Cardiovascular disease, type 2 diabetes

and hypertension in adults

CASE MANAGEMENT DESK GUIDE

Evidence document


This document contains the evidence which supports the recommendations for interventions in this generic desk guide for the management of cardiovascular disease and associated conditions in adults, according to the GRADE scheme by WHO. Evidence, references and recommendations will not appear in the version for use by clinicians. Recommendations and actions in blue will be adapted by the country working group.

In making our recommendations we have considered both the disease and the context.

The following criteria has been used:

-Balance between desirable and undesirable effects

-Quality of evidence

-Values and preferences

-Cost (resource allocation)

(Guyatt et al. 2008)

Strength of recommendation / Rationale
Strong / The panel is confident that the desirable
effects of adherence to the recommendation
outweigh the undesirable effects.
Conditional / The panel concludes that the desirable
effects of adherence to a recommendation
probably outweigh the undesirable effects.
However:
  • the recommendation is only applicable to a specific group, population or setting OR
  • new evidence may result in changing the
balance of risk to benefit
OR
  • the benefits may not warrant the cost or
resource requirements in all settings.

(WHO 2010a)

Evidence level / Rationale
High / Further research is very unlikely to change
confidence in the estimate of effect.
Moderate / Further research is likely to have an
important impact on confidence in the
effect.
Low / Further research is very likely to have an
estimate of effect and is likely to change the
estimate.
Very low / Any estimate of effect is very uncertain.

(WHO 2010a)

Limitations of evidence review:

The recommendations made in the generic desk guide are based on available literature and current guidelines. Whilst every attempt has been made to perform a thorough literature search to identify appropriate and relevant evidence, it is not a fully systematic literature review; therefore it cannot be guaranteed that all available evidence has been considered.However, the recommendationsalso incorporate internationally approved evidence-based guidelines, includingcurrent NICE guidelines, WHO “CVD-Risk Management Package for low and medium resource settings” (2002), WHO “Package of Essential Non-communicable Disease Interventions (PEN) for Primary Health Care” (2010b) and IDF Global Guidelines for Type 2 Diabetes (2012). These have used equivalent evidence scoring systems, thus it can be assumed that the grading of the recommendations made here is valid.

Introduction

This is a generic desk guide for the management of cardiovascular disease, diabetes and hypertension in adults in low-middle income countries.

These guidelines and related tools must be adapted to the local health service context in country by the Ministry of Health and NGO partners through a working group process. This process should acknowledge available resources, including; staff, drugs, basic equipment, tests (and units); prior to pilot, evaluation and scale-up in country.

This desk guide is a concise “quick reference” for doctors, clinical officers, paramedics, nurses and counsellors to use when providing routine care and health education to all patients. The initial assessment pages are designed for use with any adult who presents at a primary care facility e.g. health centre or district hospital outpatient department. The objective is to enable effective opportunistic screening, diagnosis and treatment of patients with chronic non-communicable diseases, in particular, cardiovascular disease, type 2 diabetes mellitus, hypertension and underlying risk factors. The desk guide clearly indicates when other guidelines should be used, i.e. when the management of disease, such as acute illness, is not within the scope of this guide.

It provides a systematic approach to the monitoring of patients with these diseases and the prevention and identification of complications. It clearly indicates when referral to district hospital and assessment by a more senior clinician is appropriate, in conjunction with continuing routine care at the nearest health unit. It will help to educate patients about lifestyle measures and specific treatments so individuals can take responsibility for their own care. This document only includes brief lifestyle education messages and will be accompanied by a more detailed guide on lifestyle advice and treatment support, for use by the health educator/clinician.

These materials are intended as a guide for clinical use and incorporate the best current evidence and recommendations, but are not comprehensive. Users and planners should adapt to their country context. They should be aware that all decisions remain with the clinicians using them. These materials cannot be reproduced for sale.

This desk guide was drafted by Professor John Walley, Dr KirtiKain*, Dr Rachel Weston, Dr Kirstie Graham and Dr Jessica Searle of LIHS/Nuffield Centre for International Health and Development, University of Leeds, UK. Early revision of the materials was undertaken by the Tanzanian MoH NCD and TDA expert working group, led by Professor Andrew Swai(MOHSW, Tanzania) and Dr Kaushik Ramaiya(IDF/TDA) anddeveloped through asubsequent pilot course. Additional contributions from Professors Anthony Harries (IUATLD), Xiaolin Wei (Chinese University of Hong Kong)and Drs Akan Otu (University of Calabar Teaching Hospital), Halima Buni(Tripoli University of Medical Sciences) andWajihaJaved (ASD, Pakistan) have also been incorporated through a further review process.

