Antibiotics for treating urogenital Chlamydia trachomatis infection in men and non-pregnant women.

BACKGROUND: The genital infection caused by Chlamydia trachomatis (CT) is a common sexually transmitted infection (STI) globally. The infection is mainly asymptomatic in women, thus it can produce infertility and chronic pelvic pain. In men infection is mainly symptomatic, but can evolve to prostatitis. Clinical practice guidelines for CT urogenital infections do not give any specific recommendation about which antibiotic use as first option OBJECTIVES: To assess the efficacy and safety of antibiotic treatment for CT genital infection in men and non-pregnant women. SEARCH METHODS: The Cochrane Sexually Transmitted Infections' (STI) Information Specialist developed the electronic searches in electronic databases (CENTRAL, MEDLINE, Embase and LILACS), and trials registers. We searched studies published from inception to June 2018. SELECTION CRITERIA: We included parallel, randomised controlled trials (RCTs) of men, and sexually-active, non-pregnant women with CT infection (urethritis or uterine cervicitis or asymptomatic), diagnosed by cell culture for CT, nucleic acid amplification tests (NAAT) or antigen-based detection methods, who had been treated with any of the antibiotic regimens recommended by any of the updated to 2013 CT Guidelines. DATA COLLECTION AND ANALYSIS: Four review authors screened evidence according to selection criteria and independently extracted data and assessed risk of bias. Two authors developed the 'Summary of findings' tables. We used a fixed-effect meta-analysis model for combining data where it was reasonable to assume that studies were estimating the same underlying treatment effect. We estimated the pooled risk ratio in order to establish the effects of the comparisons. Our primary outcomes were microbiological failure and adverse events, and our secondary outcomes were clinical failure, antimicrobial resistance and reinfection. MAIN RESULTS: We selected 14 studies ( 2715 participants: 2147 (79.08%) men and 568 (20.92%) women). The studies were conducted mainly at STD clinics. Sample sizes ranged from 71 to 606 participants; follow-up was 29.7 days on average.For the comparison: azithromycin single dose versus doxycycline once or twice daily for 7 days, in men treated for CT, the risk of microbiological failure was higher in the azithromycin group (RR 2.45, 95% CI 1.36 to 4.41; participants = 821; studies = 9; moderate-quality evidence), but regarding clinical failure, the results showed that the effect is uncertain (RR 0.94, 95% CI 0.43 to 2,05; I² = 55%; participants = 525; studies = 3; low-quality evidence). Regarding adverse events (AE) in men there could be little or no difference between the antibiotics (RR 0.83, 95% CI 0.67 to 1.02; participants = 1424; studies = 6; low-quality evidence). About women treated for CT, the effect on microbiological failure was uncertain (RR = 1.71, 95% CI 0.48 to 6.16; participants = 338; studies = 5; very low-quality evidence). There were no studies assessing clinical failure or adverse events in women, however, we found that azithromycin probably has fewer adverse events in both genders (RR 0.83, 95% CI 0.71 to 0.98; I² = 0%; participants = 2261; studies = 9; moderate-quality evidence).For the second comparison: doxycycline compared to ofloxacin, for men treated for CT the effect on microbiological failure was uncertain (RR 8.53, 95% CI 0.43 to 167.38, I² not applicable; participants = 80; studies = 2; very low-quality evidence), as also it was on clinical failure (RR 0.85, 95% CI 0.28 to 2.62; participants = 36; studies = 1; very low-quality evidence). The effect of in women on clinical failure was uncertain (RR 0.94, 95% CI 0.39 to 2.25; I² = 39%; participants = 127; studies = 2; very low-quality evidence).Regarding adverse events, the effect in both men and women was uncertain (RR 1.02 95% CI 0.66 to 1.55; participants = 339 studies = 3; very low-quality evidence). The effect on microbiological failure in women and in men and women together, the effect on microbiological failure was not estimable. The most frequently AE reported were not serious and of gastrointestinal origin.No studies assessed antimicrobial resistance or reinfection in either comparison. AUTHORS' CONCLUSIONS: In men, regimens with azithromycin are probably less effective than doxycycline for microbiological failure, however, there might be little or no difference for clinical failure. For women, we are uncertain whether azithromycin compared to doxycycline increases the risk of microbiological failure. Azithromycin probably slightly reduces adverse events compared to doxycycline in men and women together but may have little difference in men alone. We are uncertain whether doxycycline compared to ofloxacin reduces microbiological failure in men or women alone, or men and women together, nor if it reduces clinical failure or adverse events in men or women.Based on the fact that women suffer mainly asymptomatic infections, and in order to test the effectiveness and safety of the current recommendations (azithromycin, doxycycline and ofloxacin), for CT infection, especially in low and middle income countries, future RCTs should be designed and conducted to include a large enough sample size of women, and with low risk of bias. It is also important that future RCTs include adherence, CT resistance to antibiotic regimens, and risk of reinfection as outcomes to be measured. In addition, it is important to conduct a network meta-analysis in order to evaluate all those studies that included in one arm only the current antibiotic treatments for CT infection that are recommended by the updated clinical practice guidelines.

