Θεραπεία στο ΣΔτ2 και ΧΝΝ

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1 Διαβητολογική Εταιρεία Βορείου Ελλάδος Θεσσαλονίκη, Νοεµβρίου 2013 Θεραπεία στο ΣΔτ2 και ΧΝΝ Παντελής Α. Σαραφίδης, MD, MSc, PhD Λέκτορας Νεφρολογίας Ιατρικής Σχολής Α.Π.Θ. Οι παρουσιάσεις στοχεύουν σε εκπαιδευτικούς σκοπούς και µόνο και δεν αντικαθιστούν την ανεξάρτητη επιστηµονική κρίση. Οι τοποθετήσεις ως προς τα δεδοµένα και οι απόψεις που εκφράζονται προέρχονται αποκλειστικά από τον οµιλητή, ο οποίος έχει λάβει Honorarium fees πάνω στο αντικείµενο από τη Novartis Hellas και την Astra-Zeneca Hellas

2 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Βασικά Επιδηµιολογικά Δεδοµένα

3 Estimates of Diabetes Prevalence in World Regions Estimated prevalence 0 (millions) Africa Americas Eastern Europe Southeast Mediterranean Asia Western Pacific WHO Report World Health Organization. Geneva;1997.

4 Trends in Diabetes Incidence in the U.S., by age National Health Interview Survey, Geiss et al., Am J Prev Med 2005

5 Prevalence of CKD and Estimated Number of Adults with CKD in the US (NHANES 88-94) Stage Description GFR (ml/min/1.73 m2) Prevalence* N (1000s) % 1 2 Kidney Damage with Normal or GFR Kidney Damage with Mild GFR 90 5, , Moderate GFR , Severe GFR Kidney Failure < 15 or Dialysis *Stages 1-4 from NHANES III ( ). Population of 177 million with age 20. Stage 5 from USRDS (1998), includes approximately 230,000 patients treated by dialysis, and assuming 70,000 additional patients not on dialysis. GFR estimated from serum creatinine using MDRD Study equation based on age, gender, race and calibration for serum creatinine. For Stage 1 and 2, kidney damage estimated by spot albumin-to-creatinine ratio 17 mg/g in men or 25 mg/g in women in two measurements.

6 Αριθµός ασθενών µε ΧΝΝ τελικού σταδίου παγκοσµίως 2,500,000 1,490, , Lysaght, J Am Soc Nephrol, 2002

7 Βασική αιτία ΧΝΝ τελικού σταδίου ασθενών που εντάσσονται σε πρόγραµµα υποκατάστασης της νεφρικής λειτουργίας Αριθ µός αιµο καθα ιρόµ ενων (χιλι άδες ) Άλλ α 10 % ΣΔ 50.1% Σπειραµατονεφρίτις 13% 243,524 ΑΥ 27% 281, ,240 No. ασθενών Προέκταση 95% CI United States Renal Data System. Annual data report

8 Incident counts & adjusted rates of ESRD by primary diagnosis Incident ESRD patients; rates adjusted for age, gender, & race. USRDS 2008, Figure 2.8 (Volume 2)

9 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Φυσική Ιστορία

10 Εξέλιξη της διαβητικής νεφροπάθειας σε ασθενείς µε ΣΔ τύπου 1 Pre- Microalbuminuria Macroproteinuria End-stage renal disease G F R (m L/ mi n) Al b u mi n ur ia (m g/ 24 h) Years Mogensen C, et al. 2003

11 Cumulative risk of proteinuria and renal failure in patients with type 1 and type 2 diabetes Hasslacher C, et al. Nephrol Dial Transplant 1989

12 Feehally J, Floege J, Johnson RJ (eds). Comprehensive Clinical Nephrology, 3rd Edn. Mosby Elsevier, Philadelphia, PA, 2007 Εξέλιξη της XNN σε ασθενείς µε ΣΔ Serum creatinine plot for a 58- year-old man with CKD secondary to diabetic nephropathy. An exponential increase over time is seen between 2000 and However, an abrupt rise occurs in April 2005 when the patient receives contrast medium for coronary angiography without prior hydration. The patient s kidney function never recovered to the previous baseline, and he began hemodialysis in December 2005.

