Module 4 Managing Patients with Hypertension and Diabetes
Module 4 Managing Patients with Hypertension and Diabetes This program meets the accreditation criteria of The College of Family Physicians of Canada and has been accredited for up to X Mainpro-M1 credits. Case Development & Disclosures Case Authors Pierre Larochelle, MD, PhD, FRCPC, FACP, FAHA , Institute of Clinical Research of Montreal (IRCM) Carl Fournier, MD, CCFP CHEP Continuing Education Committee Sol Stern, MD MCFP David Dannenbaum, MD
CCFP John Hickey MD, CCFP Karen Mann, BN, MSc, PhD Case Series Editor: Sheldon W. Tobe, MD, MScCH HPTE, FRCPC, FACP, FASH 2 Conflict Disclosure Information Presenter 1: Grants/Research Support: _____________________ Speakers Bureau/Honoraria: ___________________ Consulting Fees:_____________________________ Other: ____________________________________ 3 Module 4: Hypertension and Diabetes Mrs. J.D. A 58 year old patient who just moved to your city. She is on active treatment for her hypertension and her diabetes.
4 Outline of Todays Activity Introduction Case Presentation Key Learnings & Questions Wrap Up 5 Statement of Need My greatest challenge as a health care professional in the management of patients with hypertension is ___________ 6 Learning Objectives Upon completion of this activity, participants will be able to: 1. Plan the investigation of patients with hypertension and
diabetes including evaluation for nephropathy 2. Assess the risk associated with diabetes in patients with hypertension including the impact of diabetic nephropathy 3. Demonstrate knowledge of the blood pressure target in hypertensives living with diabetes 7 Learning Objectives 4. Select treatment for patients with hypertension and diabetes with nephropathy Contrast this with patients with hypertension and diabetes without nephropathy Choose appropriate antihypertensive medications Discuss the risks of dual RAAS blockade with ACEi or ARB 5. Identify patients with BP not at goal and plan their investigation and treatment 8 History of Present Illness Mrs. J.D. is a 58 year old patient who sees you because of her BP and diabetes She was told at age 45 years that her blood pressure was too high
She had no symptoms except ankle edema which she noted in the evenings. She was given treatment with hydrochlorothiazide 12.5 mg daily She was followed intermittently for the next few years and was told that her BP was at the upper limit of normal and that her blood sugar was also borderline high 9 History of Present Illness At age 52 years, she was found to have BP over 155 mmHg and treatment with irbesartan 150 mg daily was added to her diuretic dose High blood glucose was found and metformin was started At age 55 years, her BP was still above 140/90 mmHg and atenolol 25 mg was added to her treatments 10 History of Present Illness At her initial visit to you, she complains of shortness of breath on climbing stairs and also that her ankles are swollen by the evening She has no chest pain. She does not sleep well and is tired during the day. She has nocturia 2 or 3 times and also frequent urination during the day
She has pain in her knees and hips linked to her work in a supermarket where she must stand all day She has flushing episodes She is short of breath on mild exercise 11 Past History Married, lives with husband Works in a supermarket as a cashier for the last 15 years Does not smoke, drinks socially, sedentary, follows no diet but does not use the salt shaker No known allergies G2 P2 A0 (age 32 and 34 years) Cholecystectomy Menopause at age 52 years 12 Family History Father Died at age 72 of MI and renal disease Mother Alive and well at 84 years. She has been treated for hypertension for the last 25 years
Brother HTN, CAD, smoker Sister Obesity, diabetes 13 Current Medications Hydrochlorothiazide 12.5 mg Ramipril 5 mg day Bisoprolol 5 mg day Metformin 500 mg BID ASA 81 mg day Lorazepam 1.0 mg HS Ibuprofen 1 to 3 tabs/day 14
Physical Examination Height: 160 cm Weight: 88 kg BMI: 33.7 kg/m2 BP (left arm, seated): 148/92 mmHg using an automated device Pulse: 56 Funduscopic: Gr I Neck-Thyroid palpable, no nodule Heart: Normal Lungs: Normal Abdomen: no murmurs Arteries: Normal Ankle edema: pitting ++ Neuro: decreased vibration and monofilament in feet 15
