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Diabetes mellitus and hyperlipidemia Diabetes mellitus and hyperlipidemia Presentation Transcript

  • Diabetes Mellitus andHyperlipidemia Case report December 20th, 2012 臨藥科技所 碩一 陳秋縈 指導老師 張智仁醫師
  • Case 1 2
  • Case 1Age 65 Gender femaleHT/BW 152cm/52.6kg BMI 22.8Present illness• 罹患糖尿病已有十幾年之久,並無規則性治療• 近日內發現下肢水腫及眼睛視力模糊,於94年9月5日來院求診Past medical history• 數年前開過白內障手術• 糖尿病病史已有十幾年Family history• 雙親皆罹患肺癌死亡• 高血壓及糖尿病病史不清楚Physical examination• 左眼紅腫潮紅,上下肢沒有特殊發現• 血壓 130/70 mmHg 3
  • Lab Data Normal 09/07 11/02 12/18 AC Sugar (mg/dl) 70-110 176 110 99 HbA1c (%) <6 9.4 - - Cholesterol (mg/dl) <200 289 263 - TG (mg/dl) <150 1180 287 -Blood Creatinine (mg/dl) 0.4-1.5 2.8 2.8 - GPT (U/L) <60 28 24 - Uric acid (mg/dl) 2.6-6.0 9.3 8.9 - Hb (g/dl) 12-16 - 7.2 - 尿蛋白 ++ ++ 尿糖 + -Urine WBC - - RBC - - Ketone - - 4
  • Case 1如何解讀該病患之數據?如何使用藥物來治療? 5
  • Initial Diabetes Evaluation Classify the diabetes Review previous treatment and glycemic control Detect the presence of diabetes complications Formulating a management plan Provide a basis for continuing careDiabetes Care. 2012 Jan;35 Suppl 1:S11-63 6
  • Initial Diabetes Evaluation 65yr, BMI:22.8, 糖尿病病史已有十幾年, 並無規則性治療 AC Sugar: 176 mg/dl HbA1C: 9.4% Classify the diabetes  Long-standing type 2 DM Review previous treatment and glycemic control  Poor glycemic control  Without regular treatment Correlation of A1C with Average Glucose → Poor compliance?Diabetes Care. 2012 Jan;35 Suppl 1:S11-63 7
  • Detect the Presence of Diabetes ComplicationsNephropathy- Assess albuminuria status Our patient 9/7, 12/18: 蛋白尿 ++,下肢水腫, 左眼紅腫潮紅 Definitions of abnormalities in albumin excretion 24-Hour Collection Spot Collection Timed Collection Category (mg/24 h) (mg/g creatinine) (µg/min) Normal <30 <30 <20 Microalbuminuria 30–299 30–299 20–200 Macroalbuminuria ≥300 ≥300 ≥200 Spot urine: albumin/Cr ratio≈ g/d of albuminuria Urine dipstick testing: semiquantitative measurements  Insensitive for microalbuminuria + 30 mg/dL (≈ estimate protein loss ≥300 mg/d ) ++ 100 mg/dL Macroalbuminuria +++ 300 mg/dL ++++ 1000 mg/dLAm J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154 8
  • Detect the Presence of Diabetes Complications Nephropathy- Assess renal function Our patient 65y, female, 52.6kg, Cr 2.8 mg/dL  MDRD equation eGFR= 18.02 ml/min/1.73 m2  Cockcroft-Gault equation CCr= 16.63 ml/min Stage Description GFR (ml/min/1.73 m2) 1 Kidney damage with normal or increased GFR ≥90 2 Kidney damage with mildly decreased GFR 60–89 3 Moderately decreased GFR 30–59 4 Severely decreased GFR 15–29 5 Kidney failure <15 or dialysisLikelihood of DKD According to Staging by GFR and Level of Albuminuria Diabetes Care. 2012 Jan;35 Suppl 1:S11-63 Diabetic Kidney Disease Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154 9
  • Detect the Presence of Diabetes ComplicationsRetinopathy Our patient 數年前白內障手術, 近日眼睛視力模糊 Glaucoma, cataracts, and other disorders of the eye occur earlier and more frequently in people with diabetes 26% of adults with type 2 DM developed retinopathy over 4 years Risk factors  Duration of diabetes -main risk factor  Poor glycemic control Relation of glycemic control and DM duration to retinopathy  Nephropathy  HypertensionDiabetes Care. 2012 Jan;35 Suppl 1:S11-63BMJ 2012 Feb 22;344:e874Harrisons Principles of Internal Medicine, 18e 10
