the included studies, the overall incidence rate of ESRD ranged from 3.48 to 22.46 per 1000 patient-years and was found to be associated with age, race, level of A1C, duration of diabetes, level of blood pressure, glycemic and lipid control, and retinopathy or macrovascular complications at baseline.31,34
Prevalence
Diabetes affects more than 400 million people worldwide, and the prevalence is growing rapidly, especially for T2D. T2D is associated with a high risk of microvascular and macrovascular complications including CKD and CVD.35 The definition of kidney disease associated with T2D varied among the included studies reporting prevalence rate, and data should be interpreted with caution. The prevalence of decreased eGFR in the T2D population (< 60 mL/min/1.73m2), regardless of albuminuria, ranged from 19.6% in Canada35 to 29.6% in Italy.36 The prevalence of albuminuria (UACR > 30 mg/g) ranged from 15.4% in Spain22 to 38.8% in China.37 The prevalence of decreased eGFR and albuminuria was lower and ranged from 7.8% to 10.3% in Italy38 and the United States,39 respectively. In Italy, the prevalence was reported for different phenotypes: 18.9% for albuminuric DKD with preserved eGFR and 7.9% for albuminuric DKD with reduced eGFR. The prevalence of diabetic nephropathy in patients with T2D in China was 30.9% (defined as albuminuria category 2, UACR 30-299 mg/g) and 7.9% (defined as albuminuria category 3, UACR ≥ 300 mg/g). The prevalence of DKD (defined as albuminuria or decreased eGFR) among patients with T2D in Japan was 43.5%. The prevalence of DKD (defined as G3-G5< 60 mL/min/1.73m2) in T2D in the UK was 37.2%. The prevalence of CKDin patients with T2D in Brazil was 31.5%. The prevalence of CKD (defined as albuminuria or decreased eGFR) in patients with T2D in Canada was 33%. Among included studies, the prevalence of ESRD among patients with T2D seems to not exceed 1%.34,40,41
Mortality
The results of the identified studies demonstrated that the higher prevalence of kidney disease among patients with T2D contributes to the high mortality rates among this population.42 In a study conducted in United States based on the third National Health and Nutrition Examination Survey among individuals with both T2D and kidney disease, the standardized 10-year mortality rate was 31.1% (95% CI, 24.7%-37.5%), whereas a rate of 11.5% (95% CI, 7.9%-15.2%) was reported among patients without kidney disease. The same pattern was observed for CV mortality; the standardized 10-year mortality was estimated at 6.7% (95% CI, 4.2%-9.1%) and 19.6% (95% CI, 14.7%-24.4%) among patients with diabetes without CKD and with CKD, respectively.39 Similar results were obtained in 2 other studies.25,43 In China, the results of a multivariable analysis showed that CKD was associated with an increased risk of all-cause death and CV death (HR, 1.63; 95% CI, 1.38-1.93 and HR, 1.54; 95% CI, 1.20-2.13, respectively).43 These results were confirmed by a study conducted in the UK, showing that the combination of reduced eGFR with increased UACR was associated with a higher risk of premature death (21.7 per 1000 person-years; 95% CI, 19.8-23.7) compared with patients who had reduced eGFR and normal albumin-to-creatinine ratio levels (19.5 per 1000 person-years; 95% CI, 17.0-22.4).25 Additionally, according to results of a study conducted in Japan, the incidence rate of death was higher in patients with reduced eGFR (< 60 mL/min/1.73m2) than those with greater eGFR (≥ 60 mL/min/1.73m2).21 Those with more severe kidney disease (eGFR < 60 mL/min/1.73m2) were characterized by a mortality rate ranging from 7.7 to 11.8 per 1000 person-years, whereas the rate for those with less-advanced kidney disease (eGFR ≥ 60 mL/min/1.73m2) ranged from 1.3 to 4.8 per 1000 person-years.21,44
CKD Progression
Most of the studies reported disease progression among patients with CKD and T2D as progression to ESRD, change in eGFR, or change in albuminuria occurred. It was found that higher levels of albuminuria at baseline significantly increased the risk of progression of eGFR-based kidney dysfunction.21,30,45 Additionally, patients with albuminuria were more likely to require dialysis in the future(HR, 4.23; 95% CI, 2.45-7.30; P < .05; and HR, 40.1; 95% CI, 25.3-63.6; P < .05 for micro- and macroalbuminuria, respectively).30
