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NICE Final Recommends Treatment Options For Primary, Secondary Prevention Of Osteoporotic Fragility Fractures In Postmenopausal Women, UK
Procter & Gamble Pharmaceuticals (P&GP) welcome the new Final
Appraisal Determination (FAD) Guidance for the primary and secondary prevention of
osteoporosis from NICE.
The revised NICE FAD recommends risedronate - alongside etidronate - as the first alternative
treatment option to generic alendronate for postmenopausal women who are unable to comply
with the special administration instructions, have a contraindication to, or are intolerant of
alendronate (and also meet certain criteria such as BMD T- scores [a measurement of Bone
Mineral Density], age and independent risk factors for fracture)i,ii.
Suggested Treatment Flowi,ii
First treatment option
Generic alendronate* (T-score ≤-2.5SD)
First alternative
Risedronate* or etidronate*
Second alternative
Strontium ranelate* or raloxifene**
Third alternative
Teriparatide**
* Dependent on age, T score, independent clinical risk factor for fracture, and indicators of
low BMD
** Recommended for secondary prevention only
Recommended treatment options are not only based on the clinical efficacy of the therapies but
also the acquisition cost of the available osteoporosis medicines and form a clear stepwise
process. There are still some complexities within the guidance regarding thresholds for age and
level of conditioni,ii. The Guidance is still in draft form until finalised guidance is issued later this
year.
"For some patients, alendronate is not a suitable treatment and it is essential that these
individuals have access to other treatments." Professor Juliet Compston, Professor of Bone Medicine, University of Cambridge
What the revised NICE FAD Guidance says
Previous draft NICE FAD guidance had only recommended alendronate as a treatment option
for postmenopausal osteoporosis patients. However this decision was met with opposition from
patient groups such as the National Osteoporosis Society (NOS) (please see section notes to
the editors). The revised position of the NICE FADs recommend risedronate, alongside
etidronate, as the first alternative treatment option following generic alendronatei,ii. Strontium
ranelate has been recommended as a second alternative therapy only where patients are not
able to comply with special instructions for the administration of either alendronate and
risedronate or etidronate, or who have a contraindication to or are intolerant of alendronate and
risedronate or etidronatei,ii.
"It remains vitally important that my patients have a choice of therapy as many will get upper
gastrointestinal problems with generic alendronate. I am pleased that NICE now supports my
prescribing of risedronate where I feel it is the best alternative to alendronate." Dr Pam Brown, The Grove Medical Centre, Swansea
Why is the revised NICE FAD Guidance important?
The revised position of the NICE FAD Guidance is particularly important for post-menopausal
osteoporosis patients as NICE recognise that one third of participants in post-marketing
studies of alendronate reported the occurrence of adverse gastrointestinal eventsi,ii.
Osteoporosis care should now better meet the needs of individual patients as treatment
options have been recognised by NICE for patients who cannot take generic alendronate.
"There are significant differences between bisphosphonates, many patients cannot tolerate
alendronate and need to be able to receive an alternative treatment like risedronate." Dr Alun Cooper, GPwSI, Bridge Medical Centre, Crawley
There is a wealth of evidence supporting the efficacy of bisphosphonates as the leading
treatment class in the management of osteoporosis. However, not all bisphosphonates have
the same tolerability profiles, mode of administration and efficacy at key osteoporotic
sitesiii,iv,v. Managing osteoporosis involves a balance between choosing a treatment that best
protects the individual from fracture, has an adequate tolerability profile, and makes best use
of NHS resources.
Final Guidance is expected from NICE later this year and without further appeal must be
implemented by all healthcare professionals within 3 months of publication.
Notes
-- Approximately 80% of patients who could not tolerate alendronate were able to tolerate
risedronatevi. There are limited data available on switching patients between
bisphosphonates. In a randomised, double-blind study of 66 patients that had previously
discontinued treatment with 10mg/day alendronate due to upper gastrointestinal adverse
events, when switched to risedronate (5mg daily) patients showed a similar incidence of
upper GI events to placebo at 3 monthsvi.
Oral bisphosphonates have been associated with upper gastrointestinal disorders.
