NICE Guidelines-2011

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Optimizing Hypertension Management Challenges & Way Forward

Hypertension:

Hypertension is one of the most important preventable causes of premature morbidity and mortality It is a major risk factor for: Stroke Myocardial infarction Heart failure Chronic kidney disease Cognitive decline Premature death. Hypertension

Hypertension:

Untreated hypertension is usually associated with a progressive rise in blood pressure. The risk associated with increasing blood pressure is continuous. Hypertension

Hypertension Worldwide Statistics:

Hypertension Worldwide Statistics Country Diagnosed Hypertensive Aware Treated Controlled US 24% 42% 52% 24% UK 19% 63% 50% 30% France 41% 79% 59% 24% Germany 53% 12% 32% 22% Canada 22% 59% 40% 16% Italy 58% 79% 51% 19% China 14% 26% 12% 3% Chockalingam, Am J Hypertens, 1998; Chamontin et al, Am J Hypertens , 1998; Marques-Vidal et al, Q J Med , 1997; Trenkwalder et al, J Hypertens , 1994; Vincenzi et al, G Ital Cardiol , 1992; Colhoun et al, J Hypertens , 1998; Franklin et al, Hypertension , 2001; Tao et al, Chin Med J , 1995.

Prevalence in Pakistan:

Hypertension is the most common cardiovascular disease in Pakistan. There are estimated 12 million cases of Hypertension in the country. Only 3% of the hypertensive population in Pakistan is adequately controlled. In 2000, the estimated number of adults with hypertension worldwide was 972 million out of which 639 million (65.7%) live in developing countries. By 2025 there will be 1.5 billion hypertensive patients world wide. Hypertension affects 1 in 3 individuals over the age of 45 years. Prevalence in Pakistan National Guidelines For Detection, Prevention, Control & Management of Hypertension A Collaborative Group , 2009

Underdiagnosed & Undertreated:

Blood Pressure in Pakistan is under diagnosed & undertreated, especially in elderly. The NHSP also showed that > 70% of all hypertensive patients are unaware of their disease. In addition, 80% of those with hypertension would be classified as being at high risk. Despite the fact that the average number of annual visits to the healthcare providers vary from 4.9 to 5.8 . 79.7% GPs used incorrect BP Cutoffs to diagnose hypertension in patients > 60 years. Underdiagnosed & Undertreated National Guidelines For Detection, Prevention, Control & Management of Hypertension A Collaborative Group , 2009

PowerPoint Presentation:

Kearney et al, Lancet 2005 Economic burden of Hypertension more than CAD There will be 1.5 billion hypertensive patients by 2025

Hypertension & Target-Organ Sequelae :

Hypertension & Target-Organ Sequelae Eyes Retinopathy Kidneys Nephropathy Vasculature Peripheral arterial disease Cerebral Stroke Transient ischemic attack Heart Disease Angina Myocardial infarction Left ventricular hypertrophy Heart failure Coronary revascularization From Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1997;157:2413-2446.

Major Risk Factors that increase mortality:

Smoking Dyslipidemias Diabetes Mellitus Age >60 Gender: men, postmenopausal women Family history Major Risk Factors that increase mortality

Impact of High-Normal Blood Pressure on Risk of Major Cardiovascular Events* in Men:

*Defined as death due to cardiovascular disease or as having recognized myocardial infarction, stroke, or congestive heart failure. Cumulative Incidence of Major Cardiovascular Events (%) 16 12 10 8 6 4 2 0 14 0 2 4 6 8 10 12 Time (Years) Optimal <120/80 mm Hg Normal 120–129/80–84 mm Hg High-Normal 130–139/85 – 89 mm Hg Impact of High-Normal Blood Pressure on Risk of Major Cardiovascular Events * in Men Vasan RS. N Engl J Med. 2001;345:1291-1297. Blood Pressure:

Prevalence of Cardiovascular Disease :

Prevalence of Cardiovascular Disease 10 20 30 40 50 60 High BP CAD CHF Stroke Other 50,000,000 12,200,000 4,600,000 4,400,000 2,800,000 Prevalence (millions) BP=blood pressure, CAD=coronary artery disease, CHF=congestive heart failure American Heart Association ® . 2000 Heart and Stroke Statistical Update. 1999. (24%)

Cardiovascular Mortality Risk Increases as Blood Pressure Rises*:

Lewington S, et al. Lancet . 2002;360:1903-1913; Chobanian AV, et al. JAMA . 2003;289:2560-2572. Cardiovascular Mortality Risk Increases as Blood Pressure Rises * Cardiovascular Mortality Risk Systolic/Diastolic Blood Pressure (mm Hg) 0 1 2 3 4 5 6 7 8 115/75 135/85 155/95 175/105 2x 4x 8x * Measurements taken in individuals aged 40–69 years, beginning with a blood Pressure of 115/75 mm Hg.

