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news - aspirin

WDDTY vol 18 no 10

Aspirin may be a major killer, and one that none of us even suspects Aspirin is the ultimate lifestyle drug, and is seen as one of our great allies in warding off heart disease. With the encouragement of health guardians around the world, we pop 100 billion pills of this 'just-incase' drug every year, and 37 per cent of them are taken by healthy people as part of their daily health regime.

It's the inexpensive and readily available magic bullet that can protect us against cardiovascular disease, mankind's greatest killer. The humble aspirin can, according to its proponents, reduce blood pressure and help thin the blood, so lowering the risk of stroke and heart attack - two functions that today dwarf its original purpose as a painkiller, an anti-inflammatory and antipyretic (fever-reducer).

Best of all, it appears to be a relatively benign drug. The American Association of Poison Control Centres receives reports of just 59 aspirin deaths in the US each year, while researchers put the mortality rate for all painkilling, non-steroidal, anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen and naproxen at around 7600 deaths a year ( Scand J Rheum Suppl, 1992; 92: 21-4)

Either way, doctors argue that these figures represent an entirely acceptable risk compared with the many thousands more who might otherwise have died because of heart disease.

But scientists are now discovering that we have all been dramatically - and catastrophically - misled by the assurances of the medical community. Far from being benign, aspirin may be a major killer in our society, and one that is never suspected.

The new claim centres on the drug's well-documented side-effect of causing serious - and, in some cases, fatal - gastrointestinal (GI) bleeding. But researchers in a separate study have discovered a new, and worrying, side-effect of aspirin - it may be a major cause of stroke among the elderly. Because of its widespread use, researchers warn that these little pills may soon overtake hypertension (high blood pressure) as the major cause of stroke.

what studies now tell us

In the first of the new studies, researchers reckoned that the drug is killing 20,000 Americans and sending another 100,000 to hospital - every year just because of GI problems. Astonishingly, each of these deaths and reactions is slipping under the radar, and is not being associated with aspirin at all.

Researchers at the Eastern Virginia Medical School made their alarming discovery when they interviewed patients at a clinic that specializes in GI problems. They found that one in five patients was taking aspirin or some other painkilling NSAID, but the fact wasn't being reported to the medical staff because it wasn't regarded as significant.

"This reflects a common misperception that these medications are insignificant or benign when actually their chronic use, particularly among the elderly and those with conditions such as arthritis, is linked to serious and potentially fatal GI injury and bleeding," said Dr. David Johnson, one of the Virginia researchers.

If the researchers' death and injury rates for the US is correct, this could mean that the worldwide aspirin and other NSAID death toll is 100,000 individuals every year. What's more, a further 500,000 of us will need hospital care to treat a serious reaction to the drug, such as the result of a GI reaction (Proceedings of the Annual Scientific Meeting of the American College of Gastroenterology, 15 October 2007). Currently, none of these deaths is even recorded as an aspirin fatality.

Equally worrying is the drug's effect among the over-75's. Far from protecting them against stroke, it appears to be causing just such an attack that it is either fatal or results in disability. Researchers at Oxford University have discovered that the drug has caused a sevenfold increase in intracerebral haemorhagic stroke - bleeding within the brain - during the past 25 years among groups of elderly patients who participated in their trial.

Research-team leader Professor Peter Rothwell says that aspirin may soon replace high blood pressure as the leading cause of intracerebral haemorrhagic stroke, especially among the over-y5s.

"There are elderly people who take aspirin as a lifestyle choice," he says, "and, in that situation, the trials have shown there's no benefit. And what our study suggests is that, particularly in the very elderly, the risks of aspirin outweigh the benefits."

In Rothwell's study, researchers assessed the records of stroke victims between 1981 and 1985, and again between 2002 and 2006. While the overall rate of stroke caused by high blood pressure had dropped by 65 per cent between those two periods, the rate among the over-75s remained the same, mainly because there had been an increase in the number of strokes among patients taking blood-thinners such as aspirin.