In a study conducted in the United States, the progression rate from stage G1 to G5 increased from 0.8 to 8.8 per 1000 person years among patients with albuminuria levels from A1 to A3, respectively.45 In another study, the progression rate was reported as 25.8, 74.2, and 78.2 per 1000 person-years for eGFR stages G1 and G2 (progression to stages G3-G5), G3 (progression to stage G4-G5), and G4-G5 (progression to ESRD), respectively (stage of albuminuria was not reported).46 In Japan, at an eGFR stage of G3 to G5, the crude progression rate to renal replacement therapy at A1, A2, and A3 albuminuria stages were 0.0, 1.9, and 87.8 per 1000 person-years, respectively.21
CV Complications
The results of several studies demonstrated the risk of CV events among patients with CKD and T2D and highlighted the substantial effect of these conditions on morbidity and resource use. Although the methods varied considerably among the studies in terms of duration of follow-up and CV events that were evaluated, collective data from 5 studies showed an association among the stage of CKD (based on eGFR level or albuminuria) and incidence of CV events. The results from these studies showed that the risk of CV events progressed with CKD stage.5,25,36,43,47,48
In China, it was found that the risks of coronary heart disease, stroke, or heart failure increased exponentially with the decrease in eGFR, with the HR increasing from 1.63 to 4.55, associated with stage G3 to G5 CKD, compared with stage G1 CKD.43 Additionally, the level of albuminuria showed a positive linear association with CV events. Microalbuminuria among men and women was associated with an HR of 1.58 and 1.48 for CV events, respectively, compared with normoalbuminuria.43 Similar results were obtained in 2 other studies.36,47 Results from a single study showed that a lower eGFR was associated with an increased risk of both myocardial infarction (HR increasing from 1.27-2.34 among patients with CKD stage G3-G5, respectively) and ischemic stroke or transient ischemic attack (HR increasing from 1.09-1.78 among patients with CKD stage G3-G5, respectively) compared with stage G1 to G2 CKD.47 In Italy, eGFR was found to be a risk factor for the development of CV events (including myocardial infarction and congestive heart failure) in patients with T2D of over 4.5 years’ duration.36
Discussion
This review highlights the burden of CKD among patients with T2D. The prevalence of CKD in patients with T2D has increased over the past 2 decades.49 In part, this is an effect of the improved management of CV complications, resulting in increased life expectancy among these high-risk patients.50 Moreover, the occurrence of CKD is expected to increase among patients with T2D, owing partially to an increase of the median age of the worldwide population, as well as the growing global prevalence of T2D.
CKD progression is associated with a range of complications, including increased risk of infections, anemia, pruritus, CVD, peripheral arterial disease, CV events, and all-cause mortality. In patients with T2D, the presence of CKD is clinically important given its effect on health care resource utilization and costs of care, as well as the burden of disease and reduction in health-related quality of life. In the late stages of CKD, patients may progress to ESRD, which requires renal replacement therapy via dialysis or kidney transplantation.
This review provides information regarding incidence and prevalence of CKD worldwide, as well as the current unmet needs for those with disease progression. In patients with T2D, CKD results in frequent complications and increased mortality; therefore, prevention and early, effective management of disease are the main challenges in clinical practice. Slowing the progression of CKD to ESRD is an urgent medical objective, and, unfortunately, it is still a major unmet need for patients with T2D. In patients with T2D, CKD is strongly associated with CVD, so the management of CV risk factors and careful monitoring of eGFR and albuminuria may represent opportunities to reduce the risks of CV events and mortality.