  • Detect the Presence of Diabetes ComplicationsHypertension Our patient BP 130/70 mmHg Diagnosis  Repeat SBP ≥130 mmHg or DBP ≥80 mmHg The diagnostic cutoff is lower in diabetes than those without diabetes (BP ≥140/90 mmHg) BP should be confirmed on a separate dayDiabetes Care. 2012 Jan;35 Suppl 1:S11-63 11
  • Detect the Presence Of Diabetes ComplicationsDyslipidemia 09/07 11/02 Total Cholesterol (mg/dL)Cholesterol (mg/dl) 289 high 263 high <200 DesirableTG (mg/dl) 1180 very high 287 high 200-239 Borderline high ≥ 240 High Factors contribute to elevated TG  Obesity Triglyceride (mg/dL)  Physical inactivity <150 Normal  Cigarette smoking 150-199 Borderline high  Excess alcohol intake 200-499 High  High carbohydrate ≥ 500 Very high  Genetic disorders  Drugs  Several diseases: type 2 DM, CKD, nephrotic syndrome Hyperlipidemia in type 2 DM  Hypertriglyceridemia and low HDL cholesterol  Associated with high levels of insulin and insulin resistanceNCEP ATP III. Circulation. 2002;106:3143-3421.Harrisons Principles of Internal Medicine, 18e 12
  • Other ConditionsAnemia Our patient Hb : 7.2 g/dl Possible cause: complications of CKD Need further test for evaluation  CBC, reticulocyte count, Fe, TIBC, TSAT, ferritin, stool OBAsymptomatic hyperuricemia Our patient Uric acid : 9.3 mg/dl Possible cause: secondary hyperuricemia due to decreased renal clearance  Drug therapy is not justifiable by risk/benefit analysisAm J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154 13
  • Formulating a Management Plan of Diabetes Problem list • Long-standing Type 2 DM • Diabetic nephropathy with CKD stage 4 • Diabetic retinopathy • Dyslipidemia Treatment strategies • Glycemic control • Slow progression of of diabetic nephropathy • BP control • Lipid management • Antiplatelet agent • Patient education 14
  • Management PlanTreatment of diabetic nephropathy Goal: slow the progression of nephropathy Reduction of protein intake  Earlier stages of CKD: 0.8-1g/kg/d  Later stages of CKD: 0.8 g/kg/d Treat with ACE or ARB  If micro- or macroalbuminuria  Monitor Creatinine and K level − Discontinue when K > 5.6 mmol/L or Creatinine ↑> 30% above baseline Continued monitoring of urine albumin excretion to assess both response to therapy and progression of disease Diabetes Care. 2012 Jan;35 Suppl 1:S11-63 Arch Intern Med 2000 Mar 13;160(5):685 15
  • ACEI/ARBDrug approved for DM nephropathy Our patient Clcr=16.63 ml/min Strength Dosage for DM Dose adjustment in CYP450 per tab nephropathy renal dysfunction metabolismACEI 25mg tid Clcr 10-50 mg/minCaptopril 25 mg CYP2D6 (major) AC1h PC2h 75% q12-18h Clcr 10-30 mg/minLisinopril 10mg 10-20mg qd - 2.5-5mg/dARBIrbesartan 150 mg 300 mg qd No CYP2C9 (minor) CYP2C9 (major)Losartan* 50 mg 50-100 mg qd No CYP3A4 (major)*成大醫院無此品項 16
  • Lipid ManagementRisk assessment and treatment goal LDL-C level vs. CHD risk: Log-linear relationship  30mg/dL change in LDL-C, 30% changed in relative risk for CHD LDL-C: primary target of lipid-lowering therapy Risk assessment: high risk  Goal: LDL-C < 100 mg/dl NCEP Goals for LDL-C LDL-C Goal Optional Risk Level Risk Category mg/dL Goal CHD or High risk < 100 < 70 CHD risk equivalent DM Moderately ≥ 2 risk factors < 130 < 100 high risk 10-year risk 10%-20% ≥ 2 risk factors Moderate risk < 130 10-year risk < 10% Lower risk ≤ 1 risk factor < 160NCEP ATP III guidelines 17Circulation 2004; 110:227.
