Results A total of 747 adverse drug reactions were identified; 361 for biopharmaceuticals and 386 for SMs. Within the sub group of immunosuppressants, neoplasms (20 % vs 2%, p < 0.01) and infections and infestations (22 % vs 9 %, p < 0.01) occurred significantly more frequent for biopharmaceuticals. Adverse drug reactions of SMs were more often renal and urinary

disorders (7 % vs 0 %, p < 0.01), blood and lymphatic system disorders (10 % vs 3 %, p = 0.04), and vascular disorders (7 % vs 1 %, p = 0.02). In the subgroup of antineoplastics, immune system disorders occurred more frequently for biopharmaceuticals, (6 % vs 1 %, p = 0.04). With the exception of immune system disorders and renal disorders, the overall differences between biopharmaceuticals and SMs were mostly caused by products authorized

as immunosuppressants. For the subset of products authorized after 2004, the median time to the first safety issue was 18 Stem Cells & Wnt inhibitor months (95 % CI 12.4-21.5) for biopharmaceuticals and HER2 inhibitor 17 months (95 % CI 12.5-21.5) for SMs and did not differ significantly within subgroups.

Conclusion Even within a group of medicinal products approved in the same indication, differences were observed in the nature of adverse drug reactions between biopharmaceuticals and SMs. The considerable differences in the nature of adverse drug reactions between biopharmaceuticals and SMs were not associated with differences in the timing of regulatory actions.”
“We studied 3162 heart failure patients included in the Spanish BADAPIC registry in order to determine whether statin treatment influences prognosis. Patients were followed up for 35 +/- 22 months (median, 32 months). Patients on statins were more often male and had higher prevalences of risk factors, ischemic heart disease and systolic dysfunction (P<.001) than those not on statins. After adjustment

for age, risk factors, ischemic heart disease, renal failure, ejection fraction, anemia, heart rate and drug treatment, statin treatment was found to be a favorable independent predictor of survival: the hazard ratio for mortality was 0.73 (95% confidence interval, 0.45-0.88; P<.001). During find more follow-up, the 3-year survival rate was higher in patients treated with statins (75% vs. 68%; P<.001). In patients with heart failure, statin treatment appears to be independently associated with better survival.”
“Background and Objectives: With technical adaptations, recent studies showed SLNB could predict cervical nodes status of head and neck carcinoma with high accuracy. However, as for tongue carcinoma, such technical adaptations seem to be not enough because the tongue has peculiar characteristic which may demand a specific procedure for accurate lymphatic mapping. This investigation explored the effect of lingual septum on lymphatic mapping of tongue to provide data for achieving an accurate lymphatic mapping for managing early tongue carcinoma.