PowerPoint Presentation:

Benefit of lowering BP Sustaining a 12 mmHg reduction in SBP over 10 years will prevent one death for every 11 patients treated with Stage I HTN with additional CVD risk factors Why treat hypertension? 35-40%  in stroke morbidity and mortality 20-25%  CAD events 21%  vascular mortality 52%  in CHF 35%  in LVH

Treatment Retionale:

Short-term goal of antihypertensive therapy: Reduce blood pressure Long-term goal of antihypertensive therapy: Reduce mortality due to hypertension-induced disease: Stroke Congestive heart failure Coronary artery disease Nephropathy Peripheral artery disease Retinopathy Treatment Retionale

Hypertension Guidelines:

NICE 2006 JNC VII 2003 ESH 2003 WHO / ISH 1999 CCS 1999 PHL 1998 PHL 2010 NICE 2011 Hypertension Guidelines ESH – European Society of Hypertension, ISH – International Society of Hypertension, CCS – Canadian Cardiac Society, PHL – Pakistan Hypertension League

NICE GUIDELINES National Institute for Health & clinical Excellence (CG-clinical guidelines -127) :

NICE GUIDELINES National Institute for Health & clinical Excellence (CG-clinical guidelines -127) Clinical management of primary hypertension in adults © National Institute for Health and Clinical Excellence, 2011. All rights reserved. NICE clinical guideline 127 – Hypertension

Brief History:

This clinical guideline (published August 2011) updates and replaces NICE clinical guideline 34 (published June 2006) It offers evidence-based advice on the care and treatment of adults with primary hypertension The original Guidelines was developed by the Newcastle Guideline Development & research unit in 2004. Updated by the National Clinical Guideline Centre (NCGC) (formerly the National Collaborating Centre for Chronic Conditions) and the British Hypertension Society (BHS) in 2006 and 2011. Brief History © National Institute for Health and Clinical Excellence, 2011. All rights reserved. NICE clinical guideline 127 – Hypertension

Groups that will not be covered:

People with diabetes. Children and young people (younger than 18 years). Pregnant women. Secondary causes of hypertension (for example, Conn's adenoma, phaeochromocytoma and renovascular hypertension). People with accelerated hypertension (that is, severe acute hypertension associated grade III retinopathy and encephalopathy). People with acute hypertension or high blood pressure in emergency care settings. Groups that will not be covered

Diagnosing hypertension:

When using home blood pressure monitoring (HBPM) to confirm a diagnosis of hypertension, ensure that: for each blood pressure recording, two consecutive measurements are taken, at least 1 minute apart and with the person seated blood pressure is recorded twice daily, ideally in the morning and evening blood pressure recording continues for at least 4 days, ideally for 7 days Discard the measurements taken on the first day and use the average value of all the remaining measurements to confirm a diagnosis of hypertension. Diagnosing hypertension

Guidance:

Stage 1 hypertension Clinic blood pressure is 140/90 mmHg or higher and subsequent ABPM daytime average or HBPM average blood pressure is 135/85 mmHg or higher. Stage 2 hypertension Clinic blood pressure is 160/100 mmHg or higher and subsequent ABPM daytime average or HBPM average blood pressure is 150/95 mmHg or higher. Severe hypertension Clinic systolic blood pressure is 180 mmHg or higher or clinic diastolic blood pressure is 110 mmHg or higher. Guidance ABPM – Ambulatory Blood Pressure Monitoring, HBPM – Home Blood Pressure Monitoring

PowerPoint Presentation:

If the person has severe hypertension, consider starting antihypertensive drug treatment immediately. While waiting for confirmation of a diagnosis of hypertension, carry out investigations for target organ damage and a formal assessment of cardiovascular risk. If hypertension is not diagnosed but there is evidence of target organ damage such as left ventricular hypertrophy, albuminuria or proteinuria, consider carrying out investigations for alternative causes of the target organ damage. If hypertension is not diagnosed, measure the person’s clinic blood pressure at least every 5 years subsequently, and consider measuring it more frequently if the person’s clinic blood pressure is close to 140/90 mmHg. Guidance

Key priorities for implementation:

Offer antihypertensive drug treatment to people aged under 80 years with stage 1 hypertension who have one or more of the following: Target organ damage Established cardiovascular disease Renal disease Diabetes A10-year cardiovascular risk equivalent to 20% or greater. Key priorities for implementation

Initiating Treatment:

Offer antihypertensive drug treatment to people of any age with stage 2 hypertension. For people aged under 40 years with stage 1 hypertension and no evidence of target organ damage, cardiovascular disease, renal disease or diabetes, consider seeking specialist evaluation of secondary causes of hypertension and a more detailed assessment of potential target organ damage. This is because 10-year cardiovascular risk assessments can underestimate the lifetime risk of cardiovascular events in these people. Initiating Treatment