Discussion Question 1 This patient has hypertension and diabetes. What investigations are appropriate for this patient? 16 Discussion Question1) This patient has hypertension and diabetes. What investigations are appropriate for this patient? a) What are the essential laboratory test required in a patient with hypertension and diabetes? b) How frequently should you obtain these tests? 17 a) Routine Laboratory Tests Preliminary investigations of patients with hypertension and diabetes 1. 2. 3. 4. Urinalysis Blood chemistry (potassium, sodium and creatinine)
Fasting glucose Fasting total cholesterol and high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), triglycerides 5. Standard 12-leads ECG Currently there is insufficient evidence to recommend routine testing of microalbuminuria in people with hypertension who do not have diabetes 18 b) Frequency of Follow Up Investigations During the maintenance phase of hypertension management, tests (including electrolytes, creatinine, glucose, and fasting lipids) should be repeated with a frequency reflecting the clinical situation Diabetes develops in 1-3%/year of those with drug treated hypertension. The risk is higher in those treated with a diuretic or beta blocker, in the obese, sedentary, with higher fasting glucose and who have unhealthy eating patterns. Assess for diabetes more frequently in these patients 19
Discussion Question 2 What is the impact of finding nephropathy in a patient with diabetes? Discussion Question 2) If you find nephropathy: a) What is the impact of achieved BP on patient outcomes? (the patients BP is 148/92 mmHg using an automated device) b) What is the impact for the patient? Incidence of Renal Events by Achieved BP Levels in ADVANCE Study De Galan BE cJASN 2009 Diabetes and Lifetime CVD Risk 0.7 Diabetic 0.6 Non-diabetic
Adjusted cumulative incidence Adjusted cumulative incidence Men 0.5 0.4 0.3 0.2 0.1 0 50 60 70 Age 80 90 Women 0.7
Diabetic Non-diabetic 0.6 0.5 0.4 0.3 0.2 0.1 0 50 60 70 80 90 Age Lloyd Jones et al. Circulation 2006;113:791-8 23 Relation Between Age and CVD in Patients with Diabetes Compared to Those Without
Women 30 25 Number of events per 1,000 person-years Number of events per 1,000 person-years Men Men with diabetes Men without diabetes 20 15 10 5 0 0 0 5 0 5 0 5 0 5
76 -8 0 160 200 45 180 Diabetes, recent AMI No diabetes, recent AMI Diabetes, no recent AMI No diabetes, No recent AMI 220 41 - 200 240 40
Diabetes, recent AMI No diabetes, recent AMI Diabetes, no recent AMI No diabetes, No recent AMI 220 31 - 240 Women Number of events per 1,000 person-years Number of events per 1,000 person-years Men Age Age Booth et al. Lancet 2006;368:29-36 25
Major Causes of ESRD Number of dialysis patients (x1000) Primary diagnosis in patients who start dialysis Other 10% 700 Diabetes 50.1% 600 Glomerulonephritis 13% Hypertension Predicted 27% Patients (n) 95%CI
2008 ESRD: end-stage renal disease United States Renal Data System. Annual data report. 2000 26 Multivariate Relative Risks for Primary Outcomes in the HOPE Study Microalbuminuria 1.59 Coronary artery disease 1.51 Diabetes 1.42 Creatinine 120 mol/L 1.4 Male 1.2
Waist/hip ratio (0.1) 1.13 Age (1 yr) 1.03 Ramipril 0.79 0 1 Relative risk 2 Mann et al. Ann Intern Med 2001;134:629-36 27 Abnormal Urinary Albumin Levels Setting
Urinary albumin/creatinine level (mg/mmol) Men Chronic kidney disease Diabetes Women >30 >2 >2.8 28 Proteinuria Levels a Predictor of Stroke and Cardiovascular Events in Type 2 Diabetes U-prot <150 mg/L U-prot 150-300 mg/L U-prot >300 mg/L 40 0.9
32 Discussion Question 3 What is the blood pressure target in people with diabetes and hypertension? Discussion Question 3) What is the blood pressure target in people with diabetes and hypertension? 1. What is the classification of hypertension and what are the BP threshold and target values for a patient with hypertension and diabetes? 2. How does recent evidence support these recommendations? 34 European Society of Hypertension Classification of Blood Pressure Category Systolic Diastolic Optimal
The category pertains to the highest risk blood pressure *ISH: isolated systolic hypertension J Hypertension 2007;25:1105-87 35 II. Indications for Pharmacotherapy Usual blood pressure threshold values for initiation of pharmacological treatment of hypertension Condition Initiation SBP or DBP mmHg Systolic or diastolic hypertension 140/90 Diabetes Chronic kidney disease 130/80 140/90
141.4 83.2 80 499 139.7 81.1 Major CV events* (per 1000 pt yrs) Strict BP Control Reduces Cardiovascular Events in Patients with Diabetes: HOT Trial p<0.005 30 25 24.4 18.6 20 15
11.9 10 5 0 90 *includes myocardial infarction, stroke and all other causes of death from CV; **mean of all BPs from 6 months of follow-up to end of study 85 80 Target DBP (mm Hg) Hansson et al. Lancet 1998;351:1755-62 37 Blood Pressure: Tight vs. Less Tight Control Less tight control (n=156) 180 160 160
