BN003644 20 de novembro de 2006 11:32 HORALOCAL
Further data support the contribution of FOSRENOL(R) (lanthanum
carbonate) to the overall renal health of the ESRD patient while
reducing mean phosphate levels to within guideline targets
BASINGSTOKE, England and SAN DIEGO, Nov. 20 /PRNewswire/ -- New data
presented on Friday 17th November at the American Society of
Nephrology (ASN) Annual Meeting, show FOSRENOL is an effective
phosphate binder with a similar efficacy profile to standard
therapy(1). The 2 year data demonstrate that patients treated with
FOSRENOL showed similar phosphate control and lower serum calcium
levels than standard therapy. Treatment with FOSRENOL for 2 years had
no adverse effects on bone histology and was not associated with an
increased incidence of osteomalacia (bone softening). More patients
treated with FOSRENOL also demonstrated increases in bone formation
rate than patients receiving standard therapy(1).
Professor Hartmut Malluche, lead investigator of the study, said
'Patients with end-stage renal disease are seriously ill and the
burden of their illness is often compounded by co-existing
conditions. They can experience significant bone problems as a result
of hyperphosphataemia, which can sometimes be exacerbated by their
treatment for the condition. These data show that FOSRENOL not only
effectively controls hyperphosphataemia, but also demonstrates some
positive effects on bone status compared with standard therapy over
the 2 year study period.'
During year two, a greater proportion of patients in the standard
therapy group showed movement of bone volume away from the normal
range compared with the FOSRENOL group (50 percent versus 31
percent). Similarly, improvements toward normal bone formations rates
were seen in 38 percent of patients receiving FOSRENOL at both one
and two years. Patients in the standard therapy group showed
improvements of only 24 and 12 percent at one and two years, and bone
formation worsened in 63 percent of the patients in the two-year
group(1). The results were not measured for statistical significance.
FOSRENOL's therapeutic profile is further reinforced by the
publication of new cognitive function data in Kidney International
this month(2). This data assessed the comparative cognitive decline
in dialysis patients taking FOSRENOL and standard therapy to control
phosphate levels. Cognitive decline is a significant problem in this
population and it is important that any treatment does not affect
this further. These long term two year data show that FOSRENOL does
not adversely affect the decline of cognitive function compared to
standard therapy(2). There is a paucity of evidence looking at
cognitive function in this patient population and this study provides
important additional insight into the overall decline in cognitive
function in these patients.
Dr Raymond Pratt, Vice President Shire Pharmaceutical Development,
said: 'These results further add to the robust body of evidence on
FOSRENOL, with studies successfully conducted in more than 5,500
patients, and with a small number followed for up to 6 years now.
Shire is proud of this comprehensive data which support the benefits
FOSRENOL can bring to patients with CKD on dialysis.'
These studies are promising news for the estimated 1.4 million people
on dialysis worldwide(3) who are at risk from the serious
consequences of hyperphosphataemia, shown to be associated with
long-term morbidity and mortality(4). The majority of CKD patients
will eventually develop hyperphosphataemia(5) which, if not managed
successfully, may cause serious long-term health risks including
renal osteodystrophy (resulting in bone pain, brittle bones and
skeletal deformities)(6), and potentially contribute to
cardiovascular disease, which accounts for almost half of all deaths
among dialysis patients(7,8). As a result, patients on dialysis are
often already taking as many as eight or nine different
medications(9). As FOSRENOL is associated with a lower tablet burden
than existing phosphate binders (as few as one pill per meal), it may
offer simplified dosing for these patients(10).
FOSRENOL has been available in the US for 22 months with over 53,000
patients receiving Fosrenol since launch. The first European launches
took place at the end of 2005 and Shire continues to bring Fosrenol
to market around the world across this year and into 2007, subject to
national licensing, pricing and reimbursement negotiations.
References
(1) Malluche HH, Pratt RD. Renal osteodystrophy: Comparison of
evolution over 1 and 2 years during treatment with lanthanum
carbonate or standard phosphate binders. Presented at ASN Renal Week,
San Diego, November 14-19 2006.
(2) Altman P, Barnett ME, Finn WF. Cognitive function in stage 5 CKD
patients on hemodialysis: no adverse effects of lanthanum carbonate
compared with standard phosphate-binder therapy. Kidney Int advance
online publication, October 11, 2006
(3) Grassman A, Gioberge S, Moeller S, Brown G. ESRD patients in
2004: global overview of patient numbers, treatment modalities and
associated trends. Nephrol Dial Transplant 2005; 20: 2587-2593.
(4) Block G, Klassen PS, Lazarus MJ, Ofsthun N, Lowrie EG, Chertow
GM. Mineral metabolism, mortality, and morbidity in maintenance
hemodialysis. J Am Soc Nephrol 2004; 15:2208-18.
(5) Lederer E, Ouseph R, Erbeck K. Hyperphosphataemia.
www.emedicine.com/med/topic1097.html . Accessed 23-Mar-06.
(6) Martin K, Gonzalez A. Strategies to minimize bone disease in
renal failure. Am J Kidney Dis 2001; 38: 1430-36
(7) Salusky IB, Goodman WG. Cardiovascular calcification in
end-stage renal disease. Nephrol Dial Transplant 2002; 17: 336-339.