  • Lipid ManagementLDL-C lowering therapy LDL-C goal  < 100 mg/dl  Reduction of 30-40% from baseline is alternative if not achieved on maximum tolerated drug therapy Add statin therapy to lifestyle therapy regardless of baseline lipid levels in adults with diabetes if either − Overt CVD − Age > 40 y with one or more other CVD risk factors (ADA Grade A)NCEP ATP III. Circulation. 2002;106:3143-3421.Circulation 2004; 110:227. 18
  • Lipid Management Cholesterol (mg/dl) 09/07 289 11/02 263 high highHypertriglyceridemia TG (mg/dl) 1180 very high 287 highVery high TG (≥ 500mg/dl) Drug of choice Goal of therapy  TG lowering to prevent acute pancreatitis (first priority)  Prevention of CHD (second priority) Fibrate Consider LDL-C reduction only after TG < 500 mg/dL or Nicotinic acid Drug of choice TG-lowering Use in very high TG Fibrate or niacin Most effective First choice Statin Not powerful Not first-line Bile acid sequestrants tend to ↑TG contraindicatedHigh TG (200-499mg/dl) Goal Statin  Primary: achieve LDL-C target  Secondary: achieve non-HDL-C target − 30mg/dL higher than LDL-C goal: 130mg/dlNCEP ATP III. Circulation. 2002;106:3143-3421. 19
  • Our patientLipid Management • DM • Clcr=16.63 ml/minDrug of consideration • Hyperuricemia MetabolismDrug Class agent Renal dose adjustment enzyme Niacin Relative contraindication: Hyperglycemia, hyperuricemia Gemfibrozil CCr 10-50 mg/min 50% dose Fibrate Fenofibrate Avoid use in CCr <30 mL/min Atorvastatin No CYP3A4 Pravastatin Initial 10 mg qd in significant impairment None Fluvastatin Use with caution in severe impairment CYP2C9 Statin CYP2C9/ Rosuvastatin Initial 5 mg qd in Ccr <30 ml/min 2C19 Simvastatin Initial 5 mg qd in Ccr< 30 ml/min CYP3A4Drug information handbook 21th edition 20
  • Summary of Lipid Management 09/07 11/02Cholesterol (mg/dl) 289 high 263 highTG (mg/dl) 1180 very high 287 high 11/029/07 Goal:Goal: LDL-C < 100 mg/dl (primary) TG < 500 mg/dl non-HDL-C < 130mg/dl (secondery)Therapy: Therapy: TG lowering to prevent acute pancreatitis LDL lowering to prevent CHDDrug of choice: Drug of choice: Gemfibrozil PravastatinMonitor parameters: Monitor parameters: Cholelithiasis AST/ALT and CPKNCEP ATP III. Circulation. 2002;106:3143-3421. 21
  • Management PlanAntiplatelet agents Consider aspirin therapy (75-162 mg/day) as a primary prevention strategy in those with type 1 and type 2 diabetes at increased CV risk (10-yr risk > 10%)  Includes men > 50 years or women > 60 years with at least one additional major risk factor − Family history of CVD, HTN, smoking, dyslipidemia, albuminuriaDiabetes Care. 2012 Jan;35 Suppl 1:S11-63 22
  • Intensive glycemic controlUKPDS: A 1% fall in HbA1c results in a reduction ofrelative risk of complications 0 Reduction in risk (%)* -10 -12 -16 Any diabetes-related endpoint p=0.029 p=0.052 -21 Microvascular endpoint -20 -25 p=0.015 p=0.0099 MI -34 -30 p=0.000054 Retinopathy -40 Albuminuria at 12 years -50UKPDS: United Kingdom Prospective Diabetes Study*Percent risk reduction per 0.9% decrease in HbA1CUKPDS. Lancet. 1998;352:837-853. 23