Early versus delayed erythropoietin for the anaemia of end-stage kidney disease.

BACKGROUND: Anaemia is a common complication in people with chronic kidney disease (CKD) and mainly develops as a consequence of relative erythropoietin (EPO) deficiency. Anaemia develops early in the course of disease and peaks among people with end-stage kidney disease (ESKD). Many types of EPO - also called erythropoiesis-stimulating agents (ESAs) - are used to treat anaemia in people with ESKD.ESAs have changed treatment of severe anaemia among people with CKD by relieving symptoms and avoiding complications associated with blood transfusion. However, no benefits have been found in relation to mortality rates and non-cardiac fatal events, except quality of life. Moreover, a relationship between ESA use and increased cardiovascular morbidity and mortality in patients with CKD has been reported in studies with fully correcting anaemia comparing with partial anaemia correction. Until 2012, guidelines recommended commencing ESA treatment when haemoglobin was less than 11 g/dL; the current recommendation is EPO commencement when haemoglobin is between 9 and 10 g/dL. However, advantages in commencing therapy when haemoglobin levels are greater than 10 g/dL but less than 11 g/dL remain unknown, especially among older people whose life expectancy is limited, but in whom EPO therapy may improve quality of life. OBJECTIVES: To assess the clinical benefits and harms of early versus delayed EPO for anaemia in patients with ESKD undergoing haemodialysis or peritoneal dialysis SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 8 July 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs) and quasi-RCTs evaluating at the clinical benefits and harms of early versus delayed EPO for anaemia in patients with ESKD undergoing haemodialysis or peritoneal dialysis. Studies comparing EPO with another EPO, placebo or no treatment were eligible for inclusion. DATA COLLECTION AND ANALYSIS: It was planned that two authors would independently extract data from included studies and assess risk of bias using the Cochrane risk of bias tool. For dichotomous outcomes (all-cause mortality, cardiovascular mortality, overall myocardial infarction, overall stroke, vascular access thrombosis, adverse effects of treatment, transfusion), we planned to use the risk ratio (RR) with 95% confidence intervals (CI). We planned to calculate the mean difference (MD) and CI 95% for continuous data (haemoglobin level) and the standardised mean difference (SMD) with CI 95% for quality of life if different scales had been used. MAIN RESULTS: Literature searches yielded 1910 records, of these 1534 were screened after duplicates removed, of which 1376 were excluded following title and abstract assessment. We assessed 158 full text records and identified 18 studies (66 records) that were potentially eligible for inclusion. However, none matched our inclusion criteria and were excluded. AUTHORS' CONCLUSIONS: We found no evidence to assess the benefits and harms of early versus delayed EPO for the anaemia of ESKD.

