New European Guidelines for Management of Arterial Hypertension

Classification of Hypertension

The relationship between blood pressure levels and cardiovascular risk is continuous and direct, and this makes any numerical definition and classification of hypertension arbitrary, the guidelines committee has stressed. Any numerical definitions must be flexible, resulting from evidence of risk and availability of effective and well-tolerated drugs. Since no new epidemiologic evidence has emerged since 1999, the WHO/ISH classification (also that of JNC 6, but not JNC 7) has been retained (Table 1), with the reservation that the threshold for hypertension must be considered as flexible -- ie, higher or lower based on the total (global) cardiovascular risk profile of each individual. Accordingly, the definition of high-normal blood pressure includes values that may be considered as high (ie, hypertensive) in high-risk individuals or acceptable in those at lower risk.

Table 1. WHO/ISH Definition and Classification of Blood Pressure Levels

Category	Systolic (mm Hg)	Diastolic (mm Hg)
Optimal	< 120	< 80
Normal	120-129	80-94
High-normal	130-139	85-89
Hypertension:
Grade 1 (mild)	140-159	90-99
Grade 2 (moderate)	150-179	100-109
Grade 3 (severe)	>/= 180	>/= 10
Isolated systolic hypertension	>/= 140	< 90

According to the guidelines, when a patient's SBP and DBP levels fall into different categories, the higher category should apply. Moreover, in older patients with isolated systolic hypertension, the blood pressure can also be assessed as grades 1, 2, and 3, according to SBP values in the ranges indicated, provided diastolic values are < 90 mm Hg.

In another departure, the ESH committee believes that use of the term "hypertension" should be avoided in classifying blood pressure, and instead used only to promote the case for tight blood pressure control. Notably, they avoid and do not support the term "prehypertension," as used in JNC 7, although they point out that they were not aware of the term when the new European guidelines were prepared.

Total Cardiovascular Risk

Total (global) cardiovascular risk makes up an important part of the new guidelines. The committee points out that hypertension is often accompanied by other risk factors. Total cardiovascular risk quantification allows more accurate prognostic evaluation of the patient. The timing and type of antihypertensive treatment depend on this profile, and the blood pressure threshold and targets for therapy are modified, and the need for accompanying antihypertensive treatment modulated, by it.

Because of this, the classification using stratification for total cardiovascular risk has been expanded from the scheme in the 1999 WHO/ISH guidelines to indicate the added risk in some groups of individuals with normal or high blood pressure (Table 2).

Table 2 Stratification of Risk to Quantify Prognosis

Other Risk Factors and Disease History	Blood Pressure
	Normal	High-normal	Grade 1	Grade 2	Grade 3
No other risk factors	Average risk	Average risk	Low added risk	Moderately added risk	High added risk
1-2 risk factors	Low added risk	Low added risk	Moderate added risk	Moderate added risk	Very high added risk
>/= 3 risk factors, TOD, or diabetes	Moderate added risk	High added risk	High added risk	High added risk	Very high added risk
ACC	High added risk	Very high added risk	Very high added risk	Very high added risk	Very high added risk

ACC = associated clinical conditions; TOD = target organ damage

The total level of risk is the main indication for intervention, but lower or higher pressure values are also more or less stringent indicators for blood pressure-lowering intervention. The terms "low added," "moderate added," "high added," and "very high added" risk are calibrated to indicate an approximate absolute 10-year risk of cardiovascular disease of < 15%, 15% to 20%, 20% to 30%, and > 30% added risk, respectively, according to Framingham criteria, or an absolute risk of fatal cardiovascular disease of < 4%, 4% to 5%, 5% to 8%, and > 8%, respectively, according to the SCORE (Systemic Coronary Risk Evaluation) chart. The word "added" is used because it accounts for an increase in relative risk and, for example, could negate the misleading impression that patients at "low risk" are below average risk (they are actually at low added risk).

