Basingstoke, England (ots/PRNewswire) -
- New Data Show FOSRENOL Is an Effective Monotherapy - Leading to
Improved Phosphate Reduction in Dialysis Patients Previously
Receiving Alternative Phosphate Binder Therapies
New data show calcium-free FOSRENOL (lanthanum carbonate) further
reduces phosphate levels in dialysis patients previously receiving
other monotherapies or combined phosphate binders, including calcium
carbonate and sevelamer hydrochloride. The data, presented today
at the XLIII ERA-EDTA Congress in Glasgow, also showed that FOSRENOL
significantly increased the number of patients achieving Kidney
Disease Outcome Quality Initiative (K/DOQI) targets compared to those
who were previously treated with other monotherapies.
Dr Alastair Hutchison from the Manchester Institute of Nephrology
& Transplantation and one of the trial's lead investigators said,
"These study results add further weight to the extensive data package
which demonstrates FOSRENOL is an effective phosphate binder.
FOSRENOL offers patients with hyperphosphataemia an effective
treatment option which could simplify their management by reducing
tablet burden to as little as one tablet taken during each meal."
A total of 359 dialysis patients were treated with FOSRENOL as
monotherapy and were available for analysis from this multicentre,
open label study, following a switch from their previous binder
therapy. Over 40% of patients were previously on combination
phosphate binder therapy (2 or more binders). The study found that at
12 weeks of FOSRENOL monotherapy, patients' mean serum phosphate
levels were 1.84 mmol/L compared with 1.99 mmol/L on other previously
received phosphate binding therapies*. In addition, there was an
increased percentage of patients who reached KDOQI targets. The study
also demonstrated that FOSRENOL was well-tolerated throughout.
(* For patients assessed at Week 12, the mean change from
screening to Week 12 was -0.13 (P < 0.05).)
Further data presented at the ERA-EDTA Congress showed that
treatment with FOSRENOL was associated with a high level of patient
and physician satisfaction, based on a number of assessments and
linked to a reduction in tablet burden. The majority of patients
and physicians expressed a preference for FOSRENOL over previous
"Poor patient adherence is a problem often found in patients with
hyperphosphataemia," says Dr Rajnish Mehrotra from the Harbor-UCLA
Medical Center, California and one of the lead investigators of the
trial. "These findings show that FOSRENOL may help to tackle this
Other data presented at the meeting also extended FOSRENOL's
existing body of evidence. Data from 93 patients, 17 of whom were
followed for up to 6 years in an open-label extension study, showed
that FOSRENOL effectively maintained reductions in mean serum
phosphate levels whilst remaining tolerated.
These studies are promising news for the nearly one million people
on dialysis worldwide who are at risk from the serious consequences
of hyperphosphataemia, shown to be associated with long-term
morbidity and mortality. Up to 70 percent of CKD patients will
develop hyperphosphataemia which, if not managed successfully, may
cause serious long-term health risks leading to renal osteodystrophy
(resulting in bone pain, brittle bones and skeletal deformities), and
potentially contribute to cardiovascular disease, which accounts for
almost half of all deaths among dialysis patients. As a result,
patients with hyperphosphataemia are often already taking as many as
eight or nine different medications. As FOSRENOL is associated
with a lower tablet burden than existing phosphate binders, it may
offer simplified dosing for these patients.
Dr Raymond Pratt, Vice President Shire Global Medical Affairs,
said, "Shire welcomes the presentation of these data which further
add to the robust evidence supporting the effectiveness and
tolerability of FOSRENOL in patients with hyperphosphataemia, as well
as showing a high-level of patient and physician satisfaction. Shire
is very proud to be able to offer a calcium-free alternative with
proven efficacy and tolerability for patients in need of an effective
and well-tolerated phosphate binder, which may also help to simplify
the management of their condition."
FOSRENOL has been available in the US for 18 months with over
44,000 patients receiving Fosrenol since launch and will continue to
be launched across Europe in the remainder of 2006 and into 2007.
Notes to Editors:
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. 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. Accumulating evidence shows that
hyperphosphataemia contributes to cardiovascular disease, which
accounts for almost half of all deaths among dialysis patients. 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.
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. Although these
agents can be effective, some can cause potentially serious side
effects including hypercalcaemia, bone toxicity and tolerability
Lanthanum carbonate (FOSRENOL(R))
FOSRENOL(R) works by binding to dietary phosphate in the GI tract;
once bound, the FOSRENOL(R)/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(R) involving over 5500 patients, some
of whom have been treated for up to 6 years. This programme has
demonstrated that FOSRENOL(R) is an effective phosphate binder with a
tolerability profile for long-term use. FOSRENOL(R) 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(R) 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(R) 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
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.
It is unknown whether lanthanum is excreted in human breast milk.
The excretion of lanthanum in milk has not been studied in animals.
Breast feeding is not recommended when the mother is treated with
Tissue deposition of lanthanum has been shown with Fosrenol in
animal studies. In 105 bone biopsies from patients treated with
Fosrenol for up to 4.5 years, rising levels of lanthanum were noted
over time . No clinical data are available on deposition of lanthanum
in other tissues. Safety data exceeding 24 months are currently
limited. The risk/benefit from longer-term administration should be
Patients with acute peptic ulcer, ulcerative colitis, Crohn's
disease or bowel obstruction were not included in clinical studies
Approximately 24% of all ESRF patients who participated in
registration clinical studies, reported a drug related adverse
reaction, as determined by the investigator. No individual ADR was
reported at a frequency greater than 10%. The most commonly reported
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 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
. Hutchison A et al. Efficacy of Lanthanum Carbonate
Monotherapy in Dialysis Patients Previously Receiving Alternative
Phosphate Binder Therapy. Presented at the XLIII ERA-EDTA Congress,
Glasgow, UK, 15-18 July, 2006.
. Mehrotra R et al. A New Formulation of Lanthanum Carbonate is
Preferred by Patients and Physicians. Presented at the XLIII ERA-EDTA
Congress, Glasgow, UK, 15-18 July, 2006.
. Hutchison A et al. Sustained Safety, Tolerability and
Efficacy of Lanthanum Carbonate: Results from up to Six Years of
Treatment. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK,
15-18 July, 2006.
. Block G et al. Mineral Metabolism, Mortality, and Morbidity
in Maintenance Hemodialysis. Am Soc Nephrol 2004; 15: 2208-18.
. Lederer E et al. Hyperphosphataemia.
www.emedicine.com/med/topic1097.html. Accessed 23-Mar-06.
. Block G et al. 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
. United States Renal Data System. Medication Use Among
Dialysis Patients in the DMMS. American Journal of Kidney Disease
1998; 32 (2) Suppl 1 (August): S60-68
. 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
ots Originaltext: Shire Pharmaceuticals Group Plc
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