Step 1 treatment:

Offer people aged 80 years and over the same antihypertensive drug treatment as people aged 55–80 years, taking into account any co-morbidities. Offer step 1 antihypertensive treatment with a calcium-channel blocker (CCB) to people aged over 55 years and to black people of African or Caribbean family origin of any age. If a CCB is not suitable, or if there is evidence of heart failure or a high risk of heart failure, offer a thiazide-like diuretic such as chlortalidone or indapamide in preference to a conventional thiazide diuretic such as bendroflumethiazide or hydrochlorothiazide. For people who are already having treatment with bendroflumethiazide or hydrochlorothiazide and whose blood pressure is stable and well controlled, continue treatment with the same therapy Step 1 treatment

Step 1 treatment:

Do not combine an ACE inhibitor with an ARB to treat hypertension. Beta-blockers are not a preferred initial therapy for hypertension. However, beta-blockers may be considered in younger people, particularly: those with an intolerance or contraindication to ACE inhibitors and angiotensin II receptor antagonists women of child-bearing potential people with evidence of increased sympathetic drive. If therapy is initiated with a beta-blocker and a second drug is required, add a calcium-channel blocker rather than a thiazide-like diuretic to reduce the person’s risk of developing diabetes. Step 1 treatment

Step 2 treatment:

If blood pressure is not controlled by step 1 treatment, offer step 2 treatment with a CCB in combination with either an ACE inhibitor or an ARB. If a CCB is not suitable for step 2 treatment, offer a thiazide-like diuretic. For black people of African or Caribbean family origin, consider an ARB in preference to an ACE inhibitor, in combination with a CCB. Step 2 treatment

Step 3 treatment:

Before considering step 3 treatment, review medication to ensure step 2 treatment is at optimal or best tolerated doses. If treatment with three drugs is required, the combination of ACE inhibitor or angiotensin II receptor blocker, calcium-channel blocker and thiazide-like diuretic should be used. Step 3 treatment

Step 4 treatment:

Regard clinic blood pressure that remains higher than 140/90 mmHg after treatment with the optimal or best tolerated doses of an ACE inhibitor or an ARB plus a CCB plus a diuretic as resistant hypertension, and consider adding a fourth antihypertensive drug and/or seeking expert advice. For treatment of resistant hypertension at step 4: Consider further diuretic therapy with low-dose spironolactone if the blood potassium level is 4.5 mmol/l or lower. Use particular caution in people with a reduced estimated glomerular filtration rate because they have an increased risk of hyperkalaemia. Consider higher-dose thiazide-like diuretic treatment if the blood potassium level is higher than 4.5 mmol/l. Step 4 treatment

Step 4 treatment:

When using further diuretic therapy for resistant hypertension at step 4, monitor blood sodium and potassium and renal function within 1 month and repeat as required thereafter. If further diuretic therapy for resistant hypertension at step 4 is not tolerated, or is contraindicated or ineffective, consider an alpha- or beta-blocker. If blood pressure remains uncontrolled with the optimal or maximum tolerated doses of four drugs, seek expert advice if it has not yet been obtained. Step 4 treatment

The NICE Hypertension Guidelines 2006:

The NICE Hypertension Guidelines 2006

The NICE Hypertension Guidelines 2011:

The NICE Hypertension Guidelines 2011 Age under 55 years Aged over 55 years or black person of African or Caribbean family origin of any age A C A + C A + C + D Resistant hypertension A + C + D + consider further diuretic or alpha- or beta-blocker Consider seeking expert advice Key A – ACEI or ARB C – CCB D – Thiazide like diuretic

Patient education and adherence to treatment:

Provide appropriate guidance and materials about the benefits of drugs and the unwanted side effects in order to help people make informed choices. Provide an annual review of care to monitor blood pressure , provide people with support and discuss their lifestyle, symptoms and medication. Because evidence supporting interventions to increase adherence is inconclusive, only use interventions to overcome practical problems associated with non-adherence if a specific need is identified. Target the intervention to the need. Interventions might include: suggesting that patients record their medicine-taking encouraging patients to monitor their condition simplifying the dosing regimen using alternative packaging for the medicine using a multi-compartment medicines system. Patient education and adherence to treatment © National Institute for Health and Clinical Excellence, 2011. All rights reserved.

Lifestyle interventions:

Lifestyle interventions Lifestyle advice should be offered initially and then periodically to people undergoing assessment or treatment for hypertension. Ascertain people’s diet and exercise patterns because a healthy diet and regular exercise can reduce blood pressure. Offer appropriate guidance and written or audiovisual materials to promote lifestyle changes. Relaxation therapies can reduce blood pressure and people may wish to pursue these as part of their treatment. Ascertain people’s alcohol consumption and encourage a reduced intake if they drink excessively, because this can reduce blood pressure and has broader health benefits. © National Institute for Health and Clinical Excellence, 2011. All rights reserved.

