Abstract
11500 Background: The renal safety profile of ibandronate (IA) was assessed retrospectively across a spectrum of oncology patients including multiple myeloma, breast, prostate, and non-small cell lung cancer. Patient groups were classified as IA switchers (with prior zoledronic acid (ZA) therapy) (n=34) or early IA (without prior ZA therapy) (n=72). Renal impairment rates and trends in renal function were compared during ZA and IA treatment periods in patients switching from ZA to IA (n=32 observable in both treatment periods). Methods: Medical records from two German oncology clinics, spanning May 2001 to March 2006, were reviewed. Serum creatinine (SCr) was analyzed from baseline to last evaluation. Renal impairment was defined as a SCr increase of =0.5mg/dL or =1.0mg/dL from baseline values of <1.4mg/dL or =1.4mg/dL, respectively; or =25% decrease in glomerular filtration rate (GFR) from baseline. Results: Both groups had similar baseline renal function. Physicians reported that renal-related problems led to 22 patients (69%) switching from ZA to IA. Patients switched from ZA therapy to IA showed a significant trend towards renal function deterioration during the ZA treatment period (p=0.016) but experienced a trend towards improved renal function after switching to IA (p=0.082). Patients receiving IA with prior ZA therapy exhibited significantly higher renal impairment rates versus those without prior ZA therapy (50.0% versus 11.1%, relative risk (RR)=4.5, p<0.0001 [SCr] and 70.6% versus 38.9%, RR=1.8, p=0.0024 [GFR] for patients with and without prior ZA therapy, respectively). Cox proportional hazards models, adjusted for significant covariates, found significantly higher hazards ratios (HRs) in the IA switchers group versus the early IA group (HR=7.7, p<0.01 [SCr] and HR=4.3, p<0.01 [GFR]). Conclusions: ZA naïve patients had a significantly lower renal impairment risk compared to those who received ZA followed by IA. Patients switching from ZA to IA showed recovery of renal function, suggesting that patients may benefit from IA early in the treatment cycle or by switching to IA treatment. A prospective randomized study is warranted. No significant financial relationships to disclose.
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