The
Pharmaceutical Journal Vol 266 No 7132 p103 NICE approves treatments for Alzheimer’s disease. . .
. . . and for motor neurone disease
Government campaign to inform parents about MMR vaccine safety
Decreased stroke risk in women who eat fish?
Linezolid receives licence in UK
Study confirms benefits of low-dose aspirin
Bacteria shown to protect against ear infections
Vaccination factsheet
Agnus castus “a therapeutic option” for PMS
Blood glucose levels - a predictor of cardiovascular risk?
Dietary advice tips: (11) Multiple sclerosis
News in Brief
Patients with mild to moderate Alzheimer’s disease should be prescribed acetylcholinesterase
inhibitors on the NHS, according to guidance issued on January 19 by the National
Institute for Clinical Excellence (NICE).
The Department of Health said that it would be monitoring health authorities
and trusts shortly after the publication of the guidance and six months later,
to ensure that they were taking “full and proper” account of the guidance.
The NICE guidance states that donepezil (Aricept), rivastigmine (Exelon) and
galantamine (Reminyl) should only be prescribed when:
In addition, the patient must benefit demonstrably from taking the drug and
be reassessed every six months.
At a press conference on January 19, Mr Andrew Dillon (chief executive, the
NICE) said that the institute had estimated the total annual cost of drug treatment
to be £42m but added that this might be an overestimate. “It has been difficult
to assess patient numbers and cost, because not all patients will be diagnosed
early enough and others will deteriorate despite the drug,” he said.
However, when asked why the guidance had been issued more quickly than that
for multiple sclerosis treatments, he said that the economic modelling for Alzheimer’s
disease had been more straightforward.
Mr Dillon was asked about patients with an MMSE score of 10 or 11, who were
not regarded as having severe disease clinically but who, according to the guidance,
would be considered ineligible for treatment. In reply, he said that it was
up to clinicians to decide on the best course of action for individuals and
that the MMSE score of 12 was intended as a guide.
He acknowledged that implementing the guidance would be a challenge to the NHS,
as resources for diagnosis and care of patients with the disease varied throughout
Britain. However, it was one that “they would have to rise to”. Mr Dillon pointed
out that the guidance only applied to Alzheimer’s disease and not to other types
of dementia, such as Lewy body dementia.
Miss Katey Karam, a spokeswoman from Age Concern, told The Journal on
January 22 that the charity welcomed any national effort to standardise services
for older people. The charity hoped that monitoring systems would be put in
place to ensure equity of access to services for everyone needing the drugs.
Dr Roy Jones (director, Research Institute for the Care of the Elderly, St Martin’s
hospital, Bath) welcomed the guidance. He told The Journal on January
24: “There has been a growing consensus to support the efficacy of these compounds.
This has arisen both from the randomised, controlled trials with all three compounds
and from formal and informal postmarketing experience. The decision by the NICE
reflects that experience and hopefully will lead to the disappearance of postcode
prescribing for people with Alzheimer’s disease.”
He added that there would need to be improvements in the general assessment
of patients who may have dementia but this should, in any case, have been available
in the past. If treatment reduced the need for services or delayed institutionalisation
by even a few weeks, it was likely to be cost- effective, although many of the
costs were not currently borne by the NHS.
The conditions set out in the guidance by the NICE were not perfect but were
both reasonable and practical. Dr Jones said he was pleased that the NICE had
listened carefully to the evidence of specialists, patients and carers in reaching
its final conclusions.
Although the acetylcholinesterases were by no means a cure, and did not work
at all in some patients with the disease, they undoubtedly improved the quality
of life of many patients and their families. “This decision is an important
one for them,” he said.
In a press release issued by the Association of the British Pharmaceutical Industry
on January 19, Dr Trevor Jones (director general) welcomed the guidance. The
NICE’s decision seemed to indicate that it was now listening to representations
made on behalf of patients and the pharmaceutical industry, he said. However,
he questioned whether all patients would receive treatment, saying: “We still
need solid evidence that positive recommendations made by NICE are being carried
through in practice.”
The guidance applies to England and Wales only and is available at the NICE
website (www.nice.org.uk).
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Riluzole (Rilutek), the only licensed drug treatment for patients with motor
neurone disease, was made available for NHS use by the National Institute for
Clinical Excellence on January 19.
The institute says that riluzole is only recommended for patients with amyotrophic
lateral sclerosis, which accounts for up to 85 per cent of cases, and that a
specialist should start any treatment with the drug.
Mr Andrew Dillon (chief executive, the NICE) said at a press conference on January
19 that arrangements had to be put in place to allow early diagnosis because
the time from diagnosis of motor neurone disease (MND) to death was usually
about three years.
“The additional months of life which this medicine [riluzole] offers . . . makes
it an important and worthwhile treatment,” he said, adding that riluzole was
both clinically- and cost-effective when used according to the licensed indications.
