Medication Adherence: Important Factor in the Treatment of Postmenopausal Osteoporosis

DENVER, Sept. 14- Amgen Inc. 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 (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 ), 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.

Home-Spun or Hard Fact?

Fast-Food Family Planning May Contribute to High Levels of Unintended Pregnancies

NEWBURY, England,- Women's health experts are warning that old wives' tales and ignorance about modern contraceptive options could be fuelling Britain's high levels of unintended pregnancy, following new research into contraception myths by pollster Opinion Health.(1)

Fast-foods and store cupboard staples were often suggested as methods of contraception women had heard of.(1) Coca-cola, kebabs, chocolate bars or wrappers, crisp packets and chewing gum were proposed as contraceptives and one in five women questioned mentioned a kitchen cupboard staple as a possible option, with eating garlic or using bread, cling film or even chicken skin as a barrier method given as alternatives.(1)

These myths are compounded by a lack of general understanding of even the most popular methods of contraception. The survey revealed that half of women hold the false belief that oral contraceptive use over an extended period of time can cause infertility(1) and nearly 10 percent of women think that it always takes a number of years to regain fertility after discontinuation of The Pill.(1) In fact, no matter how long The Pill is taken for, the effects are fully reversible and it is possible to get pregnant straight away in the absence of other forms of contraception.(2)

The survey also highlighted that there is a myth that oestrogen is only present in combined oral contraceptive pills in order to disguise the taste(1) when in fact the combined pill was designed to have the combination of oestrogen and progestogen to offer protection from pregnancy and shorter lighter periods. Surprisingly, those questioned who were using oral contraception often showed a lower level of knowledge about The Pill than those not using it.

These and other myths - ranging from the ridiculous to the concerning - are held by women across all ages, according to the research.

Dr Annie Evans, Women's Health Specialist at the Bristol Sexual Health Centre, commented: "It is not surprising that this survey has uncovered how widespread contraceptive myths still are in this country, given that Britain continues to have the highest unintended pregnancy rate in Europe*,(3) with as many as 50% of births being unintended.(4) It is vital that women are made aware of the facts, using the credible sources of information available to them."

Despite the accurate information available to women online, in the media and from their healthcare professionals, over a third of women mistakenly believe that the greatest risk of getting pregnant whilst using the combined contraceptive pill is to miss a pill in the middle of the pack.(1) The truth is that missing the first and last pills of the pack pose the greatest risk of getting pregnant.(2)

Dr Anne Szarewski, Associate Specialist at the Margaret Pyke Centre commented: "Combined oral contraceptive pills are the most widely prescribed contraceptive option, but they are particularly plagued by myths. Many women are unaware that they even contain oestrogen and progestogen, both of which play different but important roles. It is vital that women of all ages are aware of the facts, to have a full understanding of their contraception and so avoid the distress of an unintended pregnancy."


Other myths exposed by the survey include:

- One in six women believed that the contraceptive pill is effective as
soon as a woman starts taking it (increasing to one in three in
the 18-20 age group).(1) Whilst this is closer to the truth than other
tales, it is only if the first pill is taken on the first day of the
menstrual cycle.

- Some believe that using combined oral contraceptives will protect them
against HIV, when in fact only condoms will protect you against HIV.

- Some believe that if a woman is not using contraception she is safe
from getting pregnant if she only has sex on her period. In fact, there
is still the possibility of becoming pregnant during your period if you
have sex without using contraception.(5)


The results from this survey also show that, contrary to popular belief, older women believe more myths than younger women. The importance of sex education is also underlined, with those women that have received it showing a better understanding of the facts about contraception, and in particular, about combined oral contraceptives.

The more credible sources of accurate information that there are made available to women, the better chance there is of dispelling these outdated myths. Balanced, factual information about a range of contraceptive options can be found on the comprehensive new website http://www.contraception.co.uk which was recently launched by leading contraception manufacturer Bayer Schering Pharma.