13 Επιδείνωση ΧΝΝ σε ηλικιωµένους Physicians should remember that the most common cause of end-stage renal disease among elderly persons with preexisting CKD is acute kidney injury secondary to radiocontrast procedures, anti-inflammatory drugs, or worsening heart failure, not a gradual decrease consistent with the natural history of CKD itself. Use of RAS blockers in such patients puts them at increased risk for worsening CKD. Sarafidis PA & Bakris GL, Ann Intern Med 2009

14 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Διαγνωστική Προσπέλαση

15 ΑΔΡΟΙ ΒΙΟΧΗΜΙΚΟΙ ΔΕΙΚΤΕΣ Ουρία (Blood urea, BU) Φ.Τ.: mg/dl = 0,1-0,5 g/l Κρεατινίνη Ορού (Serum Creatine, Scr) Φ.Τ.: Άνδρες 0,7-1,3 mg/dl = µmol/l Γυναίκες 0,6-1,1 mg/dl = µmol/l

16 GFR vs serum creatinine

17 egfr 22 y.o. bodybuilder Weight 120 kg Plasma creat 1.6 mg/dl..egfr 123 ml/min 85 y.o. elderly woman Weight 46 kg Plasma Creat 1.6 mg/dl.egfr 18.6 ml/min

18 Calculating Creatinine Clearance & egfr Cockcroft-Gault Equation CrCl men = (140 - Age) x LBW (x 0.85 if women) Scr x 72 Modified MDRD Equation egfr men = 186 x (Scr) x (age) egfr women = egfr men x egfr African American = egfr men x CKD-EPI equation men: 141 minimum (cr/0.9, 1) maximum (cr/0.9, 1) Age (if black) women: 141 minimum (cr/0.7, 1) maximum (cre/0.7, 1) Age (if black)

19 Calculating Creatinine Clearance & egfr a) AUC of CKD-EPI (continuous line), MDRD (dashed line) and Tan-C (dotted and dashed line) equations for the diagnosis of moderate CKD (GFR <60 ml/min/1.73 m2). b) AUC of CKD-EPI, MDRD and Tan-C equations for the diagnosis of mild CKD (GFR <90 ml/min/1.73 m2). Iliadis, Didangelos, Demka et al. Diabetologia 2011

20 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Γλυκαιµικός Έλεγχος

21 DCCT Diabetes Control Complications Trial intensive insulin therapy can delay the development of microalbuminuria HbA1c from 9.0% to 7.0% p < 0.04 T y p e 1 D of microalbuminuria by 39% of macro- 54% * insulin pump or (>3/ D ) insulin injections, 1441 patients were followed for 6.5 years The Diabetes Control and Complications Trial Research Group (DCCT) N Engl J Med. 1993;329;977-86

22 UKPDS 33: relative risk reduction with intensive treatment T y p e 2 D Rel ativ e risk red ucti on for inte nsiv e trea tme nt (%) * A ny di ab et es en dp oi nt * * M icr ov as cu lar en dp oi nt M I * C at ar ac t ex tra cti on * R eti no pa th y (1 2 ye ar s) Al bu mi nu ria (1 2 ye ar s) Intensive treatment reduced HbA1c by 0.9% (7.9% to 7.0%) in 3,867 pts type 2 diabetes for a median of 10 years * p < 0.05 ** p < 0.01 * UKPDS 33. U.K. Prospective Diabetes * Study Lancet 1998;352(9131):

23 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Ειδικά προβλήµατα του γλυκαιµικού ελέγχου στη ΧΝΝ

24 Gerich JE. Diabet Med 2010;27: Gluconeogenesis 20 25%* Glucose production ~70 g/day Gluconeogenesis 25 30%* Glycogenolysis 45 50%* *post-absorptive state

