Certainly, that seems to be good enough for heart consultants who have embraced the new antistroke drug clopidogrel. In the US alone, specialists have prescribed it in the two years since its approval to 3 million patients who are at risk of heart attack or stroke, or who have undergone heart surgery.

Its success is pretty much down to the results of a clinical trial involving 20,000 patients which has given the drug a clean bill of health. This was music to the ears of consultants whose first choice was ticlopidine, another antiplatelet agent. But ticlopidine was thought to trigger the usually fatal condition thrombotic thrombocytopenic purpura in a small minority of cases.

Then, word started getting around that doctors were beginning to see just such a link with clopidogrel. With the backing of special grants, a team of researchers from Northwestern University in Chicago decided to investigate further. They looked at the records of 11 patients who developed thrombotic thromocytopenic purpura, and found that 10 of them had been taking clopidogrel at the time. One later died.

Unlike with ticlopidine, the condition started early in the treatment, usually within 14 days, tended to recur and required up to 30 plasma transfusions before the patient started to improve

(N Engl J Med 2000; 342: 1773-7).

Researchers point out that ticlopidine had a clean bill of health for seven years before the link with the thrombosis was discovered.

So, as we say, just how safe is safe. . . ?

The analysis of four major studies, involving 20,000 postmenopausal women taking HRT for five years, found that such women in their 50s had a higher risk of breast cancer, while those in their 60s had greater chances of stroke or pulmonary embolism (blood clots in the lung).

The researchers estimated that, over five years, there would be six extra cases of breast cancer, stroke or pulmonary embolism for every 1000 healthy women aged 50-59 taking HRT. The number doubles to 12 per 1000 for users aged 60-69.

Reductions in the number of expected cases of bowel cancer or hip fracture were low at 1.7 and 5.5, respectively, per 1000 HRT users in the two age groups (Lancet, 2002; 360: 942-4).

These results support the Women’s Health Initiative (WHI) study of healthy women taking HRT, halted earlier this year because of health risks with HRT, and show no changes in the risks of endometrial cancer or coronary heart disease.

In another study, postmenopausal HRT raised levels of C-reactive protein (CRP), one of several inflammatory markers of increased cardiovascular risk (JAMA, 2002; 288: 980-7). Using data from the WHI, it was noted that women with high levels of CRP were more likely to suffer a heart attack or fatal heart failure within three years of starting HRT.

Among women with high CRP levels, HRT use increased CRP levels by 55 per cent vs women with normal CRP levels. These latter women had CRP levels that were raised 70 per cent vs healthy women not taking HRT.

These new findings mean that doctors can no longer safely recommend HRT for every menopausal ill (JAMA, 2002; 288: 882-4).

However, the brakes are about to be put on this meteoric success following a recent warning from the US drug-regulating Food and Drug Administration (FDA). The warning states: “Risperdal has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis” – better known as Alzheimer’s – a group comprising a fair proportion of annual sales, we imagine.

The warning follows on the heels of trials that discovered a significantly higher incidence of cerebrovascular reactions compared with placebo among 1230 elderly Alzheimer’s patients.

Interestingly, doctors in Canada were sent similar warning letters six months before their American counterparts. The letters were triggered by reports of 37 incidents of stroke-like events, including 16 deaths, associated with the drug.

But these warnings are nothing new. Earlier studies have been coming up with similar conclusions for some time, including one that linked 29 cases of stroke, plus four deaths, among a group of 764 Risperdal patients.

Common side-effects include anxiety, sleepiness, tremors, rapid heartbeat and tardive dyskinesia, or uncontrollable jerkiness of the facial and body muscles.

Despite the warnings, the manufacturer continues to push Risperdal through the various international regulatory bodies. Spain has just approved an injectable form, known as Risperdal Consta, a version that has also been approved for use in the UK and Ireland. It is designed to act over a two-week period.

We wonder if UK doctors are about to receive a similar warning letter or if they will, at the very least, restrict its use to schizophrenia, for which the drug was originally intended.

Researchers from Copenhagen University reanalysed 58 studies that were carried out over a 30 year period until 1997. They concluded that, overall, the results did not support a general recommendation to reduce sodium intake. However, reducing salt in the diet could be used as a supplementary treatment in hypertension (JAMA, 1998; 279: 1383-91).

It’s a witticism with which doctors would agree, especially following a study among men in the North of England. Researchers discovered that the rate of fatal heart attacks and strokes soared on Saturday afternoons among football supporters if their favoured local side lost a home match. Losing away from home seemed to be more forgivable, and tended not to cause a fatal attack.

The researchers studied medical records covering a five-year period and discovered a connection with Saturday afternoons, home football matches (when the home team lost), men and heart failure.

The controls were the women, who were nowhere near as affected by football results as their menfolk (J Epidemiol Commun Health, 2003; 57: 429-32).

In America, Geneva Pharmaceuticals, the distributor of Ticlid, has issued a “Dear Doctor. . .” letter but, significantly, has addressed it to “Dear concerned health professional”.

