Comparative risks of bleeding, ischemic stroke and mortality with direct oral anticoagulants versus phenprocoumon in patients with atrial fibrillation.

PURPOSE: The pivotal trials for stroke prevention in non-valvular atrial fibrillation (NVAF) compared rivaroxaban, dabigatran, and apixaban with warfarin, as did most claims-based studies. Comparisons with phenprocoumon, the most frequently used vitamin K antagonist (VKA) in Germany, are scarce. METHODS: Risk of bleeding, ischemic stroke, and all-cause mortality in patients with NVAF were analyzed using data for 2010 to 2014 from a large German claims database. New users of oral anticoagulants from January 2012 to December 2013 were included and observed over 1 year. Baseline characteristics were adjusted using propensity score matching and logistic regression. Several sensitivity analyses were carried out. RESULTS: Fifty-nine thousand four hundred forty-nine rivaroxaban, 23,654 dabigatran, 4894 apixaban, and 87,997 matched phenprocoumon users were included. Adjusted hazard ratios (95% confidence intervals) compared with phenprocoumon were as follows: hospitalized bleedings: rivaroxaban 1.04 (0.97; 1.11), dabigatran 0.87 (0.77; 0.98), and apixaban 0.65 (0.50; 0.86); ischemic stroke: rivaroxaban 1.05 (0.94; 1.17), dabigatran 1.14 (0.96; 1.35), and apixaban 1.84 (1.20; 2.84); all-cause mortality: rivaroxaban 1.17 (1.11; 1.22), dabigatran 1.04 (0.95; 1.13), and apixaban 1.14 (0.97; 1.34). CONCLUSIONS: With rivaroxaban, no significant differences were observed compared to phenprocoumon with regard to hospitalized bleedings or ischemic strokes. Dabigatran was associated with fewer bleedings and a similar risk of ischemic strokes compared to phenprocoumon. Apixaban was also associated with fewer bleedings but was unexpectedly associated with more ischemic strokes, possibly reflecting selective prescribing. The association of rivaroxaban with higher all-cause mortality unrelated to bleedings or strokes has been described previously but remains to be explained.

Population-based hormone receptor-specific incidence trends of breast cancer in Germany.

OBJECTIVES: Several countries reported a drop in prescription of hormone replacement therapy (HRT) in the 2000s, followed by decreases in breast cancer incidence among postmenopausal women aged 50-69 years. The aim of this study was to provide hormone receptor specific incidence rates of breast cancer in Germany. METHODS: Breast cancer data were extracted from the cancer registries of the Federal States of Brandenburg and Saarland and the area of Munich for the period from 1998 to 2007. We obtained nationwide data on HRT prescription in 1998-2007 from health insurances. Multiple imputation was used on missing values for the receptor status. Age-standardized (European standard population) and age-specific rates were calculated. RESULTS: The age-standardized incidence rates in breast cancer were virtually constant over the entire period in all regions. In particular, no substantial changes over time occurred within the age- and receptor-specific analyses. In the same period we observed a drop in HRT use, starting in 1999 and leveling off in 2004. The incidence trends of carcinoma in situ of the female breast increased during the study period. CONCLUSIONS: In our data, we did not observe an association between the decline in HRT prescription and breast cancer incidence among women aged from 50 to 69 years. The lack of temporal changes in breast cancer incidence may be explained by introduction of opportunistic and organized mammography screening and low absolute levels of HRT prescription in Germany.

Trends in hormone therapy and breast cancer incidence - results from the German Network of Cancer Registries.

OBJECTIVE: Menopausal hormone therapy (HT) is a proven risk factor for breast cancer. Recent reports presented declining trends in breast cancer incidence, which were attributed to parallel declining trends in HT. Therefore, we analyzed recent data on hormone therapy and breast cancer incidence in Germany. METHODS: We performed a population-based survey using breast cancer incidence (from cancer registries) and hormone prescription data (from health insurances) for the time period from 1997 to 2006. Age-standardized rates were calculated and joinpoint regression analyses for trends were performed. RESULTS: Prescription of HT started to decline in 1999; about 2 years later, a parallel decline in breast cancer incidence was observed. HT prescription decreased by 69% up to 2006, and breast cancer incidence by 6.8% for all age groups (2002-2005) and 12.8% in the age group from 50 to 69 years. The reductions in HT prescription and breast cancer incidence were markedly correlated across the federal states in Germany. CONCLUSION: The recent decline in breast cancer incidence following decreasing HT prescription suggests a causal relationship between the risk of breast cancer and HT in Germany. Even after the 'big HT drop' in Germany, significant differences in HT prescription as well as breast cancer incidence persist at the federal state level. These results should be discussed in a public health context.