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Current guidelines for patient care in type 2 diabetes rest on randomized controlled trials and key opinion leader opinion grounded in clinical experience. A major impetus for BG control in T2D is the associated high risk of cardiovascular (CV) disease. Another major determinant of microvascular risk, and CV risk in general, is high blood pressure (BP). Current international guidelines are based on little evidence of a relationship between BG and BP levels or of clinical outcome, beyond UKPDS data.
The BG intervention aimed at reducing HbA1c to _6.5% versus usual treatment based on local recommendations.
In the BP arm, reducing systolic BP by 5.6 mm Hg reduced the composite primary end point by 9%, with relative risk reductions of 18% in CV mortality, 14% in all-cause mortality, 18% in new or worsening nephropathy, and 21% in new microalbuminuria. In the BG arm, the benefits achieved with intensive gliclazide MR therapy are particularly instructive for T2D patient care. The ADVANCE results have shown, for the first time, that reducing HbA1c below 6.5% (ie, a level approximating the normal range) using established drugs in the routine care setting is feasible, beneficial, and safe. It is feasible in that it was achieved in all participating study centers worldwide (no intersite heterogeneity), and it was sustained for as long as the study lasted. Both intensified strategies in ADVANCE were tested during an era of general improvement in T2D care. CETP inhibition is a promising target for improving cardiovascular outcomes in patients with dyslipidemia by lowering HDL-C.
Prof John Betteridge, London, discusses the evolution of diabetes therapy, the epidemic rise in diabetes, current and emerging diabetes therapies.
CETP inhibitor TA-8995 resulted in non-ABCA1- and ABCA1-specific cholesterol efflux and contemporary preBeta-1 HDL increase.
Evolocumab was well tolerated and associated with significant reductions of atherogenic lipids compared with placebo and ezetimibe.
ACC 2016 Stephen Nicholls discusses the results of the ACCELERATE-study, in which the favourable effects of the CETP-inhibitor evacetrapib on cholesterol did not translate into any reduction in the primary endpoint. In this study, treatment with anacetrapib increased the HDL apoA-I and CETP levels by decreasing their fractional clearance rate. 1.2 An elevated ACR should be confirmed in the absence of urinary tract infection with 2 additional first-void specimens collected during the next 3 to 6 months.
2 of 3 samples should fall within the microalbuminuric or macroalbuminuric range to confirm classification. Most professional societies concerned with diabetes and kidney disease now advocate screening for microalbuminuria in patients with diabetes.34,35 These recommendations have been made although there are no conclusive data that early intervention and treatment of microalbuminuria prevents CKD stage 5 or mortality in such patients. Tests for microalbuminuria are widely available, relatively inexpensive, and easy to perform.
The sensitivity and specificity of ACR estimates are greater than 85% compared with timed urine collections.242 Some reported variation is dependent upon the method of albumin and creatinine measurement. The evidence for the usefulness of eGFR alone as a screening test for CKD in diabetes is less secure. Screening for kidney disease should begin 5 years after the diagnosis of type 1 diabetes and at the diagnosis of type 2 diabetes. Although transient increases in albuminuria in newly diagnosed type 1 diabetes are well described, it is thought that this increase represents acute metabolic perturbations and the level of albuminuria usually reverts to normal after glycemic correction.
AER has a high day-to-day variability, probably reflecting the multiple factors that can influence the appearance of albumin in the urine.36 These include such metabolic perturbations as ketosis and hyperglycemia and such hemodynamic factors as physical exercise, dietary protein intake, diuresis, and the presence of urinary tract infection. In most people with diabetes, CKD should be attributable to DKD in the presence of: (1) macroalbuminuria or microalbuminuria plus retinopathy, and (2) in people with type 1 diabetes, in the presence of microalbuminuria plus duration of diabetes longer than 10 years.