Analysis of the evolocumab (Repatha®) patient support program for patients with cardiovascular disease in Colombia. / Análisis del programa de apoyo al paciente de evolocumab (Repatha®) para pacientes con enfermedades cardiovasculares en Colombia.

BACKGROUND: Cardiovascular diseases are considered the leading cause of death globally. This study describes the demographic characteristics, treatment patterns, self-reported compliance and persistence, and to explore variables related to non-adherence of patients enrolled in the cardiovascular patient support program (PSP) for evolocumab treatment in Colombia. METHODS: This retrospective observational of the data registry of patients who entered the evolocumab PSP program. RESULTS: The analysis included 930 patients enrolled in the PSP (2017-2021). Mean age was 65.1 (SD±13.1) and49.1% patients were female. The mean compliance rate to evolocumab treatment was 70.5% (SD±21.8). A total of 367 patients (40.5%) reported compliance higher than 80%. Persistence analysis included 739 patients (81.5%) where 87.8% of these patients were considered persistent to treatment. A total of 871 patients (93.7%) reported the occurrence of at least one adverse event during the follow-up period (mostly non-serious). CONCLUSION: This is the first real-life study describing patient characteristics, compliance and continuity of treatment for dyslipidemia in a patient support program in Colombia. The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab.

Statin associated adverse reactions in Latin America: a scoping review.

OBJECTIVES: We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries. DESIGN: Scoping review. METHODS: A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design. RESULTS: Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statin-versus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose. CONCLUSIONS: We identified differences in the frequency of ADRs in both observational studies and RCTs from LATAM countries. This could be due to the absence of standard definitions and reporting of ADRs as well as differences among the study's interventions, population characteristics or design. The variability of ADRs and the absence of definitions are similar to studies from other geographical locations. Further placebo-controlled trials and real-world data registries with universal definitions should follow.

Effectiveness assessment of maternal and neonatal health video clips in knowledge transfer using neuromarketing tools: A randomized crossover trial.

Audiovisual educational material has been used effectively as a knowledge translation strategy in patient education. Given the need to impact maternal mortality rates, 12 video clips related to maternal and neonatal health information were designed based on the results of a previous systematic review (SR). The content was formulated based on clinical practice guideline recommendations and validated following a formal consensus methodology. This study evaluated the effectiveness of knowledge transfer from the 12 video clips in terms of attention, emotional response, and recall by using neuroscience tools. In a randomized cross-over trial, 155 subjects (pregnant women, non-pregnant women, and men) received random sequences of 13 video clips, including a control video clip. Participants' attention levels were evaluated through eye tracking, their emotional reactions were monitored by electrodermal activity and pupillary diameter, and their recall was tested via a questionnaire. An analysis was performed to evaluate differences in the groups and between the video clips and the control clip using variance analysis models that considered period, sequence, and carry-over effects. Results revealed that fixation length was greater in women than in men, while the greatest emotional effects occurred in men. All three groups had good recall results, without any significant differences between them. Although the sequencing did influence attentional processes, no carry-over effect was demonstrated. However, a differential effect was noted among video clips in all three outcomes, that is, when adjusted for group, level of education, and having had children. The control clip generated less attention, emotional reaction, and recall than the experimental video clips. The video clips about maternal and neonatal health were shown to be effective in the transference and comprehension of information. Therefore, cognitive neuroscience techniques are useful in evaluating knowledge translation strategies through audiovisual formats.