The institute estimates that the cost of making riluzole available will be up
to £7.5m.
Mr George Levvy (chief executive, Motor Neurone Disease Association) welcomed
the decision saying: “The extra time gained by taking riluzole can mean so much
to people with so little time left. . . . Until now, people with MND who wanted
riluzole were dependent on the prescribing policy of their local health authority.
. . . For people refused riluzole, the choice was stark.”
In a press release issued on January 19, the Department of Health announced
that health authorities and trusts would be monitored shortly after the publication
of the guidance and again six months later, to ensure that they were taking
“full and proper” account of the recommendations.
The guidance applies to England and Wales only and is available from the NICE
website (www.nice.org.uk).
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A £3m national publicity campaign to provide reassurance about the safety
of the combined measles, mumps and rubella (MMR) vaccine is about to be launched
by the Department of Health.
The campaign, which aims to provide information to parents and health care professionals,
was announced by Professor Liam Donaldson (chief medical officer, DoH) at a
press briefing on January 22. The briefing followed a summit meeting, attended
by several health organisations, at which the latest report by Dr Andrew Wakefield
(Royal Free hospital, London) into the safety of MMR vaccination was discussed.
In the report, Dr Wakefield and Dr Scott Montgomery say that pre-licensing safety
studies were short-term, with periods of observation lasting, at most, 28 days,
and often considerably less. They also refer to a small post-licensing study
in the United Kingdom, reported in 1991, that compared reactions to the MMR
vaccine with those of a monovalent measles vaccine. The researchers of this
study identified a high rate of gastrointestinal disorders, occurring in 41.9
per cent and 37.8 per cent of children receiving the respective vaccines, which
was as frequent as the established clinical features of rash and pyrexia. However,
these gastrointestinal problems were dismissed at the time as representing normal
“background” illness.
Dr Wakefield and Dr Montgomery add that use of spaced, separate vaccines would
remove concurrent exposure to the component viruses of MMR, which they say might
otherwise increase the risk of chronic immune-mediated disease (Adverse Drug
Reactions and Toxicological Reviews 2000;19:265).
In response to the report, the DoH says that “many studies recorded safety data
for up to six weeks, which is standard for vaccines” and that some recorded
data for a year. The DoH adds that the safety of MMR vaccines has been repeatedly
reviewed by the Government’s independent advisory committees, including the
Committee on Safety of Medicines and the Joint Committee on Vaccination and
Immunisation, and that they have concluded that an association between MMR vaccine
and inflammatory bowel disease or autism is not supported. The Department says:
“The paper by Dr Wakefield does not present any new data, it merely reviews
a number of published articles. It is highly selective and studies that do not
support the author's views are not mentioned.”
A statement, issued by the Department, on the safety of the MMR vaccination
programme, which a number of individuals and organisations have signed (including
the Royal Pharmaceutical Society), says: “There is a real concern about [Dr
Wakefield’s] advice that the vaccines should be given separately, since children
would be left unnecessarily unprotected from these potentially serious diseases.
We strongly recommended that children are protected with MMR and not left at
risk.”
The Society has released a statement saying that it has joined other health
care professionals to support MMR vaccinations. In the statement the Society’s
president (Mrs Christine Glover) says: “The Society is looking forward to working
with the Department of Health in restoring the public’s confidence in MMR following
claims about the jab’s safety.”
Commenting on the MMR vaccine’s proposed link with autism, Dr Liz Miller (Public
Health Laboratory Services) said that there was no evidence that the vaccine
was unsafe in those genetically susceptible to autism or that “the measles vaccine
given on its own will behave any differently”.
The National Autistic Society (NAS) has issued a statement in response to Dr
Wakefield and Dr Montgomery’s report. In the statement, the NAS calls upon the
Government “to carry out, as a matter of urgency, research into the safety of
the MMR vaccine” and, in the meantime, to provide an alternative to the triple
vaccine for those parents who want their children immunised, but do not trust
the MMR vaccine.
The NAS says that it is supportive of the immunisation programme but is concerned
that the programme may be jeopardised if parents are not given an alternative.
The NAS also says that Government money should be spent on the vital research
needed to answer the questions raised about MMR and autism, not advertising.
“These hollow advertising campaigns only serve to patronise parents and raise
their suspicions,” it says.
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Women who often eat fish or omega-3 fatty acids are less likely to suffer
a stroke, according to researchers in the United States.
Dr Hiroyasu Iso (Channing laboratory, Harvard medical school, Boston) and colleagues
documented 574 cases of stroke after 14 years of follow-up of the 79,839 women
enrolled in the Nurses’ Health Study.
