Data Show Medication Adherence is an Important Factor in the Treatment of Postmenopausal...
* Reuters is not responsible for the content in this press release.
Data Show Medication Adherence is an Important Factor in the Treatment of
Postmenopausal Osteoporosis
Poor Adherence Can Lead to Higher Fracture Risk, More Frequent Hospital
Admissions and Higher Medical Costs
DENVER, Sept. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today
announced the presentation of data highlighting the links between medication
satisfaction, adherence to therapy and fracture risk reduction among women
with postmenopausal osteoporosis. The data were presented at the 31st annual
meeting of the American Society for Bone Mineral Research (ASBMR).
"These data enhance our understanding of why many women discontinue treatment
with current osteoporosis therapies, suggesting that convenience,
effectiveness and side effects are important factors," said David Macarios,
executive director for Global Health Economics at Amgen. "This new research
reinforces the view that poor adherence can lead to negative outcomes
including fractures, more frequent hospital admissions and higher medical
costs."
Impact of Treatment Satisfaction (Perceived Benefits, Convenience, Side
Effects) on Persistence with Postmenopausal Osteoporosis Therapy (Abstract No.
SA0317)
Data collected from the Prospective Observational Scientific Study
Investigation Bone Loss Experience (POSSIBLE US(TM)) study showed that women
who were less satisfied with their osteoporosis therapy were more likely to
discontinue or switch their therapy compared to women who were more
satisfied.(i) The prospective registry study enrolled 5,015 patients, the
majority of whom were using an oral bisphosphonate at the time of study entry,
and used the self-administered Treatment Satisfaction Questionnaire for
Medication every six months to measure patient satisfaction with convenience,
perceived effectiveness and side effects of therapy.
In this study, in which women self-reported their adherence to therapy, 25
percent (n=2402) reported discontinuation of their initial therapy within the
first study year and an additional 7 percent reported that they switched from
their initial therapy to another therapy. Women who were less satisfied with
the convenience of their treatment were approximately 39 percent (adjusted HR
0.72) more likely to discontinue or switch their initial therapy, and women
who were less satisfied with the effectiveness of their treatment were
approximately 25 percent (adjusted HR 0.80) more likely to discontinue or
switch. Furthermore, among women reporting moderate or severe treatment side
effects, those who were less satisfied with treatment were 61 percent
(adjusted HR 0.62) more likely to discontinue or switch.
Comorbidities, Bone Loss and Concomitant Medication Use in European
Postmenopausal Women: POSSIBLE EU((R)) (Abstract No. MO0339)
Amgen also reported preliminary findings from a similar longitudinal cohort
study, the Prospective Observational Scientific Study Investigating Bone Loss
Experience in Europe (POSSIBLE EU((R))), designed to describe the
characteristics and management of postmenopausal women (N = 3,403) receiving
bone loss medication in 5 countries in the European Union (France, Germany,
Italy, Spain and the UK). Data were collected via physician-completed
questionnaires at study entry and at 3-month intervals for 1 year.
Interim analysis showed that at study enrollment, the majority (84 percent) of
patients were receiving oral bisphosphonate therapy and the largest proportion
(31 percent) of patients received 5 or more concomitant medications. Upper
gastrointestinal (GI) problems were common in this population, particularly in
patients who switched bone loss medication at baseline. In this European
population, comorbid conditions and the use of multiple medications were
common. POSSIBLE EU analyses are ongoing exploring the association between
patient characteristics, treatment satisfaction and adherence.
Impact of Adherence to Osteoporosis Medication on Risk of Fracture (Abstract
No. SA0368) and Association Between Adherence to Osteoporosis Medication and
Inpatient Stays and Medical Services Costs (Abstract No. SU0387)
Two retrospective analyses were conducted from a study that examined the
impact of medication adherence on risk of fracture, hospitalization and
healthcare costs among women initiating osteoporosis medication. The two
analyses used medical and pharmacy claims from 32,573 women who initiated
treatment on alendronate, risedronate, teriparatide, ibandronate or raloxifene
in a large U.S. health plan. One analysis showed that patients with low
adherence had a 20.4 percent higher risk of fracture than did patients with
high adherence (p<0.0001).(ii)
A second analysis found that patients with low adherence had a 31.2 percent
higher probability of a hospital stay (p<0.001) and 11.4 percent higher mean
medical costs (p=0.001) versus patients with high adherence, even after
adjusting for other important patient characteristics such as comorbidities,
prior fracture history, and hospitalizations.(iii) The mean monthly medical
costs were significantly higher for low-adherence ($507) vs. high-adherence
($405) patients.
Fracture is one of the most common health events suffered by postmenopausal
women with osteoporosis.(iv) Globally, one woman in three over 50 years of age
will experience a fracture in her lifetime.(3) A woman who has broken a bone
as a result of osteoporosis has more than an eight-out-of-ten chance of
breaking another bone.(v) Half of women who break a hip, a life changing
event, will permanently need assistance to walk.(vi)
Osteoporosis: Impact and Prevalence
Often referred to as the "silent epidemic," osteoporosis is a global problem
that is increasing in significance as the population of the world both
increases and ages. The World Health Organization (WHO) has recently
identified osteoporosis as a priority health issue along with other major
non-communicable diseases.
