MORE than two million Australians living with osteoporosis are set to benefit from the first once-a-month osteoporosis therapy, after it was today listed on the Pharmaceutical Benefits Scheme (PBS).
Actonel (risedronate sodium) 150mg Once-a-Month is a bisphosphonate PBS-listed for the treatment of osteoporosis in patients with a prevalent fracture, in patients aged 70 and over with a BMD T-score of -3.0 or less and in patients on long term (three months or more), high dose (over 7.5mg prednisolone or equivalent) corticosteroid therapy with BMD T-score of -1.5 or less.
Actonel Once-a-Month is designed to help simplify patients’ lives by offering a convenient dosing regimen of only one oral tablet per month. Actonel Once-a-Month offers the efficacy and safety of daily Actonel 5mg.
According to Professor John Eisman, Director of the Osteoporosis and Bone Biology Program at Garvan Institute of Medical Research, despite the fact that osteoporosis affects more than one-in-ten Australians and costs the community more than $7b per annum in direct and indirect health care costs, the disease is not being optimally managed or treated.
“Current evidence suggests that more than 70% of women and 90% of men who have experienced a fragility fracture are not on effective treatments to reduce their risk of subsequent fracture.
“The perception of inconvenience of a weekly regimen associated with taking an oral bisphosphonate (first thing in the morning on an empty stomach, with a full glass of water, with the patient remaining upright for the half-hour prior to eating), may contribute to this treatment gap,” said Prof. Eisman.
“The introduction of a once-a-month dosing regimen, designed to simplify patient’s lives, may help narrow this gap.”
Actonel Once-a-Month has been shown to be equivalent in efficacy and safety to Actonel Once-a-Day.
In a randomised, double-blind, active-controlled, parallel group study, Actonel Once-a-Month demonstrated comparable increases in BMD at the lumbar spine and hip and similar decreases in bone turnover markers (NTX, CTX, BAP) compared to Actonel Once-a-Day. The incidence of vertebral fractures was similar in both groups, suggesting equivalent anti-fracture efficacy.
The overall adverse event profiles were similar for both daily and monthly regimens, and both dosing regimens were shown to be well tolerated.
In two crossover trials where patients trialed both monthly and weekly dosing regimens (monthly ibandronate and weekly alendronate), approximately two-thirds of study participants preferred the monthly dosing regimen – 66.1% in one study and 65.7% in the other.
A once-a-month osteoporosis therapy should help address some of the challenges faced by patients taking current regimens comprising daily or weekly dosing, said Professor Peter Ebeling, Head of Endocrinology, Western Hospital, Melbourne.
“With this novel once-a-month dosing regimen, patients need only take 12 tablets per year, compared with 52 tablets for weekly therapies, or 365 tablets or sachets for daily therapies.
“This more convenient dosing regimen may allow patients to concentrate on living more effective lives, rather than focusing on their disease,” said Prof Ebeling.
“Patient preference is an important driver of compliance and persistence with medication. This is important because just over half of all patients prescribed daily or weekly osteoporosis therapies stop taking their medication at 12 months, which can increase their fracture risk.
“We should not assume our patients are happy with a weekly dosing regimen. Instead, as always, we should involve them in the decision-making process and offer them this new monthly dosing option,” Prof. Ebeling said.
Patients prescribed Actonel Once-a-Month will have access to the ‘ActNow’ patient support programme, which offers a monthly medication reminder service via mail, email or SMS. The programme also offers patients free vitamin D and calcium supplements, if recommended by a doctor, along with monthly news bulletins, tips on falls prevention and exercise and ongoing support from registered nurses.
Actonel Once-a-Month will be available on the PBS from 1 July 2009 at a cost of $32.90 per month.
Actonel 150mg Once-a-Month is co-marketed by sanofi-aventis and Procter & Gamble Pharmaceuticals.