Falls in hospitalized older adults and the use of fall risk-increasing drugs and anticholinergic medications in Colombia: a case‒control study.

Introduction: In-hospital falls are multicausal in older hospitalized patients. Drugs with anticholinergic load and psychotropic effects can increase the risk of falling. Objective: This study aimed to determine the associations between fall risk-increasing drugs (FRIDs) and the anticholinergic risk score (ARS) with falls in hospitalized older hospitalized patients. Methods: This was a case‒control study of patients ≥65 years of age of either sex treated in four clinics in Colombia between 2018 and 2020. Each patient who suffered a fall during hospitalization was matched with four hospitalized patients who did not. Sociodemographic, clinical, and pharmacologic variables and the use of the ARS and FRIDs were evaluated. The risk associated with FRIDs was estimated using conditional logistic regression. Results: There were 250 patients and 1,000 controls (ratio of 1:4), with a mean age of 77.4 ± 7.4 years and a predominance of men (n = 800, 64.0%). The majority of falls occurred during hospitalization (n = 192 patients, 76.8%). Polypharmacy, calcium channel blockers, antiepileptics, antipsychotics, sodium-glucose cotransporter type 2 inhibitors, and nonsteroidal anti-inflammatory drugs were associated with falls during hospitalization. With an ARS score of 3, the probability of falling during the hospital stay increased (aOR: 2.34; 95% CI: 1.64-3.32). Conclusion: There is an association between suffering a fall and the use of drugs with anticholinergic load or FRIDs in hospitalized adults more than 65 years of age in Colombia.

Challenging dogmas: Intravenous versus oral beta-lactam antibiotic provocation tests.

Background: Drug provocation tests (DPT) are considered the gold standard procedure to ascertain the diagnosis of beta-lactam (BL) allergy. Regarding route of administration, current recommendations prioritize oral challenges, considering them safer, and reserving the intravenous route for drugs for which this is the only formulation. Objective: To compare in terms of tolerance and safety two protocols of BL DPT, using an oral protocol (OR-DPT) and an intravenous protocol (IV-DPT). Methods: A descriptive, retrospective study was performed, including adult patients who underwent IV-DPT or OR-DPT for suspected immediate or delayed hypersensitivity to BL antibiotics, over a period of 4 years (between January 2018 and December 2021). Demographical data, index hypersensivity reactions' characteristics and tolerance to DPT were reviewed. Results: A total of 1036 patients underwent DPT, mean age of 56.8 (standard deviation, SD, 17.8) years, 655 were women (63.2%). Immediate drug hypersensitivity reactions (DHR) had occurred in 564 of patients (54.4%). OR-DPT were performed in 439 (42.4%) and IV-DPT in 597 (57.6%). The frequency of reactions during DPT, regardless of the route used, was low (3.6%): only 16 (3.6%) in OR-DPT and 21 (3.5%) in IV-DPT. From IV-DPT, 16 out 21 DHR during DPT were immediate compared with 4 out of 16 in OR-DPT. Adjusted relative risk of developing a hypersensitivity reaction during IV-DPT versus OR-DPT was 1.13 (95% confidence interval (CI)0.57-2.22). Conclusion: The results suggest that OR-DPT and IV-DPT are both safe procedures when adequately performed. However, IV-DPT protocols showed a higher rate of immediate DHR during DPT probably due to the selection of basal high-risk patients to undergo IV-DPT. In conclusion, IV-DPT may be considered as an option for challenges in drug-allergy studies, entailing a precise administration.

Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice.

