Gender analysis of moxifloxacin clinical trials

Purpose: To determine the inclusion of women and the sex-stratification of results in moxifloxacin Clinical Trials (CTs), and to establish whether these CTs considered issues that specifically affect women, such as pregnancy and use of hormonal therapies. Previous publications about women’s inclusion in CTs have not specifically studied therapeutic drugs. Although this type of drug is taken by men and women at a similar rate, adverse effects occur more frequently in the latter. Methods: We reviewed 158 published moxifloxacin trials on humans, retrieved from MedLine and the Cochrane Library (1998–2010), to determine whether they complied with the gender recommendations published by U.S. Food and Drug Administration Guideline. Results: Of a total of 80,417 subjects included in the moxifloxacin CTs, only 33.7% were women in phase I, in contrast to phase II, where women accounted for 45%, phase III, where they represented 38.3% and phase IV, where 51.3% were women. About 40.9% (n = 52) of trials were stratified by sex and 15.3% (n = 13) and 9% (n = 7) provided data by sex on efficacy and adverse effects, respectively. We found little information about the influence of issues that specifically affect women. Only 3 of the 59 journals that published the moxifloxacin CTs stated that authors should stratify their results by sex. Conclusions: Women are under-represented in the published moxifloxacin trials, and this trend is more marked in phase I, as they comprise a higher proportion in the other phases. Data by sex on efficacy and adverse effects are scarce in moxifloxacin trials. These facts, together with the lack of data on women-specific issues, suggest that the therapeutic drug moxifloxacin is only a partially evidence-based medicine.

La villa de la C/ Olimpo y la organización territorial de la periferia urbana de Lucentum (Alicante)

Esta investigación establece la secuencia estratigráfica, cronológica y funcional de un núcleo de poblamiento suburbano del municipio romano de Lucentum, con el fin de dibujar las líneas maestras de la evolución productiva de su ager periurbano. El yacimiento presenta cuatro fases principales que abarcan un dilatado arco temporal: estructuras de época tardorrepublicana (fase I, ss. II-I aC), una reestructuración viaria y urbanística de época augustea (fase II), el desarrollo de una villa con estructuras de transformación mercantil datada a partir de época tardojulia o flavia (fase III) y, por último, una fase bajoimperial (fase IV, ss. IV-v dC), en la que la villa sufre fuertes reestructuraciones.