BP (mmHg) Tight control (n=297) 154 140 144 94 100 87 80 82 60 0 cohort, median values 2 4
6 8 Years from randomization UKPDS. BMJ 1998;317:703-13 38 Any Diabetes-Related Endpoints Patients with events (%) 50 Less tight blood pressure control (n=390) Tight blood pressure control (n=758) 40 30 20 10 Risk reduction with tight control: 24% p=0.0046 0 0
cohort, median values 3 6 Years from randomisation 9 UKPDS. BMJ 1998;317:703-13 39 ACCORD: Mean SBP Over Time (Intensive vs Standard BP control groups) Mean # meds: SBP (mmHg) 140 3.2 3.4 3.5 3.4
1.9 2.1 2.2 2.3 Intensive Standard 130 Average after 1st year: 133.5 standard vs. 119.3 intensive, = 14.2 120 110 0 (n) 2174 1973 1150
ACCORD Study Group. N Engl J Med 2010;362:1575-85 41 ACCORD: Primary Outcome (Nonfatal MI, Nonfatal Stroke, or CVD Death) HR: 0.88 95%CI 0.73-1.06; p=0.20 ACCORD Study Group. N Engl J Med 2010;362:1575-85 42 ACCORD: Results and Rationale for Lack of Impact on BP Recommendations Overall BP study was neutral with no benefit of systolic target <120 mmHg vs. <140 mmHg for primary outcome, yet: Power issue: annual rate of primary outcome 1.87% in the intensive arm versus 2.09% in the standard arm vs 4%/year event rate projected during sample size calculations
Significant interaction between BP and glycaemia control studies such that those in usual care glycaemia group (A1c 7%+) had a significant improvement in primary outcome with lower BP target Secondary outcome for stroke reduction showed a benefit for lower BP target (41% RRR) Therefore no clear evidence supporting a change in BP targets for people with diabetes at this point ACCORD study NEJM 2010 43 Discussion Question 4 What is the management of a patient with diabetes and above target blood pressure without nephropathy? Discussion Question 4) What is the management of a patient with diabetes and BP above target? 1. Treatment of hypertension in diabetes without nephropathy 2. Treatment targets
3. Multi-risk factor intervention Treatment of Systolic-Diastolic Hypertension without Diabetic Nephropathy Threshold equal or over 130/80 mmHg and TARGET below 130/80 mmHg Diabetes without nephropathy 1. ACE inhibitor or ARB or 2. Dihydropyridine CCB or thiazide diuretic IF ACE inhibitor and ARB and DHP-CCB and thiazide are contraindicated or not tolerated, SUBSTITUTE Cardioselective BB* or Long-acting NON DHP-CCB Combination of first line agents Addition of one or more of: Cardioselective BB or Long-acting CCB
Combinations of an ACE inhibitor with an ARB are specifically not recommended in the absence of proteinuria More than 3 drugs may be needed to reach target values for diabetic patients DHP: dihydropyridine *cardioselective BB: acebutolol, atenolol, bisoprolol, metoprolol 46 Treatment Targets Usual blood pressure targets Condition Initiation SBP or DBP mmHg Systolic or diastolic hypertension <140/90 Diabetes Chronic kidney disease <130/80 <140/90
47 Multi-risk factor intervention Target A1c of 7.0% Target LDL < 2.0 Smoking cessation if appropriate Diet Exercise BP control and use of RAAS blockers STENO-2 Study (Type 2 DM) 160 patients randomly assigned to intensified intervention with achievement of blood pressure targets, tight glucose regulation, use of the RAAS blockers, aspirin, lipid lowering agents and focused behaviour modifications Treatment to target in STENO-2
HbA1c less than 6.5% Cholesterol less than 4.5 mmol Triglycerides less than 1.7 mmol BP less than 130/80 mmHg Use of RAAS blockade Gaede et al. N Engl J Med 2008;358:580-91 49 Primary composite endpoint (%) STENO-2: Effect of a Multifactorial Vascular Protective Strategy on Macro- and Microvascular Outcomes 60 50 Conventional therapy Intensive therapy 40 30 20
63 61 59 19 Gaede et al. N Engl J Med 2003;348:383-93 50 STENO-2 Extended Follow-up: Effect of a Multi-factorial Vascular Protective Strategy on Total Mortality 60 Conventional therapy Intensive therapy Total mortality (%) 50 40 END OF TRIAL HR: 0.54
95%CI 0.32-0.89; p=0.02 30 20 Intensive therapy BP measurements Baseline: 146/85 End of intervention study: 131/73 End of follow-up: 140/74 10 0 0 1 2 3 4 5 6 7 8 Follow-up (yrs)
9 10 11 12 13 Gaede et al. N Engl J Med 2008;358:580-91 51 STENO 2: Number of events for each component of the composite end point Gaede P, NEJM; 2008; 358:580-91 STENO-2: Progression to Macroalbuminuria Gaede P, NEJM; 2008; 358:580-91 Case Progression Mrs. J.D. returns to your office. What is your treatment plan?