Background: Data related to adverse drug reactions (ADRs), specifically immune-related adverse events (irAEs), in long-term treatment with immunotherapy in real-world practice is scarce, as is general information regarding the management of ADRs. Objectives: To characterize and describe the incidence of ADRs in patients who began immunotherapy treatment in clinical practice. Methods: In a prospective observational study cancer patients ≥18 years of age who were treated with a monotherapy regime of PD-1/PD-L1 inhibitors were evaluated. The study period was from November 2017 to June 2019 and patients were followed up until June 2021. Patients were contacted monthly by telephone and their electronic health records were reviewed. Each ADR was graded according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). Results: Out of 99 patients, 86 met the inclusion criteria. Most were male (67.4%), with a median age of 66 (interquartile range, IQR: 59-76). The most frequent cancer was non-small cellular lung cancer (46 cases, 53.5%), followed by melanoma (22, 25.6%). A total of 74 patients (86%) were treated with anti-PD-1 drugs and 12 (14%) were treated with anti-PD-L1 drugs. The median treatment durations were 4.9 (IQR: 1.9-17.0) and 5.9 months (IQR: 1.2-12.3), respectively. Sixty-three patients (73%) developed from a total of 156 (44% of the total number of ADR) irADRs, wherein the most frequent were skin disorders (50 cases, 32%, incidence = 30.5 irADRs/100 patients per year [p-y]), gastrointestinal disorders (29, 19%, 17.7 irADRs/100 p-y), musculoskeletal disorders (17, 11%, 10.4 irADRs/100 p-y), and endocrine disorders (14, 9%, 8.6 irADRs/100 p-y). A total of 22 irADRs (14%) had a latency period of ≥12 months. Twelve irADRs (7.7%) were categorized as grade 3-4, and while 2 (1.3%) were categorized as grade 5 (death). Sixty-one irADRs (39.1%) in 36 patients required pharmacological treatment and 47 irADRs (30.1%) in 22 patients required treatment with corticosteriods. Conclusion: The majority of patients treated with anti-PD1/PDL1-based immunotherapy experienced adverse reactions. Although most of these reactions were mild, 11.5% were categorized as grade 3 or above. A high percentage of the reactions were immune-related and occurred throughout the treatment, thereby indicating that early identification and close monitoring is essential.

Validez predictiva de la capacidad funcional del cuestionario CUPAX en pacientes ancianos afectos de fractura de cadera / Predictive validity of the functional capacity of the CUPAX questionnaire in older adults with hip fracture

Antecedentes y objetivoLa fractura osteoporótica de cadera es una enfermedad relevante por su prevalencia e impacto social y sanitario. El objetivo de este estudio es explorar la validez predictiva del cuestionario CUPAX sobre la mortalidad, el lugar de residencia y la funcionalidad posfractura.Materiales y métodosEstudio observacional prospectivo. Se incluyeron 206 pacientes mayores de 65 años ingresados tras una fractura de cadera. Se recogió la puntuación del cuestionario CUPAX prefractura y al año, y el lugar de residencia y la supervivencia al alta hospitalaria y a los 6 y 12 meses. El análisis estadístico se ha realizado con los programas SAS® 9.4 y Stata® 13.1.ResultadosLa edad mediana de la muestra fue 87 años (80,1% mujeres). La tasa de mortalidad intrahospitalaria y al año fue del 5,8% y 19,1%, respectivamente. La mayoría de los pacientes procedían de su domicilio (71,4%), y el destino al alta más frecuente fue un centro sociosanitario (48,2%). El porcentaje de retención del nivel funcional previo en el total de la muestra fue del 50%, siendo mayor en los pacientes más jóvenes. El área bajo la curva ROC para la mortalidad al año fue 0,697 (IC 95%: 0,626-0,760) y para el destino al alta de los pacientes procedentes del domicilio 0,659 (IC 95%: 0,576-0,741). La valoración de la retención funcional al año permite identificar 3 grupos de pacientes en función del valor del CUPAX prefractura.ConclusionesEstos hallazgos apoyan la utilidad clínica del cuestionario CUPAX como herramienta funcional predictiva en pacientes ancianos afectos de fractura de cadera.

Predictive validity of the functional capacity of the CUPAX questionnaire in older adults with hip fracture. / Validez predictiva de la capacidad funcional del cuestionario CUPAX en pacientes ancianos afectos de fractura de cadera.