Análisis del programa de apoyo al paciente de evolocumab (Repatha®) para pacientes con enfermedades cardiovasculares en Colombia / Analysis of the evolocumab (Repatha®) patient support program for patients with cardiovascular disease in Colombia

Antecedentes: Las enfermedades cardiovasculares son la principal causa de muerte a nivel mundial. El objetivo es describir las características demográficas, los patrones de tratamiento, cumplimiento terapéutico y continuidad del tratamiento y explorar las variables relacionadas con la falta de adherencia de los pacientes inscritos en un programa de apoyo al paciente (PSP, por sus siglas en inglés) cardiovascular para al tratamiento con evolocumab en Colombia. Métodos: Estudio observacional-retrospectivo del registro de datos de los pacientes que ingresaron al programa PSP de evolocumab. Resultados: El análisis incluyó a 930 pacientes inscritos en el PSP (2017-2021). La edad media fue de 65,1 años (DE±1,1) y el 49,1% eran mujeres. La tasa media de cumplimiento del tratamiento con evolocumab fue del 70,5% (DE±21,8). Un total de 367 pacientes (40,5%) reportaron una tasa de cumplimiento superior al 80%. El análisis de continuidad incluyó a 739 pacientes (81,5%); el 87,8% de estos pacientes fueron considerados persistentes en el tratamiento. Un total de 871 pacientes (93,7%) reportaron al menos un evento adverso durante el período de seguimiento (en su mayoría no graves). Conclusión: Este es el primer estudio de la vida real sobre el tratamiento para la dislipidemia en un programa de apoyo a pacientes en Colombia. La adherencia encontrada fue superior al 70%, cifra similar a los hallazgos de otros estudios de vida real. Entre las causas del bajo cumplimiento se destacan las barreras administrativas y médicas para la suspensión o abandono del tratamiento con evolocumab. (AU)

Background: Cardiovascular diseases are considered the leading cause of death globally. This study describes the demographic characteristics, treatment patterns, self-reported compliance and persistence, and to explore variables related to non-adherence of patients enrolled in the cardiovascular patient support program (PSP) for evolocumab treatment in Colombia. Methods: This retrospective observational of the data registry of patients who entered the evolocumab PSP program. Results: The analysis included 930 patients enrolled in the PSP (2017-2021). Mean age was 65.1 (SD±13.1) and49.1% patients were female. The mean compliance rate to evolocumab treatment was 70.5% (SD±21.8). A total of 367 patients (40.5%) reported compliance higher than 80%. Persistence analysis included 739 patients (81.5%) where 87.8% of these patients were considered persistent to treatment. A total of 871 patients (93.7%) reported the occurrence of at least one adverse event during the follow-up period (mostly non-serious). Conclusion: This is the first real-life study describing patient characteristics, compliance and continuity of treatment for dyslipidemia in a patient support program in Colombia. The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab. (AU)

Enterotoxigenic Escherichia coli associated with childhood diarrhoea in Colombia, South America.

INTRODUCTION: Intestinal Escherichia coli pathogens are major causes of diarrhoeal disease in children under five years of age worldwide. The aim of this study is to evaluate the association of E. coli pathotypes with childhood diarrhoea in Colombia. METHODOLOGY: A case-control study was conducted in 815 samples from children younger than five years of age in Cartagena, Colombia (466 cases and 349 controls). Controls were randomly selected 1:1 to cases, to obtain 349 cases and 349 controls. RESULTS: This study revealed that 27 (7.44%) cases and 12 (3.43%) controls were positives for any of the E. coli pathotypes. The difference observed was statistically significant indicating that E. coli pathotypes were associated with cases of childhood diarrhoea. Enterotoxigenic E. coli (ETEC) was the most common pathotype associated with childhood diarrhoea. Additional E. coli pathotypes were also identified. CONCLUSIONS: We conclude that after the adjustment by age, sex and socioeconomic stratum, the odds ratio obtained by logistic regression shows an association between infection with ETEC and childhood diarrhoea.

Inequalities in prescription of hydrochlorothiazide for diabetic hypertensive patients in Colombia.

