BASINGSTOKE, England, June 25 /PRNewswire/ --
- Not for Distribution in the US
- New Research Provides Important Insights Into Adherence Issue
- Data Reveal Perceptual and Practical Barriers Including the Need for
Phosphate Binders With Simplified Dosing
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ). New data from a patient
adherence survey presented on Friday 22nd June at the XLIV ERA-EDTA Congress
in Barcelona highlight that over 40% of patients with chronic kidney disease
(CKD) forget to take their phosphate-binding medication.(1) Phosphate binders
are used to treat hyperphosphataemia (unusually high levels of phosphorous in
the blood), which, if not managed successfully, can lead to serious health
consequences including increased rates of cardiovascular morbidity and
mortality and other complications.(2)
The research reveals that poor patient adherence to phosphate binders is
linked to practical barriers such as the complexity of the dosing regimen and
not understanding how to take them, as well as perceptual barriers regarding
patient beliefs about their need for medication and concerns about adverse
events.(1)
Rob Horne, Professor of Behavioural Medicine at the School of Pharmacy,
University of London, conducted the research which assessed the behavioural
patterns of 221 patients with CKD across 8 centres in the UK.
"CKD can have a devastating impact on patients' lives. The study shows
that adherence to phosphate-binding medication is adversely affected by a
number of factors, both practical and perceptual," said Professor Horne. "On
the practical side, daily treatment requires often complex dosing schedules
on top of an already difficult treatment regimen. This can include long
dialysis sessions, strict fluid and dietary restrictions and a complicated
medication schedule involving up to 25 tablets per day. Phosphate binders
used to manage hyperphosphataemia can alone add up to 12 tablets per day."
"On the perceptual side, it is essential to recognise that personal
beliefs about the value of medication are important. Our study showed that
non adherence was linked to doubts about the need for treatment and concerns
about taking phosphate binders. We now need to develop more effective methods
for helping patients to get the best from their medicines by facilitating
informed choice and improved adherence. This should involve the provision of
bespoke information to meet individual needs and address concerns as well as
efforts to overcome the practical barriers to adherence by making the regimen
as convenient and easy to use as possible." he added.
The research, using validated questionnaires(1), produced the following
findings:
- Over 40% of patients forgot to take their phosphate-binder
medication sometimes, often or always;
- 38% forgot to take their medication at mealtimes;
- 23% of patients reported altering their dose;
- 19% decided to miss doses;
- 21% took less medication than instructed.(1)
Over 70%3 of the estimated 1.5 million people with CKD on
dialysis worldwide(4) will develop hyperphosphataemia due to their failing
kidneys being unable to effectively rid their bodies of the excess phosphate
absorbed from food. If not managed successfully, hyperphosphataemia can lead
to serious health problems including renal osteodystrophy (a bone disorder
resulting in painful, brittle bones that may fracture or lead to deformities)
and cardiovascular disease which accounts for almost half of all deaths in
dialysis patients.(5)
Despite the availability of existing therapies, effective phosphate
management remains a challenge with up to 75% of dialysis patients exceeding
the National Kidney Foundation Kidney Disease Outcomes Quality Initiative
(NKF/KDOQI) guidelines for serum phosphate levels less than 1.78 mmol/L (5.5
mg/dL).(6)
"This research highlights that a combination of treatment factors,
including tablet burden, can contribute to poor patient adherence which may
compromise their ability to meet specified global targets for phosphate
levels," said Professor Horne.
FOSRENOL is a newly introduced treatment option in Europe for the
nephrologist to use in the management of hyperphosphataemia in CKD patients
on dialysis. It is a non-calcium based binder with a high affinity for
phosphate that binds to the phosphate in food to effectively reduce serum
phosphorous levels.(7) FOSRENOL can be used effectively as a monotherapy and
is associated with a lower tablet burden than existing phosphate binders with
the majority of patients requiring just one chewable tablet during each
meal.(8) This compares to other therapies that are often used in combination
and may require up to 12 tablets per day. This simplified dosing regime may
remove some of the practical barriers to patient adherence identified in the
research.
"Adherence is emerging as a key issue for patients with CKD, with many
still having phosphate levels above the recommended global target. Shire is
sponsoring Professor Horne's research as part of its commitment to exploring
new ways to improve patient adherence and ultimately better patient
outcomes," said David Milton, Senior Vice President, Shire Renal Business
Unit. "FOSRENOL is our effective phosphate binder that offers the added
benefit of a reduced pill burden with the majority of CKD patients on
dialysis requiring just one tablet during each meal. As part of this
commitment, Shire is also developing additional FOSRENOL formulation options
aimed at making it even simpler for patients," he added.