BACKGROUND AND OBJECTIVES: Osteoporotic hip fracture is a relevant pathology due to its prevalence and social and health impact. The aim of this study is to explore the predictive validity of the CUPAX questionnaire on mortality, place of residence and post-fracture functionality. MATERIALS AND METHODS: Prospective observational study. Two hundred and six patients older than 65 years were included, admitted after a hip fracture. The CUPAX questionnaire score was collected before fracture and one year later, and the place of residence and survival at hospital discharge, and after 6 and 12 months. The statistical analysis was carried out with the SAS® 9.4 and Stata® 13.1 programmes. RESULTS: The median age of the sample was 87.0 years (80.1% women). The in-hospital and one-year mortality rate were 5.8% and 19.1%, respectively. Most of the patients were admitted from home (71.4%), and the most frequent discharge destination was a social health centre (48.2%). The percentage of retention of previous functional level in the total sample was 50%, being higher in the younger patients. The area under the curve ROC for mortality one year later was .697 (95% CI .626-.760) and .659 (95% CI .576-.741) for the discharge destination of patients admitted from home. Evaluation of functional retention one year after the fracture, identified three groups of patients based on the pre-fracture CUPAX value. CONCLUSIONS: These findings support the clinical utility of the CUPAX questionnaire as a predictive functional tool in elderly patients with hip fracture.

Cardiovascular events and mortality among type 2 diabetes mellitus patients newly prescribed first-line blood glucose-lowering drugs monotherapies: A population-based cohort study in the Catalan electronic medical record database, SIDIAP, 2010-2015.

AIM: To assess cardiovascular (CV) events and all-cause mortality in type 2 diabetes mellitus (T2DM) patients treated with first-line monotherapies of non-insulin antidiabetic drugs (NIADs). METHODS: Longitudinal retrospective cohort study in the Catalan database SIDIAP (Information System for the Development of Research in Primary Care). T2DM patients ≥18 years newly prescribed first-line monotherapies during 2010-2015 were followed since their first prescription until the composite of major adverse CV events, MACE (myocardium infarction [MI], stroke and all-cause death), its components, heart failure (HF) and peripheral artery disease (PAD) or censoring. Cox proportional hazard models were used to estimate hazard ratios 95% confidence interval (HR [95%CI]). RESULTS: Compared with metformin, the use of sulfonylureas, dipeptidyl peptidase-4 inhibitors (DPP-4 i) and meglitinides were significantly associated with higher risk for MACE (1.55 [1.42-1.68]); 1.49 [1.22-1.84] and 2.01 [1.29-3.12]) and all-cause mortality (1.67 [1.52-1.84], 1.65 [1.30-2.] and 2.08 [1.26-3.42]). Sulfonylureas users had increased risk of MI (1.38 [1.03-1.85]) stroke (1.31 [1.11-1.54]), HF (1.49 [1.28-1.72]) and PAD (1.24 [1.02-1.51]). Meglitinides users were at increased risks of MI, HR 2.03 (1.10-3.74). CONCLUSION: In first-line monotherapies, compared with metformin, sulfonylureas were associated with increased risks in all the outcomes; DPP-4 i and repaglinide showed increased risks of MACE and mortality. Residual confounding cannot be ruled out.

Cuestionario CUPAX: desarrollo y validación de una nueva escala para la valoración del nivel funcional de pacientes mayores de 65 años con fractura de cadera / The CUPAX questionnaire: Development and validation of a new scale for assessment of the functional level of elderly patients with a hip fracture

