Clinical management of cUTI, cIAI, and HABP/VABP attributable to carbapenem-resistant Gram-negative infections in Spain.

OBJECTIVE: Carbapenem-resistant Gram-negative (CRGN) infections are a major public health problem in Spain, often implicated in complicated, healthcare-associated infections that require the use of potentially toxic antibacterial agents of last resort. The objective of this study was to assess the clinical management of complicated infections caused by CRGN bacteria in Spanish hospitals. METHODS: The study included: 1) a survey assessing the GN infection and antibacterial susceptibility profile in five participating Spanish hospitals and 2) a non-interventional, retrospective single cohort chart review of 100 patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) attributable to CRGN pathogens. RESULTS: In the participating hospitals CRGN prevalence was 9.3% amongst complicated infections. In the retrospective cohort, 92% of infections were healthcare-associated, and Klebsiella pneumoniae and Pseudomonas aeruginosa were the most common pathogens. OXA was the most frequently detected carbapenemase type (71.4%). We found that carbapenems were frequently used to treat cUTI, cIAI, HABP/VABP caused by CRGN pathogens. Carbapenem use, particularly in combination with other agents, persisted after confirmation of carbapenem resistance. Clinical cure was 66.0%, mortality during hospitalization 35.0%, mortality at the time of chart review 62.0%, and 6-months-post-discharge readmission 47.7%. CONCLUSIONS: Our results reflect the high burden and unmet needs associated with the management of complicated infections attributable to CRGN pathogens in Spain and highlight the urgent need for enhanced clinical management of these difficult-to-treat infections.

Novetats farmacològiques en pediatria a Espanya: any 2011 / No disponible

No disponible

Seguridad de los bifosfonatos en el tratamiento de la osteoporosis / Bisphosphonates safety in osteoporosis treatment

Además de los efectos secundarios de los bifosfonatos descritos en fases de precomercialización, en los últimos años se han publicado series de casos, estudios de farmacovigilancia y alertas por parte de las agencias reguladoras sobre otros efectos secundarios no descritos previamente. El objetivo de nuestro estudio es describir la aparición de efectos secundarios potencialmente atribuibles a bifosfonatos en la práctica clínica habitual de estos medicamentos. En este trabajo se revisan los efectos adversos de dos bifosfonatos (ácido alendrónico y ácido risedrónico) en una cohorte histórica a través de la revisión de sus historias clínicas. Se incluyeron 110 pacientes de 63.4 años, 103 (93,6%) de los cuales eran mujeres. 33 (30%) continuaban en tratamiento con bifosfonatos en el momento de recogida de datos. 68 (61,8%) recibían tratamiento con ácido risedrónico. La prevención primaria de fracturas fue el motivo de inicio de bifosfonatos en el 88,2% de los casos (n = 97) y en 6,4% (n = 7) de pacientes existía un diagnóstico de fractura previa (prevención secundaria). El resto de tratamientos estaban fuera de indicación. En nuestra población, 82 (74,5%) pacientes sufrieron algún efecto adverso atribuible a los bifosfonatos. Los efectos adversos más frecuentes fueron dolores musculoesqueléticos (58,2%) y trastornos gastrointestinales (24,5%).En general, los bifosfonatos son un grupo de fármacos bien tolerados. La incidencia de efectos adversos en nuestra población ha sido similar a la descrita hasta el momento en la bibliografía (AU)

Apart from bisphosphonates adverse events described in premarketing phases; case reports, pharmacovigilance studies and alerts from regulatory agencies about other adverse events not previously described have been published in the last years. The objective of our study is the description of adverse events potentially attributable to bisphosphonates in the usual clinical practice. We describe the adverse events of two bisphosphonates (risedronate and alendronate) in a historical cohort through a revision of medical hystory. A total of 110 patients of 63.4 years were included, 103 (93.6%) of them were women. 33 (30%) were receiving bisphosphonate treatment at the data collection time. 68 (61.8%) received risedronic acid. In 88.2% (n=97) of our patients the reason to start a bisphosphonate treatment was primary prevention of fractures, and in 6.4% (n=7) of patients there was a previous diagnosis of fracture. The rest of treatments were off-label. 82 (74.5%) of our patients had any adverse event potentially attributable to bisphosphonates. The most frequent adverse events were musculoskeletal pain (58.2%) and gastrointestinal effects (24.5%).Bisphosphonates are a well tolerated therapeutic group. The adverse events incidence in our population was similar to the incidence described in literature (AU)