The most common risk factors for cardiovascular disease used for stratification are:

1.       Levels of SBP/DBP

2.       Men aged > 55 years

3.       Women aged > 65 years

4.       Smoking

5.       Dyslipidemia

Total cholesterol > 6.5 mmol/L (> 250 mg/dL)
or

LDL-cholesterol > 4.0 mmol/L (> 155 mg/dL)
or

HDL-cholesterol :

Men: < 1.0 mmol/L (< 40 mg/dL);

Women: < 1.2 mmol/L (< 48 mg/dL)

6.       Family history of premature cardiovascular disease (men < 55 years, women < 65 years)

7.       Abdominal obesity (abdominal circumference >/= 102 cm [40 in] in men, 88 cm [35 in] in women)

8.       C-reactive protein >/= 1 mg/dL

Obesity is defined as abdominal obesity to draw attention to an important sign of the metabolic syndrome (carrying extra weight may not be a problem, unless it is all carried around the abdominal girth). C-reactive protein was added after increasing evidence pointed to its value as a predictor of cardiovascular events; it has been shown to be as reliable a predictor as LDL-cholesterol levels, and because of CRP's association with the metabolic syndrome.

The importance of target organ damage (TOD) for determining overall cardiovascular risk is also emphasized. The practicing physician should seek evidence for organ involvement, including electrocardiogram/echocardiogram investigations for left ventricular (LV) hypertrophy, ultrasound evidence of arterial wall thickening or atherosclerotic plaque, slight increase in serum creatinine, and microalbuminuria.

Other factors the guidelines points to as influencing prognosis are the presence/absence of diabetes mellitus and of associated clinical conditions, including cerebrovascular disease, heart disease, renal disease, peripheral vascular disease, and advanced retinopathy.

Goals of Treatment

The primary goal of treatment is to achieve the maximum reduction in the long-term total risk of cardiovascular morbidity and mortality. On the basis of current evidence from trials, blood pressures should be lowered to < 140/90 mm Hg at least, and, if tolerated, to levels < 130/80 mm Hg in diabetic patients.

Therapeutic Approach

The guidelines for initiating antihypertensive treatment are based on 2 criteria:

1.       The total level of cardiovascular risk (Table 2), and

2.       SBP and DBP levels (Table 1).

The total level of cardiovascular risk is the main indication for intervention, but lower or higher blood pressure values are also less or more stringent indicators for blood pressure-lowering intervention.

Recommendations for individuals with high normal blood pressure (SBP 130-139 or DBP 85-89 mm Hg on several occasions) include:

1.       Assess other risk factors, TOD (particularly renal), diabetes, associated clinical conditions

2.       Initiate lifestyle measures and correction of other risk factors or disease

3.       Stratify absolute risk:

Very high/high: begin drug treatment
Moderate: monitor blood pressure frequently
Low: no blood pressure intervention

Recommendations for individuals with grades 1 and 2 hypertension (SBP 140-179 mm Hg or DBP 90-109 mm Hg on several occasions) include:

1.       Assess other risk factors (TOD, diabetes, associated clinical conditions)

2.       Initiate lifestyle measures and correction of other risk factors or disease

3.       Stratify absolute risk

Very high/high: begin drug treatment promptly

Moderate: monitor BP and other risk factors for >/=3 months:

-- SBP >/= 140 or DBP >/= 90 mm Hg: begin drug treatment

-- SBP < 140 or DBP < 90 mm Hg: continue to monitor

Low: monitor BP and other risk factors for 3-12 months:

-- SBP >/= 140 or DBP >/= 90 mm Hg: consider drug treatment and elicit patient's preference

-- SBP < 140 or DBP < 90 mm Hg: continue to monitor

Recommendations for individuals with grade 3 hypertension (SBP >/= 180 or DBP >/= 110 mm Hg on repeated measurements within a few days):

1.       Begin drug treatment immediately.

2.       Assess other risk factors, TOD, diabetes, associated clinical conditions.

3.       Add lifestyle measures and correction of other risk factors or diseases.

Lifestyle Changes

Lifestyle measures recommended include smoking cessation, weight reduction, reduction of excessive alcohol intake, physical exercise, reduction of salt intake, and increase in fruit and vegetable intake and decrease in saturated and total fat intake.

