Date: August 2010
Volume: 40 Number: 08
This section includes all of the latest news
stories and research updates from the August 2010 issue of GM. If you
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News
The £50m cancer drugs lottery
The extra £50 million cash injection promised by
the Health Secretary for the purchase of new cancer drugs may not be
the victory for patient groups that some believe.
The emergency cancer fund will enable a doctor
whose patient has had funding for a drug declined on the basis of
NICE guidance to appeal to their regional Strategic Health Authority
(SHA) panel, which has the power to overrule NICE, and draw on their
share of the £50 million to fund the drugs.
The fund is intended to help cancer patients
access these drugs to extend life or improve quality of life for 6
months from October, before the previously announced £200 million
fund comes into effect from April next year.
But an editorial published in the Lancet at the
beginning of August says: "This raises the spectre of appeals
being granted or declined, not on the basis of patients'
conditions, but because of where they live.
"Scratch the surface and it quickly becomes
clear that what this fund represents is not the victory for patient
groups that some believe. Rather, it is the product of political
opportunism and intellectual coherence."
A report by UK National Cancer Drug Director Mike
Richards provided a timely opportunity for the UK Health Secretary to
announce the policy. The comparison of
treatment for various diseases in 14 developed countries showed that
the UK ranked highly for the provision of heart disease and stroke
treatments, whilst it ranked 12th for cancer drugs that had been on
the market for less than 5 years.
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Nine new Quality Standards
The National Institute for Health and Clinical
Excellence (NICE) has nine new Quality Standards that it will develop
in 2010 and 2011. These standards will
cover the management of breast cancer, type-1 and type-2 diabetes,
chronic kidney disease, end-of-life care, glaucoma, depression,
chronic heart failure, treatment for alcohol dependence and chronic
obstructive pulmonary disease.
Their development was referred to NICE by the
Department of Health following advice from the National Quality
Board. Quality Standards developed by NICE are considered markers of
excellent care. They are produced in collaboration with the NHS and
social care professionals along with other partners and service
users.
Dr Fergus Macbeth, Director of the Centre for
Clinical Practice at NICE, said that the Institute's quality
standards "provide the NHS and the public with clear statements
and associated measures, which will be used to assess existing
practice and improve future services."
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NICE green light for rituximab
Recommendations made by the National Institute for
Health and Clinical Excellence for the use of the targeted antibody
rituximab (Mabthera) to treat patients with chronic lymphocytic
leukaemia (CLL) have been extended to include most of those with
relapsed and difficult-to-treat disease.
The authority increased its indications for use of
rituximab in patients with CLL after findings from the REACH trial
revealed that it increased the length of remission by 10 months when
combined with fludarabine and cyclophosphamide (FC), compared with
chemotherapy alone (30.6 vs 20.6 months).
In addition, the triple therapy combination almost
doubled the likelihood that patients would achieve a complete
response, compared with those treated with chemotherapy alone (24% vs
13%).
The advice excludes patients who have received the
full therapeutic dose of rituximab in the first-line setting or are
refractory to fludarabine.
Dr Claire Dearden, Consultant Haematologist at the
RoyalMarsdenHospital, commented: "When added to chemotherapy,
rituximab consistently delivers superior outcomes to chemotherapy
alone, putting more patients into longer remissions, the key goal of
treatment for chronic leukaemia.
"NICE's decision to widen its
recommendation to include relapsed and refractory CLL patients is
very encouraging and will mean that many more people will now be able
to benefit from this potent treatment combination."
The REACH trial included patients who had
previously received one prior therapy for CLL and required further
treatment.
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Pill lowers BP and cholesterol
Caduet, a pill that combines a statin and a
calcium channel blocker, has been shown to lower heart disease risk
by 27% compared with standard therapy, using the Framingham coronary
heart disease model.
The findings stem from the final results of the
CRUCIAL (Cluster Randomised Usual Care vs Caduet Investigation
Assessing Long-term Risk) trial, revealed at the 20th European
Society of Hypertension (ESH) meeting in Oslo, Norway.
The clinical trial involved 1461 men and women
aged 35-79 years from 19 countries who had hypertension. Using the
European SCORE model, the researchers showed that the combination of
atorvastatin and amlodipine also reduced the risk of death from
cardiovascular disease by 2%.
