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Data Show Medication Adherence is an Important Factor in the Treatment of Postmenopausal Osteoporosis

September 13, 2009

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.

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(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)

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SOURCE Amgen Inc.


Source: newswire