OBJECTIVE: Evaluating differences in the suitable prescription of thiazides in hypertense patients, according to affiliation regime. MATERIALS AND METHODS: This was an analytical cross-sectional study. The database from a previous study was used regarding two groups of hypertense patients (subsidised regime and contributory regime) who had attended out-patient consultation between 01-09-2007 and 29-02-2008. Ideal therapy was evaluated in both groups. Univariate and multivariate analysis was carried out. RESULTS: 136 patients (contributory: 41.9 %; subsidised: 58.1 %). Subsidised regime patients were older (mean=68.8±10) than those from the contributory regime (mean=64.1±11.1) (t-test, p=0.0110). Prescribing antihypertensive drugs was ideal in 49/136 of the patients (36.0 %). Ideal prescription accounted for 24/79 (30 %) of the patients in the subsidised regime and 25/57 (43.8 %) in the contributory one (OR=1.79; 95 % CI:0.88-3.64). Older people (aged ≥ 65 yo) were at risk of receiving a non-ideal prescription (OR=2.12; 95 %CI:1.02-4.38) whilst this was not so in the subsidised regime (OR=1.62; 95 % CI:0.78-3.35). CONCLUSIONS: Ideal prescription of antihypertensive drugs was low in the population being studied. There were differences regarding age ideal prescription but not concerning affiliation regime. It is suggested that a longitudinal study be carried out in the future.

Case study: HIV drug resistance in a 13 year old boy, a multicausal problem / Estudio de caso: resistencia a los medicamentos contra el VIH en un niño de 13 años, un problema multicausal

Background: In 2011, at least 34 million people live with HIV. HIV vertical infected children require close follow-up from all the way through diagnosis to treatment and management of complications. Case summary: This is the case of a 13-year-old male patient with HIV (vertical transmission) diagnosed at 4 months old. His HIV diagnosis was made in the context of opportunistic manifestations of immunodeficiency because his mother did not access prenatal check-ups. He developed AIDS sequelae such as spastic paraparesia derived from HIV myelopathy and CMV retinitis due to immunodeficiency; these diseases presented in first two years of life. After three years from HAART initiation, the patient was exposed to inadequate HAART (ritonavir without another protease inhibitor), and experienced a first change of therapy due to virological failure. Subsequent treatment regimens ­a sum of 7­ presented failures in their formulation and this, along with delays due to administrative issues, led to the patient developing multiresistance to most of antiretrovirals given. The patient died mainly from multiorganic failure due to HIV and wasting syndrome. Conclusion: Congenital HIV is a fundamental issue in public health. It is a preventable disease, and perinatal management, including diagnosis and treatment, is a must. Treatment has demonstrated effectiveness when it is given with proper schemes and adherence. Administrative barriers led to failures in treatment and this affects the prognosis of any patient with HIV. This case is an example that highlights the relationship between virological and clinical failures with health system barriers, in HIV infected children. Managing gaps in diagnosis, antiretroviral administration, and follow up of HIV infected children translates into the prognosis of future adolescents and adults.

Antecedentes: en 2011, al menos 34 millones de personas viven con el VIH. Los niños infectados con VIH vertical requieren un seguimiento cercano desde el diagnóstico hasta el tratamiento y el tratamiento de las complicaciones. Resumen del caso: este es el caso de un paciente masculino de 13 años con VIH (transmisión vertical) diagnosticado a los 4 meses de edad. Su diagnóstico de VIH se realizó en el contexto de manifestaciones oportunistas de inmunodeficiencia porque su madre no accedió a controles prenatales. Desarrolló secuelas del SIDA tales como la paraparesia espástica derivada de la mielopatía por VIH y la retinitis por CMV debido a la inmunodeficiencia; estas enfermedades se presentaron en los primeros dos años de vida. Después de tres años desde el inicio de HAART, el paciente estuvo expuesto a TARGA inadecuado (ritonavir sin otro inhibidor de proteasa) y experimentó un primer cambio de terapia debido a falla virológica. Los regímenes de tratamiento subsiguientes -una suma de 7- presentaron fallas en su formulación y esto, junto con retrasos debidos a problemas administrativos, llevaron al paciente a desarrollar una resistencia múltiple a la mayoría de los antirretrovirales administrados. El paciente murió principalmente por falla multiorgánica debido al VIH y al síndrome de desgaste. Conclusión: el VIH congénito es un problema fundamental en la salud pública. Es una enfermedad prevenible y el tratamiento perinatal, incluidos el diagnóstico y el tratamiento, es obligatorio. El tratamiento ha demostrado efectividad cuando se administra con esquemas y adherencia adecuados. Las barreras administrativas condujeron a fallas en el tratamiento y esto afecta el pronóstico de cualquier paciente con VIH. Este caso es un ejemplo que destaca la relación entre las fallas virológicas y clínicas con las barreras del sistema de salud, en los niños infectados por el VIH. La gestión de las brechas en el diagnóstico, la administración de antirretrovirales y el seguimiento de los niños infectados por el VIH se traduce en el pronóstico de futuros adolescentes y adultos.