The team discovered that the use of these drugs had increased dramatically and especially among healthy people who were taking the drugs as a preventative. From 1981 to 1985, only 4 per cent of patients were taking a blood-thinner, but this had risen to 40 per cent between 2002 and 2006 (Lancet Neurology, 2007; 6: 487-93).

In fact, the true dangers of aspirin have been known for some time, although no one has been prepared to do anything about it. Scientists from the West Midlands Regional Health Authority in Birmingham were among the first to raise the warning flag 12 years ago, when they did an investigation into the reasons why people were in hospital for treatment of bleeding peptic ulcer.

At that time, they discovered that 12.8 per cent of the 1121 patients being investigated were regular users of aspirin, which they defined as five days a week for at least a month. When they compared these patients against other patients with the same problem, but who were not regularly taking aspirin, it was evident that taking the NSAID had increased the risk of hospitalization for bleeding peptic ulcer by 2.3 times at a low dose of just 75 mg, and by up to 3.9 times at the more standard dose of 300 mg (BMJ, 1995; 310: 827-30). The 300-mg dose is the recommended level for just-in-case, or prophylactic, use against heart disease.

These researchers didn't track the progress of patients after identifying their cause of hospitalization, but one group of scientists did - and came up with a horrifying picture. Of those who were being treated in hospital for serious upper gastrointestinal bleeding or perforation, 10 per cent had died.

who are most at risk?

This alarming scenario was derived from an analysis of 12 studies published between 1980 and 2000. Those who were especially at risk were older individuals, and there were around twice as many men as women who ended up in hospital (J Clin Epidemiol, 2002; 55: 1057-63).

So, as well as age and gender, people who take several NSAIDs in combination also increase their risk of having a serious GI reaction. In a separate study, researchers who examined patients' records from databases in the UK and Spain found that 60 per cent of those who suffered a GI reaction from an NSAID were aged over 60, 13 per cent were using several NSAIDs in combination, and 6 per cent had a recent history of peptic ulcers, even though patients with pre-existing GI problems should not be taking any sort of NSAID in the first place (BMC Medicine, 2006; 4: 22).

But perhaps the most lethal drug combination is an NSAID with an SSRI (selective serotonin reuptake inhibitor) type of antidepressant such as Prozac, Zoloft or Paxil. In fact, this is a common drug cocktail, especially among arthritis sufferers, who are often given an NSAID to ease their joint pain and inflammation, and an SSRI to ease their mild depression.

When these two drugs are taken concomitantly, the risk of upper GI haemorrhage increases by 6.3 times. Translated into everyday usage, a patient has to take the combination just 82 times before suffering a serious gastrointestinal adverse reaction. Such an event would occur less than three months into the treatment, assuming the combination is taken daily.

Researchers from the University of East Anglia made this discovery when they carried out a meta-analysis of four trials involving a total of 153,000 patients who were taking either an SSRI or a NSAID, or a combination of the two types of drug. Patients who took just the SSRI increased their risk of a GI reaction 2.4 times, and those taking just an NSAID had a 3.2 times greater risk (Aliment Pharmacol Ther, 5 October 2007; doi: 10.1111/j.1365-2036.2007.03451).

Lead researcher Dr. Yoon K. Loke commented: "Before I did this study, I didn't worry at all when I saw patients who were on combinations of SSRIs and NSAIDs. Now that I have seen the fairly substantial excess risk, physicians should review the patients' charts - do they need to be on these drugs at all, or are there safer alternatives?"

Gastrointestinal problems with aspirin have been known for a long time - even if the actual severity and extent have only recently been revealed - and manufacturers have tried to reduce the risks by either producing a version that is enteric-coated, which allows the tablet to transit through the stomach to the small intestine before releasing the medicine, or buffered, where the standard pill is coated with a substance that neutralizes stomach acid.

