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FOSRENOL(R) Data Show Evidence Of Trends Towards Improved Bone Formation In CKD Stage 5 Patients, New Data Presented At ASN Meeting
Treatment with the phosphate binder
FOSRENOL(R) (lanthanum carbonate) was associated with slight improvements
in bone formation in chronic kidney disease (CKD) Stage 5 patients with
hyperphosphatemia (high phosphorus levels in the blood), according to long-
term (two-year) data presented at the American Society of Nephrology (ASN)
meeting. Additional studies presented at ASN document the efficacy and
safety of the reformulated and higher-dose FOSRENOL(R) tablets.
Of the approximately 20 million Americans who have some form of kidney
disease, more than 530,000 have developed CKD Stage 5. Even with dialysis
and a low-phosphorus diet, most CKD Stage 5 patients in the United States
will develop hyperphosphatemia. Without effective treatment,
hyperphosphatemia may lead to renal osteodystrophy, a collection of bone
diseases characterized by bone pain, brittle bones, skeletal deformities
and fractures.
"Renal osteodystrophy develops early during chronic kidney disease, so
by the time many patients reach dialysis, they may have painful and
debilitating bone conditions. Treating hyperphosphatemia through diet and
an effective phosphate binder can help patients maintain bone health while
on dialysis," explained Hartmut H. Malluche, M.D., study author and chief
of Nephrology, Bone and Mineral Metabolism in the Department of Internal
Medicine at the University of Kentucky College of Medicine. "Our study
showed that FOSRENOL(R) treatment was associated with increased bone
formation in participants and that there were no signs of bone
abnormalities, such as progressive evolution of mineralization defects or
decreases in bone turnover."
This planned sub-study of a large Phase III clinical trial evaluated
potential differences between standard therapy and lanthanum carbonate on
the evolution of abnormalities of bone turnover, bone balance and
mineralization in patients with CKD Stage 5. Investigators used bone
biopsies to assess participants' bone health at baseline and at one and two
years of treatment with FOSRENOL(R) (n=32 and 32, respectively) or standard
phosphate binder therapy (n=34 and 24, respectively). The study results
showed that FOSRENOL(R) effectively reduced serum phosphorus levels. In
addition, FOSRENOL(R) treatment was associated with lower serum calcium,
higher serum parathyroid hormone (PTH) and increased biochemical parameters
indicative of bone formation. Individual patients showed improvements in
their bone turnover and formation after two years of FOSRENOL(R) treatment,
compared to standard treatment (n=12 and 3, respectively).
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(R) group (50 percent versus 31 percent).
Similarly, improvements toward normal bone formation rates were seen in 38
percent of patients receiving FOSRENOL(R) 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. The results were not measured for
statistical significance.
"The lower calcium and higher PTH levels in patients treated with
FOSRENOL(R) may allow health care professionals a greater window for use of
vitamin D analogs to improve bone health in patients on dialysis," added
Dr. Malluche.
Additional Data Demonstrate FOSRENOL(R) as Monotherapy Is Effective in
Patients With CKD Stage 5
In a separate 12-week, open-label Phase IIIb study in CKD Stage 5
patients most participants treated with only FOSRENOL(R) experienced
reduced serum phosphorus and enhanced achievement of Kidney Disease
Outcomes Quality Initiative (K/DOQI) targets, including those previously
receiving combination phosphate binder therapy.
"FOSRENOL(R) is an effective, well-tolerated phosphate binder that may
simplify treatment for CKD Stage 5 patients," said Alastair J. Hutchison,
M.D., Renal Unit, Manchester Royal Infirmary. "Changing patients to
FOSRENOL(R) monotherapy, not only reduces serum phosphorus levels, but also
reduces phosphate binder pill burden."
The majority of participants who reached the K/DOQI target required
approximately 3 grams (g) of FOSRENOL(R) daily, demonstrating that most
patients can be controlled with a single 1 g tablet per meal. (Dosing based
on three meals per day. Number of meals per day may vary. To achieve
certain doses, additional tablets may be required.)
Of the 367 patients enrolled, 274 (75 percent) completed the study.