Choice of Antihypertensive Agents

The guidelines stress that the main benefits of antihypertensive therapy are due to the lowering of blood pressure per se. They list the standard major classes of antihypertensive agents suitable for the initiation and maintenance of therapy:

1.       Diuretics

2.       Beta-blockers

3.       Calcium channel blockers (CCBs)

4.       ACE inhibitors

5.       Angiotensin-receptor blockers (ARBs).

Regarding a final class, alpha-adrenergic receptor blockers, the arm of the only trial testing an alpha-blocker (the doxazosin arm of ALLHAT) was terminated early, for an excess of cardiovascular events. Although the termination has been criticized, evidence favoring alpha-blockers as antihypertensive therapy is more scanty than evidence of the benefits of other antihypertensive agents. Nevertheless, alpha-blockers should be considered as a therapeutic option, particularly for combination therapy.

In direct contrast to JNC 7, the European guidelines refrain from recommending specific classes of drugs as initial treatment; nevertheless, the guidelines recognize that there is evidence to support variable effects of specific drug classes on special subsets of patients. These include the elderly, pregnant women, diabetic patients; patients with concomitant cerebrovascular disease, coronary heart disease, or congestive heart failure; deranged renal function; or resistant hypertension. Specific indications are given for the major classes of antihypertensive drugs (Table 3).

Table 3. Indications for the Major Classes of Antihypertensive Drugs

Drug	Conditions Favoring Use
Diuretics (thiazide)	CHF; elderly; ISH; hypertensives of African origin
Diuretics (loop)	Renal insufficiency; CHF
Diuretics (antialdosterone)	CHF; post MI
Beta-blockers	Angina pectoris; post MI; CHF (up-titration); pregnancy; tachyarrhythmias
CCBs (dihydropyridine)	Elderly; ISH; angina pectoris; peripheral vascular disease; carotid atherosclerosis; pregnancy
CCBs (verapamil, diltiazem)	Angina pectoris, carotid atherosclerosis; supraventricular tachycardia
ACE inhibitors	CHF; LV dysfunction; post MI; nondiabetic nephropathy; type 1 diabetic nephropathy; proteinuria
ARBs	type 2 nephropathy; diabetic microalbuminuria; proteinuria; LV hypertrophy; ACE inhibitor cough
Alpha-blockers	BPH; hyperlipidemia

ARBs, angiotensin receptor blockers; BPH, benign prostatic hyperplasia; CCBs, calcium channel blockers; CHF, congestive heart failure; ISH, isolated systolic hypertension; MI, myocardial infarction; LV, left ventricular

Finally, if, in the judgment of the physician, treatment can proceed with a single pharmaceutical agent, it is recommended that monotherapy be started gradually in most patients.

Combination Therapy

In direct contrast to JNC 7, the European guidelines state that emphasis on a preferred class of drugs for "first-line therapy" is probably outdated, given the need to use 2 or more drugs in combination in order to achieve goal blood pressure. Taking into account baseline blood pressure and the presence or absence of complications, the guidelines recommend initiating therapy either with an adequate dose of a single agent or with a low-dose combination of 2 agents.

Drug combinations found to be effective and well tolerated include:

1.       Diuretic and beta-blocker

2.       Diuretic and ACE inhibitor or ARB

3.       CCB (dihydropyridine) and beta-blocker

4.       CCB and ACE inhibitor or ARB

5.       CCB and diuretic

6.       Alpha-blocker and beta-blocker

7.       Other combinations (eg, with centrally acting agents, including alpha₂-adrenoceptor agonists and imidazoline-I₂ receptor modulators, or ACE inhibitors or ARBs) can be used, if necessary.

8.       In many cases, 3 or 4 drugs may be necessary.

There are advantages and disadvantages associated with both monotherapy and combination therapy, the guidelines state. A disadvantage of combination therapy is the potential exposure of patients to unnecessary drugs, but control of blood pressure and its complications is more likely. Use of low-dose combinations are more likely to be free of side effects, and fixed-dose combinations available in Europe are likely to have the practical advantage of optimizing compliance. The decision as to which approach should be prescribed in which patients will likely depend on the initial blood pressure, risk factors, and the presence or possibility of TOD.

Other Aspects of the Guidelines

As well as detailed sections on treatment of special populations, other hypertension treatment areas covered in the guidelines include the present status of genetic analysis, relative benefits of ambulatory/home blood pressure, follow-up strategies, the importance of long-acting agents, evaluation of adverse effects, and implementation/compliance/adherence. Treatments for associated risk factors include lipid-lowering agents, antiplatelet therapy, and glycemic control.