Dr Abel Pavia, a leading international
cardiologist from the Hospital General in Mexico, described the
findings as "remarkable". He said: "If you are male,
aged 45 or over, or female aged 55 or over, you are at risk of heart
disease. Caduet is the only treatment that successfully combines a
blood-pressure lowering drug with a cholesterol-lowering
medication."
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Stroke surgery target shortfall
Greater efforts must be made to stem the
persistent delays in referral and surgery of patients with symptoms
of stroke or transient ischaemic attack (TIA), an editorial in The
Lancet claims.
NICE guidance published in 2008 recommends a
maximum 14-day wait between symptoms and surgery, and the 2007
National Stroke Strategy set a target of 48 hours.
However, a recent report published by the UK
Vascular Society and the Royal College of Physicians shows that just
3% of patients had an operation within 48 hours of symptoms and
around a third did so within the two-week timeline.
Comparison with an audit
conducted two years ago by the same organisations
shows some improvement in delays at all stages of the process from
presentation to surgery.
Waits longer than 14 days were mainly due to
delayed referral (40%), scarcity of staff or operating theatres (18%)
and delayed presentation (18%).
The editorial concludes: "The persistence of
delays in presentation and referral shows the continued importance of
awareness campaigns. Improved identification and urgent referral of
patients at high risk will need to be coupled with further
reorganisation of services to ensure availability of staff and
specialist services.
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Telemonitoring for heart failure
Increasing access to remote monitoring for
patients with chronic heart failure could reduce deaths and
hospitalisations, while also lowering healthcare costs, according to
a Cochrane review.
The review of studies involving over 9500 patients
showed that remote monitoring can reduce the large burden of chronic
heart failure on healthcare resources.
For remote monitoring, patients provide vital
data, such as heart rate and rhythm, blood pressure and weight, in
structured telephone conversations. Telemonitoring involves the
digital transfer of data using wireless or Bluetooth
technology.
The authors analysed data from 25 peer-reviewed
studies that compared patients managed using telemonitoring and those
given standard care. The study participants were followed-up for
between 3 and 18 months.
Results showed that telemonitoring reduced death
rates of patients with chronic heart failure to 102 per 1000,
compared with 154 deaths per 1000 patients in those given standard
care. Structured telephone conversations were associated with a
non-significant improvement in mortality.
Lead researcher Dr Sally Inglis of Baker IDI Heart
and Diabetes Institute in Melbourne, Australia, said the technologies
offer specialised care to patients who would otherwise have limited
access.
In Brief...
A supplement of resveratrol
(Transmax) appears to improve glucose tolerance in older adults with
pre-diabetes, a pilot study suggests. The
first human trial of resveratrol supplements showed that moderate
doses improved insulin resistance and lowered post-meal glucose
levels in individuals with impaired glucose tolerance. Ten
individuals were included in the study. Investigators from Albert
Einsein College of Medicine's Clinical Trial Unit presented the
results at the American Diabetes Association's Annual Scientific
Meeting.
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Parkinson's disease (PD) development may be in
part determined by an individual's human leukocyte antigen (HLA)
genes and levels of inflammation, research suggests.
Research published in Nature Genetics showed
strong links between variants in the HLA region and patients with
sporadic and late-onset PD. Scientists have
seen hints of a link between PD and immune function for years. The
latest research provides more convincing evidence.
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The care funding commission
announced by the Government has been tasked with one of the biggest
challenges facing society in the 21st century.
The national charity Counsel and Care says the
commission must be radical and long-term in its approach, setting its
sights beyond the current financial crisis to develop a care funding
solution that is "fair, simple and
sustainable". Stephen Burke,
Chief Executive of Counsel and Care, said: "The care funding
commission must be ambitious and radical in creating a new way to
fund care that will support our ageing population for generations to
come and deliver better care for all who need it. We hope it
approaches the task with an open mind and the courage to find the
best solution for older people and their families.
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The 2009 NICE update on the use
of newer agents to treat patients with type-2 diabetes has been
endorsed by GPs, a survey shows. A year
after publication of the guidance, a poll of 300 GPs found that 67%
felt it had had a positive impact.