Historically, detection of macroalbuminuria was the basis of the diagnosis of DKD (Table 6). Several small series of patients with type 1 and type 2 diabetes describe cases of typical diabetic glomerulopathy with normoalbuminuria and normal or decreased GFR. Because diabetes is a common condition, coincidence with other nondiabetic CKD is relatively frequent. It is the opinion of the Work Group that in the absence of another identifiable and treatable cause of kidney disease, patients with diabetes and CKD should be treated as if they have DKD.
A kidney biopsy may be required in some patients with diabetes and CKD to determine the underlying cause of the kidney disease.
Caution should be used when administering radiographic contrast agents to patients with diabetes and CKD because their risk of RCN is higher than in those without these diseases.
RCN is identified by both a change in kidney function (eg, GFR or serum creatinine level) and the time course over which kidney function changes. Patients who develop RCN have greater mortality, both short and long term, than those who do not.293,294 Accordingly, efforts to prevent or minimize RCN should be implemented in those with diabetes and CKD. Although there is much interest in finding medicines to prevent RCN, few are known to be beneficial and none has been studied in a large population of patients with diabetes and CKD. No data are available to confirm that detection of microalbuminuria and initiation of treatment at this early stage of DKD leads to a decrease in hard end points (GFR decrease, CKD stage 5, and mortality). The current recommendations for microalbuminuria screening by the ADA34,35 do not specifically recommend use of a first morning urine sample or overnight collections.
Another limitation of this guideline relates to the classic definition of DKD according to AER, which has been used in the vast majority of treatment trials (see CPR 1). The diagnosis and staging of DKD in an individual patient should include an evaluation of other related factors. Ideally, ACR should be measured in first-void urine samples, but sometimes this may be impractical.
Metabolomics studies hold promise for the discovery of pathways linked to disease processes. Prof John Betteridge reviews the impact of various diabetic drugs on glycemic control, vascular prevention and Beta cell function. De Diabetes Educatie Service is een service van sanofi-aventis aan de medische professie en houdt u op de hoogte van actuele resultaten en ontwikkelingen op het gebied van insulinetherapie bij diabetes mellitus.
De huidige editie behandelt een gezamenlijke consensus statement van de American Diabetes Association en de European Association for the Study of Diabetes over het management van hyperglycemie bij type 2 diabetes mellitus. In deze Diabetes Educatie Service wordt eerst ingegaan op de glucose homeostase en de effecten van ongecontroleerde hyperglycemie. Welke behandeldoelen moeten we nastreven en welke therapeutische interventies passen daarbij? De American Diabetes Association en de European Association for the Study of Diabetes hebben richtlijnen bijgewerkt voor het management van de hyperglycemie in niet-zwangere volwassenen met type 2 diabetes. ADA 2016 In 360 T2DM patiënten met albuminurie werden bloed-glucosewaardes significant verlaagd met linagliptine, wat goed verdraagbaar was en geen dosisaanpassing behoeft bij risico op nierfalen.
Het congres van de European Association for the Study of Diabetes (EAD), het grootste diabetescongres ter wereld, werd in 2012 gehouden op 1-5 oktober in Berlijn. At Sanofi Diabetes, our priorities are focussed on the needs of people with diabetes around the world.
We want people to live 'beyond' diabetes, to achieve aspirations and to make the most of everyday! Det är mycket vanligt att de olika kategorierna i en skala symboliseras av eller kodas om till siffror. The most recent guidelines (2006) and update (October 2008) were a response to the emergence of new drug classes, while the rationale for patient care continues to be informed by the United Kingdom Prospective Diabetes Study (UKPDS), which was conducted in newly diagnosed type 2 diabetics recruited between 1977 and 1991 and the results of which became available in 1998.
Until 2008, not a single study had tested this recommendation in this specific, yet prevalent, setting.