ANTECEDENTES Y OBJETIVO: Las fracturas de cadera en pacientes ancianos tienen una elevada frecuencia y morbimortalidad. No disponemos de instrumentos validados en castellano que puedan valorar fielmente la capacidad funcional previa a la fractura. El objetivo de este estudio fue desarrollar y validar el cuestionario CUPAX en pacientes ancianos con fractura de cadera. MATERIALES Y MÉTODOS: Estudio de validación observacional y prospectivo. Se incluyó a 215 pacientes mayores de 65 años, que ingresaron en nuestro centro tras sufrir una fractura de cadera. Se evaluaron mediante el cuestionario CUPAX, índice de Barthel y score de Parker. Se realizó el estudio estadístico para valorar la validez y fiabilidad del cuestionario. RESULTADOS: La edad mediana de la muestra fue 84 años (75,3% mujeres). La mayoría de los pacientes presentaban fractura de localización extracapsular, eran previamente deambulantes y sufrían la caída en su domicilio. El estudio estadístico sobre la validez y la fiabilidad del cuestionario obtuvo los siguientes resultados. El coeficiente alfa de Cronbach mostró una excelente consistencia interna (valor de 0,94). El análisis factorial mostró 3 factores subyacentes. El coeficiente de correlación intraclase (CCI) interobservador fue 0,82 (IC del 95%: 0,75-0,87) y el CCI intraobservador fue 0,96 (IC del 95%: 0,95-0,97). La correlación con otras escalas funcionales fue valorada mediante el coeficiente de correlación de Spearman: 0,83 con el índice de Barthel y 0,81 con el score de Parker. CONCLUSIONES: Estos hallazgos apoyan la validez del cuestionario CUPAX como herramienta de valoración del nivel funcional previo en pacientes ancianos afectados de fractura de cadera

BACKGROUND AND AIM: Hip fractures in elderly patients are very frequent and are associated with high morbidity and mortality. We do not have validated instruments in Spanish that can faithfully assess functional capacity prior to fracture. The aim of this study was to develop and validate the CUPAX questionnaire in elderly patients with a hip fracture. MATERIALS AND METHODS: Prospective and observational validation study. We included 215 patients older than 65 years, who were admitted to our centre after suffering a hip fracture. They were evaluated using the CUPAX questionnaire, Barthel Index and Parker Score. The statistical study was performed to corroborate the validity and reliability of the questionnaire. RESULTS: The median age of the patient population was 84.0 years (75.3% women). The majority were patients who had suffered an extracapsular fracture; they had walking capacity and suffered a fall in their place of residence. The statistical analysis on the validity and reliability of the questionnaire obtained the following results: Cronbach's alpha coefficient showed excellent internal consistency (value of .94). Factor analysis showed 3 underlying factors. The interobserver intraclass correlation coefficient (ICC) was .82 (95% CI:.75-.87), and the intraobserver ICC was .96 (95% CI:.95-.97). Correlation with other functional scales was assessed using the Spearman correlation coefficient, which was .83 with the Barthel Index and .81 with the Parker score. CONCLUSIONS: These findings support the validity of the CUPAX questionnaire as a tool to measure the previous functional level in elderly patients affected by a hip fracture

Cardiovascular outcomes, heart failure and mortality in type 2 diabetic patients treated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs): A systematic review and meta-analysis of observational cohort studies.