The researchers found that the amount of fish eaten by the women was inversely
proportional to their risk of stroke, particularly thrombotic stroke. However,
there was no association with the risk of haemorrhagic stroke. Compared with
women who ate fish less often than once a month, the relative risk of stroke
for those who ate it one to three times a month was 0.93. The figures for women
who ate fish once a week, two to four times a week, or five or more times a
week were 0.78, 0.73 and 0.48, respectively.
The authors suggest several mechanisms for the reduction in risk - a reduction
in platelet aggregation, a lowering of blood pressure in hypertensive subjects
and a reduction in plasma fibrinogen concentrations. They comment: “These effects
may contribute to the prevention of atherosclerotic development and the thrombotic
process.” The study is published in the Journal of the American Medical Association
(2001;285:304).
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Linezolid (Zyvox), the first drug in a new class of antibacterial agents known
as oxazolidinones (PJ, February 19, 2000 p294),
has received a licence in the UK. Pharmacia & Upjohn will be officially launching
the product on February 8.
Linezolid is available now as tablets and as a solution for infusion. An oral
suspension is expected to be available in April. As linezolid has an oral bioavailability
of nearly 100 per cent, the company says that no dosage adjustment is required
when switching from the intravenous route to the oral route (see p130).
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Low-dose aspirin treatment prevents cardiovascular events in patients with
one or more cardiovascular risk factors, the results of a new study confirm
(Lancet 2001;357:89).
In a randomised, controlled trial conducted in 315 general practices and 15
hospital-based clinics, Dr Maria Roncaglioni and colleagues (Collaborative Group
of the Primary Prevention Project) tested the effects of chronic treatment with
aspirin and vitamin E on the frequency of major fatal and non-fatal cardiovascular
events in 4,150 patients.
They found that daily treatment with 100mg enteric-coated aspirin lowered the
frequency of cardiovascular death and total cardiovascular events. The relative
risks for these end points were 0.56 (95 per cent confidence interval, 0.31-0.99)
and 0.77 (0.62-0.95) respectively. Vitamin E showed no effect on any specified
endpoint, they say.
Bleeding complications accounted for a large proportion of the reported adverse
events for patients treated with aspirin, say the researchers. However, only
one death caused by haemorrhage occurred in the aspirin group compared with
three in the no-aspirin group.
The researchers comment that the study included men and women with major cardiovascular
events, who were identified and treated in clinical practice, and that the category
of candidates for aspirin prophylaxis should be widened. They say that the findings
for vitamin E were inconclusive and add that “there are no real reasons for
including antioxidants among recommendable prevention strategies”.
In a leading article (ibid, p84), Dr Walter Rosser (department of family and
community medicine, University of Toronto, Canada) comments that the results
of the trial, along with those of two other studies, “should give general practitioners
the confidence to recommend low doses of aspirin (80-100mg daily) for primary
prevention in individuals who have one or more risk factors but whose blood
pressure is contained within the normal range.”
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Children who are prone to otitis media may benefit from treatment with streptococcal
bacteria, say researchers from Sweden. Such treatment could also decrease antibiotic
consumption, they say.
Dr Kristian Roos (Lundby hospital, Gothenburg) and colleagues identified 108
children prone to acute otitis media aged between six months and six years.
Following 10 days of antibiotic treatment, the children were randomly assigned
to receive either an alpha-streptococcal or placebo solution that was sprayed
into the nose twice daily for a further 10 days. After 60 days, the same spray
was started for another 10 days.
They found that at three months, 42 per cent of the children given the streptococcal
spray were free of infection compared with 22 per cent of those given placebo.
Furthermore, at their last visit, fewer children in the active-spray group had
secretory otitis media.
The researchers comment: “As otitis-prone children are heavy consumers of antibiotics,
the impact on the development of antibiotic resistance among pathogens causing
otitis media in this group of children may be considerable.” (British Medical
Journal 2001;322:210.)
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A factsheet on vaccination of the elderly has been produced by the European
Vaccine Manufacturers (EVM) group.
The EVM says the factsheet has been written for pharmacists, as well as for
other health care professionals and the general public. It states that pharmacists
are in an ideal position to provide information to the elderly regarding the
importance of vaccination, and to help counteract common myths and misconceptions
by providing clear and understandable explanations of what vaccines will and
will not do. EVM factsheets can be downloaded from the EVM webpage (www.efpia.org/1_efpia/evm/evm.htm).
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Women with premenstrual syndrome may benefit from treatment with the dry extract
of Vitex agnus-castus, say researchers from Germany.
Dr R. Schellenberg (institute for health care and science, Hüttenberg) and colleagues
gave 170 women with premenstrual syndrome either agnus castus 20mg daily or
placebo for three menstrual cycles.
At the end of the study, over half of the women taking agnus castus had had
a positive response, compared with about a quarter of those in the placebo group.