Implementation of Guidelines

The importance of closing the gap between experts' recommendations and the poor blood pressure control seen in European medical practice is emphasized in the new guidelines. It is hoped that translations of the guidelines into the many European languages will be sanctioned by the national hypertension societies and leagues, so that the guidelines can be widely disseminated to improve blood pressure control in Europe.

Diabetes education booklet

Introduction to diabetes

Approximately 1.4 million people in the UK have diabetes and it is suggested by Diabetes UK that there could be another one million people with diabetes and are unaware they have it. The majority of people with diabetes (85% - 90% will have Type 2 diabetes). The remainder will have Type 1 diabetes.

Diabetes Mellitus is a condition in which the amount of sugar in the blood is too high. When we eat a meal the starchy and sugary carbohydrates are changed into sugar (glucose ) during dijestion and this sugar then  passes into the bloodstream. When the pancreas senses that there is a rising level of glucose in the blood it secretes a hormone called insulin. Insulin changes glucose into energy which provides fuel for the body. Insulin is vital for life because without it, the glucose could not be changed into energy and the body could not function without energy. It is often said that insulin acts like a key – unlocking the cell to allow the energy in. Obviously, like a car, we only need a certain amount of energy to provide for the requirements of the body. If we eat more than we need this will be stored as fat.

Signs and symptoms of diabetes

·         Excessive thirst

·         Frequency in  passing of urine

·         Blurred vision

·         Loss of weight

·         Tiredness

·         Mood changes

·         Frequent infections e. boils, thrush etc

Types of diabetes

There are two main types of diabetes:

·         Type 1 ( used to be called insulin dependent ) affecting children and young adults mostly

·         Type 2 diabetes ( used to be called non insulin dependent ) is commoner in the over 40 year olds although children as young as sixteen and obese are alsodeveloping Type2 diabetes

 Main Aim of treatment

The main aim of treatment of both types of diabetes is to normalise blood glucose levels to protect against long term damage to the eyes, kidneys, nerves,

heart and all the blood vessels. Some experts call diabetes “a blood vessel disease”  because preventing narrowing of the blood vessels is key to preventing complications.

Type 1 diabetes

The exact cause of Type 1 diabetes is unknown but thought to be due to a viral infection or environmental factors. In type 1 diabetes there is total destruction of the cells in the pancreas  ( beta cells ) that produce the insulin. The onset of type1 diabetes is acute, because as stated earlier insulin changes glucose into energy but in the absence of insulin, glucose builds up in the blood and is not turned into energy. In an effort to overcome the lack of fuel for the normal functioning of the body, fats and proteins are broken down instead. This is why

patients are often underweight at diagnosis.

Once treatment with insulin is started the patient will begin to feel better quickly and will regain the lost weight.

Treatment for type1 diabetes

People with Type 1 diabetes will need injections of insulin for the rest of their lives. Insulin is destroyed by the gastric juices so cannot be taken in tablet form.

People with Type1 diabetes will need a minimum of two injections daily and often more. They will also need to eat a healthy diet and take regular exercise and do regular self blood glucose testing

If you have been diagnosed with Type 1 diabetes please ask your health professional for the special  section on “ Insulin Ttreatment” which will give you much more specific and detailed information.

Type 2 diabetes

Type 2 diabetes occurs when the pancreas secretes less insulin than normal or when the insulin secreted fails to work properly (called insulin resistance). People who are overweight are five times more likely to develop Type 2 diabetes and four out of five people with Type 2 diabetes are overweight. Excess weight increases your body’s own glucose production and thus your body’s need for insulin too. At the same time, this extra insulin increases fatty acids stores and further increases insulin resistance. It becomes a vicious circle.

Type 2 diabetes is particularly associated with central excess weight ( apple shaped rather than pear shaped). Health risks increase when waist circumference is greater than 37inches (94cms) in men and 31.5 inches (80cms ) in women. Reducing calorie intake if you are overweight will help your body use insulin better by reducing insulin resistance.

You will find a whole section of this book devoted to healthy eating, weight control and exercise.

Type 2diabetes has a gradual onset. You may not feel any symptoms beyond a little tiredness which is often mistakenly attributed to age and working hard. As Type2 diabetes progresses  you may become aware of some of the signs already mentioned or you may be diagnosed  whilst being investigated for something else. It is suggested by experts that most people have had Type2 diabetes for at least five years before diagnosis.