  • Three Clinical Trials Assessing Intensive vs. Conventional Glycemic Control in Type 2 DM Patients baseline characteristics ACCORD ADVANCE VADT Number of Pts. 10,251 11,400 1,791 Age (yrs) 62.2 66.0 60.4 BMI (kg/m²) 33.2 28.5 31.3 Duration of diabetes (yrs) Long-standing 10.0 8.0 11.5 Previous CV disease (%) 35.2 32.2 31.3 Mean A1C (%) 8.3 7.5 9.4 Median achieved A1C ACCORD ADVANCE VADT Intensive control 6.4 % 6.5 % 6.9 % Conventional control 7.5 % 7.3 % 8.6 % Difference - 1.1 % - 0.8% - 1.7%N Engl J Med. Jun 12 2008;358(24):2560-2572. ACCORD: Action to Control Cardiovascular Risk in DiabetesN Engl J Med. Jan 8 2009;360(2):129-139. ADVANCE: Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled EvaluationN Engl J Med. Jun 12 2008;358(24):2545-2559. VADT: Veterans Affairs Diabetes Trial 24
  • Effect of Intensive Glucose Lowering inMacrovascular Complications of Type 2 DM ACCORD ADVANCE VADTPrimary Non-fatal MI Non-fatal MI Non-fatal MIoutcome Non-fatal stroke Non-fatal stroke Non-fatal stroke CVD death CVD death CVD death Revascularization Hospitalization for CHFHazard ratio 0.87 (0.730 – 1.04) 0.90 (0.78 – 1.04) 0.94 (0.84 – 1.06)for primaryoutcome (95% CI)Hazard ratio 1.065 (0.801 – 1.416) 1.22 (1.01 – 1.46) 0.93 (0.83 – 1.06)for mortality (95% CI) (P= 0.04) No significant reduction in CVD outcomes with intensive glycemic control in long-standing diabetes (mean duration 8-11 years)N Engl J Med. Jun 12 2008;358(24):2560-2572.N Engl J Med. Jan 8 2009;360(2):129-139.N Engl J Med. Jun 12 2008;358(24):2545-2559. 25
  • Glycemic Control“Individualized” treatment target A1C More Stringent Less Stringent ADA < 7% as close to normal (6%) as possible AACE ≤ 6.5% < 8% Life expectancy 65yr Duration of diabetes Long-standing Presence of complications Neuropathy retinopathy Risk of hypoglycemia, adverse events CKD stage 4, elderly Patient attitude and expected treatment efforts 之前無規則性治療? Support system UnknownEndocr Pract. 2009; 15:540-59.Endocr Pract. 2011; 17(suppl 2):287-302.Diabetes Care. 2012; 35(1 suppl):S11-63. 26
  • Diabetes Care 2012;35:1364–1379Diabetologia 2012;55:1577–1596
  • 28
  • Endocr Pract. 2009; 15:540-59.
  • Factors to Consider When Selecting TherapyA patient-centered approach Long-standing Type 2 DM, HbA1C: 9.4%  Remaining ß-cell function  Combination therapy or insulin Age: 65yr  At risk for adverse events and drug interactions from polypharmacy Weight: BMI 22  Weight loss is not a major goal CKD stage 4  Potential for hypoglycemia  Dose adjustment Retinopathy  Injection require good visual (and also motor skills, cognitive ability, caregivers support) Patient preference and supporting system  Poor compliance?Diabetes Care. 2012; 35(1 suppl):S11-63.Diabetes Care 2012;35:1364–1379 30
  • Drug Of Choice Class and agents Use in renal impairmentConsiderations in CKD Metformin Contraindicated in Scr ≥1.4 mg/dl 1st generation SU Avoid use 2nd generation SU Glipizide No dose adjustment Gliclazide No dose adjustment Glimepiride Initial at low dose Glyburide Avoid use Meglitinides Repaglinide Initial at low dose Nateglinide Initial at low dose, avoid in stage5 Thiazolidinedione Pioglitazone No dose adjustment Alpha-glucosidase inhibitors Acarbose Avoid in Scr >2mg/dl DPP-4 inhibitor Sitagliptin Reduce dose Saxagliptin Reduce dose Vildagliptin Reduce dose Linagliptin No dose adjustment GLP-1 agonists Exenatide Avoid in GFR < 30 mL/min/1.73 m2 Am J Kidney Dis. 2012 Nov;60(5):850-86. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154 31