Fifty-nine per cent of GPs said their prescribing
of DPP-IV inhibitors - including sitagliptin - had risen over the
previous year and 44% claimed they prescribed more glucagon-like
peptide-1 analogues. Additionally, 40% said they were less likely to
prescribe older treatments, such as sulphanylureas and
thiazolidinediones. Eugene Hughes, a GP specialist in type-2 diabetes
from the Isle of White, called the results "encouraging".
He said early control of blood glucose can reduce
complications.
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The European Medicines Agency
has granted its first licence for the treatment of macular oedema in
patients with retinal vein occlusion.
Ozurdex is an innovative, biodegradable implant
that releases 700 mcg of the potent anti-inflammatory dexamethasone,
which acts locally to reduce oedema, control inflammation and improve
the patient's visual acuity.
Retinal vein occlusion is the second most common
retinal vascular disease, following diabetic retinopathy, and is an
important cause of vision loss.
In affected patients, blockage of the retinal vein
leads to an inflammatory response, excessive build up of fluid in the
retina and thickening of the macula. Mr
Winfried Amoaku, Associate Professor of Ophthalmology at Queen's
Medical Centre, Nottingham, said: "Until the approval of
Ozurdex, ophthalmologists had limited treatment options to offer
patients with retinal vein occlusion.
"The availability of a licensed, effective
treatment for both branch and central retinal vein occlusion which
offers patients long-lasting vision improvement from a single
intravitreal injection is a significant advance for clinicians and
patients."
Retinal vein occlusion is a common cause of vision
loss, affecting five in every 1000 people over the age of 30
years.
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Advance reports
Calcium tied to mild rise in heart attacks
High levels of calcium supplementation have been
linked with a significantly increased risk of heart attacks, but not
cardiac death, in a review of 11 randomised controlled trials.
While the review of data for 12,000 women
published in the BMJ has raised some concern, the National
Osteoporosis Society (NOS) has identified some major limitations in
the conclusions. The increased risk was
only observed in those elderly women who took pills that boosted
their calcium levels above the daily recommended intake, the National
Osteoporosis Society (NOS) points out. And
the participants were taking calcium alone, which means the findings
may not apply to patients taking calcium plus vitamin D, according to
NOS. This is important because calcium plus
vitamin D is often advised for patients with osteoporosis.
The study followed a recent trial that suggested
the supplements may increase rates of myocardial infarction and
cardiovascular events in healthy older women.
Professor Ian Reid from the University of
Auckland, New Zealand, and colleagues reviewed the results of 11
randomised controlled trials of calcium supplements without
coadministration of vitamin D.
The analysis considered differences in study
design and quality to minimise bias. Overall, calcium supplementation
was associated with a 30% increase in the risk of heart attack and a
smaller, non-significant increase in the risk of stroke and
mortality. Previous trials have documented
no increase in cardiovascular risk associated with a higher dietary
intake of calcium.
Dr Claire Bowring of the NOS said that if a
patient is unable to get sufficient calcium through their diet,
"supplementation may be warranted but it needs to be done with
consideration. She also stressed: "It cannot be assumed that
osteoporosis treatments will be effective without ensuring that
people have sufficient levels of calcium."
1.Bolland M, Avenell A, Baron J et al. Effect of
calcium supplements on risk of myocardial infarction and
cardiovascular events: meta-analysis. BMJ 2010; 341: c3691
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But so is the cold!
If reviewing the effect of established therapies
on cardiovascular risk wasn't enough, it appears that
cardiologists and GPs should also take note of the weather.
Another study published by the BMJ has shown that
a drop in the average outdoor temperature is associated with an
increased risk of cardiac events.
Results, adjusted for air pollution, influenza
activity, seasonality and long-term trends, linked each 1
C decline
in external temperature on a single day to a cumulative 2% increase
in the risk of heart attack over the next 28 days, which equates to
about 200 extra heart attacks over the following 28 days.
Older people, aged 75-84 years, and patients with
a history of coronary heart disease appeared more vulnerable to these
effects of temperature reductions. In contrast, individuals receiving
long-term aspirin therapy were less vulnerable.
The researchers correlated data from 84,010
hospital admissions for heart attack recorded in the Myocardial
Ischaemia National Audit Project from 2003-2006 with daily
temperatures from the British Atmospheric Data Centre., focusing on
15 geographical areas in England and Wales. No increase in risk with
a 1
C temperature fall was detected at higher
temperatures.