Comments on these guidelines are welcome, please send to .

* LIGHT, University of Leeds, UK.

Contents

Introduction

ASSESSMENT OF CARDIOVASCULAR DISEASE (CVD), HYPERTENSION AND TYPE 2 DIABETES

Hypertension...... 11

Diagnose hypertension...... 11

Target bp levels & investigations...... 14

Manage hypertension...... 16

Special circumstances...... 19

Managing the patient...... 22

Hypertension patient education...... 24

Type 2 Diabetes...... 27

Diagnose type 2 diabetes...... 27

Manage diabetes...... 30

Oral hypoglycaemic drugs...... 33

Follow-up...... 36

Insulin...... 38

Diabetes foot care...... 40

Diabetes patient educatioN...... 40

Hypoglycaemia...... 43

Hyperglycaemia...... 44

Treatment supporter & patient adherence...... 45

Appointment reminders...... 48

Cardiovascular risk assessment...... 50

APPENDICES...... 54

primary prevention of cvd with statins...... 55

Education leaflet...... 56

Treatment card & contract...... 58

Diabetes annual review card...... 60

CVD/Hypertension/Diabetes register...... 61

Referral form...... 63

Drugs for hypertension...... 64

Drug contraindications...... 65

Major side effects...... 66

Acronyms...... 68

Useful resources...... 69

References...... 71

Assessment of cardiovascular disease,diabetes and hypertension

Ask the patient about:

  • the presenting problem – allow them to describe it in their own words
  • any other symptoms or concerns relevant to the presenting problem
  • past medical history: including CVD, diabetes, kidney disease, high cholesterol
  • lifestyle risk factors: smoking, obesity
  • family history of CVD, hypertension, high cholesterol, or diabetes, especially in a first degree relative < 50 years
  • current medications

If suspected CVDdisease, hypertension or diabetes, also ask if they have had:

  • any pain/pressure/heaviness in their chest, which:

lasted more than 30 minutes (heart attack)

is brought on by walking/exercising and goes away after stopping exercise/resting (angina)

  • one-sided: vision loss, or weakness or numbness of the face/arm/leg (TIA/Stroke)
  • breathing difficulty (especially when lying flat) and/or ankle swelling (heart failure)
  • pain in the legs when walking, relieved with rest (peripheral vascular disease)

Refer urgently to the hospital if there are any symptoms now

If previous symptoms, or if a known diagnosis of CVD, refer to a doctor for initial assessment.

Test for diabetes and HIV (see p27) if patient has any:

  • thirst and frequency of urine(and dipstick urine for leucocytes and nitrites)
  • unexplained weight loss
  • feeling weak, tired all the time
  • recurrent infections; vaginal/underarm thrush, skin boils
  • “pins and needles” in the feet

If patient has symptoms such as cough, fever, diarrhoea:

  • <2 weeks: consult national treatment guidelines or WHO IMAI
  • >2 week history of cough: send 2 sputumsamples to the lab for TB microscopy, and consider:
  • COPD/asthma (if wheeze): consult national treatment guidelinesor WHO IMAI

Examine the adult patient

If patientlooks very ill, check signs of severe illness, and if any signs as below, referurgently to hospital:

  • respiratory rate >20/min, or
  • pulse >100 bpm
  • shock e.g. BP <90mmHg systolic
  • very high BP >200mmHg systolic or >120mmHg diastolic
  • fever >39°C, abdominal pain and guarding, chest pain, shortness of breath, altered consciousness, too low/ high glucose (<4mmol/l or >20mmol/l)

If no signs of severe illness examine as relevant to the presenting problem

Check BP

  • especially if >40 years, and if any risk factors or headache

Check waist circumference

  • If >40 years and looks overweight

If waist > 102cm (m) or > 88cm (w), explain about obesity risks, and refer to health educator

Check fasting plasma blood glucose if:

  • symptoms of diabetes (p9)
  • 40 and family history of diabetes or CVD
  • BP > 140/90
  • personal history CVD, renal disease or TB
  • lifestyle risk factors: age > 40and if overweight/ obese or smoker
  • is pregnant (if FBG raised, refer)

Diagnose hypertension

If BP > 140/90 recheck after sitting for 5 minutes

Adviselifestyle changes for all patients with hypertension(p22)

Follow up all patientseach monthuntilBP target reached, more frequently if severe hypertension or complications

