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Participant Information

What is the Polypill Prevention Programme?
Research published in 2003 in the British Medical Journal showed that taking a carefully selected combination of commonly used medications at the right doses (the Polypill) can have a major impact on preventing heart attacks and strokes in the general population. In people without a history of cardiovascular disease, the combination comprises three separate medications to lower blood pressure, a statin to lower serum cholesterol and folic acid to lower homocysteine. Ideally these would all be contained within a single pill, but as this is not yet available for general use, the components are being offered as separate tablets. The dose of each of the component medications has been chosen to minimise the risk of side effects, while maintaining efficacy; in particular, the three blood pressure lowering treatments are given at half the standard dose (three drugs at half standard dose are safer and more effective than one or two at standard dose).

What are the medications used?
The specific medications that are included in the Polypill programme are:
1. Simvastatin 40mg (a statin) - lowers cholesterol
2. Bendrofluazide 1.25mg (a thiazide) - lowers blood pressure
3. Lisinopril 5mg (an ACE inhibitor) - lowers blood pressure
4. Amlodipine 2.5mg (a calcium channel blocker) - lowers blood pressure
5. Folic acid 0.8mg (a B vitamin) - lowers serum homocysteine

What effect would the Polypill components have in preventing heart attack and stroke?
A person's risk of a heart attack or stroke would be reduced by about 80%.

Is the Polypill Prevention Programme suitable for me?
Yes, if you are aged 55 and over and do not have a history of cardiovascular disease.

I am not known to have high cholesterol or high blood pressure so why is it appropriate for me to take the Polypill?
Heart attacks and strokes are common in people over age 55 (about 1 in 2 people will be affected in their lifetime), and most events occur in people with near average levels of risk factors such as blood pressure or cholesterol.

Do I need to take these pills every day?
Yes, it is important that they are taken every day to obtain the full expected effect.

How long would I take the pills for?
Indefinitely. It is necessary to continue taking the pills daily to obtain the preventive effect.

When should I take the pills?
The best time is in the evening, because the cholesterol lowering tablet is more effective at night.

Are there any side effects?
Some people may experience minor discomfort, but serious side effects are extremely rare. If you experience side effects it is a simple matter to withdraw the component likely to be responsible or to consider an alternative.

Are there any people who should not take the pills?
Yes. If you already have cardiovascular disease it would be better to take a different combination of medications, including aspirin. People with certain diseases should not take one or more of the component medications; these are heart failure, diseases of the aortic valve, active liver disease, porphyria, chronic renal failure, stenosis of a renal artery, and a history of angioedema. People who have previously taken one of the five classes of medication and developed side effects should not take the combination. Otherwise anyone over age 55 could participate in the programme.

Is a prescription needed?
Yes.

How do I find a participating physician who can prescribe the Polypill components for me?
If you telephone the Wolfson Institute we will let you know how to do this.

How do I obtain the pills?
. There is no need to go to a chemist. A pharmacist in Oxford will send you a three months supply of pills by post.
You will also be sent:
. a pill cutter (as some of the pills need to be cut in half to obtain the desired dose)
. a small pill box with seven compartments, one for each day of the week (because it is easier to prepare a week's supply of pills altogether than do it separately each day).

How do I get a repeat prescription?
We will contact you and make arrangements for one to be issued and a further three months supply of pills sent to you.

Who do I contact if I have a problem?
The coordinating office at the Wolfson Institute maintains a helpline (020 7882 6281). If we are not available at the time of your call we would return your call as soon as possible. A doctor would usually be available to talk to you and if not, one could call you back.

Is the programme being monitored?
Yes. Periodically we plan to contact you to discuss your progress on the prevention programme and to find out if you are having any problems with taking the Polypill components and, if you are, what they are and how they can be dealt with.

Will my doctor know?
Yes, provided we obtain your agreement we will send a standard letter to you GP so that he or she is made aware of the medication you would be taking.

 
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by Wolfson Institute Website Manager © Queen Mary, University of London 2011
Centre for Environmental and Preventive Medicine, Wolfson Institute of Preventive Medicine, Barts and The London, Charterhouse Square, London EC1M 6BQ Tel: 020 7882 3850 Fax: 020 7882 6270