Q) How many tablets would I need to take?
A) Two tablets will need to be taken at the same time every day. Your study nurse will give advice about the best time to take them. One tablet will be Atorvastatin (study drug A) and the other will be Quinapril (study drug Q).
Study drug A is a type of drug known as a statin which is used to help reduce the level of fats that circulate in the blood. Study drug Q is an Ace Inhibitor which is a type of drug used to help reduce diseases of the heart and kidneys.
AdDIT is a randomised study with placebo tablets and you will not be able to tell whether the tablets you receive have active ingredients or not.
Q) What size are the tablets?
A) Compared with many others, the tablets are generally quite small and smaller than candy/sweets such as M&M’s. The photo shows the tablets alongside a small UK coin which is 18mm in diameter. The red tablet (ACE I / placebo) measures 8mm at its widest point and the white tablet (Statin / placebo) measures 9mm x 5mm.
Q) I can’t take tablets. Can I crush them?
A) So that the results of the study are accurate is important that everyone participating receives exactly the same dose of the study drugs. Sometimes crushing tablets means fragments of them are lost and the dose is reduced.
It may help to keep the tablet whole but to take them on a spoon of yoghurt or jam.
Q) Are there any medicines or food I can’t take with the study drugs?
A) Your study doctor will tell you about any medicines that should be avoided. It will be very important for you at study visits to give as much information as you can when you are asked about your health and whether or not you have needed to take any new medicines. When you join the study your family doctor will also receive information about AdDIT and will know about any drugs that need to be avoided.
In terms of foods, grapefruit juice should not be drunk in large quantities and alcohol should be avoided. See also the section on alcohol below.
Q) If I am on study drugs does this mean I can’t drink any alcohol?
A) It is important for anyone who is taking the study drugs or any other medication that they limit how much alcohol they drink. When taken with alcohol drugs such as ACE inhibitors can cause a drop in blood pressure and feelings of dizziness and fainting. Drinking large amounts of alcohol whilst taking drugs such as statins could have harmful effects on the liver.
Q) Should we keep the study drugs in the fridge if we go to a hot country?
A) The advice from the manufacturers is that the study drugs should be stored below
25°C. When travelling to a hot country you would need to keep them in a cool place and out of direct sunlight but it would probably not be necessary to keep them in the fridge.
Q) What are the effects of the study drugs on fertility?
A) Theoretically the drugs could affect sperms and boys would need to tell their study doctors if their partners become pregnant or if they are planning a pregnancy. Statins and ACE inhibitors can affect the early stages of pregnancy and the way the baby will grow, perhaps leading to abnormalities. This is why we ask all girls in the study who have started their periods, and their parents, for permission to carry out 6-monthly pregnancy tests. We would expect any girls who are known to be sexually active to be using adequate contraception. Should they become pregnant in spite of these precautions, the study drugs would be stopped and they would be withdrawn from the study. We would ensure that they have all the appropriate counselling and care that is needed.
Q) If we move house can I transfer to another study site?
A) Yes, you could transfer to another study site if there is one nearby. You would need to talk to your study doctor about how this should be organised.
Q) Can we claim travel/parking expenses?
A) Yes, there are funds available to cover travel for study visits but only if they are outside your usual clinic visits eg if you travel to a centre for cIMT scans.
Remember to keep receipts for any travel tickets or parking as you will need these to make your claim. Your study nurse will explain more about this. Travel will normally be paid for the study participant and one accompanying adult.
Q) Will we find out what drugs we have been taking?
A) We will be asking your permission at the end of the study if we can continue to contact you to find out how you are keeping and about your general health. As some people’s thoughts and feelings about their health can be affected by this kind of information, it will be important for the study that you remain unaware of the drugs you have been taking.
Q) What results will we get from the study and when?
A) It will take some time to complete the analysis of all the data that will be collected. Analysis of the data collected from screening is already underway and details of any findings will be included on the website and in study newsletters as they become available. At the very end of the study, which we now anticipate will be December 2016, we will aim to send a summary of the study results with details of any publications to everyone who has participated.