Healthcare Industry News:  osteoporosis 

Biopharmaceuticals

 News Release - September 17, 2006

Women More Likely to Stay on Once-Monthly Boniva(R) Versus Once-Weekly Osteoporosis Medicines

PHILADELPHIA, PA, Sept. 17 (HSMN NewsFeed) -- According to six-month results of ongoing studies, women with postmenopausal osteoporosis taking once-monthly BonivaŽ (ibandronate sodium) were approximately 25 percent more likely to stay on therapy than women taking the once-weekly medications, alendronate or risedronate.(1) To ensure the results reflect the independent effect of once-monthly dosing with Boniva, the analyses controlled for factors that could affect persistence* with therapy, including age, other medical conditions, and out-of-pocket costs for the medications -- as recommended by leading health and pharmacoeconomic research organizations.(2,3) These findings were presented today at the 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR). The three medications studied were bisphosphonates, the most frequently prescribed class of medications for the treatment and prevention of postmenopausal osteoporosis.(4)

The findings are important in light of other presentations and previously published reports showing that staying on daily or weekly bisphosphonate therapy (persistence) may result in fewer fractures(5,6,7) and reduced healthcare costs and use of resources.(8,9,10)

"Treatment with bisphosphonates clearly reduces risk of fractures, but only if patients keep taking their medications," said lead investigator, Stuart L. Silverman, M.D., clinical professor of medicine and rheumatology at Cedars-Sinai/UCLA. He said that osteoporosis is often asymptomatic, which can reduce a patient's motivation to stay on therapy and increase their risk of debilitating fractures. "The greater persistence seen with once-monthly compared to once-weekly bisphosphonates is encouraging, particularly because the findings were consistent across two large and robust U.S. claims databases."

About the Data

These results were based on retrospective analyses of ongoing studies using two managed care databases: HealthCore and i3 Innovus, which contain prescription and health information on approximately 17.5 and 16 million enrollees, respectively.(1) These two analyses included data for 6,127 and 10,526 women who were 45 years of age or older, and who received a prescription for either once-monthly Boniva (n=277 and 1,025) or a once-weekly bisphosphonate (n=5,850 and 9,501). Patients were considered nonpersistent if they had a refill gap of 45 days or more for once-monthly Boniva, or 30 days or more for a weekly bisphosphonate. The investigators controlled for potentially confounding factors -- including age, copay and comorbidities -- as recommended by the International Society of Pharmacoeconomics and Outcomes Research and the World Health Organization.(2,3)

Compared to women who had prescriptions for a once-weekly bisphosphonate, those who had a prescription for once-monthly Boniva were 27.2 percent (p = 0.0002) and 21.7 percent (p<0.0001) more likely to persist with therapy, based on the HealthCore and i3 Innovus database analyses, respectively. The authors concluded that the increase in persistence with once-monthly Boniva was approximately 25 percent overall.(1)

Persistence and Clinical Outcomes Studies

Also at ASBMR, two presentations based on a three-year retrospective study found that, compared to women (n=26,080) who were not persistent with their daily or weekly bisphosphonate regimen, those who were persistent (n=6,864) were only half as likely to have an osteoporosis-related hospitalization,(9) had shorter hospital stays (3.6 vs. 5.9 days),(9) and had significantly lower osteoporosis-related and total healthcare costs(8) (p< 0.0001 for all comparisons). These findings underscore the importance of a newly published study showing that women who were persistent in taking daily or weekly bisphosphonate therapy had significantly fewer fractures.(7)

"It is becoming increasingly well-documented that improved persistence with osteoporosis treatments can lead to better outcomes for the millions of women suffering from postmenopausal osteoporosis -- from reducing fracture risk, to hospitalization, to the use of medical services," said Jeffrey R. Curtis, M.D., M.P.H., assistant professor of medicine, division of clinical immunology and rheumatology at University of Alabama, Birmingham. "Now, given the substantial body of evidence, clinicians need to consider persistence as a critical component when evaluating the overall effectiveness of a medication."

About BonivaŽ (ibandronate sodium)

Boniva Tablets are contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of Boniva. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and vitamin D is important in all patients.

Patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent). For complete prescribing information for Boniva, see contact information at the end of the news release or go to www.boniva.com.

About osteoporosis

osteoporosis (literally "porous bones") is a disease in which bones become brittle and more likely to break. In the U.S., approximately ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia),(11) placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.(11) Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.(12)

About Roche and GlaxoSmithKline

Hoffmann-La Roche, Inc. (Roche) and GlaxoSmithKline (GSK) have a worldwide collaboration (excluding Japan) to promote Boniva for the treatment and prevention of postmenopausal osteoporosis.

Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit www.rocheusa.com.

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. For company information, visit GSK on the World Wide Web at www.gsk.com.

Boniva is a registered trademark of Roche Therapeutics, Inc.

* In these healthcare utilization studies, persistence was defined as continuity of medication usage, and assessed by the length of time from the end of one prescription to the beginning of the next.

References

(1) Silverman SL, Chesnut III CH, Amonkar MM, Margolis J, Barr CE. Improved persistence in women treated with once-monthly ibandronate versus weekly bisphosphonates: a first look. Poster SU335 presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research, September 15- 19, 2006, Philadelphia, PA.

(2) International Society of Pharmacoeconomics and Outcomes Research, Medication Compliance Special Interest Group, Checklist for Medication Compliance Studies Using Retrospective Drug Utilization Data

(3) Sabate E. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003 (http://www.who.int/chronic_conditions/adherencereport/en/).

(4) Stafford RS, Drieling RL, Hersh AL. National trends in osteoporosis visits and osteoporosis treatment, 1988-2003. Arch Intern Med. Jul 26 2004;164(14):1525-1530.

(5) Caro JJ, Ishak K, Huybrechts K, Raggio G, Naujoks C. The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos. Int. 2004; Dec;15(12):1003-1008.

(6) Sebaldt R, Shane L, Pham B, et al. Impact of non-compliance and non- persistence with daily bisphosphonates on longer-term effectiveness outcomes in patients with osteoporosis treated in tertiary specialist care. J Bone Miner Res 2004;19(Suppl. 1): (Abstract M423).

(7) Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, Silverman S. 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.

(8) Curtis JR, Amonkar MM, Mucha L, Barr CE, Saag KG. Osteoporotic women adherent to bisphosphonate therapy have reduced osteoporosis-related and total healthcare costs. Poster SU320 presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research, September 15-19, 2006, Philadelphia, PA.

(9) Curtis JR, Amonkar MM, Baser O, Barr CE, Saag KG. Adherence to bisphosphonate therapy results in reduced osteoporosis-related and overall healthcare utilization. Poster SU322 presented at: 28th Annual Meeting of the American Society for Bone and Mineral Research, September 15-19, 2006, Philadelphia, PA.

(10) McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas. 2004 Jul 15;48(3):271-87

(11) America's Bone Health: The State of osteoporosis and Low Bone Mass in Our Nation: The National osteoporosis Foundation; February 2002.

(12) Bone Health and osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2004.


Source: GlaxoSmithKline

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