The economic burden of osteoporosis is comparable to that of other major
chronic diseases; for example, in the U.S., the costs associated with
osteoporosis-related fractures are equivalent to those of cardiovascular
disease and asthma.(vii) (viii) (ix) It has been reported that osteoporosis
results in more hospital bed-days than stroke, myocardial infarction or breast
cancer.(x)
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics
have changed the practice of medicine, helping millions of people around the
world in the fight against cancer, kidney disease, rheumatoid arthritis, and
other serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically
improve people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
Forward-Looking Statements
This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below and more
fully described in the Securities and Exchange Commission (SEC) reports filed
by Amgen, including Amgen's most recent annual report on Form 10-K and most
recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's
most recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless otherwise
noted, Amgen is providing this information as of Sept. 13, 2009 and expressly
disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate or development
of a new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe and
effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
the future. We develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the parties or
may prove to be not as effective or as safe as we may have believed at the
time of entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products after they
are on the market. Our business may be impacted by government investigations,
litigation and products liability claims. We depend on third parties for a
significant portion of our manufacturing capacity for the supply of certain of
our current and future products and limits on supply may constrain sales of
certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies
imposed by third-party payors, including governments, private insurance plans
and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed
care and healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others' regulations
and reimbursement policies may affect the development, usage and pricing of
our products. In addition, we compete with other companies with respect to
some of our marketed products as well as for the discovery and development of
new products. We believe that some of our newer products, product candidates
or new indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against products that
have lower prices, established reimbursement, superior performance, are easier
to administer, or that are otherwise competitive with our products. In
addition, while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and there can be no
guarantee of our ability to obtain or maintain patent protection for our
products or product candidates. We cannot guarantee that we will be able to
produce commercially successful products or maintain the commercial success of
our existing products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of our
products or product candidates. Further, the discovery of significant problems
with a product similar to one of our products that implicate an entire class
of products could have a material adverse effect on sales of the affected
products and on our business and results of operations.
The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the U.S. Food and Drug Administration (FDA), and no
conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates. Only the FDA can determine whether the product
candidates are safe and effective for the use(s) being investigated. Further,
the scientific information discussed in this news release relating to new
indications for our products is preliminary and investigative and is not part
of the labeling approved by the U.S. Food and Drug Administration (FDA) for
the products. The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be drawn
regarding the safety or effectiveness of the products for these uses. Only the
FDA can determine whether the products are safe and effective for these uses.
Healthcare professionals should refer to and rely upon the FDA-approved
labeling for the products, and not the information discussed in this news
release.
(i) Do T, et al. Impact of Treatment Satisfaction (Perceived Benefits,
Convenience, Side Effects) on Persistence with Postmenopausal Osteoporosis
(PMO) Therapy. Presented at the ASBMR Annual Meeting, September 12, 2009.
(ii) Halpern R, et al. Impact of Adherence to Osteoporosis Medication on Risk
of Fracture. Presented at the ASBMR Annual Meeting, September 12, 2009.
(iii) Iqbal SU, et al. Association Between Adherence to Osteoporosis
Medication and Inpatient Stays and Medical Services Costs. Presented at the
ASBMR Annual Meeting, September 13, 2009.
(iv) Melton LJ, et al. (1992) Perspective. How Many Women Have Osteoporosis? J
Bone Miner Res, 1992;7:1005
(v) Kanis JA, et al. A Meta-Analysis of Previous Fracture and Subsequent
Fracture Risk. Bone, 2004;35:375.
(vi) Magaziner J, et al. Predictors of Functional Recovery One Year Following
Hospital Discharge for Hip Fracture: A Prospective Study. J Gerontol,
1990;45:M101.
(vii) Burge R, et al. J Bone Miner Res. 2007; 22:465-475
(viii) "Osteoporosis Fast Facts." National Osteoporosis Foundation. Accessed
on August 19, 2009 at http://www.nof.org/osteoporosis/diseasefacts.htm
(ix) "Economic Cost of Cardiovascular Diseases." American Heart Association.
Accessed on February 24, 2009 at
http://www.americanheart.org/statistics/10econom.html.
(x) Lippuner K, et al. "Incidence and direct medical costs of hospitalisations
due to osteoporotic fractures in switzerland." Osteoporosis
International.1997;7:414-25.
CONTACT: Amgen, Thousand Oaks
Sarah Reines: (805) 447-9783 (media)
Arvind Sood: (805) 447-1060 (investors)
(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
SOURCE Amgen Inc.
media, Sarah Reines: +1-805-447-9783, or investors, Arvind Sood:
+1-805-447-1060, both of Amgen, Thousand Oaks
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters