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Clinical Trial Service Unit at Oxford University

Good News for Kidney Patients: World's Largest Kidney Disease Trial Shows Big Benefits From Reducing Cholesterol

Denver, November 20 (ots/PRNewswire)

Around a quarter of all
heart attacks, strokes, and operations to open blocked arteries could
be avoided in people with chronic kidney disease by using the
combination of ezetimibe and simvastatin to lower blood cholesterol
levels. That's the conclusion from the world's largest ever
randomized trial in kidney disease.
Unveiling the key findings today (Saturday 20 November) at the
American Society of Nephrology, the trial's principal investigator
Professor Colin Baigent said: "This is excellent news for patients
who have kidney disease. It was already known that
cholesterol-lowering could reduce the risk of heart attacks, strokes
and the need for surgery to unblock arteries in people with normal
kidney function. But, this trial now shows that cholesterol-lowering
has similar effects in people with chronic kidney disease,
irrespective of the severity of their illness. Taking ezetimibe plus
simvastatin long-term would avoid around one quarter of heart
attacks, strokes and operations to unblock arteries, leading to their
prevention in at least 250,000 people with kidney disease worldwide
each year."
The Study of Heart and Renal Protection (SHARP) involved almost
9,500 volunteers aged 40 or over with chronic kidney disease
recruited from 380 hospitals in 18 countries. Patients included in
the trial had lost at least 50% of their normal kidney function, with
a third of them requiring dialysis treatment. None had had a previous
heart attack or needed bypass surgery or "stents" to unblock their
heart arteries. Volunteers in this double-blind placebo-controlled
trial were randomly allocated to take either cholesterol-lowering
therapy with a tablet containing ezetimibe 10mg daily and simvastatin
20mg daily, or matching dummy "placebo" tablets. Study treatment and
follow-up continued for an average of 5 years.
SHARP was designed, conducted and analysed independently of all
funding sources by the Clinical Trial Service Unit and
Epidemiological Studies Unit (CTSU) of Oxford University, with
guidance by an independent Steering Committee that included many of
the world's leading kidney specialists. The study was supported by
Merck & Co., (which is known as MSD outside the U.S. and Canada) who
also supplied the study treatments, with additional support from the
Australian National Health and Medical Research Council (NHMRC), the
British Heart Foundation (BHF) and the UK Medical Research Council
(MRC). Planning began in the mid-1990s, with two pilot studies
followed by a main study that started in 2003 and ended in September
of this year.
    Summary of major findings
    - The patients allocated to take ezetimibe plus simvastatin had one-sixth
      fewer heart attacks, strokes or operations to unblock arteries ("major
      atherosclerotic events"), with similar reductions observed in all
      types of patient studied.
    - During this long trial, the proportion of patients who stopped taking
      their allocated treatment was about one third, but this was not
      generally due to side-effects and was the same for both real and dummy
      treatments. If taken without interruption, however, ezetimibe plus
      simvastatin could have even larger effects than were seen in SHARP,
      potentially reducing risk by about one quarter.
    - Adding 10mg daily of ezetimibe to 20mg daily of simvastatin produced a
      large reduction in LDL ("bad") cholesterol safely. This combination
      treatment may be particularly good for kidney patients, as it avoids
      the possibility of side-effects with high statin doses.
    - There was no support for previous concerns with ezetimibe about
      possible adverse effects on cancer, and no evidence of an increased
      risk of muscle or liver problems.
Professor Baigent said: "We knew from previous trials that
statins reduce the risk of heart attacks and strokes in people with
normal kidney function. But it had been widely believed that raised
cholesterol was not an important cause of heart disease or stroke in
people with chronic kidney disease, so that lowering cholesterol
might not be beneficial for them. SHARP now provides the first direct
evidence that cholesterol-lowering is indeed effective in kidney
patients, and that the benefits are substantial."
SHARP co-principal investigator, Dr Martin Landray said that
SHARP provides reassuring evidence about the safety of the ezetimibe
and simvastatin combination: "There was no evidence of any serious
adverse effects and, in particular, no support for earlier concerns
that ezetimibe might cause cancer. SHARP shows clearly that the large
cholesterol reduction produced with this treatment is safe, and
provides similar benefits to those seen in people with normal kidney
The SHARP results are also relevant to people who don't have
chronic kidney disease. The combination of ezetimibe and a statin
produced similar benefits to those resulting from the same LDL
cholesterol reduction achieved with a high dose of a statin. Since
the lower the cholesterol the bigger the risk reduction, these
results suggest that patients who remain at high risk of major
atherosclerotic events despite maximal statin therapy may benefit
further from adding ezetimibe to their current statin regimen.
Chronic kidney disease affects about one in 10 people worldwide.
People with chronic kidney disease tend to have a very high risk of
developing heart disease or experiencing a stroke. Until now, it has
not been known how to prevent these conditions in such patients.
Consequently, it is likely that the SHARP results will result in
cholesterol-lowering treatment being used widely in this large group
of high-risk people who were previously not being given such
NEWS TELECONFERENCE 10.45AM MT (Denver) Saturday 20th November
2010. This news conference will last no longer than 40 minutes. This
is almost immediately after, and in addition to, the news conference
being organised by ASN in the morning.
In order to join this conference call, all participants will be
required to provide the following conference ID # 25065869
Operator assisted toll-free US dial-in number (888) 260-6134
Operator assisted INTERNATIONAL dial-in number (706) 643-1635
A recording of the conference will be available for replay two
hours after the call's completion: Dial in US (800) 642-1687 or
INTERNATIONAL  (706) 645-9291
American Society of Nephrology (ASN) Renal Week
ASN Renal Week 2010, the largest nephrology meeting of its kind,
provides a forum for 13,000 professionals to discuss the latest
findings in renal research and engage in educational sessions related
to advances in the care of patients with kidney and related
disorders. Founded in 1966, the American Society of Nephrology (ASN)
is the world's largest professional society devoted to the study of
kidney disease. Comprised of 11,000 physicians and scientists, ASN
continues to promote expert patient care, to advance medical
research, and to educate the renal community. ASN also informs
policymakers about issues of importance to kidney doctors and their
patients. ASN funds research, and through its world-renowned meetings
and first-class publications, disseminates information and
educational tools that empower physicians.


CONTACT: For further information please contact: Andrew
Trehearne:+44(0)789-404-2600 or,
Please note that Iwill be in Denver from late afternoon, Wednesday 17
November - Sunday 21November