Therefore, risedronate should be used with caution in patients with stricture,
achalasia, those with active/recent history of upper gastrointestinal problems
and patients who are unable to follow the dosing instructionsiv.
-- Nine multicenter, randomized, double blind, placebo controlled studies of risedronate
were pooled and evaluated to determine the frequency of upper gastrointestinal (GI) tract
adverse events associated with risedronate, especially among high risk patients (those on
NSAIDS, PPIs and H2As). The results of this extensive evaluation indicate that among
these high risk patients the incidence of upper gastrointestinal adverse events with those
on risedronate was similar to that in control patientsvii.
-- In June 2007 the previous version of the NICE FADs were published. Despite the length
and depth of the consultation NICE failed to incorporate many of the recommendations
which their stakeholders had made. The two documents recommended only one of the
entire range of treatments that are available for osteoporosis - generic alendronate. In
October 2007 independent appeals were made by the National Osteoporosis Society, the
Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and sanofi aventis),
and Servier as no alternative treatments were provided for women with osteoporosis who
could not tolerate or for whom alendronate was contraindicated. This appeal was
successful. Furthermore the NOS presented a petition to Downing Street demanding
treatment options for postmenopausal patients with osteoporosis.
-- There has been a huge demographic shift in the UK over the past twenty years, so the
population is growing older. Consequently, osteoporosis related disability is now highly
significant, particularly in terms of patient quality of life, morbidity/mortality costs and the
overall socio-economic burden:
- Three million people are at risk of osteoporosis in the United Kingdomviii.
- It is estimated that treating osteoporotic fractures in postmenopausal women
costs the NHS and government £1.7 billion a year, the equivalent of £5
million a dayviii.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble Pharmaceuticals and Aventis part
of the sanofi-aventis Group, in May 1997 to promote bone health and disease awareness through
numerous activities to support physicians and patients around the globe.
About Procter & Gamble Pharmaceuticals [NYSE:PG]
Procter & Gamble Pharmaceuticals has a rich heritage in health care that extends back more than 150
years. Then and now, P&G is driven by our mission to improve the lives of people around the world
every day. P&G's health care products include prescription medicines, over-the-counter medications
and oral care products. P&G began developing and marketing prescription products in the late-1960s.
Three billion times a day, P&G brands touch the lives of people around the world. The company has one
of the strongest portfolios of trusted, quality, leadership brands, including Actonel®, Asacol®, Crest®,
Didronel PMO®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®, Thermacare®, Vicks®,
Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®, Fairy®, Ace®, Lenor®, M.
Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®, Eukanuba®, Duracell®, Olay®, Head &
Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of 138,000 employees working
in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth
information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit
http://www.pgpharma.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).
References
i - National Institute for Health and Clinical Excellence, Alendronate, etidronate, risedronate,
raloxifene, and strontium ranelate for the primary prevention of osteoporotic fragility fractures
in postmenopausal women. Final Appraisal Determination, July 2008
ii - National Institute for Health and Clinical Excellence, Alendronate, etidronate, risedronate,
raloxifene, and strontium ranelate for the secondary prevention of osteoporotic fragility
fractures in postmenopausal women. Final Appraisal Determination, July 2008
iii - Alendronate SmPC, Available online at Electronic Medicines Compendium, July 2008
iv - Risedronate SmPC, Available online at Electronic Medicines Compendium, July 2008
v - Etidronate (Didronel PMO) SmPC, Available online at
Electronic Medicines Compendium,
July 2008
vi - Adachi JD, et al. Aging Clin Exp Res 2001; 13: 347-354
vii - Taggart H, et al. Mayo Clin Proc. 2002; 77: 262-270
viii -
National Osteoporosis Society, Annual Report 2007
Procter & Gamble Pharmaceuticals
View drug information on Actonel; Asacol.
Final recomandã Nisa Tratamentul opþiuni pentru primar, secundar prevenirea fracturilor osteoporotice fragilitatea În menopauzã Femeile, Marea Britanie - NICE Final Recommends Treatment Options For Primary, Secondary Prevention Of Osteoporotic Fragility Fractures In Postmenopausal Women, UK - articole medicale engleza - startsanatate