Once BP stable, follow up 3-6 monthly

BP < 140/90: No hypertension

  • Give brief lifestyle advice
  • Review in 5 years

BP 140-159/90-99: Stage 1 hypertension

•If a history of CVD, kidney disease, diabetes,target organ damage*, or a 10-year cardiovascular risk of 20% or more; start drug treatment immediately

•If cardiovascular risk assessment (p50) is unavailable, use the CVD risk factors** in the table below to guide treatment

**CVDRISK FACTORS
ONE OF:
•Kidney disease
•Diabetes
OR TWO OF:
•High cholesterol
•Smoking
•Family history of CVD < 50 years in first degree relative
•Age > 60
•Obesity
  • Male

•If no CVD or end organ damage and low CVD risk – advise lifestyle changes (p22)and review BP in 3 months. If BP is still high, start drug treatment.

BP 160-179/ 100-109:Stage 2 hypertension

  • Advise lifestyle change and start drug treatment immediately

BP > 180/ 110: Severe hypertension

  • Start drug treatment immediately and/or
  • Refer to next level (hospital/ doctor)

Age < 40 and BP >140/80:

  • Refer for investigation of secondary causes of hypertension

Type 2 diabetes and hypertension

BP >140/80:

  • Advise lifestyle change and start anti-hypertensive immediately (see p22)

It is recommended that systolic blood pressure is lowered to 140mmHg or less. (Conditional recommendation, moderate quality of evidence)

This recommendation stems from the discussion of evidence in the ‘Prevention of Cardiovascular Risk’ guidelines produced by WHO (2007). One trial suggests that BP of 139/83mmHg gives maximal cardiovascular benefit, whilst other evidence more generally supports a decrease in BP. This recommendation is ‘conditional’ as it does not apply to certain groups with additional co morbidities.

It is recommended that all individuals who have hypertension with BP >160/100 are given anti-hypertensives immediately. (Strong recommendation, high quality of evidence)

This recommendation is supported by the ‘Prevention of Cardiovascular Risk’ guidelines produced by WHO (2007). It is noted that anti-hypertensive treatment has been found to be beneficial in all clinical trials for individuals with BP >160/100mmHg.

It is recommended that individuals who have hypertension with BP >180/110 are immediately referred to hospital. (Based on current guidelines)

This recommendation is as per current NICE guidelines (2011). Given this has been recently updated, no further review of evidence has been completed, therefore a GRADE profile has not been produced.

It is recommended that individuals with BP >140/90 mmHg and target organ damage, CVD, renal disease or diabetes begin anti-hypertensives immediately. (Based on current guidelines)

This recommendation is as per current NICE guidelines (2011). Given this has been recently updated, no further review of evidence has been completed, therefore a GRADE profile has not been produced.

.

It is recommended that all individuals with hypertension are encouraged in physical activity, healthy eating and, if appropriate, smoking cessation and reducing alcohol intake. (Strong recommendation, high quality of evidence)

This recommendation is as recommended by NICE (2011) and WHO (2007). Evidence for each of these interventions has been reviewed, discussed and assigned a GRADE profile in their respective sections. Collectively, one can be confident that the desirable effects of adherence to these interventions outweigh the undesirable effects. The recommendation is applicable and warrants the resource requirements to all populations and settings. Furthermore, new evidence is very unlikely to change the balance of risk to benefit.

Target BP levels

Hypertension only< 140/90 mmHg

Hypertension + diabetes< 140/80 mmHg

Hypertension + diabetes

+ kidney/eye disease

OR history of TIA/stroke <130/80 mmHg

Investigations

According to availability, check for the following in people diagnosed with hypertension:

End organ damage

  • Urine dipstick for blood and protein (kidney disease)
  • Creatinine, electrolytes and eGFR (kidney disease)
  • ECG to look for enlarged left ventricle

Cardiovascular risk

  • Check fasting cholesterol/lipids
  • Check fasting glucose

It is recommended that in patients with diabetes, blood pressure should be reduced to at least 140/80 mmHg. (Strong recommendation, high quality of evidence)

This recommendation is based on high quality evidence from a systematic review of 27 RCTs (n=158,709), including 33,395people with diabetes and 125,314people without diabetes (Turnball et al 2005). The review found that people with diabetes achieve greater reduction in the risk of total major cardiovascular events and death with regimens targeting intensive blood pressure lowering goals than do people without diabetes. There was a significant reduction in stroke, and a non- significant reduction in coronary heart disease and heart failure with more intensive treatment compared with less intensive treatment.The NICE Guideline Development Group (2011) therefore recommended a target BP less than 140/80mmHg for most people with type2 diabetes and less than 130/80mmHg for those at greater risk (including people with chronic kidney disease, retinopathy, or prior stroke or transient ischaemic attack as discussed below).

