In Response to Jackson Letter to the Editor Regarding “Safety of Intravenous and Oral Bisphosphonates and Compliance with Dosing Regimens”

Abstract

The burden of suffering associated with metastatic bone disease is so high that we want to be sure that information on effective therapies is reported in the most complete and balanced way. According to Dr. Body, the gastrointestinal (GI) safety profile of oral ibandronate (50 mg) based on the pooled analysis of two randomized placebo-controlled trials [1] was misrepresented. Of course this was not our purpose; however, if the authors chose not to report the overall incidence of treatment-related GI adverse events, which is an important measure of tolerability for an oral bisphosphonate, one is left with assumptions. Certainly, the reported incidence of treatment-related abdominal pain, nausea, and esophagitis was two to three times higher in the ibandronate group compared with placebo. Thus, based on the reported incidence of these common upper GI adverse events, the general statement that “patients treated with oral ibandronate were twice as likely to experience treatmentrelated GI adverse events as those receiving placebo” is consistent with the reported data. This statement is also consistent with the reported incidence of GI adverse events in the dose-finding study [2]. Moreover, the reporting of safety data from patients with osteoporosis who received