A response was defined as a greater than 50 per cent reduction in the symptoms
that were measured (irritability, mood alteration, anger, headache, breast fullness
and other symptoms). Significant differences were seen for five of these six
symptoms but there was no change in the “other symptoms” category, which included
bloating.
The authors say that agnus castus is an effective treatment and, when no cause
of premenstrual syndrome can be identified, it “ought to be considered a therapeutic
option”, (British Medical Journal 2001;322: 134).
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Blood glucose levels may provide an indication of cardiovascular risk, research
shows. It is known that glycated haemoglobin (HbAlc) concentrations
can predict cardiovascular risk in people with diabetes but the new data show
that the relationship is also true for people without diabetes.
Professor Kay-Tee Khaw (professor of clinical gerontology, Institute of Public
Health, University of Cambridge) and colleagues examined the relationship between
HbAlc, diabetes and mortality in 4,662 men aged between 45 and 79
years.
Men with established or undiagnosed diabetes were at greater risk of dying from
all causes, cardiovascular disease, or ischaemic heart disease than men without
diabetes. This increased risk was largely mediated through HbAlc
concentration - an increase of 1 per cent in HbAlc resulted in a
29 per cent increase in all-cause mortality, a 38 per cent increase in cardiovascular
mortality and a 44 per cent increase in mortality from ischaemic heart disease,
the researchers say.
They also found that HbAlc levels were a marker of risk in men without
diabetes. After the exclusion of men with diabetes, HbAlc above 7
per cent or a history of heart disease or stroke, the relative risk of all-cause
mortality for a 1 per cent increase in HbAlc was 1.46.
The authors say that the study has implications for public health. Although
the prevalence of diabetes is low, 70 per cent of the population have elevated
HbAlc concentrations that fall short of the level for diagnosis of
diabetes. Lowering the population mean distribution of HbAlc concentration
by diet or physical activity could reduce many people’s risk, they add (British
Medical Journal 2001;322:15).
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Multiple sclerosis is a common disease of unknown cause in which multiple
plaques of demyelination occur within the brain and spinal cord. MS affects
about 80,000 adults in the UK, and the most common age of onset is between 20
and 45 years. It is more common in women than men. MS occurs worldwide but the
prevalence varies widely, being proportional to the distance from the equator:
prevalence progressively increases as distance from the equator increases.
There is no cure for MS, so patients are often motivated to try anything that
might help, including dietary manipulation, although nutritional interventions
are not always evidence-based. The case for dietary change in MS is not proven,
but there is some evidence that the disease is linked to the consumption of
large quantities of saturated (animal) fats. Prevalence of MS seems to be lower
where polyunsaturated fats are eaten in preference to saturated.
This series of “dietary advice tips” is intended to be a reminder of the main
points to be made by pharmacists when giving nutritional information to the
public. The conditions included in the series are those where diet is a well
recognised risk factor, those in which diet contributes to the management of
the condition, and others for which patients may welcome sound dietary advice.
The series is written by Dr Pamela Mason (a pharmacist with a postgraduate qualification
in nutrition)
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A new distance learning pack on health promotion has been produced by the Centre
for Pharmacy Postgraduate Education. The pack, “Improving the public’s health
through health promotion”, highlights the important role that pharmacists can
play in health promotion. It covers key aspects of healthy living, as well as
sections on developing health promotion skills.
Four times a year, The Journal publishes a calendar of health promotion
events. The calendar for the next three months can be found on p132.
This year’s World Health day campaign slogan is “Stop exclusion - dare to care”. The World Health Organisation (WHO), co-organiser of the event, says that the theme aims to raise awareness about mental health and brain disorders. The day is part of the WHO’s year-long mental health campaign, which it hopes will focus attention on the stigma and discrimination surrounding mental health.
Blocking vasoconstriction in the penis, rather than actively causing vasodilation,
may offer an alternative method for treating erectile dysfunction, say American
researchers.
Dr Kanchan Chitaley (department of physiology, University of Michigan) and colleagues
tested the ability of the rho-kinase antagonist Y-27632 to cause erection in
rats. By blocking rho-kinase, Y-27632 activates myosin light chain, the contractile
machinery of muscle tissue. When injected into rats, it caused an increase in
pressure in the erectile tissue of the penis, which, in turn, caused erection,
they say (Nature Medicine 2001; 7:119).
Great care must be taken when giving eye-drops to patients who have other
treatments that are packaged in dropper bottles, warn clinicians from Birmingham’s
Good Hope hospital.
They report that a patient with glaucoma and a colostomy had stomal deodorant
(Translet plus one) instilled into his eyes by mistake during a stay on a medical
ward. Although he made a complete recovery, the deodorant drops had a pH of
5 and caused severe chemical injury to his eyes, they say (British Medical
Journal 2001;322:182).
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