The researchers concluded that the increased risk
of myocardial infarction largely operated in the two weeks after
exposure to the cold.
They called for further studies to clarify the
benefit of clothing and home heating, and which groups are most
vulnerable.
1. Bhaskaran K, Hajat S, Haines A et al. Short
term effects of temperature on risk of myocardial infarction in
England and Wales: time series regression analysis of the Myocardial
Ischaemia National Audit Project (MINAP) registry. BMJ 2010; 341:
c3823
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Bone cement data firms up
Bone cement is an effective and well-tolerated
treatment for patients with acute vertebral compression fracture due
to osteoporosis, according to a new study in The Lancet.
The Vertos II results suggest that vertebroplasty
also gave greater pain relief than standard, conservative treatment,
at an acceptable cost. The findings contradict those of two previous
trials, which authors Dr Caroline Klazen and Dr Paul Lohle, from St.
Elizabeth Ziekenhuis in Tilburg, The Netherlands, say were clouded by
methodological issues.
This may be because the current trial focused only
on patients with acute, osteoporotic, vertebral compression
fractures. Former trials may have been hampered in part by inclusion
of patients with subacute and chronic fractures instead of acute
fractures only and the absence of a no-intervention control
group.
The study focused on 431 patients aged 50 years
and older with demonstrated vertebral compression fractures on spinal
radiograph, who had experienced back pain for up to 6 weeks and had a
visual analogue scale (VAS) score of five or more.
Improved pain relief with vertebroplasty was shown
by a reduction in the VAS score of -5.2, 1 month after
vertebroplasty, compared with a reduction of -2.7 after conservative
treatment. One year after baseline, the reduction in VAS score was
-5.7 in the vertebroplasty group, compared with -3.7 in patients
given standard care. Drs Wardlaw (from WoodendHospital in Abredeen)
Meirhaege (from Algemeen Ziekenhuis in The Netherlands), said:
"Vertos II lends support to the large body of medical opinion
that vertebroplasty has a part to play in management of the pain of
vertebral compression fractures."
1.Klazen C, Lohle P, Ziekenhuis et al.
Vertebroplasty versus conservative treatment in acute osteoporotic
vertebral compression fractures (Vertos II): an open-label randomised
trial. Lancet 2010. doi:10.1016/S0140-6736(10)60954-3 [Epub]
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New joints can be grown from stem cells
New joints could be grown naturally using a
patient's own stem cells, a pioneering study suggests.
The results, published Online First in The
Lancet,1 bring hope that patients with failing joints could look
forward to naturally grown joints that would last longer than current
artificial joints.
As the population ages, and the number of patients
who need replacement joints under the age of 65 years increases, it
is likely that many patients will outlive their replacement joints.
These patients would then need another operation at an advanced age
and without much bone left to support another metallic joint.
In this proof-of-concept, animal study, Professor
Mao and colleagues implanted three dimensional biomaterial scaffolds
infused with growth factor in place of the forelimb thigh joint of 10
rabbits. The rabbits' own stem cells were then attracted to the
scaffolds by the growth factors, where they regenerated cartilage and
bone. Within 4 weeks, the rabbits were able to resume normal
movements.
1.
Lee C, Cook J, Mendelson A, et al. Regeneration of
the articular surface of the rabbit synovial joint by cell homing: a
proof of concept study. Lancet 2010; 376: 440-448
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After stroke... to B or not to B?
Supplementation with B vitamins is safe for who
have had a recent stroke or transient ischemic attack but it does not
reduce the risk of subsequent vascular events, research published in
the Lancet Neurology1 suggests. Results of the first,
placebo-controlled trial of B vitamins in stroke patients suggest
that they should not be recommended to prevent recurrent stroke. The
VITAmins TO Prevent Stroke trial group said the results are
consistent with B vitamin studies in other patient
populations.
1. The VITATOPS Trial Study Group. B vitamins in
patients with recent transient ischaemic attack or stroke in the
VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised,
double-blind, parallel, placebo-controlled trial. Lancet Neurology
2010; 9: 855-865
DON'T FORGET! GM's conference "The
Older patient: bridging the gap between primary and secondary
care" is on the 27th October at the Royal Society of Medicine.
For details our Early Bird offers, which have now been extended to
the 8th September, see our conference
page.