Blood pressure drug increases longevity in elderly

London: An international trial looking at the benefits of giving blood-pressure lowering medication to elderly patients has stopped early, after researchers observed significant reductions in overall mortality in those receiving treatment.

The 3,845 patient Hypertension in the Very Elderly Trial (HYVET) is the largest ever clinical trial to look at the effects of lowering blood pressure solely in those aged 80 and over. Preliminary results of the trial, which is coordinated by scientists from Imperial College London, suggest that lowering blood pressure significantly reduces both stroke and mortality in the over-80s.

A number of earlier trials had demonstrated that reducing blood pressure in the under-80s reduces stroke and cardiovascular events. However, previous smaller and inconclusive studies also suggested that whilst lowering blood pressure in those aged 80 or over reduced the number of strokes, it did not reduce, and even increased, total mortality.

Patients with high blood pressure from across the world were randomised for the double-blind, placebo-controlled trial, which began in 2001. Patients were given either the placebo or a low dose diuretic (indapamide 1.5mg SR), and an additional ACE inhibitor (perindopril), in tablet form once a day.

Emeritus Professor Chris Bulpitt, HYVET Principal Investigator from the Care of the Elderly Department at Imperial College London, said: “It was not clear prior to our study whether the over-80s would benefit from blood pressure lowering medication in the same way as younger people.

Our results are great news for people in this age group because they suggest that where they have high blood pressure, such treatment can cut their chances of dying as well as stroke.”

The Steering Committee of HYVET accepted on 12th July 2007 the recommendation of its Data Safety Monitoring Board that the trial should be stopped.

Definitive figures will not be available until all the data has been collected. Results will then be published in the peer reviewed scientific press.

Over the next few months all HYVET patients will be seen for a final visit, where all patients on trial medication will be offered the option of switching to active indapamide 1.5 mg SR based antihypertensive treatment. Prior to their final visit, all patients are advised to stay on their existing drugs until they see their trial physician.

HYVET was co-ordinated by scientists from Imperial College London, working with colleagues around the world. The main trial was funded by both the British Heart Foundation and by the Institut de Recherches Internationales Servier.

1. About stroke and high blood pressure

* Stroke is the third most common cause of death in the England and Wales. In 2004, 11% of deaths amongst those aged 75-84, and 14% of deaths amongst those aged over 85 were due to stroke, according to the Office of National Statistics.

* In the UK about 150,000 people suffer a stroke each year, the equivalent of 1 every 4 minutes.

* About one third of stroke patients die within 6 months of the event, the majority occurring in the first month.

* Disability after stroke is the most important single cause of severe disability of people living in their own homes.

* There are 2 types of stroke:

a. Haemorrhagic – caused by blood leaking into brain tissue from a
blood vessel within the brain
b. Ischeamic – caused by a clot occluding a blood vessel, resulting in
loss of blood supply to a part of the brain and subsequent damage to brain tissue.

High blood pressure increases the chance of both a blood vessel leaking or rupturing, and of a clot forming within a blood vessel. High blood pressure increases the likelihood of damage to the lining of the blood vessel, which in turn leads to an increased chance of spontaneous clot formation within the blood vessel.

* The over 80s are the fastest growing group in the population worldwide – in the UK currently they account for 4% of the total population and this is expected to rise to over 11% by 2050.

* The risk of stroke increases with age, with some estimates suggesting that the risk doubles every decade after a person reaches 55 years of age

* In the UK approximately 4% of the total National Health Service budget is spent on stroke services each year.

Delay in cancer drug treatment for UK women

London: Victims of breast cancer face an agonising three-year wait on the UK’s National Health Srvice for a drug hailed as the biggest breakthrough in 30 years. Doctors say Arimidex could save or prolong the lives of thousands of women.

It dramatically reduces the chances of the cancer spreading and cuts the risk of severe side- effects. But a decision on approving the drug is not due until March 2007.

Between now and then, the disease will claim the lives of nearly 30,000 women. At least 10,000 new patients a year would be suitable for Arimidex while thousands of others could switch treatments.

The annual bill for each woman’s treatment would be £800, compared to about £70 for tamoxifen, the current standard treatment.

After stunning trial results were unveiled yesterday, doctors want Arimidex to become the first-line therapy for early breast cancer in postmenopausal women.

But NHS patients will have to wait – unless they go private and can find a specialist prepared to prescribe the drug.

At the moment, it is only allowed for women who cannot tolerate tamoxifen and for advanced cancer cases.

Drug regulatory officials are considering whether to license Arimidex for initial therapy.

But even then, it still has to be approved by the National Institute for Clinical Excellence before being prescribed widely.

Its decision is not due before March 2007, leaving thousands of women uncertain if they are getting the best treatment.

Professor Jeffrey Tobias, one of the trial investigators, said: ‘It is clear that if Arimidex prevents the disease recurring at distant sites in the body, there is a good chance the cancer won’t come back at all.

‘More women would be surviving for longer periods, free of disease and possibly cured.’

Dr Tobias, Professor of Cancer Medicine at University College and Middlesex School of Medicine, said breast cancer therapy was at a turning point.

‘For the first time, we have a more effective and safer treatment than tamoxifen,’ he said.

‘It’s very unusual for something to emerge that is much more effective than the standard therapy.’

Although tamoxifen was cheaper, Arimidex was ‘good value for money’, he added.

Data from the biggest study of its kind showed that women on the new drug have a 10 per cent higher survival rate after five years of treatment.

It cuts the chances of breast cancer recurring by 26 per cent – over and above the 50 per cent reduction provided by tamoxifen.

Women also run less risk of the cancer spreading to distant parts of the body.

Serious side-effects, such as endometrial cancer and bloodclotting disorders, are also significantly lower. Doctors predict Arimidex will become a bigger life-saver than tamoxifen, which is credited with helping more than 20,000 British women survive since its launch in the 1980s.

Early indications suggest the death rate might be cut by a further 13 per cent compared with tamoxifen.

Study leader Anthony Howell, of the Christie Hospital, Manchester, said patients on tamoxifen should be switched to Arimidex at the ‘earliest opportunity’.

Each year, 41,000 women in the UK develop breast cancer – 30,000 of them after the menopause.

A total of 100,000 would be eligible for the new drug.

Arimidex only helps patients after the menopause as it works by shutting down the body’s supply of the female hormone oestrogen.

Professor Jack Cuzick, of Cancer Research UK, which helped fund the study, said: ‘We are very excited by these results.’

Dr Sarah Rawlings, of the charity Breakthrough Breast Cancer, said: ‘Tamoxifen has made a big impact but other treatment like Arimidex could also make a big difference.’

Sue Green, of CancerBACUP, said: ‘Women taking tamoxifen should be assured that the treatment is very effective. Anyone concerned should discuss it with their doctor.

‘We would also urge NICE to assess the data urgently so health professionals are given clear guidance.’

Tamoxifen is cheaper as it has been available in generic form for years.

Arimidex has cost millions to develop and is protected by a patent.

The study results were announced at a conference in the U.S. and on the website of medical journal The Lancet.