BACKGROUND: Cardiovascular outcomes trials (CVOTs) have assessed the effects of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on major adverse cardiovascular events (MACE) and mortality in high cardiovascular (CV) risk populations. Observational research can provide complementary evidence about these effects in unselected populations. AIM: To systematically review retrospective observational cohort studies conducted in electronic healthcare databases (EHDs) assessing GLP-1 RAs´ effects on MACE and/or hospitalisation for heart failure (HHF) and/or all-cause mortality in Type 2 diabetes mellitus (T2DM) patients. METHODS: We systematically searched studies meeting inclusion criteria, compared design, methods and population characteristics, assessed risk for bias and did a meta-analysis (MA) using a random-effects model to calculate overall hazard ratios (HRs) and 95% CI (confidence intervals). RESULTS: Sixteen studies included 285,436 T2DM patients exposed to GLP-1 RAs (exenatide bid, liraglutide, lixisenatide, long-acting exenatide), n ranged from 219 to 160,803 patients. Comparators included: no exposure, other antidiabetic medications (OADs), combined OADs, canagliflozin or multiple comparators. Ten studies estimated all-cause mortality, hazard ratios (HRs) ranged from 0.17 (95% CI 0.02-1.22) to 1.29 (95% CI 0.54-3.13). Thirteen studies assessed cardiovascular events and/or MACE; HRs ranged from 0.27 (95% CI 0.14-0.53) to 1.11 (95% CI 0.99-1.24). Eight studies assessed HHF, HRs ranged from 0.12 (95% CI 0.02-0.66) to 1.64 (95% CI 1.28-2.13). Excluding two studies because of temporal bias, we obtained pooled estimates for all-cause mortality: HR 0.63 (0.44-0.89), CV outcomes HR 0.84 (0.75-0.94) and HHF; HR 0.94 (0.78-1.14), (high between-study variability: I2  = 83.35%; I2  = 70.3%; and I2  = 90.1%, respectively). CONCLUSION: Pooled results of EHDs' studies assessing GLP-1 RAs effects favoured GLP-1 RAs for all-cause mortality and MACE while were neutral for HHF. Results should be interpreted cautiously because of studies' substantial heterogeneity and limitations of observational research.

The CUPAX questionnaire: Development and validation of a new scale for assessment of the functional level of elderly patients with a hip fracture. / Cuestionario CUPAX: desarrollo y validación de una nueva escala para la valoración del nivel funcional de pacientes mayores de 65 años con fractura de cadera.

BACKGROUND AND AIM: Hip fractures in elderly patients are very frequent and are associated with high morbidity and mortality. We do not have validated instruments in Spanish that can faithfully assess functional capacity prior to fracture. The aim of this study was to develop and validate the CUPAX questionnaire in elderly patients with a hip fracture. MATERIALS AND METHODS: Prospective and observational validation study. We included 215 patients older than 65 years, who were admitted to our centre after suffering a hip fracture. They were evaluated using the CUPAX questionnaire, Barthel Index and Parker Score. The statistical study was performed to corroborate the validity and reliability of the questionnaire. RESULTS: The median age of the patient population was 84.0 years (75.3% women). The majority were patients who had suffered an extracapsular fracture; they had walking capacity and suffered a fall in their place of residence. The statistical analysis on the validity and reliability of the questionnaire obtained the following results: Cronbach's alpha coefficient showed excellent internal consistency (value of .94). Factor analysis showed 3 underlying factors. The interobserver intraclass correlation coefficient (ICC) was .82 (95% CI:.75-.87), and the intraobserver ICC was .96 (95% CI:.95-.97). Correlation with other functional scales was assessed using the Spearman correlation coefficient, which was .83 with the Barthel Index and .81 with the Parker score. CONCLUSIONS: These findings support the validity of the CUPAX questionnaire as a tool to measure the previous functional level in elderly patients affected by a hip fracture.

Insuficiencia renal aguda relacionada con medicamentos en pacientes hospitalizados / Drug-related acute renal failure in hospitalised patients

