Measure of the Rate at which Mortality in Type 2 Diabetes Mellitus Occurs: Protocol for a Systematic Review.

Introduction: Type 2 diabetes is the third largest cause of mortality in the United Kingdom, with about 50% of patients’ having developed complications at time of diagnosis. We consider that the evidence which explores the actual hazard ratios of mortality has not been consistent. n this paper we discuss methodology and review the most recent accurate data on mortality in type 2 diabetes. Methods: A systematic review will be undertaken aimed at synthesis of evidence of relative risk of mortality in type 2 diabetes, using the Centre for Reviews and Dissemination guidelines. We will explore conflicting and unanswered questions in relation to mortality. The primary outcome is all-cause, overall-cause or total mortality expressed as hazard ratios. Sub-groups will also be explored; age, gender, socio-economic factors and causes of death. We will review abstracts published after 1990 in the English language. Our data source will include electronic databases; the Cochrane library, the Centre for Reviews and Dissemination, Medline/PubMed, and other grey literature. The study populations are type 2 diabetes patients whose mortality outcome, expressed as hazard ratio, has been evaluated. Data extraction will be undertaken by one reviewer and triangulated by the second and third reviewer. The quality of the included studies will be evaluated in accordance with the inclusion/exclusion criteria; methodological quality that meets the critical appraisal framework and the relevance to the research questions. Evidence from data will be synthesised through a descriptive epidemiological review from included studies; meta-analysis will be used if appropriate. Result & Conclusion: We expect to pool homogenous studies of large population cohorts which explore the hazard ratio of mortality, and to summarise the evidence of the actual mortality risk in type 2 diabetes, with limited bias. This will help direct future research in areas of unanswered questions and may influence healthcare policy decisions.

Tigeciclina versus vancomycin más aztreonam en el tratamiento de infecciones complicadas de piel y tejidos blandos: Experiencia en Latinoamérica / Tigecycline as effective as vancomycin plus aztreonam in the treatment of complicated skin and skin structure infections: Experience in Latin America

BACKGROUND: Treating complicated skin and skin structure infections (cSSSIs) can be challenging. Tigecycline was compared to vancomycin/aztreonam in patients with cSSSIs in a multinational trial; this article reports on the Latin American (LA) population. METHODS: Patients were randomly assigned to receive tigecycline or vancomycin/ aztreonam. Primary endpoint was clinical cure rate at test-of-cure (TOC). Several secondary endpoints and safety were also assessed. RESULTS: A subtotal of 167 LA patients from the multinational trial (N = 573) received ≥ 1 dose of study drug. At TOC, cure rates were similar between tigecycline and vancomycin/aztreonam in the clinically evaluable population.) Noninferiority of tigecycline could not be demonstrated (insufficient sample sizes). Tigecycline-treated patients had higher incidences of nausea, vomiting, anorexia; vancomycin/aztreonam-treated patients had higher incidences of pruritus and rash. CONCLUSIONS: Efficacy results in the LA population were consistent with the multinational study suggesting that tigecycline is noninferior to vancomycin/aztreonam in treating patients with cSSSI.

INTRODUCCIÓN: El tratamiento de infecciones complicadas de piel y tejidos blandos (ICPTB) puede representar un desafío. Se comparó la eficacia de tigeciclina versus vancomicina/aztreonam en pacientes con ICPTB en un estudio multicéntrico; este artículo se refiere a la experiencia en Latinoamérica (LA). MÉTODO: Se asignaron, en forma randomizada, los pacientes a dos grupos de tratamiento: tigeciclina o vancomicina/aztreonam. La meta a evaluar (outcome) primaria fue la curación clínica, denominada test de curación (TC). Se establecieron, además, metas secundarias y la evaluación de seguridad del fármaco. RESULTADOS: Un subtotal de 167 pacientes procedentes de LA, de un estudio multinacional que incluyó 573 pacientes, recibieron ≥ 1 dosis del fármaco en estudio. Al TC, los porcentajes de curación fueron similares entre tigeciclina y vanco-micina/aztreonam en los pacientes clínicamente evaluables). La no inferioridad de tigeciclina no pudo ser demostrada (tamaño de muestra insuficiente). Los pacientes tratados con tigeciclina tuvieron mayor incidencia de náuseas, vómitos y anorexia; los pacientes que recibieron vancomicina/aztreonam tuvieron mayor incidencia de prurito y rash. CONCLUSIONES: Los resultados de eficacia en LA fueron consistentes con el estudio multinacional sugiriendo que tigeciclina no es inferior a vancomicina/aztreonam en el tratamiento de pacientes con ICPTB.