Managing heart disease risk in the pharmacy
The modifiable risk factors for coronary heart disease (CHD) are generally accepted as smoking, cholesterol/lipid imbalance, hypertension, poor diet, obesity, excessive alcohol intake, physical inactivity and inadequate diabetes control. A recent literature review demonstrated the contribution of community-pharmacy-based services to the reduction of risk behaviours and risk factors for coronary heart disease. The evidence supports the wider provision of smoking cessation and lipid management through community pharmacies. Both primary and secondary prevention of CHD involve similar interventions.
Smoking cessation and nicotine replacement therapy
In recent years smoking cessation has become an increasingly important focus for the National Health Service (NHS) and the UK can now boast a world-leading smoking cessation service. Nonetheless, there are still around 13 million tobacco users in the UK and their cost to the NHS is £1.7 billion per year.
Research suggests that around 70% of smokers would like to give up, but only 2-3% of smokers manage to quit using willpower alone. Nicotine replacement therapy (NRT) is an effective aid to smoking cessation for those smoking more than 10 cigarettes a day. Smokers are about twice as likely to stop long-term smoking when prescribed nicotine replacement therapy and are up to six times more likely to succeed when NRT and behavioural support are combined. The current National Institute for Health and Clinical Excellence (NICE) guidelines recommend that nicotine replacement therapy should only be prescribed for a smoker who commits to a target stop date.
Smoking cessation – tips for customers about quitting
• Set a quit date, prepare for it and stick to it.
• Get support and advice from friends, family and health professionals.
• Consider nicotine replacement therapy for the first few weeks.
• Avoid situations where you will find it difficult not to smoke.
• Change your routine to distract yourself from times and places you associate with smoking.
• Stop completely if you can, rather than cut down.
• Get rid of all cigarettes, lighters and ashtrays before your quit date.
• Ask people not to smoke around you and tell everyone you are quitting.
• Keep busy, especially when cravings start.
• Reward yourself for not smoking.
• Calculate how much money you will save and plan how you will now spend it.
A range of Nicotine replacement therapy (NRT) products are available. They vary in the ease and frequency of use, the speed of nicotine release and the amount of behavioural replacement provided. There are no conclusive studies to show that one formulation is any more effective than another at achieving cessation. All products will increase the chances of success if used correctly.
Nicotine replacement therapy – formulation options
Patches
Discreet – easy to wear and forget about, but watch for skin irritation
Continuous nicotine release – suitable for regular smokers
16-h patch (removed at night) – reduced insomnia
24-h patch – good for early morning cravings
Three strengths – allows a step-down reduction programme.
Gum
Flexible regimen – controls cravings as they occur
Various flavours – allows customer preference
Various strengths – allows step-down reduction programme
Chewed slowly – to release nicotine and then ‘park’ gum between cheek and gum.
Nasal spray
Fast-acting – helpful for highly dependent smokers
Local side-effects (sore throat and rhinitis) – usually pass after first few days.
Sublingual tablet
Discrete – placed under tongue and dissolves over 20 min
Dose variation – one or two (2-mg) tablets may be used per hour
Sublingual – sucking or chewing the tablet will reduce its effectiveness.
Inhalator
Cigarette substitute – useful for smokers who miss hand-to-mouth action
Reduce usage over time – the recommended period is 12 weeks.
Lozenge
Various strengths – allows step-down reduction programme
Highest strength (4 mg) – good for smokers who start within 30 min of waking
Sucked until taste is strong – lozenge then ‘parked’ between cheek and gum.
Licensed indications for OTC nicotine replacement therapy
Nicotine replacement therapy can be recommended for adults and children aged 12 years or over, for pregnant women and those who are breastfeeding.
Some NRT products are licensed to aid smoking reduction with the eventual aim of smoking cessation (‘reduce to quit’). The smoker should attempt to quit when he or she is ready – but not later than 6 months after reducing the cigarette consumption. Young people (aged 12-18 years) should attempt “reduce to quit” only after consulting a health care professional.
Positive messages for new non-smokers
• Giving up smoking reduces the risk of developing smoking-related illness.
• Eight hours after quitting, nicotine and carbon monoxide levels in the blood are reduced by half and oxygen levels return to normal.
• After 24 h, carbon monoxide is eliminated.
• After 48 h, nicotine is eliminated.
• After 3 days, breathing becomes easier.