The following people are at an increased risk of developing Type2 diabetes:

• Family history of diabetes
• Asian or Afro-Caribean origin
• Women who have had gestational diabetes
• Obese people
• People who take little exercise
• Older age
• People on certain medications eg steroids, and some anti psychotic medications

Treatment for Type2 diabetes

People with Type2 diabetes will be encouraged to eat a healthy balanced  diet and take regular exercise. They will be treated with diet only for the first three months after diagnosis (unless their blood glucose is very high and they are losing weight). If diet and exercise alone does not control your blood glucose levels you may also need to take tablets.

Diabetes and Driving in UK

Having diabetes does not mean that you cannot drive as long as you doctor says you are safe to do so – this is usually when your diabetes becomes stable and controlled. You will however have to plan in advance before getting behind the wheel of your car if you are on certain tablets for your diabetes and/or taking insulin.

You must by law inform the Driver and Vehicle Licensing Agency (DVLA) if

• Your diabetes is treated with tablets or insulin
• If your treatment changes from tablets to insulin or if insulin is added to the tablets
• If there are changes in your health or condition that may affect your ability to drive safely
• If you are applying for a licence for the first time, you must answer YES to the question about diabetes.

People Treated with Insulin

After you have written to the DVLA informing them of your insulin treatment, you will be sent a form (called “Diabetic 1”), asking for more information and for the name and address of your GP/ Hospital Doctor. You will be asked to sign a consent form allowing the DVLA to contact the doctor directly for more specific information on your diabetes control, eyesight and general fitness to drive.

This does not mean that you will be refused a licence – it just ensures safety for you and other drivers. Please answer all questions fully and honestly.

People Treated with Tablets

After you have informed the DVLA that you have diabetes, they will send you a letter explaining your responsibility to re-notify them if you start having insulin or have “hypos” (low blood sugar), or if you develop any of the complications of diabetes which could affect your ability to drive.

They will not normally ask you any other questions at this stage and you will normally expect to keep your “till to” licence.

Diet alone Treated patients

No restrictions on driving and do not need to inform DVLA.

Restricted Licences

Insulin treated – a driving licence will be issued to you for one, two or three years if you are treated with insulin. Just before expiry date, you will receive a reminder to renew your licence and you will be asked to return your current licence. You will be sent another “Diabetic1” form to confirm your medical condition. Renewals of restricted licences are free.

Tablets or diet treated – usually issued with a “till to” licence. When you reach 70 years of age, you will be expected (like everyone else in UK) to renew it every one to three years. There is a charge for this renewal.

Provisional licences – applies to insulin treated only – need to be renewed every one, two or three years.

When renewing licences, it is always sensible to keep a copy of the old licence or to make a note of the driver number, before sending to the DVLA. The process takes between six – eight weeks unless there are complications.

If you drive a motorcycle the rules for informing the DVLA are the same as for a car.

Eyesight Problems

Obviously it is important to have good distance vision and good field of vision (what you can see side to side when looking straight ahead). There are various tests that an ophthalmologist can do to carry out to test these factors. Your licence may be revoked if you fail a field of vision test, but you can appeal against it. There are different types of field of vision tests, some people do better on one type versus another. The DVLA will accept the results of any approved type of test.

Large Goods Vehicles (LGV) and Passenger Carrying Vehicles (PCV)

In 1991 the titles of HGV (heavy goods vehicle) changed to LGV

                    And PSV (public services vehicles) changed to PCV.

People treated with diet alone or diet and tablets are normally allowed to hold LGV and PCV licences, provided they are otherwise in good health.

People treated on insulin are not allowed to hold these licences. If you currently hold such a licence and start using insulin you must inform the DVLA and stop driving the vehicle immediately.

In 1996, the regulation on larger vehicles was extended to include medium sized vehicles. Anyone passing their driving test after 31^st December 1996 will only be given a licence to drive vehicles up to 3.5 tonnes.

Vehicles weighing 3.5 tonnes – 7.5 tonnes (Category CI ) and mini buses (DI) are now treated as Group 2 vehicles – normally there is a complete ban on insulin users obtaining a group 2  licence. However some CI licence holders can now apply for a medical assessment and can regain ability to drive these vehicles whilst on insulin. Please write to the DVLA for more information.

