RESUMEN
INTRODUCTION: Bisphosphonates are used worldwide to treat osteoporosis and, thus, to prevent fractures. Though they have been proven in clinical trials to avoid some fractures, their effectiveness in reducing hip fractures is unclear. The aim of the present study was to explore the relationship between bisphosphonate use and hip fracture trends in Spain. METHODS: For this purpose, an ecologic study spanning 2002 to 2008 was conducted in Spain. Consumption data were obtained from the Spanish Ministry of Health and Social Policy. The number of hip fractures was obtained from hospital discharges; annual hip fracture rates were determined and standardized using the Spanish 2002 population census. A linear regression was performed between fracture rate and use of bisphosphonates; R(2) and Pearson correlation coefficient were calculated. RESULTS: From 2002 to 2008, dispensed prescriptions of bisphosphonates in Spain increased from 3.28 to 17.66 DDD/1,000 inhabitants per day. In the same period, the crude hip fracture rate increased from 2.85 to 3.02 cases per 1,000 inhabitants older than 50 years; however, when age standardized rates were estimated, the rate declined from 2.85 to 2.79. Analyzed by sex, the standardized rate for men slightly increased from 1.45 to 1.48, while for women the rate significantly dropped from 4.00 to 3.91. CONCLUSION: A small effect of bisphosphonates on hip fracture rates can not be ruled out; however, other factors might partially explain this decline. Assuming this medication was the only cause for hip fracture rate reduction, the elevated medication cost to avoid a single hip fracture makes it necessary to explore less expensive interventions.
Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Difosfonatos/uso terapéutico , Fracturas de Cadera/prevención & control , Osteoporosis/tratamiento farmacológico , Distribución por Edad , Factores de Edad , Anciano , Anciano de 80 o más Años , Femenino , Fracturas de Cadera/epidemiología , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Osteoporosis/epidemiología , Medición de Riesgo , Factores de Riesgo , Distribución por Sexo , Factores Sexuales , España/epidemiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
Prior to marketing of pandemic influenza vaccines, the only safety data were those from clinical trials. The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients' population. Out of a sample of 507 vaccinated subjects, 103 (20.3%) developed some complication. In the same period 83 reports corresponding to all vaccinated people of Castilla y León (n=131,462) were collected. Severe cases were 1 (1%) and 7 (8.4%), respectively, with the two procedures. The spontaneous reporting rate was 322-fold lower than that identified through the follow-up study; when considered the severe cases, it was 37-fold lower. Under certain circumstances reporting might be performing better than usual due to strengthening of the surveillance system. Adverse events observed for the pandemic H1N1 vaccines lie within the expected safety profile for common events with influenza vaccines. An overall benefit-risk assessment of these vaccines should be done.