Over 5,000 patients have been treated with FOSRENOL during an extensive
clinical development programme(9), with a small number having been followed
up for up to six years.(10) In the US, over 76,000 patients have been
prescribed FOSRENOL since it was launched in 2005.(11)
FOSRENOL is now available in 20 countries, including Canada, France,
Germany, Italy, UK and the US and continues to be launched in new markets
around the world.
References:
1. Horne R et al. Adherence to phosphate binding medication: Insights
from a survey using validated questionnaires. Presented at the XLIV ERA-EDTA
Congress, Barcelona, Spain, 21-24 June, 2007.
2. 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.
3. Albaaj F, Hutchison AJ. Lanthanum carbonate for the treatment of
hyperphosphataemia in renal failure and dialysis patients. Expert Opin.
Pharmacother 2005; 6(2): 319-328.
4. Global dialysis. Global dialysis: dialysis standards and
statistics. Available at www.globaldialysis.com/stats.asp. Accessed on 18 May
2007.
5. The National Institutes of Health National Institute of Diabetes and
Digestive and Kidney Diseases. U.S. Renal Data System, USRDS 2005 Annual Data
Report: Atlas of End-Stage Renal Disease in the United States. Available at
http://www.usrds.org/2005/pdf/06_morb_and_mort_05.pdf. Accessed on 18 May
2007.
6. Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and
Disease Guidelines: results from the Dialysis Outcomes and Practice Patterns
Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A.
7. Hutchison AJ, Maes B, Vanwalleghem J et al. Long-term efficacy and
tolerability of lanthanum carbonate: results from a 3-year study. Nephron
Clin Pract 2006;102(2):c61-c71
8. Vemuri N et al. Lanthanum carbonate provides serum
phosphorus control with a reduced tablet burden. Poster presented at
ERA/EDTA, Glasgow, 15-18 July 2006
9. Shire Data on File 08.2644
10. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group.
Evidence for the long-term safety and tolerability of lanthanum carbonate.
Poster presented at 38th Annual Meeting of the American Society of
Nephrology, Philadelphia, 8-13 November 2005.
11. Verispan 2007, Verispan Total Patient Tracker.
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) with over 70 per
cent of patients developing hyperphosphataemia.(ii)
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. (iii) Accumulating evidence shows that hyperphosphataemia
contributes to cardiovascular disease, which accounts for almost half of all
deaths among dialysis patients.(iv) 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.(v)
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 worldwide clinical research
programme for FOSRENOL involving over 5000 patients(vi), with a small number
followed for up to 6 years.(vii) 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. In March
2005 regulatory authorities in the EU granted marketing authorisation for
FOSRENOL in sixteen member states, thus completing the first step in securing
marketing approval throughout Europe. Later, the European process was
completed resulting in recommendation for approval in the remaining 11 member
states. FOSRENOL is now available in 20 countries, including Canada, France,
Germany, UK and the US and continues to be launched in new markets 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 minimised by
taking FOSRENOL with food and generally abated with time with continued
dosing. Hypocalcaemia was the only other commonly reported adverse reaction.
Shire Plc
Shire's strategic goal is to become the leading specialty
biopharmaceutical 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:
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 materialise, 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 commercialisation; 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 date of SPD503 (guanfacine
extended release) (ADHD); Shire's ability to secure new products for
commercialisation and/or development; Shire's ability to benefit from its
acquisition of New River Pharmaceuticals Inc.; the successful development of
JUVISTA and other risks and uncertainties detailed from time to time in Shire
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, 2006.
i. Block GA et al. Association of serum phosphorus and calcium x
phosphate product with mortality risk in chronic hemodialysis patients: A
national study. Am J Kidney Dis 1998; 31: 607-617
ii. Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and
Disease Guidelines: results from the Dialysis Outcomes and Practice Patterns
Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A
iii. Norris KC. Toward a new treatment paradigm for hyperphosphataemia
in chronic renal disease. Dial Transplant 1998; 27 (12): 767-773
iv. 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
v. Foley R et al. Clinical epidemiology of cardiovascular disease in
chronic renal disease. Am J Kidney Dis 1998; 32 (5) Suppl 3:112-119
vi Shire Data on File 08.2644
vii. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group.
Evidence for the long-term safety and tolerability of lanthanum carbonate.
Poster presented at 38th Annual Meeting of the American Society of
Nephrology, Philadelphia, 8-13 November 2005
Shire plc
For further information please contact: Investor Relations, Cléa Rosenfeld (Rest of the World), +44-1256-894-160; Eric Rojas (North America), +1-484-595-8252. Media, Jessica Mann (Rest of the World), +44-1256-894-280, Matthew Cabrey (North America), +1-484-595-8248. Public Relations. Eleanor Heightman (Rest of World), +44-207-357-8187, Con Franklin (Rest of World), +44-207-357-8187