Lifestyle interventions:

Lifestyle interventions Discourage excessive consumption of coffee and other caffeine-rich products. Encourage people to keep their dietary sodium intake low, either by reducing or substituting sodium salt, as this can reduce blood pressure. Do not offer calcium, magnesium or potassium supplements as a method for reducing blood pressure. Offer advice and help to smokers to stop smoking. A common aspect of studies for motivating lifestyle change is the use of group working. Inform people about local initiatives by, for example, healthcare teams or patient organisations that provide support and promote healthy lifestyle change. © National Institute for Health and Clinical Excellence, 2011. All rights reserved.

Selecting a suitable Antihypertensive therapy ??:

Able to get patients to goal Provide round the clock protection Offers “added” protective benefits Has good tolerability profile Selecting a suitable Antihypertensive therapy ??

Beta Blockers:

3 decade of use No morbidity and mortality benefit against placebo Antihypertensive effect decreased when diuretic added to it. Did not appear to prevent coronary events in the primary prevention trials in patients with high blood pressure Beta Blockers Messerli FH. J Clin Basic Cardiol 2001; 4: 201–204 Lever AF, Brennan PJ. MRC Trial of treatment in elderly hypertensives. High Blood Press 1992; 1: 132–7 Psaty BM, Smith NL, Koepsell TD, Furberg CD. In reply (letter). JAMA 1997;277:1759 - 60

Hydrochlorthiazide:

The antihypertensive efficacy of HCTZ in its daily dose of 12.5 and 25 mg as measured in head to head studies by ABPM measurement is consistently inferior to all other drug classes. The effect was similar at a dose of 50 mg but as out come data at this dose are lacking, HCTZ is an inappropriate first line drug for treatment of Hypertension Hydrochlorthiazide

CCB versus ARB:

VALUE: Primary Composite Cardiac Endpoint 14 12 10 8 6 4 2 0 Time (months) 0 6 12 18 24 30 36 42 48 54 60 66 Proportion of Patients With First Event (%) Valsartan -based regimen Amlodipine-based regimen HR = 1.03; 95% CI = 0.94–1.14; P = 0.49 Julius S et al. Lancet . June 2004;363:2022 –31 . CCB versus ARB

CCBs versus ARBs:

CCBs versus ARBs VALUE: Fatal and Non-fatal Stroke 6 5 4 3 2 1 0 Time (months) 0 6 12 18 24 30 36 42 48 54 60 66 Proportion of Patients With First Event (%) Valsartan-based regimen Amlodipine-based regimen HR = 1.15; 95% CI = 0.98–1.35; P = 0.08 Julius S et al. Lancet . June 2004;363:2022 –31 .

CCBs versus ARBs:

VALUE: Systolic Blood Pressure in Study Valsartan (N= 7649) Amlodipine (N = 7596) 135 140 145 150 155 mmHg Months (or final visit) Sitting SBP by Time and Treatment Group Baseline 1 24 48 2 3 4 6 12 18 30 36 42 54 60 66 CCBs versus ARBs Julius S et al. Lancet . June 2004;363:2022 –31 .

CCBs versus ARBs:

VALUE: Heart Failure Time (months) 0 6 12 18 24 30 36 42 48 54 60 66 9 8 7 6 5 4 3 2 1 0 Valsartan -based regimen Amlodipine -based regimen HR = 0.89; 95% CI = 0.77-1.03; P = 0.12 Proportion of Patients With First Event (%) Hospitalisation for HF or death from HF CCBs versus ARBs Julius S et al. Lancet . June 2004;363:2022 –31 .

CCBs versus ARBs:

VALUE: Incidence of New-onset Diabetes New-Onset Diabetes (% of patients in treatment group) 0 2 4 6 8 10 12 14 Valsartan -based Regimen (n = 5254) Amlodipine-based Regimen (n = 5168) 13.1% 16.4% 23% Risk Reduction With Valsartan 16 18 P < 0.0001 CCBs versus ARBs

Pharmacotherapy: Summary:

Pharmacotherapy: Summary BP Lowering CV Outcome Stroke Reduction Protection New DM Diuretics ++ +/- ++ - ive ACE-I/ARB + ++ + + ive CCB ( Amlodipine ) +++ + +++ Neutral

Conclusions:

Conclusions Good BP control is of vital significance. ACEI /ARB’S provide additional benefit in prevention of new onset diabetes, regression of LVH and Heart Failure. CCB e.g. Amlodipine is powerful, efficacious and safe anti-hypertensive which may be used as first line in high risk patients Most often combination therapy will be required to achieve Targets and ACEI/ARB, Amlodipine combination seems to be the best

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