Height: 160 cm; weight: 92 kg; BMI: 35.3 BP: 152/90 mmHg, by BpTru SOB: ankle edema Creatinine: 90mmol/l K: 4.0 mmol Na: 136 mmol Alb/creat: 26.2 mg/mmol 54 Discussion Question 5 Mrs. J.D. returns to your office. What is your treatment plan for her BP? Case Progression Current medications of Mrs J.D. are listed below. What changes would you propose? Hydrochlorothiazide 12.5 mg Ramipril 5 mg day
Bisoprolol 5 mg day Metformin 500 mg BID ASA 81 mg day Lorazepam 1.0 mg HS Ibuprofen 1 to three tabs day What changes would you propose the current medications? What are the benefits and risks? a) Stopping Ibuprofen b) Replacing bisoprolol with a DHP-CCB (amlodipinenifedipine-felodipine) c) Adding a DHP-CCB to the actual combination as a fourth medication d) Increasing the dose of the diuretic and the ACE-I e) Replacing hydrochlorothiazide with other diuretics (chlorthalidone or spironolactone) f) Adding a peripheral alpha blocker(doxazosin) g) Adding an alpha 2 agonist (clonidine) 57 Current Medications of Mrs. J.D. What Changes Could You Propose? a)The use of ibuprofen (NSAID) is associated with an increase of BP b)Replacing bisoprolol with a DHP-CCB. An ACEI+DHP-CCB combination can be preferred combination for hypertensive diabetics at risk of CV
complications. c) Adding a DHP-CCB to the combination is an option of four medications, if bisoprolol is maintained 58 Current Medications of Mrs. J.D. What Changes Could You Propose? d) Increasing the dose of the diuretic HCTZ and ACEI. Ramipril and HCTZ are both prescribed at low doses for this patient. Ramipril is also a short acting ACEI which could be replaced by a longer acting RAAS blocker or the dose of ramipril be doubled or given BID e) Replacing the HCTZ with chlorthalidone (long acting more potent diuretic.) Blood glucose, potassium and uric acid would have to be monitored. 59 Current Medications of Mrs. J.D. What Changes Could You Propose? f) Adding a peripheral alpha2 receptor blocker
(Doxazosin, terazosin or prazosin) an option Adverse effect is mainly orthostatic hypotension. g) Adding an alpha2 agonist (clonidine) also an option in non responsive patients Adverse effects are mainly dry mouth, bradycardia mainly in combination with a betablocker and withdrawal hypertension if medication is suddenly stopped. 60 Case Progression: How would you manage Mrs. JD if she presented with ankle edema, shortness of breath and the following lab reports? Ankle edema, shortness of breath Creatinine: 102 mmol/l Sodium: 135 mmol/l Uric acid: 550mol/l Potassium: 3.5 mmol/l 24 h urinary proteins 550 mg/L 61
Discussion Question 6 What is the management of a patient with diabetes and above target blood pressure in the setting of nephropathy? Discussion Question 6) What is the management of a patient with diabetes and above target blood pressure in the setting of nephropathy? 1. Treatment of hypertension in diabetes with nephropathy Role of blockade of the RAAS system For severe nephropathy, role and risks of dual blockade of the RAAS system Lifestyle Therapies in Adults with Hypertension: Summary Intervention Target Reduce foods with added sodium <2300 mg /day Weight loss
BMI <25 kg/m2 Alcohol restriction 2 drinks/day Physical activity 30-60 minutes 4-7 days/week Dietary patterns DASH diet Smoking cessation Smoke free environment Waist circumference Men <102 cm Women <88 cm 64
Treatment of Hypertension in Association with Diabetes Mellitus Threshold equal or over 130/80 mmHg and target below 130/80 mmHg with Nephropathy* *Urinary albumin to creatinine ratio 2.0 mg/mmol in men or 2.8mg/mmol in women* Diabetes without Nephropathy** Systolicdiastolic hypertension Isolated systolic hypertension A combination of 2 first line drugs may be considered as initial therapy if the blood pressure is 20 mmHg systolic or 10 mmHg diastolic above target Combinations of an ACEI with an ARB are specifically not recommended in the absence of proteinuria
