Women With Osteoporosis More Likely To Stay On Once-Monthly Oral Bonviva(R) Than On A Once-Weekly Treatment Regimen

Main Category: Bones / Orthopedics
Also Included In: Women's Health / Gynecology;  Endocrinology
Article Date: 18 Sep 2006 - 9:00 PST

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Women taking highly effective once-monthly oral Bonviva(R) (ibandronic acid) for postmenopausal osteoporosis were more likely to stay on treatment during the first six months relative to those on a weekly bisphosphonate (alendronate or risedronate) according to findings presented today at the 28th Annual Meeting of the American Society for Bone Mineral Research (ASBMR)1.

The ongoing real-life study, conducted by Silverman and colleagues at Cedars-Sinai/ University of California, Los Angeles, US, was based on two managed care databases called HealthCore and i3 Innovus, which include prescription and health information on approximately 17.5 and 16 million lives respectively. These two analyses assessed the actual time patients stayed on treatment and were controlled for factors that could affect persistence, including age, other medical conditions, and out-of-pocket costs for the medications,1 as recommended by leading health and pharmacoeconomic research organisations. [ISPOR and WHO 2003] It showed that women taking Bonviva were approximately 25% more like to keep taking their pills relative to those on a weekly bisphosphonate.

Growing wealth of evidence demonstrates important role of once monthly Bonviva in helping patients stay on treatment

The results of the study are consistent with previous findings linking the once-monthly oral Bonviva treatment programme with improved persistence in a real-life setting.2 Furthermore, patients have also stated a clear preference (71%) for the once-monthly oral Bonviva regimen 3,4 over a weekly treatment regimen in clinical trials. Further information presented at ASBMR indicates that the convenience of once-monthly dosing and the reduced exposure to the potential gastrointestinal side effects associated with bisphosphonate therapy, are the main reasons for this preference.5

With up to 69% of new patients on a weekly bisphosphonate stopping within a year, 6 this growing wealth of evidence suggests that monthly dosing is set to play an important role in helping to address the issue of non-persistence to osteoporosis treatments.

Stuart L. Silverman, M.D., lead investigator and clinical professor of medicine and rheumatology at Cedars-Sinai/ University of California, Los Angeles, said: "Treatment with bisphosphonates clearly reduces the risk of fractures, but only if patients keep taking their treatment. Osteoporosis is a disease that often shows no symptoms, which reduces a patient's motivation to stay on treatment and, thereby, increases their risk of breaking bones. The greater persistence seen with once-monthly compared to once-weekly bisphosphonates is very encouraging, particularly because the findings were consistent across two large and robust U.S. claims databases."

Improved persistence leads to fewer fractures and lower healthcare costs

Also at ASBMR, a three-year retrospective analysis found that improved persistence with bisphosphonate treatment is linked with lower rates of osteoporosis-related hospitalisation, shorter hospital stays and significantly reduced healthcare costs. 7,8 These findings emphasise the importance of a newly published study showing that women who were persistent in taking daily or weekly bisphosphonate treatments had significantly fewer fractures. 9

Peyman Hadji, M.D., Head of the Department of Endocrinology, Osteoporosis and Reproductive Medicine at Philipps-University of Marburg, Germany, said: "With the number of osteoporosis-related fractures in Europe estimated at 3.79 million, 10 improvements in the management of this disease are essential. These findings presented at ASBMR show that getting a patient's treatment right first time can not only improve their quality of life, but also have a significant positive outcome for healthcare services. Taking a bisphosphonate treatment for the long-term clearly reduces this risk, which is why persistence and patient preference need to be major considerations when prescribing osteoporosis treatments."

About the Persistence Data

The study showing greater persistence with once-monthly oral Bonviva was based on two managed care databases called HealthCore and i3 Innovus, which contain prescription and health information on approximately 17.5 and 16 million patients, respectively.

The HealthCore and i3 Innovus analyses included data for 6,127 and 10,526 women respectively, 45 years of age or older, who received a prescription for bisphosphonate treatment for postmenopausal osteoporosis (277 and 1,025 took once-monthly oral Bonviva and 5,850 and 9,501 took a once-weekly bisphosphonate). Unlike other studies comparing persistence among monthly versus weekly treatment regimens, this study uses rigorous criteria for defining persistence for both once-monthly oral Bonviva and weekly treatments, as recommended by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organisation.

