RESUMEN
Oral daily bisphosphonates carry a potential for gastrointestinal (GI) adverse events, which has been partly addressed by introducing once-weekly regimens. Nevertheless, the need to follow inconvenient dosing instructions every week could still hinder long-term compliance and therapeutic outcome. In addition, survey data indicates that many patients would prefer a once-monthly rather than once-weekly bisphosphonate dosing regimen. Ibandronate is a potent, nitrogen-containing bisphosphonate specifically developed for less frequent administration. In a pivotal study in postmenopausal osteoporosis, oral ibandronate, administered daily or with a between-dose interval of >2 months, demonstrated robust antifracture efficacy and an overall incidence of upper GI adverse events similar to placebo, even in patients at increased risk of such events. This and other clinical studies conducted in postmenopausal women demonstrate that oral ibandronate has an excellent upper GI safety profile.
Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Enfermedades Gastrointestinales/inducido químicamente , Osteoporosis Posmenopáusica/prevención & control , Administración Oral , Alendronato/uso terapéutico , Esquema de Medicación , Ácido Etidrónico/análogos & derivados , Ácido Etidrónico/uso terapéutico , Femenino , Fracturas Óseas/prevención & control , Humanos , Ácido Ibandrónico , Ácido RisedrónicoRESUMEN
OBJECTIVE: The risk of osteoporosis increases exponentially with age. Elderly patients, who are often frail, have declining functional status and take multiple medications, and require osteoporosis therapies that are not only effective, but also very well tolerated. Ibandronate is a potent nitrogen-containing bisphosphonate that can be given intermittently with extended between-dose intervals. Oral daily and intermittent ibandronate (interval between doses > 2 mo) was found to significantly reduce the risk of new morphometric vertebral fractures by 62% and 50%, respectively, compared with calcium and vitamin D supplementation alone. We investigated the effect of age on the safety profile of oral daily and intermittent ibandronate, with particular emphasis on the upper gastrointestinal (GI) safety profile of ibandronate. METHODS: A predefined subgroup analysis examined the tolerability of oral ibandronate in women aged < 70 and > or = 70 years. RESULTS: The incidence of adverse events in patients aged > or = 70 years receiving oral daily and intermittent ibandronate was similar and comparable to placebo. The incidence of upper GI adverse events, including dyspepsia and esophagitis, was also similar between the 2 treatment groups and placebo. CONCLUSION: Older patients (> or = 70 yrs) receiving oral daily and intermittent ibandronate are at no greater risk of adverse events than older patients receiving placebo. Older patients were at no greater risk of upper GI adverse events than younger patients or patients receiving placebo. As a result of the good efficacy and tolerability observed in this trial, a once-monthly oral regimen of ibandronate is in late-stage clinical development.