Antecedentes: La información sobre la incidencia de insuficiencia renal aguda (IRA) intrahospitalaria relacionada con medicamentos y las características de los pacientes es escasa. Objetivo: Estimar la incidencia de IRA relacionada con medicamentos en pacientes hospitalizados y comparar sus características con las de los pacientes con IRA relacionada con otras causas. Métodos: Cohorte prospectiva de pacientes con IRA intrahospitalaria (julio de 2010-julio de 2011). Se recogió información sobre características y antecedentes de los pacientes, factores de riesgo y gravedad de la IRA según la clasificación RIFLE, y medicación durante la hospitalización. El análisis de la imputabilidad de los fármacos y la evaluación de la relación causal se realizó siguiendo los métodos y el algoritmo del Sistema Español de Farmacovigilancia. Resultados: Un total de 194 casos presentaron un episodio de IRA intrahospitalaria. La edad mediana de los pacientes fue de 72 años (RI 20); el 60% eran hombres. La incidencia de IRA intrahospitalaria fue de 9,6 por cada 1.000 ingresos. Un 77,8% de los casos presentaron riesgo o daño renal según la clasificación RIFLE. En 105 (54,1%) casos, la IRA se relacionó con medicamentos; principalmente diuréticos, medicamentos que actúan sobre el sistema renina-angiotensina, inmunosupresores, bloqueadores β-adrenérgicos, bloqueantes de los canales de calcio, medios de contraste y antiinflamatorios no esteroideos. La morbilidad cardiovascular fue mayor y la frecuencia de factores de riesgo de IRA y la mortalidad menores en los pacientes con IRA relacionada con medicamentos. Conclusiones: La mitad de los episodios de IRA intrahospitalaria se relacionaron con medicamentos. Los pacientes con IRA relacionada con medicamentos presentaron más antecedentes patológicos cardiovasculares, pero menos factores de riesgo de IRA y una menor mortalidad (AU)

Introduction: The information available on the incidence and the characteristics of patients with acute renal failure (ARF) related to drugs is scarce. Objectives: To estimate the incidence of drug-related ARF in hospitalised patients and to compare their characteristics with those of patients with ARF due to other causes. Material and methods: We selected a prospective cohort of patients with ARF during hospital admission (July 2010-July 2011). Information on patients’ demographics, medical antecedents, ARF risk factors, ARF severity according to the RIFLE classification and hospital drug administration was collected. We analysed the relationship of drugs with the ARF episodes using Spanish Pharmacovigilance System methods and algorithm. Results: A total of 194 cases had an episode of hospital-acquired ARF. The median age of patients was 72 years [IQR 20]; 60% were men. The ARF incidence during hospitalization was 9.6 per 1,000 admissions. According to the RIFLE classification, a risk of kidney damage or kidney injury was present in 77.8% of cases. In 105 (54.1%) cases, ARF was drug-related; the drugs most frequently involved were diuretics, agents acting on the renin-angiotensin system, immunosuppressants, β-blocking agents, calcium channel blockers, contrast media and non-steroid anti-inflammatory drugs. Patients with drug-related ARF had more multi-morbidity, fewer ARF risk factors and lower mortality. Conclusions: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality (AU)

Drug-related acute renal failure in hospitalised patients.

INTRODUCTION: The information available on the incidence and the characteristics of patients with acute renal failure (ARF) related to drugs is scarce. OBJECTIVES: To estimate the incidence of drug-related ARF in hospitalised patients and to compare their characteristics with those of patients with ARF due to other causes. MATERIAL AND METHODS: We selected a prospective cohort of patients with ARF during hospital admission (July 2010-July 2011). Information on patients' demographics, medical antecedents, ARF risk factors, ARF severity according to the RIFLE classification and hospital drug administration was collected. We analysed the relationship of drugs with the ARF episodes using Spanish Pharmacovigilance System methods and algorithm. RESULTS: A total of 194 cases had an episode of hospital-acquired ARF. The median age of patients was 72 years [IQR 20]; 60% were men. The ARF incidence during hospitalization was 9.6 per 1,000 admissions. According to the RIFLE classification, a risk of kidney damage or kidney injury was present in 77.8% of cases. In 105 (54.1%) cases, ARF was drug-related; the drugs most frequently involved were diuretics, agents acting on the renin-angiotensin system, immunosuppressants, ß-blocking agents, calcium channel blockers, contrast media and non-steroid anti-inflammatory drugs. Patients with drug-related ARF had more multi-morbidity, fewer ARF risk factors and lower mortality. CONCLUSIONS: Half of ARF episodes during hospitalisation were drug related. Patients with drug-related ARF had higher cardiovascular morbidity than those with ARF related to other causes, but they had a lower frequency of ARF risk factors and mortality.