• After 2-12 weeks, circulation is improved and smokers’ coughs start to get better.
• After 6 months, lung efficiency will have improved by 5-10%.
• After 5 years, the risk of having a heart attack is half of that of a smoker.
• After 10 years, the risk of heart attack is the same as that of a non-smoker.
• After 10-15 years, the risk of developing lung cancer is only slightly greater than that of a non-smoker.
• Research has shown that people who stop smoking before the age of 35 years survive about as well as lifelong non-smokers.
Weight management
Being overweight increases the chance of having a heart attack. This is in part because obese individuals are more likely to have high blood pressure, diabetes and high blood fats. Less fat, sugar and alcohol in the diet is helpful for weight control. In order to achieve a healthy body weight, it is also important to build regular, moderate exercise into a daily routine.
Pharmacy staff should counsel customers whose body mass index (BMI) is >25 kg/m2 on an appropriate plan for weight loss. A 3-month programme of weight reduction should aim for a 5- to 10-kg weight loss over 3 months or 0.5 kg per week (combining diet, exercise and behavioural strategies).
Pharmacy staff can give advice on a healthy diet. The recommended calorie intake should be between 1200 and 1600 kcal per day. People should be advised to moderate fat intake by eating less fatty meat, fatty cheese, full-cream milk, fried food, lard, etc., and to reduce the amount of sugar. They should consider eating more vegetables, fruit, cereals, wholegrain bread, poultry, fish, rice, skimmed or semi-skimmed milk, grilled food, lean meat, pasta, etc.
If the customer does fry food, suggest choosing a vegetable oil high in polyunsaturates (‘good fats’), such as sunflower or rapeseed oil. Suggest considering a low-fat spread that contains plant stanol esters. Such plant stanol-containing supplements have been shown to reduce cholesterol levels and may be useful adjuncts in lowering cholesterol levels. Reducing cholesterol levels is possible through dietary manipulation. However, the magnitude of such reductions is modest, even with strict adherence to a diet plan. In addition, many patients will find it hard to sustain a strict dietary regimen.
Physical inactivity is an important contributor to coronary heart disease. CV benefits of regular physical activity include reduced blood pressure and less likelihood of obesity, which help to reduce the risk of developing CHD. At least 30 min of steady activity for 5 or more days a week is recommended. This time can be accumulated during the day in periods of 10 min or more. Walking, jogging, swimming, cycling and dancing are all excellent choices. Remember to advise patients to start slowly and gradually build up their exercise.
OTC orlistat in the USA
Orlistat has been available on prescription in the UK for several years. The USA Food and Drug Administration approved the drug product orlistat 60-mg capsule (trade name Alli) in 2007 for OTC marketing as a weight-loss aid. A similar application for OTC status in the UK and mainland Europe is anticipated; hence, we include this section on its use.
In the USA, OTC orlistat is to be used only in conjunction with a weight-loss programme that includes a reduced calorie diet, a low-fat diet and an exercise programme. It is approved for OTC use in adults 18 years and older.
The amount of weight loss achieved with orlistat varies. In 1-year clinical trials, between 35 and 55% of subjects achieved a 5% or greater decrease in body mass, although not all of this mass was necessarily fat. Between 16 and 25% achieved at least a 10% decrease in body mass. After orlistat was stopped, a significant number of subjects regained weight – up to 35% of the weight they had lost.
The main side-effects of orlistat are gastrointestinal (GI) related. Side-effects are most severe when beginning therapy, and in trials they decreased in frequency with time, with nearly half of side-effects lasting less than a week, but some persisting for over 6 months. Because orlistat’s main effect is to prevent dietary fat from being absorbed, the fat is excreted unchanged in the faeces and so the stool may become oily or loose (steatorrhoea). Increased flatulence is also common. Bowel movements may become frequent or urgent, and cases of faecal incontinence have been seen in clinical trials. To minimise these effects, foods with high fat content should be avoided; the manufacturer advises consumers to follow a low-fat, reduced-calorie diet.
Patients should be advised to wear dark trousers and take a change of clothes with them to work. Oily stools and flatulence can be controlled by reducing the dietary fat content to somewhere in the region of 15 g per meal, and it has been suggested that the decrease in side-effects over time may be associated with long-term compliance with a low-fat diet.
