Efficacy of high doses of penicillin versus amoxicillin in the treatment of uncomplicated community acquired pneumonia in adults. A non-inferiority controlled clinical trial / Eficacia de dosis altas de penicilina frente a amoxicilina en el tratamiento de la neumonía no complicada adquirida en la comunidad en adultos. Ensayo clínico controlado de no inferioridad

Introduction: Community-acquired pneumonia (CAP) is treated with penicillin in some northern European countries. Objectives: To evaluate whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-severe CAP. Design: Multicentre, parallel, double-blind, controlled, randomized clinical trial. Setting: 31 primary care centers in Spain. Participants: Patients from 18 to 75 years of age with no significant associated comorbidity and with symptoms of lower respiratory tract infection and radiological confirmation of CAP were randomized to receive either penicillin V 1.6 million units, or amoxicillin 1000mg three times per day for 10 days. Main measurements: The main outcome was clinical cure at 14 days, and the primary hypothesis was that penicillin V would be non-inferior to amoxicillin with regard to this outcome, with a margin of 15% for the difference in proportions. EudraCT register 2012-003511-63. Results: A total of 43 subjects (amoxicillin: 28; penicillin: 15) were randomized. Clinical cure was observed in 10 (90.9%) patients assigned to penicillin and in 25 (100%) patients assigned to amoxicillin with a difference of -9.1% (95% CI, --41.3% to 6.4%; p = .951) for non-inferiority. In the intention-to-treat analysis, amoxicillin was found to be 28.6% superior to penicillin (95% CI, 7.3-58.1%; p = .009 for superiority). The number of adverse events was similar in both groups. Conclusions: There was a trend favoring high-dose amoxicillin versus high-dose penicillin in adults with uncomplicated CAP. The main limitation of this trial was the low statistical power due to the low number of patients included

Introducción: En algunos países la neumonía adquirida en la comunidad (NAC) se trata con penicilina. Objetivo: Evaluar si penicilina V a dosis altas es igual de efectiva que amoxicilina a dosis altas en la NAC no complicada. Diseño. Ensayo clínico paralelo, doble ciego, controlado y multicéntrico. Emplazamiento: Treinta y un centros de salud en España. Participantes: Se reclutaron pacientes de 18 a 75 años de edad sin comorbilidad asociada importante, con síntomas de infección respiratoria inferior y confirmación radiológica de neumonía, que fueron asignados aleatoriamente a 1,6M unidades de penicilina V o amoxicilina 1.000 mg, 3 veces al día, durante 10 días. Mediciones principales: La variable de resultado principal fue curación clínica a los 14 días y se planteó la hipótesis de que penicilina no era inferior a amoxicilina con un margen de 15% para la diferencia de proporciones. Registro EudraCT 2012-003511-63. Resultados: Se aleatorizaron 43 personas (amoxicilina: 28; penicilina: 15). Se observó curación clínica en 10 pacientes asignados a penicilina (90,9%) y en 25 asignados a amoxicilina (100%), observándose una diferencia de -9,1% (IC 95%: -41,3 a 6,4%; p = 0,951) para no inferioridad. En el análisis por intención de tratar amoxicilina fue 28,6% superior a penicilina V (IC 95%: 7,3% a 58,1%; p = 0,009 para superioridad). El número de eventos adversos fue similar en ambos grupos. Conclusiones: Se observó una tendencia de un mayor beneficio de amoxicilina frente a penicilina en adultos con NAC no complicada. La principal limitación fue la baja potencia estadística debido al bajo número de pacientes incluidos

Efficacy of high doses of penicillin versus amoxicillin in the treatment of uncomplicated community acquired pneumonia in adults. A non-inferiority controlled clinical trial.

INTRODUCTION: Community-acquired pneumonia (CAP) is treated with penicillin in some northern European countries. OBJECTIVES: To evaluate whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-severe CAP. DESIGN: Multicentre, parallel, double-blind, controlled, randomized clinical trial. SETTING: 31 primary care centers in Spain. PARTICIPANTS: Patients from 18 to 75 years of age with no significant associated comorbidity and with symptoms of lower respiratory tract infection and radiological confirmation of CAP were randomized to receive either penicillin V 1.6 million units, or amoxicillin 1000mg three times per day for 10 days. MAIN MEASUREMENTS: The main outcome was clinical cure at 14 days, and the primary hypothesis was that penicillin V would be non-inferior to amoxicillin with regard to this outcome, with a margin of 15% for the difference in proportions. EudraCT register 2012-003511-63. RESULTS: A total of 43 subjects (amoxicillin: 28; penicillin: 15) were randomized. Clinical cure was observed in 10 (90.9%) patients assigned to penicillin and in 25 (100%) patients assigned to amoxicillin with a difference of -9.1% (95% CI, -41.3% to 6.4%; p=.951) for non-inferiority. In the intention-to-treat analysis, amoxicillin was found to be 28.6% superior to penicillin (95% CI, 7.3-58.1%; p=.009 for superiority). The number of adverse events was similar in both groups. CONCLUSIONS: There was a trend favoring high-dose amoxicillin versus high-dose penicillin in adults with uncomplicated CAP. The main limitation of this trial was the low statistical power due to the low number of patients included.