(8) Block G, Port FK. Re-evaluation of risks associated with
hyperphosphataemia and hyperparathyroidism in dialysis patients:
recommendations for a change in management. Am J Kidney Dis 2000; 35
(6): 1226-1237.
(9) United States Renal Data System. Medication use among dialysis
patients in DMMS. Am J Kidney Dis 1998; 32 (2) Suppl 1 (August):
S60-68.
(10) Mehrotra R. Efficacy and safety of reformulated higher dosage
lanthanum carbonate. Presented at ASN Renal Week, San Diego, November
14-19 2006.
Notes to editors:
Managing Hyperphosphataemia
Phosphorus, an element found in nearly all foods, is absorbed from
the gastrointestinal tract into the blood stream. When the kidneys
fail, they no longer effectively filter out phosphates, even with the
help of blood-cleansing dialysis machines. While the normal adult
range for phosphorus is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), the
blood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL
(2.1mmol/L). Such levels have been linked to a significantly higher
illness and death risk for patients who have undergone at least one
year of dialysis(i). Most dialysis patients develop
hyperphosphataemia.
Hyperphosphataemia disrupts the delicate interplay between the body's
levels of calcium, parathyroid hormone (PTH) and vitamin D. Over
time, hyperphosphataemia can ultimately lead to calcification of the
heart, lung and some arteries(ii). Accumulating evidence shows that
hyperphosphataemia contributes to cardiovascular disease, which
accounts for almost half of all deaths among dialysis patients(iii).
In fact, studies have shown that cardiovascular mortality in dialysis
patients aged 25-34 years is more than 5 times greater than that in
people aged 65-74 in the general population(iv).
Since dialysis and diet restrictions alone generally cannot control
phosphate levels, patients traditionally manage hyperphosphataemia by
taking phosphate binding agents with every meal and snack. Such
binders "soak up" phosphate in the gastrointestinal tract, before it
can be absorbed into the blood.
FOSRENOL(R) (lanthanum carbonate)
FOSRENOL(R) works by binding to dietary phosphate in the GI tract;
once bound, the lanthanum/phosphate complex cannot pass through the
intestinal lining into the blood stream and is eliminated from the
body. As a consequence, overall phosphate absorption from the diet
is decreased significantly. Shire has conducted an extensive clinical
research programme for FOSRENOL involving over 5500 patients, with a
small number followed for up to 6 years now. This programme has
demonstrated that FOSRENOL is an effective phosphate binder with a
good tolerability profile for long-term use. FOSRENOL was approved
by the FDA in October 2004 and is now available for prescription in
the US. In March 2005 regulatory authorities in the EU granted
marketing authorization for FOSRENOL in sixteen member states, thus
completing the first step in securing marketing approval throughout
Europe. FOSRENOL has since been launched in Ireland, Sweden,
Finland, Denmark and Austria. The final step in the European process
was recently completed resulting in recommendation for approval in
the remaining 11 member states. Further roll-outs are underway across
the rest of Europe and other countries around the world. The company
has out-licensed the rights to develop, market and sell FOSRENOL in
Japan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serum
calcium levels should therefore be monitored at regular time
intervals for this patient population and appropriate supplements
given.
No data are available in patients with severe hepatic impairment.
Caution should, therefore, be exercised in these patients, as
elimination of absorbed lanthanum may be reduced.
FOSRENOL should not be used during pregnancy.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease
or bowel obstruction were not included in clinical studies with
Fosrenol.
The most commonly reported Adverse Drug Reactions (ADRs) (>1/100,
1/10) are gastrointestinal reactions such as abdominal pain,
constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting.
These are minimized by taking FOSRENOL with food and generally abated
with time with continued dosing. Hypocalcaemia was the only other
commonly reported adverse reaction.
Shire
Shire is a global specialty pharmaceutical company with a strategic
focus on meeting the needs of the specialist physician and currently
focuses on developing and marketing products in the areas of
attention deficit and hyperactivity disorder (ADHD), gastrointestinal
(GI), renal diseases and human genetic therapies. Shire has
operations in the world's key pharmaceutical markets (US, Canada, UK,
France, Italy, Spain and Germany) as well as a specialist drug
delivery unit in the US.
For further information on Shire, please visit the Company's website:
www.shire.com .
(i) Block GA et al. Association of serum phosphorus and calcium x
phosphate product with mortality risk in chronic hemodialysis
patients: A national study. American Journal of Kidney Diseases 1998;
31: 607-617
(ii) Norris KC. Toward a new treatment paradigm for
hyperphosphataemia in chronic renal disease. Dialysis &
Transplantation 1998; 27 (12): 767-773
(iii) Block G, Port FK. Re-evaluation of risks associated with
hyperphosphataemia and hyperparathyroidism in dialysis patients:
recommendations for a change in management. Am J Kidney Dis 2000; 35
(6): 1226-1237
(iv) Foley R et al. Clinical epidemiology of cardiovascular disease
in chronic renal disease. American Journal of Kidney Disease 1998; 32
(5) Suppl 3:112-119
SOURCE Shire PLC
11/20/2006
CONTACT: Media, Jessica Mann, +44-1256-894-280, or Investor
Relations, Clea Rosenfeld, +44-1256-894-160, both of Shire; or Glen
Halliwell, +44-207-397-7479, or Julia Kirby, +44-79-6617-2179 (on
site), both of Resolute Communications
Web site: http://www.shire.com
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