Mean serum phosphorus levels at enrollment for the patients taking only one
alternative phosphate binder was 6.14 mg/dL, with just 36 percent achieving
the K/DOQI target, but after converting to FOSRENOL(R) and completing 12
weeks of monotherapy, 52 percent reached the target (P < 0.05). Similarly,
mean levels of patients receiving two binders were 6.11 mg/dL at screening,
with only 35 percent reaching the K/DOQI target, but the proportion
increased to 44 percent after completing 12 weeks of FOSRENOL(R)
monotherapy.
Majority of CKD Stage 5 Patients Achieved Phosphorus Control on
Reformulated and Higher Dose FOSRENOL(R) Tablets
According to another study evaluating the efficacy and safety of
reformulated FOSRENOL(R), higher daily doses, 3,750 or 4,500 milligrams
(mg), of FOSRENOL(R) may provide serum phosphorus control for those CKD
Stage 5 patients who do not respond to doses of 3 g per day, without a
dose-related increase in adverse events.
"This study demonstrates that higher doses of FOSRENOL(R) may help
patients with difficult to control serum phosphorus levels reach K/DOQI
targets," said Rajnish Mehrotra, M.D., Division of Nephrology and
Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA
Medical Center. "The reduction in phosphate binder tablet burden that
higher doses of FOSRENOL(R) provides may help improve patient adherence to
their medication regimen and, thus, their phosphorus control."
Of note, participants previously receiving monotherapy with sevelamer
HCl, with a highest total daily dose of 14,400 mg (18 tablets), required a
markedly smaller daily dose of FOSRENOL(R) in the study. The total average
FOSRENOL(R) daily doses at weeks four, eight and 24 did not exceed 3,500
mg, 4,200 mg and 3,400 mg, respectively, resulting in patients needing a
maximum of five FOSRENOL(R) tablets to maintain phosphorus control.
Managing Hyperphosphatemia
Phosphorus, an element found in nearly all foods, is absorbed from the
gastrointestinal tract into the bloodstream. When the kidneys fail, they no
longer effectively remove phosphorus. While the normal adult range for
phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levels of many
patients on dialysis often exceed 6.5 mg/dL. Such levels have been linked
to a significantly higher morbidity and mortality risk for patients who
have undergone at least one year of dialysis. Research has shown that for
each mg/dL increase in mean serum phosphorus, the relative risk of death
increases by six percent. There are no controlled clinical trials with
FOSRENOL(R) demonstrating a reduction in morbidity or mortality.
Hyperphosphatemia is managed with a combination of dialysis, diet
restriction and phosphorus-binding agents, since diet and dialysis alone
generally cannot adequately control phosphorus levels. Such binders "soak
up" phosphorus in the gastrointestinal tract, before it can be absorbed
into the blood, and aid patients in maintaining acceptable levels of mean
serum phosphorus.
Despite the availability of phosphorus-binding agents, it remains a
challenge for some CKD Stage 5 patients to maintain target ranges.
According to the K/DOQI Clinical Practice Guidelines for Bone Metabolism
and Disease, Guideline 3, Evaluation of Serum Phosphorus Levels, fewer than
30 percent of dialysis patients are able to maintain serum phosphorus
levels in the target range.
FOSRENOL(R)
FOSRENOL(R) is indicated to reduce serum phosphate in patients with end
stage renal disease (ESRD).
FOSRENOL(R) (lanthanum carbonate) is an effective, non-calcium,
phosphate binder that reduces high phosphorus levels in ESRD patients.
FOSRENOL(R) is formulated as an easy-to-use, unflavored, chewable-only
tablet that can be taken without water, an important consideration for ESRD
patients who must restrict their fluid intake.
FOSRENOL(R) is available in a broad range of dosage strengths,
including the reformulated strengths of 500 mg, 750 mg and 1 g, as well as
the original 250 mg. With the reformulated doses, patients can achieve
serum phosphorus target levels with as few as three tablets per day.
(Dosing based on as few as three tablets per day. Number of meals per day
may vary. To achieve certain doses, additional tablets may be required.)
FOSRENOL(R) works by binding to dietary phosphorus in the
gastrointestinal tract. Once bound, the FOSRENOL(R)/phosphorus complex
cannot pass into the bloodstream and is eliminated from the body, thereby
decreasing serum phosphorus levels.