Gliclazide modified release (Diamicron MR), a long-acting sulfonylurea, was used as first-line therapy in the intensive arm at a goal-appropriate dose, plus any other antidiabetic drugs, including insulin, in order to achieve the _6.5% target. Glycemic strategies are subject to debate over the intensity of glycemic control required and how best to achieve it.
In fact, BG control improved over time, in contrast to the observations made just 3 years after inclusion in UKPDS.32 Note also that weight gain, which the UKPDS data suggested was inevitable over time, was not observed in ADVANCE.
American Association of Clinical Endocrinologists Diabetes Mellitus Clinical Practice Guidelines Task Force.
Action in Diabetes and Vascular disease: PreterAx and DiamicroN MR Controlled Evaluation Collaborative Group.
In the absence of an established diagnosis, the evaluation of patients with diabetes and kidney disease should include investigation into the underlying cause(s). This definition is independent of such markers of CKD as pathological change or a decreased GFR, and it initially was confined to those now considered to have macroalbuminuria. Given the strongly positive relationship between the duration of diabetes and DKD, particularly in type 1 diabetes,231 the presence of elevated albuminuria in diabetes of short duration should raise concerns about non-DKD.


For this guideline, we included studies of people with type 1 or type 2 diabetes and CKD stages 1 to 5 regardless of whether kidney biopsies were performed. Annual incidence rates of microalbuminuria of 1% to 2% are reported consistently for both type 1 and type 2 diabetes.
Moreover, there is continuing debate around the effect of gender on the definition of normal values. Nevertheless, the ADA and other diabetes professional societies recommend annual screening for microalbuminuria based on the treatment possibilities discussed in CPR 1. Many patients with diabetes and CKD may have elevated or high-normal GFRs, particularly in the early years after diagnosis.
Because of this variability, most professional societies recommend confirmation of an elevated ACR with an additional 2 tests during the subsequent 3 to 6 months (Fig 6).34,35 To reduce variability, these repeated estimates should be performed on first-voided urinary specimens. Kidney biopsy in macroalbuminuric patients with type 1 diabetes consistently shows advanced diabetic lesions of increased mesangial volume, increased glomerular basement membrane thickness, and tubulointerstitial pathologies.228,229, 247,248 The severity of these abnormalities is related closely to the amount of albuminuria and the decrease in GFR (Table 9 and Table 10). Prevalence rates of microalbuminuria and macroalbuminuria increase after 10 years, presumably reflecting cumulative glycemic exposure (see Guideline 2).
These data bring into question the reliance on increased AER alone or in combination with GFR for diagnosis of DKD.
Accordingly, evaluation of a person with atypical features should include additional diagnostic testing in selected cases, depending on the clinical presentation. Nevertheless, the risk of RCN is higher in people with diabetes and CKD than in either condition alone.
However, the evidence for prevention of RCN in these patients is relatively limited (Table 16 and Table 17).
Table 18 summarizes the clinical trials that report results in patients with diabetes and CKD.
These guidelines and results of a number of clinical trials are described in a recent review of methods for preventing RCN.
Furthermore, the predictive value of microalbuminuria for DKD is not as high as originally considered. However, postural microalbuminuria or proteinuria may be a confounding factor, particularly in young type 1 patients. AER does not map easily to the KDOQI™ stages of CKD (Table 6) because staging is based on eGFR. Apart from albuminuria and GFR, patients should be evaluated for the presence of hypertension, poor glycemic control, dyslipidemia, and smoking. Alternatively, if a random urine specimen is abnormal, the second test could be done in a first-voided morning sample obtained within the subsequent 3 to 6 months. Cardiovascular disease (CVD) represents the leading cause of death and morbidity worldwide. Hierbij is getracht om meer duidelijkheid te scheppen in de steeds complexer wordende behandeling van diabetes mellitus type 2. Daarna wordt er een overzicht gegeven van de verschillende behandelstappen die in het consensus statement besproken worden en wordt er ook een vergelijking gemaakt met de herziene NHG-Standaard Diabetes Mellitus.