25 G. Bolli, presented at EASD 7 September 2008

26 G. Bolli, presented at EASD 7 September 2008

27 Several factors, including uremic toxins and pro-inflammatory substances, may increase IR in ESRD, leading to a blunted ability to suppress hepatic gluconeogenesis and regulate peripheral utilization. Compensatory increased insulin secretion may not occur in ESRD because of concomitant metabolic acidosis, deficiency of vitamin D, and secondary hyperparathyroidism. Hemodialysis further alters insulin secretion, clearance, and resistance as the result of periodic improvement in uremia, acidosis, and phosphate handling. Shrishrimal et al. Clev Clin J Med 2009 G. Bolli, presented at EASD 7 September 2008

28 Ricks et al, Diabetes 2012 A1C goal for CKD stage 1-4: <7% A1C goal for CKD stage 5: 7-8%

29 1. elevated concentrations of urea 2. decreased life span of RBC 3. iron deficiency 4. EPO (erythropoietin) 5. hemodialysis 6. peritoneal dialysis Other reasons for inaccuracy not r/t kidney function: 7. recent transfusion 8. metabolic acidosis

30 HbA1C can be falsely high or low in ESRD, but it is still a reasonable measure Glycated albumin may be a reasonable alternative Blood glucose levels can fluctuate widely due to the effects of both ESRD and different types of dialysis Multiple daily blood glucose readings provide the best guide to treatment

31 Σακχαρώδης Διαβήτης και Νεφρική Βλάβη Χρήση των αντι-διαβητικών σκευασµάτων στα προχωρηµένα και το τελικό στάδιο ΧΝΝ

32 Management of CKD in Diabetes (1) GFR (ml/min/ 1.73 m2) Recommended All patients Yearly measurement of creatinine, urinary albumin excretion, potassium Referral to nephrology if possibility for nondiabetic kidney disease exists Consider dose adjustment of medications Monitor egfr every 6 months Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, parathyroid hormone at least yearly Assure vitamin D sufficiency Consider bone density testing Referral for dietary counselling ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S35. Table 14; Adapted from

33 Management of CKD in Diabetes (2) GFR (ml/min/ 1.73 m2) Recommended Monitor egfr every 3 months Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid hormone, hemoglobin, albumin, weight every 3 6 months Consider need for dose adjustment of medications <30 Referral to nephrologists ADA. VI. Prevention, Management of Complications. Diabetes Care 2012;35(suppl 1):S35. Table 14; Adapted from

34 AVAILABLE INSULIN PREPARATIONS Product (Manufacturer) Form Product (Manufacturer) Form Rapid Acting (Onset min, duration hrs 3-4) Insulin Analog Aspart - Novolog (Novo Nordisk) Lispro - Humalog (Lilly) Glulisine Apidra (Aventis) Short Acting (Onset hr, duration hrs 5-7)* Human Insulin Novolin R (Rugular) (Novo Nordisk) Humulin R (Regular) (Lilly) Purified Insulin Regular Iletin II (Lilly) Analog** Analog** Human** Human** Pork Intermediate Acting (Onset 1-4 hrs, duration hrs 18-24)* Human Insulin Novolin N (NPH) (Lilly) Humulin N (NPH) (Lilly) Humulin L (Lente) (Lilly) Purified Insulin NPH Iletin III (Lilly) Long Acting (Onset 4-6 hrs, duration hrs 24-34)* Human Insulin Humulin Ultralente (Lilly) Human** Human** Human** Pork Human** Analog Mix Humalog 75/25 Mix Novolog Mix 70/30 (combination of fast and intermediate acting insulin with action similar to that of Humalog 75/25 mix) Insulin for Special Use Buffered Insulin (for pumps) Humulin BR Refills for Novolin Pen Novolin R PenFill Novolin N PenFill Novolin 70/30 PenFill Novolog Mix 70/30 PenFill Prefilled Pens Novolin R Novolin N Novolin 70/30 Novolog Novolog Mix 70/30 Humalog Humalog Mix 75/25 Humalog Mix 50/50 Humulin N Apidra Analog** Analog** Human** Human** Human** Analog** Human** Human** Human** Analog** Analog** Analog** Analog** Analog** Human** Analog** Basal Peakless Insulin Glargine-Lantus (Aventis) Detemir Levemir (Novo Nordisk) Mixed Insulins 70/30 Insulin Novolin 70/30 (Novo Nordisk) Humulin 70/30 (Lilly) Humulin 50/50 (Lilly) Analog** Analog** Human** Human** Human** * Onset and duration are rough estimates. They can vary greatly within the range listed and from person to person ** Human insulin is made by recombinant DNA technology

