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)
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.
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)
SOURCE Amgen Inc.