De richtlijnen zijn gepresenteerd bij de jaarlijkse meeting van de EASD in Berlijn (1-5 oktober).
Uit een fase 2b studie is gebleken dat MK-3102, een nieuwe DPP-4-remmer die eenmaal per week wordt toegediend, het HbA1c significant verlaagde bij patiënten met type 2 diabetes. Meer dan 20% van de patiënten gediagnosticeerd met coronaire hartziekte ontwikkelde diabetes.
Some of the variables, such as blood variables, can be measured by standardised, calibrated methods while others are based on subjective judgements from an expert or from the patients.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).
The Action in Diabetes and Vascular disease: PreterAx and DiamicroN MR Controlled Evaluation (ADVANCE) trial updates the UKPDS data on the control of blood glucose (BG) and blood pressure (BP) in the light of contemporary patient care.
Since the inclusion criteria did not require a given BP value, about one third of subjects were normotensive. According to the parallel, randomized, open, blinded evaluation design, the same medications were allowed in the control arm— including all sulfonylureas, with the exception of gliclazide— if required. ADVANCE, with more than 11 000 patients, is the largest ever prospective study carried out in type 2 diabetes for the prevention of vascular disease.
Nonglycemic strategies are based on the early intensified control of all other CV risk factors, in particular BP. It is beneficial in terms of microvascular prognosis, with particular respect to the kidney. BP-lowering benefit was achieved using a fixed combination of indapamide and perindopril that had already been documented as effective38,39 and safe.27 ADVANCE confirmed the suitability of this easy-to-use drug combination for protecting T2D patients from micro- and macrovascular disease, via early BP intervention. Indicators of proper patient care improved considerably during the study, irrespective of allocated treatment group. Diabetes mellitus and its degenerative complications: a prospective study of 4400 patients observed between 1947 and 1973. Studies of the rate of regression of the glomerular lesions in diabetic rats treated with pancreatic islet transplantation. Effect of 6 months of strict metabolic control on eye and kidney function in insulin-dependent diabetics with background retinopathy.
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy— a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35). Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention). Effect of intensive blood glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34).
Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38).
Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. A randomized double blind trial of Acarbose in type 2 diabetes shows improved glycemic control over 3 years (UKPDS study 44). Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROACTIVE study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. From the triumvirate to the ominous octet: A new paradigm for the treatment of type 2 diabetes.
Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Study rationale and design of ADVANCE (Action in Diabetes and Vascular disease: PreterAx and DiamicroN MR Controlled Evaluation). Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial.
Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. French medical practice in type 2 diabetes: the need for better control of cardiovascular risk factors.
Renoprotective effect of the angiotensin- receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy.
Renal insufficiency as a predictor of cardiovascular outcomes and the impact of ramipril: the HOPE randomized trial. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack.
Because women normally have lower urinary creatinine concentrations than men, their ACR values are higher for the same level of urinary albumin excretion. The Work Group supports these screening recommendations while recognizing the need for further studies to define the impact of microalbuminuria detection on hard clinical end points. Serum creatinine concentration usually increases within 48 hours of radiographic contrast administration and peaks within 7 days.


Many studies do not report incidence of RCN by the presence of diabetes and CKD, and those that do often are derived from subgroup analyses so the number of patients is small.
Studies examining the effectiveness of N-acetylcysteine, sodium bicarbonate, and hemofiltration have not specifically reported results for patients with diabetes and CKD. The American guidelines mention the use of N-acetylcysteine and other potential prophylactic drug therapies without specifically recommending these approaches.
Whether the lower predictive value is due to changes in disease natural history, improved therapies, or overestimation by the original studies is uncertain.224 However, as many as 30% to 50% of microalbuminuric patients may revert to normoalbuminuria,224, 226, 263, 264 and whether this regression is spontaneous or not cannot be determined if the patient is on ACE inhibitor or ARB treatment. Despite these limitations, it is clear that patients who are persistently normoalbuminuric tend to be at low risk of DKD, whereas microalbuminuric patients have a 3- to 4-fold increased risk.