35 Προϊόντα ινσουλίνης και ΧΝΝ Novorapid SPC 7/2012 Renal impairment : A single dose pharmacokinetic study of insulin aspart in 18 subjects with renal function ranging from normal to severely impaired was performed. No apparent effect of creatinine clearance values on AUC, Cmax, CL/F and tmax of insulin aspart was found. Data were limited in subjects with moderate and severe renal impairment. Subjects with renal failure necessitating dialysis treatment were not investigated. Levemir SPC 11/2011 Renal and hepatic impairment: There was no clinically relevant difference in pharmacokinetics of Levemir between subjects with renal or hepatic impairment and healthy subjects. As the pharmacokinetics of Levemir has not been studied extensively in these populations, it is advised to monitor plasma glucose closely in these populations.

36 Προϊόντα ινσουλίνης και ΧΝΝ Shrishrimal et al. Clev Clin J Med 2009

37 Major Classes of Medications 1. Drugs that sensitize the body to insulin and/or control hepatic glucose production 2. Drugs that stimulate the pancreas to make more insulin 3. Drugs that slow the absorption of starches Thiazolidinediones Biguanides Sulfonylureas Meglitinides DDP-IV inhibitors Alpha-glucosidase inhibitors

38 Combination Therapy for Type 2 Diabetes Sulfonylureas Biguanide s Alpha-glucosidase Inhibitors Meglitinid e Thiazolidinedione s Insulin

39 Biguanides (Metformin) Biguanides decrease hepatic glucose production and increase insulin-mediated peripheral glucose uptake. Efficacy Decrease fasting plasma glucose mg/dl ( mmol/l) Reduce A1C % Other Effects Diarrhea and abdominal discomfort Lactic acidosis if improperly prescribed Cause small decrease in LDL cholesterol level and triglycerides No specific effect on blood pressure No weight gain, with possible modest weight loss Contraindicated in patients with impaired renal function (Serum Cr > 1.4 mg/dl for women, or 1.5 mg/dl for men) Medications in this Class: metformin (Glucophage), metformin hydrochloride extended release (Glucophage XR)

40 Biguanides (Metformin) Approximately 90% of the drug is eliminated by the kidneys The plasma half-life of Metformin is prolonged in patients with a reduced creatinine clearance (CrCl). The increase in plasma half-life is proportional to the reduction in CrCl. Metformin should be avoided in patients on dialysis Mild (egfr ml/min) Moderate (egfr ml/min) Metformin 50% of dose Contraindicated (25% of dose) Severe/ESRD (egfr <30 ml/min) Avoid

41 Metformin Lactic acidosis is a rare but serious metabolic complication that can occur due to metformin accumulation. Reported cases have occurred primarily in diabetic patients with significant renal impairment As metformin is renally excreted egfr values should be determined before initiating treatment and regularly thereafter: - at least annually in patients with normal renal function - at least 2 4 times a year in patients with an egfr at the lower limit of normal (i.e ml/min) and in elderly subjects Special caution should be exercised in the elderly in situations where renal function may become impaired, e.g. initiating therapy with antihypertensives, diuretics or NSAIDs The Renal Drug Handbook, 3rd Edn, 2009

42 ADA/EASD 2012 Position Statement Current U.S. prescribing guidelines warn against the use of metformin in patients with a serum creatinine >133 mmol/l (>1.5 mg/dl) in men or 124 mmol/l (>1.4 mg/dl) in women. Metformin is eliminated renally, and cases of lactic acidosis have been described in patients with renal failure (123). There is an ongoing debate, however, as to whether these thresholds are too restrictive and that those with mild moderate renal impairment would gain more benefit than harm from using metformin (124,125). In the U.K., the NICE guidelines are less proscriptive and more evidencebased than those in the U.S., generally allowing use down to a GFR of 30 ml/min, with dose reduction advised at 45 ml/min (14). Given the current widespread reporting of estimated GFR, these guidelines appear very reasonable.

43 Salpeter et al, Cochrane Database Syst Rev Ο θόρυβος «υπέρ» της µετφορµίνης Prospective trials and observational cohort studies in patients with type 2 diabetes of least 1 month duration were included if they evaluated metformin, alone or in combination with other treatments, compared to placebo or other glucose-lowering drugs Πόσες µελέτες είχαν προκαθορισµένο κύριο Pooled data from 347 comparative trials and cohort studies revealed τελικό no cases σηµείο of fatal τη or nonfatal γαλακτική lactic οξέωση; acidosis in 70,490 patient-years of metformin use or in 55,451 patients-years in the non-metformin group. There is no evidence that metformin is associated with an increased risk of lactic acidosis, or with increased levels of lactate, compared to other anti-hyperglycemic treatments

44 Ο θόρυβος «υπέρ» της µετφορµίνης Ekstrom et al, BMJ 2012

45 Ο θόρυβος «υπέρ» της µετφορµίνης Retrospective analysis of men and women with type 2 diabetes, registered in the Swedish NDR Physicians and nurses in hospital outpatient clinics and primary healthcare clinics report to the NDR at least annually via the internet or via direct transfer of data from medical record databases. Only 8 cases of diagnosed lactic acidosis were reported during the follow-up (4 cases in metformin only, 2 cases in metformin + insulin and 2 cases in insulin only) Patients with egfr<45 ml/min/1.73m2 were 1.6%-3.3% among those receiving metformin in all groups Ekstrom et al, BMJ 2012

46 Sulfonylureas Sulfonylureas increase endogenous insulin secretion Efficacy Decrease fasting plasma glucose mg/dl ( mmol/l) Reduce A1C by % Other Effects Hypoglycemia Weight gain No specific effect on plasma lipids or blood pressure Generally the least expensive class of medication Medications in this Class: First generation sulfonylureas: chlorpropamide (Diabinese), tolazamide, acetohexamide (Dymelor), tolbutamide Second generation sulfonylureas: glyburide (Micronase, Glynase, and DiaBeta), glimepiride (Amaryl), glipizide (Glucotrol, Glucotrol XL)

47 Sulfonylureas Many sulfonylureas are excreted by the kidney leading to accumulation of the drug and metabolites with increased risk of hypoglycemia. Glyburide, glimepiride, and the first generation sulfonylureas should be avoided in CKD. The preferred sulfonylureas in dialysis patients are the short-acting glipizide (Glipizide) and gliclazide (Diamicron). The major metabolites of glipizide do not cause hypoglycemia and is primarily metabolized by the liver.

48 ADA/EASD 2012 Position Statement Most insulin secretagogues undergo significant renal clearance (exceptions include repaglinide and nateglinide) and the risk of hypoglycemia is therefore higher in patients with chronic kidney disease (CKD). For most of these agents, extreme caution is imperative at more severe degrees of renal dysfunction. Glyburide (known as glibenclamide in Europe), which has a prolonged duration of action and active metabolites, should be specifically avoided in this group.

49 Meglitinides Meglitinides stimulate insulin secretion (rapidly and for a short duration) in the presence of glucose. Efficacy Decreases peak postprandial glucose Decreases plasma glucose mg/dl ( mmol/l) Reduce A1C % Other Effects Hypoglycemia (although may be less than with sulfonylureas if patient has a variable eating schedule) Weight gain No significant effect on plasma lipid levels Safe at higher levels of serum Cr than sulfonylureas Medications in this Class: repaglinide (Novonorm), nateglinide (Starlix)

50 Meglitinides Repaglinide can be safely used in CKD and dialysis patients because it is completely metabolized by the liver (less than 8% of the drug is excreted unchanged in the urine) Nateglinide may be less safe in dialysis because the metabolites have hypoglycemic effects. Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Repaglinide 100% of dose 100% of dose % of dose Nateglinide 100% of dose 100% of dose % of dose