The concern seems to be caused by the large number of side effects, including severe and fatal blood disorders, that the drug can cause. The most dangerous is the sudden drop in the white blood cell count, a condition called neutropenia, which early trials indicated could affect around 2.4 per cent of patients.

Ticlid is, in any event, only supposed to be given to those who cannot tolerate aspirin, but Geneva Pharmaceuticals is now advising doctors to first screen patients for any possible adverse reaction before prescribing.

As Ticlid causes an adverse reaction in 60 per cent of all users, the chances of it being prescribed have probably just dropped dramatically. The most common reaction is diarrhoea, which affects more than 12 per cent of patients, followed by nausea and dyspepsia (both 7 per cent) while over 5 per cent develop a rash. Rarer, but more serious, conditions caused by the drug have included anaemia, hepatitis, kidney failure and lupus.

But the most worrying side effectseems to be neutropenia. It can often be fatal if undetected and untreated because it lowers the body’s natural resistance to disease. The drug manufacturer Roche Laboratories urges doctors to take blood tests every fortnight for the first three months, the time when neutropenia is most likely to occur.

And, concludes Geneva Pharmaceutical’s letter, if your patient does die, please tell the authorities. OK?

HEALTHY LIVING
We know how – we just don’t
In a study of 153,000 Americans, it was revealed that only 3 per cent follow all four of the so-called ‘golden rules’ for healthy living. Although many of them followed one or more of these rules, very few observed all four, which are: not smoking; maintaining a healthy weight (a body mass index of between 18.5 and 25); eating five or more vegetables and fruits every day; and exercising for at least 30 minutes, a minimum of five days every week (Arch Intern Med, 2005; 165: 854-7).

DEPRESSION
Therapy is as good as drugs
Cognitive therapy works just as well as drugs in cases of even the most severe depression. Researchers assigned 240 patients with severe depression to receive either drugs or cognitive therapy for 16 weeks. Both groups fared equally as well, and each was helped far more than those in the placebo group (Arch Gen Psychiatry, 2005; 62: 409-16).

AGEING EYESIGHT
Seeing clearly with vitamin E
Lens opacity, a common problem of getting old, can be slowed down or even prevented by regular supplementation with vitamin E. Researchers found a direct correlation between lens opacity, and the long-term use of vitamin E and a higher riboflavin or thiamine intake when they tested 408 women aged between 52 and 74 (Arch Ophthalmol, 2005; 123: 517-26).

* In a recent study, one third of 773 individuals involved in a road accident as a driver, bicycle rider or pedestrian experienced some level of anxiety, depression, fear of travel or post traumatic stress disorder (PTSD) 3 to 12 months later and, in most cases, persisted. After one year, about half the group had phobic travel anxiety, nearly 60 per cent had general anxiety, and half were diagnosed with PTSD (Am J Psychiatry, 2001; 158: 1231-8).

* New research in nearly 1300 men suggests that, during a severe asthma attack, men are less likely than women to notice the symptoms of the attack. The reason for this is unclear, but it may be that men perceive less discomfort because of greater lung size and muscle strength, or because they generally develop asthma at an earlier age than women. Men also tend to only seek medical attention when symptoms are too severe to ignore, the researchers noted (Ann Emerg Med, 2001; 38: 123-8).

* What’s lurking in that paddling pool? Physicians in Canada have found the first outbreak of a new type of Pseudomonas infection called ‘hot foot syndrome’. This discovery was made when 40 children, aged 2 to 15, developed intense pain in the soles of their feet within 40 hours of using the same wading pool. A hot, red swelling began after a few hours, along with pain so severe that the children were unable to stand up. Three children were given oral cephalexin (an antibiotic) while the others were treated with cold compresses, analgesics and foot elevation. In all cases, the condition resolved within 14 days, although it recurred in three children after they revisited the same pool (N Engl J Med, 2001; 345: 335-8).

Research among 291 stroke patients found that 6.4 per cent of those given the treatment went on to suffer a hemorrhage, and half of those died. This compares with just 0.6 per cent who suffered a hemorrhage after being given a placebo treatment.

Another study, this time among 333 stroke patients, found little difference in recovery between those given standard treatment and those given a placebo.

The one positive outcome was that patients whose treatment was started within 90 minutes of the start of the stroke did better than those whose treatment was delayed.

The concern about stroke is a real one, if a fish oil supplement is taken over the long-term. It can increase levels of fatty acid in the blood, and oxidative damage has been discovered after six months’ usage. Some researchers fear it could lead to atherosclerosis and plaques. Garlic supplements or 15 g of pectin every day can mitigate against the worst effects of fish oils, and it’s important to add extra vitamin E to your daily regime because fish oils can also increase the ‘bad’ LDL cholesterol levels.

Our sister publication PROOF! found in its lab tests that the Solgar Fish Oil Concentrate was the best on the market.