Thus, while GFR may be elevated or within the normal range in people with elevated urinary albumin excretion, loss of GFR within CKD stage 1 may already represent DKD.
Screening for microalbuminuria in patients with type 2 diabetes, if leading to multifactorial interventions, can result in reduced risks of cardiovascular events, progression of albuminuria, and development or progression of retinopathy and neuropathy.303 Similar studies in patients with type 1 diabetes are lacking. Here we used a metabolomics approach to generate unbiased small-molecule metabolic profiles in plasma that predict risk for CVD. Het middel werd goed verdragen met een veiligheidsprofiel vergelijkbaar met dat van placebo.
De olika operationella definitionerna av fysisk belastning kan komplettera varandra i samma studie. There is a strong link between the measurement process and the choice of statistical toolbox. It also frames these data within the high vascular risk profile that applies to the vast majority of type 2 diabetics.
Thus, current guidelines for T2D care were extrapolated from data obtained in newly diagnosed T2D patients, when we now know that abruptly reducing BG in uncontrolled type 1 diabetics with established microangiopathy can accelerate microvascular lesions in the initial months5 or years6 following intervention. Participants were selected primarily on the basis of their risk profile (age, diabetes duration, and previous micro- or macrovascular disease), ie, the BG arm was essentially a secondary intervention study.
Side effects were rare, mild, and mostly expected (eg, cough was slightly more frequent in the intensive arm).
A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. 13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. The effect of irbesartan in the development of diabetic nephropathy in patients with type 2 diabetes. All these factors imply that the underlying mechanisms of albuminuria are multiple, not entirely pathology dependent, and do not fit neatly into definitions of CKD.
Because of the high prevalence of diabetes in the population, many individuals with other types of CKD also may have diabetes. Accordingly, some investigators have recommended lower ACR cutoff values for normoalbuminuria in men than women.
Accordingly, whereas screening can wait until 5 years after the onset of type 1 diabetes, the inability to establish the onset of type 2 diabetes with certainty makes screening at diagnosis mandatory. For microalbuminuria, PPVs were lower at around 45%, but NPVs were close to 100%, giving sensitivities of 100% and specificities of 46% to 62%. There also may be a nonlinearity of risk of pathological damage before achievement of full growth, but this risk may be duration dependent, rather than puberty dependent.271 Moreover, postural proteinuria may be more common during adolescence, making the diagnosis of DKD more uncertain and the recommendation for screening by using overnight urine collections especially important in this age group. Despite these limitations, several strategies have been developed that may reduce RCN risk in people with diabetes and CKD, as well as in other populations. Nevertheless, some data suggest benefit of intensive glycemic and blood pressure control in patients with microalbuminuria. The formulae estimating GFR from serum creatinine values are problematic in their application to patients with diabetes.244 Nonetheless, measures of albuminuria in combination with estimates of GFR will serve as useful guides in assessing and managing patients with diabetes and CKD. Moreover, in patients developing DKD, hypertension and dyslipidemia may be risk predictors, concomitants, or consequences. Several cost-benefit analyses of screening for microalbuminuria have been published using various models.
This article describes the role of PSCK9 in cholesterol metabolism and data on PCSK9 inhibition: A summary. The statistically important measurement levels are; categorical, ordinal, quantitative discrete and quantitative continuous data. The results confirm and extend some of the UKPDS findings and help to explain the epidemiological data,17 with a marked reduction in the prevalence of microvascular and CV risk in T2D and significant improvements in renal prognosis, CV mortality, and all-cause mortality (Figure 1). Accordingly, the term DKD refers to a presumptive diagnosis of kidney disease caused by diabetes. Therefore, markers of kidney damage are required to detect early stages of CKD; eGFR alone can detect only CKD stage 3 or worse. Thus, the presence of retinopathy in patients with type 2 diabetes and macroalbuminuria is strongly suggestive of DKD, and its absence in microalbuminuria suggests non-DKDs.
