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A major report on statins, a popular cholesterol-lowering medication, has found that almost all of the listed side-effects, are not actually caused by the drug. The meta-study was published in the Lancet this week - and the researchers behind it now say they want regulators to change the warnings on drug labels. Anthony Keech is a professor of medicine, cardiology and epidemiology at the University of Sydney and one of the report's co-authors. He says the findings will be welcome news to many people.

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00:0010% of your listeners will be or viewers will be actually taking statins at any time and they're
00:08one of the most commonly prescribed drugs in Australia. So it is an important question as to
00:15what statins actually cause and do not cause in the way of side effects. We know that they slightly
00:20increase the risk of muscle pains and increase the rate of diabetes very slightly but otherwise
00:26we looked at the other 66 side effects listed in the product information when you open your little
00:32box of tablets and found that 62 of those are not in fact in excess in patients taking statins
00:39compared with patients taking a matching placebo. Now this is important because we looked at the
00:45best quality evidence available in the world, 23 trials with over 150,000 patients and over 30
00:53million reported symptoms all which had to be collated over several years and we found
00:59that the only things in excess of what I've already mentioned that were caused by statins
01:05were a slight increase in liver enzymes in the blood tests which normally go away if you
01:10withdraw the tablet for a period of three to six weeks and don't seem to come back and certainly
01:15don't cause any clinical problems of liver failure or hepatitis and some protein in the urine which
01:22was slightly in excess. So we're fairly reassured by this and I guess because the symptoms that are
01:28being collected are very common side effects in people it's important to understand that it's not
01:36something that the statins are normally causing. Certainly what we don't want people to do is stop their
01:41medication without talking to their doctor first. So if that is the case why are the side effects listed?
01:47It's a good question. I think two reasons. One is that the data has been based mainly on
01:53observational studies which where the patients know whether they're taking a tablet or not a statin or
01:58not and the doctors know whether they're taking a statin or not and that can introduce some bias in
02:03reporting. These data are from double blind trials. In other words neither the doctor nor the patient
02:10knows which the patient is taking a real statin or a placebo and the patient's chance of receiving
02:16either is controlled by randomisation which is chance in other words. So it's the best quality
02:23evidence available in the world whereas these other earlier reports are based on
02:27observational studies that might be quite biased. What's the impact of people being deterred from
02:34using statins because of the fear of side effects? It's a really important impact because of course they
02:41do save lives as well as reducing heart attacks and strokes. So it's amazingly important that your
02:47patients don't stop their statins without talking to their doctor and having a very good reason to do so.
02:52So they prolong life and they reduce heart attacks and strokes by over 20% just over five years and
03:00the benefits grow as time goes on with ongoing treatment with statins. They work by lowering the
03:06bad cholesterol in the bloodstream by more than 35% generally. So in light of all of that what would
03:13you like to see change when it comes to statin labels and do you think that will happen? Do you think we'll
03:18see changes? Well there is no process in Australia unfortunately for withdrawing information from
03:24product labels but I think expert groups need to look at this data that's just been published
03:29by our group from Sydney and Oxford together over this last 24 hours and determine whether in fact
03:37there needs to be much more information in the product information to explain to patients that most of
03:42the side effects they feel on a day-to-day basis are not actually caused by the drug. There are two
03:47problems one is that patients might stop the drug when they shouldn't and increase their risk of
03:52further trouble with heart attacks or strokes and secondly that they don't actually get their doctor
03:58to investigate the probable real cause of their symptoms. Yeah that's a good point. Just finally what's
04:04your advice to people who either need to take statins or have been advised to take statins but are feeling
04:10reluctant and potentially fearful of those side effects? What's your advice to those people? Well
04:16to be aware that these reports suggest that most of these symptoms in fact are not caused by the
04:21statin at all and they need to talk to their doctor about other possible explanations for their symptoms.
04:27Professor Anthony Keech from the University of Sydney thank you so much for your time this morning.
04:31Thank you it's a pleasure.
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