Tuesday, September 19, 2006

Phase III GlaxoSmith-Kline Results: Boniva users Stay on Regimen Longer and have fewer Fractures

According to six-month results of ongoing studies, women with postmenopausal osteoporosis taking once-monthly Boniva® (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)



This says that women on the once a month drug are more likely to stay on the medication which prevents post-menopausal osteoporosis. Women who are on daily or weekly doses of other bisphosphate drugs don't stay with the medication which results in frequent fractures and higher health care costs.
Osteoporosis is common in post-menopausal women because of the lack of hormones produced by the ovary.
In the normal bone, there are cells called osteoclasts and osteoblasts. Normally there is a lot of bone turnover, where the osteoclasts eat the bone [absorb it] and the osteoblasts creat new bone. In osteoporosis, the osteoclasts are winning the battle and absorb the bone, making it brittle.

Boniva is a bisphosphate drug, and works by inhibiting the osteoclast resorption.

GSK:NYSE closed down $1.26 today to 54.32 in heavy trading. GSK was also downgraded today to "underperform" by Bear Stearns.

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