Incidencia y letalidad del ictus isquémico en la población mayor de 60 años del área de Tarragona, España (2008-2011) / Incidence and lethality of ischaemic stroke among people 60 years or older in the region of Tarragona (Spain), 2008-2011

Introducción. La información existente sobre la epidemiología del ictus en nuestro país es limitada. Este estudio analizó la incidencia y mortalidad por ictus isquémico en la población general mayor de 60 años del área de Tarragona. Pacientes y métodos. Estudio de cohortes de base poblacional que incluyó a 27.204 personas de 60 o más años adscritas a nueve áreas básicas de salud en la comarca del Tarragonès. Se realizó un seguimiento prospectivo durante tres años, en los que se seleccionaron todos los episodios de ictus isquémicos ocurridos entre los miembros de la cohorte desde el 1 de diciembre de 2008 hasta el 30 de noviembre de 2011. Se incluyeron exclusivamente episodios con diagnóstico validado tras la revisión de la historia clínica y se excluyeron aquellos casos sin confirmación diagnóstica por neuroimagen. Resultados. Se observó un total de 343 casos confirmados de ictus isquémico, lo cual supuso una incidencia de 453 episodios por 100.000 personas/año (intervalo de confianza del 95% = 408-504). La incidencia fue mayor en hombres que en mujeres (531 frente a 392 por 100.000 personas/año; p < 0,001) y aumentó sustancialmente con la edad (195 frente a 517 y frente a 1.006 por 100.000 personas/año en 60-69, 70-79 y ≥ 80 años, respectivamente; p < 0,001). La incidencia fue más de ocho veces superior entre las personas con antecedentes de ictus previo en comparación con aquellas sin historia de ictus previo (2.962 frente a 340 por 100.000 personas/año; p < 0,001). El índice de letalidad global fue del 13%, y alcanzó el 21% entre las personas de 80 o más años. Conclusiones. La morbimortalidad por ictus es considerable en nuestra población. Medidas preventivas y tratamientos más eficaces son imperativos (AU)

Introduction. Data available about the epidemiology of stroke is limited. This study investigated incidence and lethality of ischaemic stroke among the general population over 60 years in the region of Tarragona. Patients and methods. Population-based cohort study that included 27,204 individuals ≥ 60 years assigned to nine Primary Care Centers in the Tarragonès county (Catalonia, Spain), who were prospectively followed between December 1st, 2008 and November 30th, 2011. During follow-up, all episodes of ischaemic stroke were recruited among cohort members. Only confirmed ischaemic cases (confirmed by neuroimaging and validated alter checking hospital medical records) were included. Results. An amount of 343 confirmed cases of ischaemic stroke were observed, which means a global incidence rate of 453 episodes per 100,000 persons/year (95% confidence interval = 408-504). Incidence was higher among men than in women (531 vs 392 per 100,000; p < 0.001) and increases substantially with increasing age (195 vs 517 vs 1,006 per 100,000 in 60-69 years, 70-79 years and ≥ 80 years, respectively; p < 0.001). Incidence was eight times greater among persons with history of prior ictus as compared with those without history of ictus (2,962 vs 340 per 100,000; p < 0.001). Overall lethality rate was 13%, reaching 21% among patients ≥ 80 years. Conclusion. Morbid-mortality by ischaemic ictus remains considerable among our population. Preventive measures and more efficacious therapies are imperative (AU)

[Incidence and lethality of ischaemic stroke among people 60 years or older in the region of Tarragona (Spain), 2008-2011]. / Incidencia y letalidad del ictus isquemico en la poblacion mayor de 60 años del area de Tarragona, España (2008-2011).