But again, far from reducing the GI risk, these coatings appear to increase it. Researchers from the Boston University School of Medicine interviewed 550 hospital patients who had major upper gastrointestinal bleeding about their aspirin use. To their surprise, they found that those who had regularly taken buffered aspirin were at a slightly greater risk of developing GI problems than were those taking regular aspirin tablets. At doses greater than 325 mg, patients taking the buffered tablets were seven times more likely to develop GI problems whereas the risk was increased nearly sixfold with the standard pills (Lancet, 1996; 348: 1413-6)

aspirin: still a wonder drug?

Extraordinarily, the popular use of aspirin seems to be immune to any bad news. This may be because aspirin is still perceived as being a 'wonder drug'. Every year, it's estimated that around 3500 studies are carried out on the drug, and researchers seem to consistently come up with new health problems that they believe it can solve. It's been claimed to fight cataracts (Arch Ophthalmol, 1992; 110: 339-42), and cancers of the prostate, colon, pancreas, upper GI tract, and lung - claims that usually no one is able to replicate and so are, eventually, forgotten.

This is, of course, in addition to its more traditional, and accepted, uses as an antipyretic to reduce fever in cases of rheumatic fever, as an anti-inflammatory in cases of rheumatoid arthritis and osteo-arthritis, and as a painkiller for minor aches and pains such as headache.

But if the risks of regularly taking aspirin outweigh its benefits among healthy over-y75s, as suggested by Oxford's Professor Rothwell, then should healthy individuals of any age be taking it?

Not according to Charles H. Hennekens, former chief of preventive medicine at Brigham and Women's Hospital in Boston, and one of aspirin's main advocates. Yet, even he believes it is wrong for any healthy individual to take aspirin as a preventative as the risks are simply too high.

"A 30-year-old woman's risk of a heart attack is typically very small, and remains so even over the next 30 years. Aspirin would give her no benefit and it could cause gastrointestinal effects or dangerous bleeding," he says in a Food and Drug Administration (FDA) report.

Children aged under 12 should also no longer be given aspirin because of the very real danger of Rey's syndrome, a rare, often fatal, disorder primarily seen in children recovering from a viral illness and associated with aspirin use (BMJ, 2002; 325: 988)

If the healthy should not be taking aspirin, this suggests that nearly 40 per cent of daily aspirin use is inappropriate, and may even be endangering thousands of lives without any realistic benefits.

Nevertheless, it should be part of the daily health regime of anyone who has a heart problem, says the American Heart Foundation. It estimates that between 5000 to 10,000 of the 900,000 lives lost each year to cardiovascular disease in the US alone could have been prevented had the patient taken a daily aspirin. It points to research that suggests that aspirin can help to prolong the lives of people who have suffered a stroke or heart attack, or recurring blockages following heart bypass surgery or angioplasty to clear obstructed arteries.

But these positive claims have to be countered with the more recent findings that the drug could be killing 20,000 Americans every year because of GI complications alone, a figure that may well increase if stroke victims are also included.

But no drug is a substitute for a sensible lifestyle. A healthy diet that is rich in vegetables and fruit, moderate exercise, and stress and cigarette-free living can do more for the healthy individual and the recovering patient alike.

As the FDA's Debra Bowen says: "Physicians really need to look at aspirin in the context of complete care, as part of a whole treatment plan for people at risk of heart attack or stroke."

It's a view shared by Dr. Peter Coleman, deputy director of research for the Stroke Association in the UK. He says: "If you are healthy and have a low risk of heart disease or stroke, the increased risk from side-effects of aspirin are likely to outweigh the benefits of preventing stroke."

Aspirin is as close as medicine has ever come to producing a magic bullet - and one that appears to be Teflon-coated, too. Nevertheless, given these latest discoveries, it's an ideal that is apparently as far away as ever.

Written by Bryan Hubbard

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