51 Thiazolidinediones Thiazolidinediones decrease insulin resistance by making muscle and adipose cells more sensitive to insulin. They also suppress hepatic glucose production. Efficacy Decrease fasting plasma glucose ~35-40 mg/dl ( mmol/l) Reduce A1C ~ % 6 weeks for maximum effect Other Effects Weight gain, edema Hypoglycemia (if taken with insulin or agents that stimulate insulin release) Contraindicated in patients with abnormal liver function or CHF Improves HDL cholesterol and plasma triglycerides; usually LDL neutral Medications in this Class: pioglitazone (Actos), rosiglitazone (Avandia), [troglitazone (Rezulin) - taken off market due to liver toxicity]

52 Thiazolidinediones TZDs are extensively metabolized by the liver (less than 1% of rosiglitazone appears unchanged in the urine) Metabolites of pioglitazone are more active than metabolites of rosiglitazone; however they do not accumulate in CKD. TZDs possibly improve uremia-associated insulin resistance. Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Pioglitazone 100% of dose 100% of dose % of dose Rosiglitazone 100% of dose 100% of dose % of dose

53 Alpha-glucosidase Inhibitors Alpha-glucosidase inhibitors block the enzymes that digest starches in the small intestine Efficacy Decrease peak postprandial glucose mg/dl ( mmol/l) Decrease fasting plasma glucose mg/dl ( mmol/l) Decrease A1C % Other Effects Flatulence or abdominal discomfort No specific effect on lipids or blood pressure No weight gain Contraindicated in patients with inflammatory bowel disease or cirrhosis Medications in this Class: acarbose, miglitol

54 Alpha-glucosidase Inhibitors The dose of these agents does not need to be adjusted in the dialysis population because they rarely cause hypoglycemia. The NKF-K/DOQI guidelines, however, recommend avoiding use of alpha-glucosidase inhibitors in the dialysis population due to the lack of clinical trials Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Acarbose % % Not studied

55 GLP-1 receptor agonists (incretin mimetics) Compound Exenatide Liraglutide Mechanism Activates GLP-1 receptors (β-cells/endocrine pancreas; brain/autonomous nervous system) Action(s) Insulin secretion (glucose-dependent) Glucagon secretion (glucose-dependent) Slows gastric emptying Satiety Advantages Weight reduction Potential for improved β-cell mass/function Disadvantages Gastrointestinal side effects (nausea, vomiting, diarrhea) Cases of acute pancreatitis observed C-cell hyperplasia/medullary thyroid tumors in animals (liraglutide) Injectable Long-term safety unknown Cost High

56 GLP-1 receptor agonists (incretin mimetics) Exanetide is primarily eliminated by the kidney. In hemodialysis, exanetide levels increased by 3.4 fold, thus it is not recommended for use in patients with CrCl<30 ml/min. Liraglutide is not largely eliminated by the kidney and the pharmacokinetics are independent of renal function. Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Exenatide BD No dose adjustment Proceed from 5 to 10 mcg conservatively Not recommended Liraglutide No dose adjustment No dose adjustment No clinical experience

57 DPP-4 inhibitors (incretin enhancers) Compound Sitagliptin (Januvia) Vildagliptin (Galvus) Saxagliptin (Onglyza) Linagliptin (Trajenta) Mechanism Inhibits DPP-4 activity, prolongs survival of endogenously released incretin hormones Action(s) Active GLP-1 concentration Active GIP concentration Insulin secretion Glucagon secretion Advantages No hypoglycemia Weight neutrality Disadvantages Occasional reports of urticaria/angioedema Cases of pancreatitis observed Long-term safety unknown Cost High

58 DPP-IV inhibitors: sitagliptin Sitagliptin is 80% renally eliminated, and subjects with decreased egfr had higher plasma sitaglipitin levels. The normal dose is 100 mg once daily Many authors suggest not to be used in egfr<60 ml/min. Saxagliptin Mild (egfr ml/min) No dose adjustment Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) 50% of dose 25% of dose