Limitations
There are 2 main limitations of this review. First, it was designed as a targeted literature review and, although the methods for conducting systematic reviews in health care are well established, there is no standard or accepted methodology for the conduct of a targeted literature review. Therefore, a structured method with the aim of providing a transparent and reproducible process was developed and reported; we believe that our methods could be applied to increase the quality and credibility of targeted reviews in general. Although the approach is resource intensive, it represents the optimal strategy for reviewing large volumes of diverse data and producing a usable, readable overview. To ensure that this review would reflect current disease epidemiology and management, high-quality studies published in 2013 and after with large sample sizes that cover most outcomes of interests were included. The presented approach has resulted in reliable knowledge about the burden of CKD in T2D in the selected countries. Additionally, a quality assessment of all included epidemiological studies was performed using the Joanna Briggs Institute critical appraisal checklist for prevalence studies, in the absence of other validated tools.
Second, it is important to highlight that most of the identified studies were not designed to address the research questions defined for this review. For example, many studies focused on patients with T2D and reported the prevalence or incidence of CKD among them, limiting the details on CKD in T2D population. Another example is that the studies included different study populations as different definitions of kidney disease associated with T2D were used in the inclusion criteria (eg, CKD, DKD, diabetic nephropathy, ESRD, microalbuminuria, macroalbuminuria, proteinuria, dialysis, etc). Although this limited the comparability of results among studies, it ensured identification of all relevant studies about patients with renal complications of diabetes, regardless of the definition used by the authors.
Conclusions
This review of the burden of CKD in patients with T2D provides an overview of the latest estimates of incidence, prevalence, mortality, disease progression, and CV complications among patients, as well as information from the most up-to-date treatment guidelines. CKD is increasingly prevalent among patients with T2D; it progresses rapidly and is associated with increased mortality, with a large clinical and humanistic burden of disease, and with vast health care costs.
Thus, identification, prevention and early management of disease are critical. Slowing the progression of CKD, in particular to ESRD, is an urgent therapeutic challenge and, unfortunately, remains a major opportunity for patients with T2D. There is a need for new treatment alternatives for patients with CKD and T2D in order to reduce the burden of disease and healthcare resource utilization.
Author affiliations: Bayer AG (KF), Wuppertal, Germany; Bayer AG (PM), Berlin, Germany; Bayer PLC (KDB), Redding, UK; Creativ-Ceutical (AM) Paris, France; Creativ-Ceutical (BS), Cracow, Poland; University of Pittsburgh (LFF), Pittsburgh, Pennsylvania; University of Tennessee Health Science Center (CPK), Memphis, TN.
Funding source: This study and supplement were funded by Bayer AG.
Author disclosures: Mr Bowrin reports having employment, holding stock ownership, and institution conflict of interest with Bayer PLC. Ms Folkerts and Mr Mernagh report employment with Bayer AG. Dr Fried reports receiving payment for a consultancy with Bayer. Mr Mernagh also reports to previously and independently consulting Bayer in HEOR activities. Dr Kovesdy reports to serving as a consultant or on paid advisory boards for Akebia Therapeutics, Ardelyx, AstraZeneca, Bayer, Boehringer Ingelheim, Cara Therapeutics, Reata Pharmaceuticals, and Tricida, as well as receiving royalties for UpToDate Inc. Dr Millier and Ms Smela are employees of Creativ-Ceutical, which received funding for the conduct of this study and preparation of the manuscript.
Authorship information: Concept and design (KDB, KF, LFF, CPK, PM, AM, BS); analysis and interpretation of data (KDB, KF, LFF, CPK, PM, AM, BS); drafting of the manuscript (KDB, KF, PM, BS); critical revision of the manuscript for important intellectual content (KDB, KF, LFF, CPK, PM, AM, BS); administrative, technical, or logistical support (KDB, KF, PM); and supervision (KDB, KF, PM, AM, BS).
Address correspondence to: Csaba P. Kovesdy, MD, University of Tennessee Health Science Center, 965 Court Avenue, Room 222, Memphis, TN 38163. Email: ckovesdy@uthsc.edu.
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