Absorption of fat-soluble vitamins and other fat-soluble nutrients is inhibited by the use of orlistat. A multivitamin tablet containing vitamins A, D, E, K and beta-carotene should be taken once a day, at least 2 h before or after taking the drug.
OTC simvastatin
The goal of OTC simvastatin 10 mg is to reduce the risk of a first major coronary event (i.e. non-fatal MI and CHD deaths) in people who are likely to be at moderate risk of coronary heart disease.
Men aged 55 years and above are likely to be at moderate risk of coronary heart disease (approximately 10-15% 10-year risk of a first major coronary event). In addition, men aged 45-54 years and women aged 55 years and above are likely to be at moderate risk of CHD if they have one or more of the following risk factors:
• Family history of CHD in a first-degree relative (parent or sibling); coronary heart disease in male first-degree relative below 55 years or female first-degree relative below 65 years
• Smoker (is currently or has been a smoker in the last 5 years)
• Overweight (BMI >25 kg/m2) or truncal obesity (waist 40 in or 102 cm in men and 35 in or 88 cm in women)
• Of South Asian ethnic origin
OTC simvastatin should be taken as part of a programme of actions designed to reduce the risk of coronary heart disease. People aged over 70 years should start OTC simvastatin following advice from their doctor. These include cessation of smoking, eating a healthy diet, weight loss and regular exercise. Simvastatin treatment can be initiated simultaneously with diet, exercise and smoking cessation.
In an essentially normal population it is reasonable to use the lowest effective dose to achieve the proportionately greatest benefit. The rare adverse events (e.g. muscular pain) associated with statin use are dose related and linked in many cases to drug-drug interactions that increase statin effects. The risk of such events with simvastatin 10 mg is very low and therefore the risk-to-benefit ratio for the self-medicating individual is favourable.
Pharmacists and their staff should encourage customers to read the patient information leaflet carefully, paying particular attention to the section on side-effects. Research with the general public suggests that their understanding of the frequency of adverse events is at variance with statutory definitions. For example, the European Union (EU) definition of a rare adverse event would suggest a frequency of between 0.01 and 0.1%. When Berry et al. asked 200 people what frequency ‘rare’ might suggest to them, a figure of 8% was reported.
The possibility of rare but important side-effects – liver disease, myopathy (unexplained generalised muscle pain, tenderness or weakness, e.g. muscle pain not associated with flu, unaccustomed exercise or recent strain or injury) and allergic reactions – should be explained and discussed with customers.
The BNF reports that statins are rarely associated with altered liver function including drug-related hepatitis. Reversible myositis is also a rare but significant side-effect of the statins. Both these reactions are thought to be dose related. Some patients may ask about these issues following the withdrawal of cerivastatin from the market. Rash and hypersensitivity reactions (including angioedema and anaphylaxis) have also been rarely reported.
If taken regularly, simvastatin 10 mg will reduce an individual’s low-density lipoprotein (LDL) cholesterol by 27% on average. The relationship between simvastatin dose and LDL cholesterol reduction is log-linear in nature: a doubling of dose from 10 to 20 mg increases the relative reduction of low-density lipoprotein cholesterol from around 27 to 32%, and doubling the dose again to 40 mg produces a further 5% improvement.
In addition, the absolute reduction of LDL cholesterol achievable with 10-mg simvastatin, if sustained, will produce around 30% relative reduction in coronary heart disease risk. This will result in a worthwhile absolute risk reduction in those at moderate risk and if the individual also modifies other risk behaviours (such as stopping smoking, weight reduction and regular exercise), the benefits will be considerable.
Aspirin 75 mg
Low-dose aspirin tablets may be sold as a P medicine in packs of up to 100 tablets. They are currently licensed for the secondary prevention of thrombotic strokes, transient ischaemic attacks (TIAs or ‘mini-strokes’), heart attacks or unstable angina.
Low-dose aspirin is recommended by the BNF, for primary prevention of vascular events, as antiplatelet therapy in patients who have an estimated 10-year coronary heart disease risk greater than or equal to 15%. Patients with hypertension should have their blood pressure controlled to minimise the risk of antiplatelet therapy contributing to the risk of cerebrovascular bleeding. Patients should be assessed for contraindications to aspirin therapy and patients at increased risk of GI bleeding may require cover with a gastroprotective agent. There is no compelling evidence to currently support the use of aspirin in low-risk subjects, such as middle-aged males with no other risk factors.
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