Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study*

Abstract

SUMMARYOsteoporosis is a common and debilitating condition associated with significant morbidity and mortality. The efficacy and safety of oral bisphosphonates for the treatment of osteoporosis are well established. However, patient adherence and persistence on treatment are suboptimal. This randomised open-label multi-centre study of 6-months' duration compared persistence on treatment in postmenopausal women with osteoporosis receiving either once-monthly ibandronate plus a patient support programme (PSP), or once-weekly alendronate. To avoid falsely elevated persistence rates often associated with clinical trials, the study was designed to reflect everyday clinical practice in the UK and follow-up visits were limited to be consistent with the primary care setting. Analysis of the primary endpoint showed that persistence was significantly higher in the ibandronate/PSP group compared with the alendronate group (p 0 0.0001). The estimated proportion of patients persisting with treatment at 6 months was 56.6% (306/541) and 38.6% (198/513) in the ibandronate/PSP and alendronate groups, respectively. Therefore, compared with alendronate, there was a 47% relative improvement in the proportion of patients persisting with treatment in the ibandronate/PSP group. Secondary endpoint measurements of adherence (e.g. proportion of patients remaining on treatment at study end; proportion of patients discontinuing from the study) were also significantly different in favour of ibandronate plus patient support. In summary, the PERSIST study demonstrated that persistence on treatment was increased in patients receiving once-monthly ibandronate plus patient support compared with once-weekly alendronate. Increased persistence on bisphosphonate treatment is expected to improve patient outcomes and decrease the social and economic burden of osteoporosis.

Adherence to treatment of osteoporosis: a need for study

“…Although several studies show low persistence, in the order of 20-50%, many studies show persistence rates that are rather similar to those reported in randomised controlled trials. In particular, those from the UK show rates on the order of 80% [18,22,24,25]. The lowest rates reported are from North America where in some studies, low persistence may reflect the lack of an affordable treatment for some patients, known to be an important factor in non-persistence.…”

“…In general, the longer the defined grace period, the higher the adherence rates. For example, in a study comparing alendronate and ibandronate, persistence was judged to be 38% and 56%, respectively, when allowing a two-week grace period, though at 6 months, 73 and 80% of patients had refilled 5 of the 6 monthly prescriptions [18].…”

“…If treatment is stopped, but restarted, a patient may be considered to be non-persistent, depending upon the drug-free interval. What is an acceptable 'grace period' varies between studies and ranges from 2 weeks [17,18] to 2 months or more [7,[19][20][21], but is often not specified. In general, the longer the defined grace period, the higher the adherence rates.…”

Ibandronate in the Management of Postmenopausal Osteoporosis

“…An open-label study and a database study including two databases (i3 Innovus and HealthCore) have compared monthly ibandronate with weekly bisphosphonates, alendronate and risedronate, and both studies reported improved rates of persistence with the monthly regimen. 62,63 In the UK, open-label study (n = 1,103), a 47% relative improvement in persistence was reported for the monthly ibandronate group versus weekly alendronate (p  0.0001). 62 As per standard clinical practice in the UK, patients in the ibandronate group were enrolled into a patient support programme.…”

“…62,63 In the UK, open-label study (n = 1,103), a 47% relative improvement in persistence was reported for the monthly ibandronate group versus weekly alendronate (p  0.0001). 62 As per standard clinical practice in the UK, patients in the ibandronate group were enrolled into a patient support programme. The database study included a total of 3,512 and 13,967 women prescribed monthly ibandronate or weekly bisphosphonates, respectively, from the i3 Innovus claims database and 1,006 and 10,658 patients, respectively, from the HealthCore database.…”