*based on at least 2 of 3 measurements 65 Definitions of Microalbuminuria and Macroalbuminuria Care Normal Microalbuminuria Macroalbuminuria Urinary excretion of albumin (g/min) <20 20200 >200 Urinary excretion of albumin (mg/24h)
<30 30300 >300 Urine albumin to creatinine ratio (mg/gm) <30 30300 >300 Urine albumin to creatinine ratio (mg/ mmol) <2.0 2.020.0 >20.0 Expert Committee on Clinical Practice Guidelines of the Canadian Diabetes Association. Clinical practice guidelines of the
2008 Canadian Diabetes Association for the Prevention and Management of Diabetes in Canada. Can J Diabetes 2008 How would you manage Mrs. JD if she presented with ankle edema and shortness of breath? 1. Is an ACEI-ARB combination an acceptable treatment option for patients with hypertension, diabetes and proteinuria? 2. What risks have been associated with this combination? 3. How would you monitor this patient? 67 How would you manage Mrs. JD if she presented with ankle edema, shortness of breath? 1. The combination of ACEI-ARB is acceptable in patients who have hypertension, diabetes and macroalbuminuria despite treatment with an ACEi or ARB 2. Risks associated with this combination include: increased risk of renal dysfunction, progression to dialysis, hypotension and hyperkalemia 3. Monitor Mrs. J.D.s BP, renal function and potassium. 68 XII. Treatment of Hypertension in Association with Diabetes Mellitus: Summary Threshold equal or over 130/80 mmHg and TARGET below 130/80 mmHg
with Nephropathy ACE inhibitor or ARB Diabetes without Nephropathy 1. ACE inhibitor or ARB or 2. DHP-CCB or thiazide diuretic A combination of 2 first line drugs may be considered as initial therapy if the blood pressure is 20 mmHg systolic or 10 mmHg diastolic above target. Combining an ACEI and a DHP-CCB is recommended. 2-drug combinations
Monitor serum potassium and creatinine carefully in patients with CKD prescribed an ACEI or ARB Combinations of an ACEI with an ARB are specifically not recommended in the absence of proteinuria More than 3 drugs may be needed to reach target values for diabetic patients If creatinine over 150 mol/L or creatinine clearance below 30 ml/min (0.5 ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of volume is desired 69 IV. Optional Laboratory Tests Investigation in specific patient subgroups For those with diabetes or chronic kidney disease: assess urinary albumin excretion, since therapeutic recommendations differ if proteinuria is present. For those suspected of having an endocrine cause for the high blood pressure, or renovascular hypertension, see following slides. Other secondary forms of hypertension require specific testing. 2015 Canadian Hypertension Education Program Patients with diabetes are at high cardiovascular risk Most patients with diabetes have hypertension Treatment of hypertension in patients with diabetes reduces total mortality, myocardial infarction, stroke, retinopathy and progressive renal failure rates Treating hypertension in patients with diabetes reduces death and
disability and reduces health care system costs In diabetes, TARGET <130 systolic and <80 mmHg diastolic If a patient has both diabetes and CKD, TARGET <130 systolic and <80 mmHg diastolic The use of the combination of ACE inhibitor with an ARB should only be considered in selected and closely monitored people with advanced heart failure or proteinuric nephropathy 71 The full slide set of the 2015 CHEP Recommendations is available at www.hypertension.ca 72
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