Inequalities in prescription of hydrochlorothiazide for diabetic hypertensive patients in Colombia / Desigualdades en la prescripción de hidroclorotiazida en pacientes hipertensos diabéticos en Colombia

Objective Evaluating differences in the suitable prescription of thiazides in hypertense patients, according to affiliation regime. Materials and methods This was an analytical cross-sectional study. The database from a previous study was used regarding two groups of hypertense patients (subsidised regime and contributory regime) who had attended out-patient consultation between 01-09-2007 and 29-02-2008. Ideal therapy was evaluated in both groups. Univariate and multivariate analysis was carried out. Results 136 patients (contributory: 41.9 percent; subsidised: 58.1 percent). Subsidised regime patients were older (mean=68.8±10) than those from the contributory regime (mean=64.1±11.1) (t-test, p=0.0110). Prescribing antihypertensive drugs was ideal in 49/136 of the patients (36.0 percent). Ideal prescription accounted for 24/79 (30 percent) of the patients in the subsidised regime and 25/57 (43.8 percent) in the contributory one (OR=1.79; 95 percent CI:0.88-3.64). Older people (aged ≥ 65yo) were at risk of receiving a non-ideal prescription (OR=2.12; 95 percentCI:1.02-4.38) whilst this was not so in the subsidised regime (OR=1.62; 95 percent CI:0.78-3.35). Conclusions Ideal prescription of antihypertensive drugs was low in the population being studied. There were differences regarding age ideal prescription but not concerning affiliation regime. It is suggested that a longitudinal study be carried out in the future.

Objetivo Evaluar las diferencias en la adecuada prescripción de tiazidas en pacientes hipertensos, según régimen de afiliación. Materiales y métodos Estudio de corte transversal analítico. Se utilizó la base de datos de un estudio previo, dos grupos de pacientes hipertensos: régimen subsidiado y régimen contributivo que asistieron a consulta externa entre el 01-09-2007 y el 29-02-2008. Se evaluó terapia ideal en los dos grupos. Se realizó análisis univariado y multivariado. Resultados Se estudiaron 136 pacientes (contributivo: 41,9 por ciento; subsidiado: 58,1 por ciento). Los pacientes del régimen subsidiado fueron mayores (promedio= 68,8±10) que los del contributivo (promedio=64,1±11.1) (t-test, p=0,0110). La prescripción de antihipertensivos fue ideal en 49/136 (36,0 por ciento). En el régimen subsidiado la prescripción fue ideal en 24/79 (30 por ciento) y en el contributivo en 25/57 (43,8 por ciento) (OR: 1,79 IC95 por ciento (0,88-3,64)). La edad ≥65años fue riesgo de prescripción no ideal (OR: 2.12, IC95 por ciento(1,02-4,38)), mientras que no lo fue estar en el régimen subsidiado (OR=1,62, IC95 por ciento(0,78-3,35). Conclusiones La prescripción ideal de antihipertensivos es baja. Hay diferencias en la edad, en la prescripción ideal, mas no por régimen de afiliación. Se sugiere un estudio longitudinal en el futuro.