  • Glycemic Control- Drug of considerationClass and agents Major concernsMeglitinides • Drug interaction (Contraindicated) Repaglinide Gemfibrozil increases repaglinide concentrations and half-lifeThiazolidinedione Pioglitazone • Fluid retention (4-15%), Bone fractures (5.1%)2nd generation SU Glipizide • Preferred SU in CKD Gliclazide • Preferred SU in CKD Glimepiride • Active metaboliteDPP-4 inhibitor Sitagliptin • Common SE: Hypoglycemia, Headache, URI, Nasopharngitis Cost: 7.58/day • Common SE: Peripheral edema (1.2-8.1% ), Hypoglycemia, Headache, UTI, URI, Saxagliptin Nasopharyngitis • Drug interaction: CYP3A4 inhibitors • Common SE: Peripheral edema (3.8-5.9% ), Hypertension, Hypoglycemia, Vildagliptin Headache, URI, Nasopharngitis Linagliptin • Hypoglycemia, Nasopharngitis Cost: 30.3/day 32
  • Summary of Glycemic control Glycemic goal  A1C<7% or less-stringent (<8%) Consideration for therapy  Remaining ß-cell function  Injection require good visual and caregivers support  Patient preference of administration route  ComplianceNon-insulin regimens Insulin regimenSU + DPP-4 inhibitor Basal insulin + DPP-4 inhibitor Glipizide 2.5mg QD PO Insulin glargine 10IU QD SC Sitagliptin 25mg QD PO Sitagliptin 25mg QD PO 33
  • Patient education 認識糖尿病  糖尿病有什麼症狀?  糖尿病會有什麼併發症?  心理社會因素? 降血糖藥與胰島素  藥物的使用方法與副作用  使用藥物的重要性  血糖自我監測  高血糖與低血糖 運動與健康飲食原則 日常護理保健Taiwan Association of Diabetes Educators 34
  • Summary of Case 1Management planStrategy Management • Protein-restricted dietDiabetic nephropathy • Irbesartan • BP should be confirmed on a separate dayBP control • Goal: <130/80 mmHg • Treat very high TG with gemfibrozil Goal: TG < 500 mg/dlLipid management • Then shift to pravastatin Goal: LDL-C < 100 mg/dl (primary) non-HDL-C < 130mg/dl (secondary)Antiplatelet agent • Aspirin • SU + DPP-4 inhibitorGlycemic control • Basal insulin + DPP-4 inhibitor • Goal: HbA1C < 7%Patient education 35
  • Case 2 36
  • Lab Data of a 45yr male Normal 2/11 8/11 11/16AC Sugar (mg/dl) 60-100 109 106 110Creatinine (mg/dl) 0.7-1.5 1.09 1.13 1.03eGFR 73 70 78ALT (U/L) 0-54 24 22 25Cholesterol (mg/dl) <200 205 273 276TG (mg/dl) <150 921 1960 1400HDL-C (mg/dl) > 40 30 35 34LDL-C (mg/dl) <100 59 35 46Sample lipemia + ++++ ++ Q 如何解讀該病患之數據? 如何使用降血脂的用藥? 37
  • Lab Data of a 45yr male Normal 2/11 8/11 11/16AC Sugar (mg/dl) 60-100 109 106 110Creatinine (mg/dl) 0.7-1.5 1.09 1.13 1.03eGFR 73 70 78ALT (U/L) 0-54 24 22 25Cholesterol (mg/dl) <200 205 273 276TG (mg/dl) <150 921 1960 1400HDL-C (mg/dl) > 40 30 35 34LDL-C (mg/dl) <100 59 35 46Sample lipemia + ++++ ++ High TC Very high TG Low HDL Low LDL 38
  • Overview of Lipoprotein Lipoprotein = Lipids + Phospholipid + Proteins Chylomicron Cholesterol (Apolipoprotein) VLDL, IDL, LDL Triglyceride ApoA, B, C… HDL *insoluble in *serve as enzyme cofactors plasma receptor ligands, lipid transfer carriers Lipid compositions of lipoprotein Chylomicron VLDL LDL HDL TG % TG rich 85 55 10 6 Cholesterol esters % 3 18 50 40 Cholesterol % 2 7 11 7 Phospholipids % 8 20 29 46 Protein % 2 10 25 55 39