59 DPP-IV inhibitors: saxagliptin The dose of saxagliptin is mg once daily No dosage adjustment is recommended for patients with CrCl >50 ml/min. The dose of saxagliptin is 2.5 mg once daily for CrCl <50 ml/min or hemodialysis (it should be given after dialysis). Saxagliptin has not been studied in patients on peritoneal dialysis. Saxagliptin Mild (egfr ml/min) No dose adjustment Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) 50% of dose 50% of dose

60 DPP-IV inhibitors: vildagliptin Vildagliptin is eliminated by metabolism (69%), kidneys (13%) and faeces In patients with varying degrees of CKD (mild: 50 to <80 ml/min, moderate: 30 to <50 ml/min and severe: <30 ml/min) vildagliptin AUC after oral dosing of vildagliptin 50 mg increased on average 1.4, 1.7 and 2-fold AUC of the metabolites LAY151 and BQS867 increased on average about 1.5, 3 and 7-fold in patients with mild, moderate and severe renal impairment, respectively. In ESRD LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment. Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose). Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Vildagliptin No dose adjustment (50 mg bd) 50% of dose (50 mg od) 50% of dose (50 mg od)

61 Lukashevich et al. Diab Obes Metab 2011 Vildagliptin in CKD double-blind RCT of 24-weeks 515 patients with T2DM and moderate or severe RI (GFR 30 to <50 or <30 ml/min/1.73 m2) untreated (no therapy in previous 8 weeks) or treated with an SU, AGI, TZD, insulin, meglitinide or a combination of agents A1C between 6.5 and 10% and BMI between 18 and 42 kg/m2. vildagliptin (50 mg od) versus placebo added to current therapy

62 Vildagliptin in CKD Lukashevich et al. Diab Obes Metab 2011

63 Kothny et al. Diab Obes Metab 2012 Vildagliptin in CKD Double-blind extension of previous RCT to 52-weeks 369 patients with T2DM and moderate or severe RI (GFR 30 to <50 or <30 ml/min/1.73 m2) untreated (no therapy in previous 8 weeks) or treated with an SU, AGI, TZD, insulin, meglitinide or a combination of agents vildagliptin (50 mg od) versus placebo added to current therapy

64 Vildagliptin in CKD Kothny et al. Diab Obes Metab

65 Vildagliptin in CKD Kothny et al. Diab Obes Metab

66 Vildagliptin in CKD Ito et al. Endocrine Journal 2011

67 Vildagliptin in CKD Ito et al. Endocrine Journal 2011

68 DPP-IV inhibitors: linagliptin Linaglipitin is different from the other DDP-IV inhibitors as it is extensively protein bound. The renal elimination of linaglipitin is very low, and dose adjustment is not needed (5 mg od).. In patients with varying degrees of CKD (mild: 50 to <80 ml/min, moderate: 30 to <50 ml/min and severe: <30 ml/min) linagliptin exposure after oral dosing increased by 1, 1.7 and 1.4-fold AUC of linagliptin in patients with ESRD was similar to moderate/severe renal impairment. Linagliptin is not removed by hemodialysis or peritoneal dialysis. Mild (egfr ml/min) Moderate (egfr ml/min) Severe/ESRD (egfr <30 ml/min) Vildagliptin No dose adjustment No dose adjustment No dose adjustment

69 Συµπερασµατικά Ο γλυκαιµικός έλεγχος στους ασθενείς µε ΣΔ τ2 είναι συχνά ιδιαίτερα δύσκολος Με τη µείωση της νεφρικής λειτουργίας εµφανίζονται παράγοντες που «ευνοούν» και άλλοι που «δυσχεραίνουν» τον γλυκαιµικό έλεγχο Υπάρχουν λίγα στοιχεία για τη φαρµακοκινητική των ινσουλινών σε προχωρηµένη ΧΝΝ Η µετφορµίνη και οι περισσότερες σουλφονυλουρίες αντενδείκνυνται σε egfr<50 ml/min/1.73 m2 Οι θειαζολιδινεδιόνες, οι µεγλιτινίδες και ορισµένοι DDP-IV αναστολείς δεν εµφανίζουν νεφρικό µεταβολισµό και µπορούν να χρησιµοποιηθούν σε όλα τα στάδια ΧΝΝ

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