Taxis

The law does not bar insulin users from driving taxis, provided they are less than nine seats. As local councils issue licences the policy may vary in different parts of the UK. Some taxi authorities issue blanket restrictions. Please contact Diabetes UK and DVLC for more information.

Diabetes in Pregnancy (Gestational Diabetes)

If you need to commence insulin in pregnancy, you should notify DVLA immediately.

You will normally be allowed to continue driving but are recommended to stop if your control becomes unstable or if you do not have good warning signs of hypoglycaemia. You should re notify the DVLA six weeks after delivery if you are still on insulin, as your licence will need to be reassessed.

If you have problems relating to your driving licence, please discuss it with your diabetes team, who will be able to advise you. DVLA wish to issue licences, not to take them away – you can help by giving as much information as possible.

DO NOT DRIVE IF

·         You have difficulty recognising early signs of hypoglycaemia  (Section   )

·         You have started on insulin and your diabetes is not yet controlled.

·         You have problems with eyesight not corrected by glasses

·         You have numbness or weakness in your feet caused by nerve damage or circulation (neuropathy or ischaemia)

·         You have been drinking alcohol.

Precautions before Driving

• Long journeys need careful planning, allowing for regular stops if you are on specific tablets for diabetes and insulin.

Normally it is wise to have something to eat every two to three and half hours if you are on insulin and not to miss meals and not to delay meals if you are on tablets and insulin.

•  Test your blood sugar before driving and regularly during a long drive or if at work before you drive home at the end of the day or shift.

• ·Always carry quick acting glucose and slow release carbohydrate in the car at all times if you are on insulin or specific diabetes tablets.

• Always carry identification on your person and in the car stating your name, how your diabetes is treated and the name of your GP.

At the first sign of Hypoglycaemia

·         Stop driving as soon as it is safe to do so

·         Remove ignition key and move into passenger seat.

·         Immediately take glucose tablets or sugary drink (both may be required)

·         Follow this with slow release carbohydrate i.e sandwich, crisps, biscuits etc.

·         Wait for at least 15 – 20 minutes until you feel better, recheck blood if possible, if you do not feel better, take more glucose and biscuits and wait a further 15 minutes.

·       If you continue to feel unwell – call for help and do not drive – if considering using motorway emergency assistance, please remember you may be unsteady on your feet, so take extra glucose before walking.

Car Insurance

 The main potential danger of diabetes and driving is the possibility of having a hypoglycaemic episode which could impair your judgement and lead to an accident.

Since the Disability Discrimination Act came into effect at the end of 1996, insurers can only refuse cover if they have evidence of increased risk.

It is virtually important to inform your motor insurance that you have diabetes.

Your motor insurance may become invalid if

·         You fail to update them on changes to your treatment or physical condition

·         You fail to notify the DVLA as mentioned previously

·         You fail to comply with DVLA restrictions or recommendations

Diabetes UK Services   has an exclusive service that will search through a panel of insurers for the best quote,  - freephone 0800 731 7431.

Life Assurance / Insurance

Some people experience difficulty getting life cover. It is important that you declare your diabetes when applying for a new policy. Any life policy you hold at the time of diagnosis is unaffected.

Any difficulties ring Diabetes UK Careline 0845  120 2960

Or write to Diabetes UK Careline, 10, Parkway, London, NW1 7AA (operates a translation service also)

Travel Insurance

Many travel insurance policies exclude pre-existing medical conditions such as diabetes, you must check carefully if your policy includes or excludes diabetes.

Some insurance companies charge an extra £10 - £15 to include diabetes. It is worth having a letter to this effect from the insurers

Diabetes UK are continually expanding the service they offer. Please see relevant telephone lists at the back of this booklet.

Diabetes and Employment

An employer cannot by law refuse to employ you or dismiss you purely because you have diabetes, according to the Disability Discrimination Act (DDA1995).

Although most people with diabetes do not consider themselves to have a disability, diabetes is covered by the Act.

Certain professions are exempt from the DDA and can refuse to employ someone with diabetes, especially if they are treated with insulin, these include

·         Air line crew

·         Armed services

·         Off shore workers

·         Train drivers

·         Any work requiring LGV and PCV

·         Police force

However, if diabetes is diagnosed whilst in this employment, it may be possible to continue with some negotiable changes in your duties.