INTRODUCTION: Data available about the epidemiology of stroke is limited. This study investigated incidence and lethality of ischaemic stroke among the general population over 60 years in the region of Tarragona. PATIENTS AND METHODS: Population-based cohort study that included 27,204 individuals >= 60 years assigned to nine Primary Care Centers in the Tarragones county (Catalonia, Spain), who were prospectively followed between December 1st, 2008 and November 30th, 2011. During follow-up, all episodes of ischaemic stroke were recruited among cohort members. Only confirmed ischaemic cases (confirmed by neuroimaging and validated alter checking hospital medical records) were included. RESULTS: An amount of 343 confirmed cases of ischaemic stroke were observed, which means a global incidence rate of 453 episodes per 100,000 persons/year (95% confidence interval = 408-504). Incidence was higher among men than in women (531 vs 392 per 100,000; p < 0.001) and increases substantially with increasing age (195 vs 517 vs 1,006 per 100,000 in 60-69 years, 70-79 years and >= 80 years, respectively; p < 0.001). Incidence was eight times greater among persons with history of prior ictus as compared with those without history of ictus (2,962 vs 340 per 100,000; p < 0.001). Overall lethality rate was 13%, reaching 21% among patients >= 80 years. CONCLUSION: Morbid-mortality by ischaemic ictus remains considerable among our population. Preventive measures and more efficacious therapies are imperative.

TITLE: Incidencia y letalidad del ictus isquemico en la poblacion mayor de 60 años del area de Tarragona, España (2008-2011).Introduccion. La informacion existente sobre la epidemiologia del ictus en nuestro pais es limitada. Este estudio analizo la incidencia y mortalidad por ictus isquemico en la poblacion general mayor de 60 años del area de Tarragona. Pacientes y metodos. Estudio de cohortes de base poblacional que incluyo a 27.204 personas de 60 o mas años adscritas a nueve areas basicas de salud en la comarca del Tarragones. Se realizo un seguimiento prospectivo durante tres años, en los que se seleccionaron todos los episodios de ictus isquemicos ocurridos entre los miembros de la cohorte desde el 1 de diciembre de 2008 hasta el 30 de noviembre de 2011. Se incluyeron exclusivamente episodios con diagnostico validado tras la revision de la historia clinica y se excluyeron aquellos casos sin confirmacion diagnostica por neuroimagen. Resultados. Se observo un total de 343 casos confirmados de ictus isquemico, lo cual supuso una incidencia de 453 episodios por 100.000 personas/año (intervalo de confianza del 95% = 408-504). La incidencia fue mayor en hombres que en mujeres (531 frente a 392 por 100.000 personas/año; p < 0,001) y aumento sustancialmente con la edad (195 frente a 517 y frente a 1.006 por 100.000 personas/año en 60-69, 70-79 y >= 80 años, respectivamente; p < 0,001). La incidencia fue mas de ocho veces superior entre las personas con antecedentes de ictus previo en comparacion con aquellas sin historia de ictus previo (2.962 frente a 340 por 100.000 personas/año; p < 0,001). El indice de letalidad global fue del 13%, y alcanzo el 21% entre las personas de 80 o mas años. Conclusiones. La morbimortalidad por ictus es considerable en nuestra poblacion. Medidas preventivas y tratamientos mas eficaces son imperativos.

Relationship between annual influenza vaccination and winter mortality in diabetic people over 65 years.

BACKGROUND: Influenza is an important cause of morbidity and mortality in older people, especially in those with some high-risk conditions such as diabetes mellitus. This study assessed the relationship between influenza vaccination status and winter mortality among diabetics 65 y and over during four consecutive influenza seasons. METHODS: Population-based cohort study including 2,650 community-dwelling individuals 65 y or older with diabetes mellitus followed between January 2002 and April 2005 in Tarragona, Spain. Influenza vaccination status was evaluated every year of the study and the primary endpoint was considered all-cause death during the study period. Deaths were classified as occurring within influenza periods (January-April) or non-influenza periods. The relationship between vaccination and winter mortality was evaluated by multivariable discrete-time hazard models. RESULTS: Influenza immunization was associated with a reduction of 33% (95% confidence interval: 4-53) in the adjusted risk of all-cause mortality throughout the overall influenza periods 2002-2005. The attributable risk to vaccination in reducing mortality was 13.5 per 100,000 person-weeks within influenza periods, estimating that one death was prevented for every 435 annual vaccinations. CONCLUSION: Our data confirm the benefit of influenza vaccination in reducing mortality and supports the strategy of annual vaccination in diabetics aged at least 65 y.

Rhabdomyolysis connected with the use of bupropion.

OBJECTIVE: To report an observation dealing with a possible side effect of a smoking cessation drug. DESIGN: A case report. STUDY PERSON: A 34-year old man who had been treated with slow-release bupropion for smoking cessation. OBSERVATION: After 5 days of treatment the patient suffered severe muscular pain and the diagnosis of rhabdomyolysis was confirmed. CONCLUSION: Rhabdomyolysis is a rare complication when treating with slow-release bupropion for smoking cessation.