It is recommended that in patients with diabetes, with established renal or vascular disease, blood pressure should be reduced to at least 130/80 mmHg. (Strong recommendation, moderate quality of evidence)

This recommendation is based on discussion of evidence by WHO (2007) and NICE guidelines (2011). There is substantial evidence suggesting that reduction of BP to a target of 130/80mmHg in this specific group of individuals is likely to provide additional benefit. However, the extent to which this is beneficial is not quantified. Although only applicable to a specific group of individuals, this is not graded as ‘conditional’ as the recommendation is clearly targeted to this population.

Manage hypertension

Anti-hypertensive drugs

  • If possible, offer drugs to take only once per day
  • Start with lowest dose
  • Increase doses step by step to maximum tolerated dose to achieve BP control
  • See monthly until stable, then every 3-6 months; re-check BP and encourage lifestyle changes
  • Monitor potential side effects.If present, lower the dose or change the drug
  • If on maximum, or highest tolerated dose, and BP not controlled, then add another drug

Step 1: Add thiazide-like diuretic

e.g. Hydrochlorothiazide 12.5mg (starting dose) [or bendroflumethiazide 2.5- 5mg] once daily

If BP not controlled, increase Hydrochlorothiazidedose to 25mg once daily (50mg maximum dose)

If BP still not controlled go to step 2

Step 2: Add either an ACE inhibitor or acalcium channel blocker, as available

If BP still high increase dose step by stepto maximum tolerated dose

If BP still not controlled go to step 3

Step 3: Add a third drug; whichever not used in step 2

Refer to hospital if:

  • BP > 200/120
  • Pregnant
  • Symptomatic of CVD
  • Urine dipstick positive (possible kidney disease)

microscopic haematuria

proteinuria on 2 or more occasions or, if available:

ACR >2.5mg/mmol in men or >3.5mg/mmol in women

  • BP still >140/90mmHg despite 3 drugs and lifestyle advice

It is recommended that drugs that only need to be taken once a day should be offered where possible. (Strong recommendation, moderate quality of evidence)

This recommendation is based on two Cochrane reviews examining adherence to medication and adherence strategies for patients with type 2 diabetes mellitus (Haynes et al. 2008; Vermeire et al. 2005). In both of these, it was found that simplifying dosing strategies showed some effectiveness in improving adherence. However, further research is likely to impact on the extent to which adherence is improved. Once daily dosing is also suggested by WHO (2007). NICE (2011) refer to previous clinical guidelines, which suggest that this is one of a number of interventions that should be considered to improve adherence, although evidence is inconclusive.

It is recommended that a low-dose diuretic, ACE inhibitor (ACEi) or calcium channel blocker (CCB) should be used as first line treatment for hypertension. (Conditional recommendation, high quality of evidence)

This recommendation is based on discussion of evidence by WHO (2007) and current NICE guidelines (2011; 2009). RCTs testing CCBs and diuretics have provided evidence that their use leads to reductions in death and illness due to CVD. Comparison of ACEi with other drug classes demonstrated similar improvements in CV mortality.

The generic guide recommends using thiazide-like diuretics as first line treatment based on cost and availability in low-middle income countries. This recommendation is based on discussion of evidence by NICE (2011). High quality evidence is derived from five RCTs (n=15,086) studying low-dose thiazide-like diuretics and seven RCTs (n=19,933) studying high-dose thiazide-like diuretics. Meta-analysis of the low-dose trials found a reduction in mortality, myocardial infarction and stroke, whilst meta-analysis of the high-dose trials found a reduction in stroke only. The recommendation to use thiazide-like diuretics as first-line treatment is only ‘conditional’ as the use of thiazide-like diuretics in specific populations/groups is contraindicated and should be based on local availability and cost.

It is recommended that calcium-channel blockers or diuretics should be used as first-line treatment for people of black African or Caribbean ethnic origin(Strong recommendation, high quality evidence)

The pathophysiology of hypertension differs in people of black African or Caribbean ethnic origin compared with south Asians and Caucasians (Khan &Beevers, 2005). Calcium-channel blockers or diuretics are recommended as first-line treatment for this group, based on a sub-group analysis from an RCT (n=11,792), indicating that they are more effective than angiotensin-converting enzyme (ACE) inhibitors. Thiazide-like diuretics are associated with a reduced risk of stroke and cardiovascular events compared with ACE inhibitors. Calcium-channel blockers are similar to thiazide diuretics for reductions in coronary heart disease, stroke, cardiovascular events, and mortality (ALLHAT, 2002).