Risk of venous thromboembolism among users of different anti-osteoporosis drugs: a population-based cohort analysis including over 200,000 participants from Spain and the UK.

The venous thromboembolism risk among anti-osteoporotics is unknown. In this primary care study, the risk with other bisphosphonates [1.05 (0.94-1.18) and 0.96 (0.78-1.18)], strontium [0.90 (0.61-1.34) and 1.19 (0.82-1.74)], in the UK and Spain respectively, and denosumab [1.77 (0.25-12.66)] and teriparatide [1.27 (0.59-2.71)] in Spain, did not differ versus alendronate. INTRODUCTION: Most of the known adverse drug reactions described for anti-osteoporosis medication (AOM) have been described in studies comparing AOM users to non-users. We aimed to compare the risk of venous thromboembolism (VTE) among incident users of different AOM compared to alendronate (first line therapy). METHODS: Two cohort studies were performed using data from the UK (CPRD) and Spain (BIFAP) primary care records separately. All patients aged ≥ 50 years with at least 1 year of data available and a new prescription or dispensation of AOM (date for therapy initiation) during 2000-2014 (CPRD) or 2001-2013 (BIFAP) were included. Users of raloxifene/bazedoxifene were excluded from both databases. Five exposure cohorts were identified according to first treatment: (1) alendronate, (2) other bisphosphonates, (3) strontium ranelate, (4) denosumab, and (5) teriparatide. Participants were followed from the day after therapy initiation to the earliest of a treated VTE (cases), end of AOM treatment (defined by a refill gap of 180 days), switching to an alternative AOM, drop-out, death, or end of study period. Incidence rates of VTE were estimated by cohort. Adjusted hazard ratios (HR 95%CI) were estimated according to drug used. RESULTS: Overall, 2035/159,209 (1.28%) in CPRD and 401/83,334 (0.48%) in BIFAP had VTE. Compared to alendronate, adjusted HR of VTE were 1.05 (0.94-1.18) and 0.96 (0.78-1.18) for other bisphosphonates, and 0.90 (0.61-1.34) and 1.19 (0.82-1.74) for strontium in CPRD and BIFAP, respectively; 1.77 (0.25-12.66) for denosumab and 1.27 (0.59-2.71) for teriparatide in BIFAP. CONCLUSIONS: VTE risk during AO therapy did not differ by AOM drug use. Our data does not support an increased risk of VTE associated with strontium ranelate use in the community.

Invasión ganglionar axilar en el carcinoma mamario T1a y T1b / Axillary lymph node involvement in T1a and T1b breast carcinoma

Objetivo. El objetivo de este estudio ha sido valorar en el carcinoma mamario invasivo T1a y T1b la relación entre factores clínicos, histológicos e inmunohistoquímicos con la invasión ganglionar axilar. Material y métodos. Se realizó una revisión retrospectiva de los carcinomas infiltrantes T1a y T1b entre el período comprendido desde enero de 1996 a diciembre de 2001. El número total de pacientes fue de 50. Las variables estudiadas en relación con la infiltración ganglionar axilar fueron: edad, palpabilidad tumoral, localización tumoral, grado histológico de Bloom-Richardson modificado, invasión vasculolinfática, presencia de receptores de estrógenos y de progesterona, expresión de ki67, p53 y de C-erb B2.Resultados. La incidencia de invasión ganglionar axilar fue del 28 por ciento (17 por ciento en T1a y 30 por ciento en T1b). En el análisis univariante se observó una relación estadísticamente significativa entre la edad (< 50), palpabilidad tumoral, invasión vasculolinfática, expresión de p53 y de C-erb B2 con la invasión ganglionar axilar. La asociación de estos 5 marcadores tuvo una sensibilidad del 56 por ciento para predecir infiltración ganglionar y un valor predictivo positivo del 75 por ciento. La ausencia de todos ellos tuvo una especificidad del 50 por ciento y un valor predictivo negativo del 100 por ciento. Conclusiones. Son necesarios nuevos estudios de series más amplias para determinar si se puede omitir la linfadenectomía axilar en un subrupo de pacientes con carcinoma mamario T1a y T1b (AU)