  • Metabolism of TG-rich Lipoproteins Chylomicrons and VLDL Exogenous from dietary fat chylomicrons Endogenous from the liver VLDL Lypolysisby lipoprotein lipase (LPL) apoCII as a cofactor in fat and muscle tissue fat and muscle tissue Nat Med. 2002 Feb;8(2):112-4. 40
  • Development of Hypertriglyceridemia Increased production and decreased clearance Exogenous from dietary fat chylomicrons Production of chylomicrons and Endogenous VLDL from intestine and liver from the liver VLDL Clearance Lipolysisby lipoprotein lipase (LPL) Reduced lipoprotein lipase activity apoCII as a cofactor in fat and muscle tissue Abnormality in lipoprotein receptor 41
  • Causes of Elevated TriglyceridesGenetic, dietary and metabolic Low prevelance TG 200-500 mg/dL TG> 1000 mg/dL Usually combined causes LDL-C usually low Our patient: very high TG TC = HDL + LDL + VLDL high low lowCMAJ 2007;176(8):1113-20 42
  • If TG >1000 mg/dL Initial goal  TG lowering to prevent acute pancreatitis Treatment  Non pharmacotherapy  TG-lowering drugs  Fibrate  Niacin  Fish oilNCEP ATP III. Circulation. 2002;106:3143-3421.Am Fam Physician. 2007 May 1;75(9):1365-1371. 43
  • Choice for Treatment of Severe HypertriglyceridemiaDrug class Effect on LDL↓ Effect on HDL↑ Effect on TG↓ Major useStatins 20-60% 5-10% 10-30% LDL-CResins 15-30% 0 to slight No change or LDL-C increase may ↑fibrate 5-15% 5-20% 35-50% TGNiacin 10-25% 15-35% 40% LDL-C, HDL-C, TGOmega 3 fatty acid ↑4-49% 5-9% 30-40% TG  Statins: not powerful TG-lowering  Resin: contraindicated, tend to raise TG  Fibrate: most effective  Niacin: less potent then fibrate but more effective at raising HDL-C NCEP ATP III. Circulation. 2002;106:3143-3421. 44
  • Choice for Treatment of Severe Hypertriglyceridemia Fibrate, niacin, omega-3 fatty acidDrug Mechanism Major side effectFibrate PPAR-α agonist Dyspepsia, elevated transaminases, Fenofibrate ↑VLDL clearance cholesterol gallstones, myopathy Gemfibrozil ↓VLDL hepatic synthesisNiacin ↓VLDL hepatic synthesis Flushing, GI upset Acipimox Worsen glucose intolerance hyperuricemia, hepatotoxicityOmega-3 fatty acid ↓VLDL hepatic synthesis Fishy aftertaste(EPA/DHA) GI upset Metabolic side effect Increase LDL  Fibrate be used as a first-line agent for reduction of TG in patients at risk for TG-induced pancreatitis DHA = docosahexaenoic acid; EPA = eicosapentaenoic acid. PPAR-α = Peroxisome proliferator-activated receptor- α J Clin Endocrinol Metab, September 2012, 97(9):2969–2989 45
  • Omega-3 Fatty AcidsAs adjunctive therapy Dosage range: 3-12 g/day 2-4 g of total EPA/DHA daily can lower TG levels by 30-50% Dose-dependent for TG-lowering Require months or years of intakeJAMA 2006; 296:1885. 46
  • Summary of case 2For severe hypertriglyceridemia Goal of therapy  First priority: TG-lowering to prevent pancreatitis  Second priority: prevention of CHD Combine therapeutic lifestyle change and drug therapy  Therapeutic lifestyle changes are recommended for all patients with elevated triglyceride levels  Fibrates recommended as first-line therapy  Niacin or omega-3 fatty acids may also be consideredJ Clin Endocrinol Metab, September 2012, 97(9):2969–2989 47
  • Thanks for Your Attention 48