FOSRENOL(R) has been clinically tested in more than 5,500 patients.
Nearly 1,000 of these patients have been treated with lanthanum carbonate
for more than one year. Over 53,000 patients have been treated with
FOSRENOL(R). The long-term safety profile of FOSRENOL(R) shows no evidence
of toxicity at clinical doses. Trials involving patients treated with
FOSRENOL(R) showed sustained serum phosphorus reduction in a majority of
patients.
Important Safety Information
The most common adverse events were gastrointestinal, such as nausea
and vomiting, and generally abated over time with continued dosing. The
most common side effects leading to discontinuation in clinical trials were
gastrointestinal events (nausea, vomiting, and diarrhea). Other side
effects reported in trials included dialysis graft complications, headache,
abdominal pain, and hypotension. Although studies were not designed to
detect differences in risk of fracture and mortality, there were no
differences demonstrated in patients treated with FOSRENOL(R) compared to
alternative therapy for up to three years. The duration of treatment
exposure and time of observation in the clinical program were too short to
conclude that FOSRENOL(R) does not affect the risk of fracture or mortality
beyond three years. While lanthanum has been shown to accumulate in the GI
tract, liver, and bone in animals, the clinical significance in humans is
unknown. Patients with acute peptic ulcer, ulcerative colitis, Crohn's
disease, or bowel obstruction were not included in FOSRENOL(R) clinical
studies. Caution should be used in patients with these conditions.
FOSRENOL(R) should not be taken by patients who are nursing or pregnant.
FOSRENOL(R) should not be taken by patients who are under 18 years of age.
For Full Prescribing Information on FOSRENOL(R), please visit
http://www.fosrenol.com.
SHIRE PLC
Shire's strategic goal is to become the leading specialty
pharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and
hyperactivity disorder (ADHD), human genetic therapies (HGT),
gastrointestinal (GI) and renal diseases. The structure is sufficiently
flexible to allow Shire to target new therapeutic areas to the extent
opportunities arise through acquisitions. Shire believes that a carefully
selected portfolio of products with a strategically aligned and relatively
small-scale sales force will deliver strong results. Shire's focused
strategy is to develop and market products for specialty physicians.
Shire's in licensing, merger and acquisition efforts are focused on
products in niche markets with strong intellectual property protection
either in the US or Europe.
For further information on Shire, please visit the Company's website:
http://www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not historical facts are forward-
looking statements. Such forward-looking statements involve a number of
risks and uncertainties and are subject to change at any time. In the event
such risks or uncertainties materialize, Shire's results could be
materially affected. The risks and uncertainties include, but are not
limited to, risks associated with: the inherent uncertainty of
pharmaceutical research, product development, manufacturing and
commercialization; the impact of competitive products, including, but not
limited to the impact of those on Shire's Attention Deficit and
Hyperactivity Disorder (ADHD) franchise; patents, including but not limited
to, legal challenges relating to Shire's ADHD franchise; government
regulation and approval, including but not limited to the expected product
approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465
(extended release of mixed amphetamine salts) (ADHD), MESAVANCETM
(mesalamine) with MMX technology (SPD476) (ulcerative colitis),
ELAPRASE(TM) (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine
dimesylate) (ADHD), including its scheduling classification by the Drug
Enforcement Administration in the United States; Shire's ability to secure
new products for commercialization and/or development; and other risks and
uncertainties detailed from time to time in Shire's and its predecessor
registrant Shire Pharmaceuticals Group plc's filings with the Securities
and Exchange Commission, particularly Shire plc's Annual Report on Form
10-K for the year ended December 31, 2005.
Shire PLC
http://www.shire.com
View drug information on Elaprase; Fosrenol, lanthanum carbonate.
FOSRENOL (R) Arata dovezi de date pentru îmbunãtãþirea Tendinþe în formarea de os în CKD Etapa 5 pacienþi, noi date prezentate la reuniunea ASN - FOSRENOL(R) Data Show Evidence Of Trends Towards Improved Bone Formation In CKD Stage 5 Patients, New Data Presented At ASN Meeting - articole medicale engleza - startsanatate