For these and other reasons, it would be incorrect in the view of the Work Group to regard the prepubertal period as risk free for the development of DKD. First, concomitant nephrotoxins (eg, nonsteroidal anti-inflammatory agents, aminoglycosides, and amphotericin) should be discontinued, if possible, before administering the radiographic contrast agent.295 Second, intravenous fluids should be administered, but caution should be used in determining the amount of fluid to avoid fluid overload.
A detailed discussion of treatment of albuminuria (microalbuminuria and macroalbuminuria) and evaluation of outcomes can be found in CPR 1. The Work Group developed a novel grid (Table 6) to combine staging by albuminuria classification and GFR, although at this time, evidence to define DKD probabilities within each box of this table is lacking.
Because DKD typically does not occur in isolation, patients with DKD should have regular surveillance for other microvascular and macrovascular complications.
These models refer mostly to type 1 diabetes and have not been confirmed prospectively in clinical trials.
Special attention should be paid to non-negative quantitative data, and to ordinal data which are very common in medicine. The study shows that lowering HbA1c below 6.5% improves microvascular prognosis without increasing the risk of major hypoglycemia, weight gain, or premature mortality.
The term diabetic glomerulopathy should be reserved for biopsy-proven kidney disease caused by diabetes.
Nevertheless, because urinary albumin excretion has an intraindividual CV of approximately 40%,36 multiple positive test results are required for classification. Although eGFR is recommended to classify patients with diabetes into stages of CKD (Table 6), some potential problems exist with the currently available estimating equations. Only a small number of patients in these series were found to have non-DKD amenable to a specific therapy, and most of those individuals had other clinical features, such as nephrotic syndrome or nondiabetic systemic illness. Care should be used in determining the appropriate diagnostic tests because administration of radiographic contrast, with or without angiography, may pose greater risks in people with diabetes and CKD than in other people. These issues are covered in more detail elsewhere in these guidelines under the sections relating to background, blood pressure control, glycemic control, lipid management, lifestyle issues, and multifactorial intervention.
International standards for measurement of creatinine and albumin should be adopted, and quality control between laboratories should be established.
In this paper the properties of the measurement levels are given and their consequences on the choice of statistical methods for description and analysis. ADVANCE also supports the use of fixed combination antihypertensive therapy, such as Preterax, to reduce BP, while recognizing that individual patient risk profiles, rather than set BP thresholds, should inform clinical decisions on antihypertensive treatment.
No cases of dementia could be attributed to treatment group allocation in ADVANCE.28 As for the BG-lowering drugs used in ADVANCE, international guidelines recommend metformin as a first-line drug in newly diagnosed T2D, combined with life-style changes. The Modification of Diet in Renal Disease (MDRD) equation, presently the most widely used estimating equation for staging CKD, has been validated in only small numbers of patients with diabetes and CKD,243 and other equations may provide better estimates of GFR in these patients.244 An NIH-sponsored study currently is ongoing with the purpose of developing a new equation derived from multiple databases along with extensive calibration studies to ensure generalizability throughout the entire range of GFRs. Because of the clinical difficulty accurately determining the onset of type 2 diabetes, known duration is less strongly related to DKD.
There should also be standardized reporting of ACRs with internationally agreed-upon categorical definitions.
Tier 2 therapy includes TZDs, GLP-1 agonists, and other drugs.15 Sulfonylureas are recommended as second-line therapy, on a par with insulin. The algorithm used in the intensive arm of ADVANCE involved the use of gliclazide MR, an established evidence-based sulfonylurea, as a first-line intensification strategy in combination with intensified general lifestyle measures.26,28 Nevertheless, metformin was also very widely used, as was insulin.



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