Patients were considered persistent if the time between prescription refills was more than 45 days for once-monthly oral Bonviva or more than 30 days for a weekly bisphosphonate.

To further ensure the validity of the results, study authors adjusted the data for potential confounding factors - including age, other medical conditions, and out-of-pocket costs for the medications - as recommended by the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) and the World Health Organisation. At six months, once-monthly Bonviva users were 27.2% and 21.7% more likely to persist with therapy versus weekly users (p = 0.0002 and p<0.0001), based on the HealthCore and i3 Innovus databases respectively. The authors concluded that the increase in persistence with once-monthly Bonviva was approximately 25% overall.

About Bonviva Bonviva is the first and only once-monthly bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women.

Bonviva, a potent and highly effective bisphosphonate, has been studied to date in clinical trials involving over 13,000 patients.

Bonviva, a highly effective bisphosphonate, works by reducing elevated bone turnover and increasing bone mineral density (BMD), therefore reducing the risk of fractures.

Bonviva has shown a vertebral fracture risk reduction of 62% in the Bone study. This study was designed to investigate vertebral efficacy and did not shown an overall effect at the hip. However, a non-vertebral fracture risk reduction of 69% was observed in a sub-group at high-risk of fractures.

Bonviva is highly potent and provides significant BMD increases at the spine and hip. BMD is an established method used by physicians to measure fracture risk.

Bonviva is the only nitrogen containing bisphosphonate that has demonstrated a reduction in vertebral fracture risk using a drug-free interval of more than one day.

Bonviva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, oesophagitis and oesophageal or gastric ulcer.

Once-monthly oral Bonviva received European Union approval in September 2005 and Swiss medic approval in August 2005. Once-monthly oral Boniva (the brand name in the US) received FDA approval in March 2005.

Roche/GSK Collaboration

In December 2001, F Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-develop and co-promote Bonviva for the treatment and prevention of postmenopausal osteoporosis in a number of major markets, excluding Japan. The Roche/GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com).

About GSK

GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. (http://www.gsk.com)

All trademarks used or mentioned in this release are legally protected.

Roche Healthkiosk, Osteoporosis References

1. Silverman SL, Chesnut III CH, Amonkar MM, Margolis J and Barr CE. Improved persistence in women treated with once-monthly ibandronate versus weekly bisphosphonates: a first look. Abstract presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, US

2. Cooper A, Drake J and Brankin E. Treatment persistence with once-monthly ibandronate and patient support versus once-weekly alendronate: results from the PERSIST study. IJCP; 60(8): 896-905

3. Emkey R, Binkley N, Seidman L, et al . BALTO I: Women treated for osteoporosis rate preference and convenience for once-monthly ibandronate versus once-weekly alendronate. Abstract presented at 27th Annual Meeting of the American Society of Bone and Mineral Research (ASBMR), 23 - 27 September 2005, Nashville, USA

4. Hadji P, Benhamou C-L, Devas V, Masanauskaite D and Barrett-Connor E. Women with postmenopausal osteoporosis prefer once-monthly oral ibandronate to weekly oral alendronate: results of BALTO II. Abstract presented at 6th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), 15-18 March 2006, Vienna, Austria

5. Dore RK. Reasons for patient preferences for once-monthly ibandronate. Abstract presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, US

6. Ettinger MP, Gallagher R, Amonkar M, Smith JC, and MacCosbe PE. Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum. 2004; 50(1): S513

7. Curtis JR, Amonkar MM, Baser O, Barr CE, and Saag KG. Adherence to bisphosphonate therapy results in reduced osteoporosis-related and overall healthcare utilization. Abstract presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, US

8. Curtis JR, Amonkar MM, Mucha L, Barr CE and Saag KG. Osteoporotic Women Adherent to Bisphosphonate Therapy Have Reduced Osteoporosis-Related and Total Healthcare Costs. Abstract presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, US

9. Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN et al. Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases. Mayo Clinic Proceedings. August 2006; 81(8):1013-1022

10. Kanis JA and Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 2005;16:229

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