Evaluación de la respuesta y seguridada diferentes esquemas de tratamiento antirretroviral en Colombia / Response assessment and safety of different schemes of Anti-HIV Agents in Colombia / Avaliação da resposta e segurança a diferentes esquemas de tratamento antirretroviral em Colombia

Introducción: establecer variables asociadas a falla terapéutica, adherencia al tratamiento, cambio de esquema y efectos indeseables asociados al tratamiento de VIH/SIDA.Métodos: estudio de corte transversal realizado en población de pacientes condiagnóstico de VIH/SIDA en tratamiento antirretroviral de 19 ciudades colombianas afiliados al Sistema General de Seguridad Social en Salud. Se evaluaron variables socio-demográficas, esquemas terapéuticos, tiempo desde inicio de la terapia y cambio de esquema, reporte de falta de adherencia, falla terapéutica y efectos indeseables. Se hicieron análisis bivariados y multivariados. Resultados: se hallaron 510 pacientes; el tratamiento antirretroviral sufriómodificaciones al primer esquema en 56,4% de casos. Se reportó: falta de adherencia en 38,8%, falla terapéutica en 26,5% de pacientes; las reacciones adversas más frecuentes fueron: dislipidemia (14,9%), intolerancia gástrica (9,2%) y anemia (7,1%). El régimen de tratamiento Lamivudina/Zidovudina + Efavirenz se asoció con menor riesgo de cambio de esquema (p<0,001), de falla terapéutica (p<0,001) y de intolerancia (p<0,001). El fracaso terapéutico se asoció con antecedentes de neumocistosis, tomar 7 píldoras al día, repartidas en 3 a 4 dosis diarias, en tratamiento para diferentes comorbilidades, con falta de adherencia y efectos indeseables asociados a los antirretrovirales. Conclusiones: la identificación de los esquemas de tratamiento asociados con peortolerabilidad por su riesgo de afectar la adherencia al manejo del VIH, con mástabletas diarias y consumidos varias veces al día, permite orientar la selección de medicamentos que garanticen mayor adherencia y tolerabilidad.

Introduction: estimate variables associated with treatment failure, treatment adherence, schema change and adverse reactions associated with the treatment of HIV/AIDS.Methods: cross-sectional study conducted in a population of patients with HIV/ AIDS antiretroviral treatment in 19 cities of Colombia affiliates at Social Security System in Health. We assessed socio-demographic variables, treatment regimens, and time from start of therapy and schema change, report non-adherence, treatment failure and adverse reactions. Were used bivariate and multivariate analysis.Results: we found 510 patients, antiretroviral therapy was modified to the first scheme in 56.4% of cases, nonadherence in 38.8%, treatment failure in 26.5% of patients, and the most common adverse reactions were: dyslipidemia (14.9%), gastric intolerance (9.2%) and anaemia (7.1%). The treatment regimen Lamivudine / Zidovudine + Efavirenz was associated with lower risk of schema change (p <0.001), treatment failure (p <0.001) and intolerance (p <0.001). Treatment failure was associated with a history of pneumocystosis, taking 7 pills a day, divided into 3-4 daily doses, in treatment for different comorbidities, lack of adherence and adverse effects associated with antiretrovirals.Conclusions: the identification of treatment regimens associated with poorer tolerability for their risk of affecting adherence to HIV management, with more tablets daily and consumed several times a day can guide the selection of drugs to ensure greater adherence and tolerability.

Introdução: estabelecer variavéis associadas à falha terapêutica, aderência ao tratamento, mudança de esquema e efeitos indesejaveis associados ao tratamento de VIH/SIDA.Métodos: estudo de corte transversal realizado em grupos de pacientes com diagnóstico de VIH/SIDA em tratamento antirretroviral de 19 cidades colombianas filiados ao Sistema Geral de Segurança Social em Saúde. Avaliaram-se variavéis socio-demográficas, esquemas terapêuticos, tempo desde o inicio da terapia e mudança de esquema, anotação sobre falta de aderência, falha terapêutica e efeitos indesejaveis. Foram feitas análises bivariados y multivariados.Resultados: acharam-se 510 pacientes, e o tratamento antirretroviral sofreu modificações ao primeiro esquema em 56,4% dos casos, se reportou: falta de aderência em 38,8%, falha terapêutica em 26,5% dos pacientes; as reações adversas mais frequentes foram: dislipidemia (14,9%), intolerência gástrica (9,2%) e anemia (7,1%). O regime de tratamento Lamivudina/Zidovudina + Efavirenz se associou com menor risco de mudança de esquema (p<0,001), de falha terapêutica (p<0,001) e de intolerância (p<0,001). O fracasso terapêutico se associou com antecedentes de neumocistosis, tomar 7 comprimidos por dia, distribuido em 3 a 4 doses diárias, em tratamento para diferentes comorbilidades, com falta de aderência e efeitos indesejados associados aos antirretroviraies.Conclusões: a identificação dos esquemas de tratamento associados com pior tolerância pelo risco de afetar a aderência ao tratamento do VIH, com mais comprimidos diários e consumidos várias vezes ao dia, permite orientar a seleção de medicamentos que garantam maior aderência e tolerabilidade.

Sobre utilización de Inhibidores de la acidez gástrica en pacientes pediátricos / Overuse of acid-suppressive therapy in pediatric patients

Objetivos: Evaluar los patrones de prescripción deranitidina y omeprazol en pacientes pediátricos ingresados enun hospital de niños; la adecuación de dichas prescripcionesy los costos generados por prescripciones incorrectas.Pacientes y Métodos: estudio de utilización demedicamentos para observar pacientes ingresados en elHospital de Niños (Córdoba –Argentina) durante 1 mes.Resultados: Durante el mes de estudio ingresaron 680pacientes, de los cuales 415 (61%) recibieron inhibidoresde la acidez gástrica (IAG). De estos, 330 pacientes (79,5%)no presentaron factores de riesgo para desarrollar úlcerapor estrés, y en 293 pacientes (70,6%) las indicacionesse consideraron incorrectas. Sólo 81 pacientes (19,5%)presentaron indicaciones y dosis correctas de IAG. Seencontró una relación de la prescripción con el ingreso aquirófano y con el uso concomitante de corticoides a dosisbajas. El consumo innecesario de IAG generó un gasto directomensual de US$ 470,42

Objectives: To evaluate prescription patterns of intravenous ranitidine and omeprazolein pediatric patients hospitalized in a children’s hospital, the adequacy of said prescriptionsand the costs originated by incorrect prescriptions.Patients and Methods: A study of medication usage was designed to observe all patientshospitalized at Hospital de Niños (Córdoba- Argentina) during one month.Results: During the month of study 680 patients were hospitalized, 415 (61%) ofthem received acid-suppressive drugs (ASD). From these, 330 patients (79.5%) did notshow risk factors to develop stress ulcer and indications were considered incorrect in 293patients (70.6%). Only 81 patients (19.5%) showed correct indications and doses of ASD.A relationship was found between prescription and access to the operating room alongwith the concomitant use of corticoid in low doses. The unnecessary consumption of ASDgenerated a direct monthly expenditure of USD 470.42

Sobre utilización de Inhibidores de la acidez gástrica en pacientes pediátricos / Overuse of acid-suppressive therapy in pediatric patients

Objetivos: Evaluar los patrones de prescripción deranitidina y omeprazol en pacientes pediátricos ingresados enun hospital de niños; la adecuación de dichas prescripcionesy los costos generados por prescripciones incorrectas.Pacientes y Métodos: estudio de utilización demedicamentos para observar pacientes ingresados en elHospital de Niños (Córdoba ûArgentina) durante 1 mes.Resultados: Durante el mes de estudio ingresaron 680pacientes, de los cuales 415 (61%) recibieron inhibidoresde la acidez gástrica (IAG). De estos, 330 pacientes (79,5%)no presentaron factores de riesgo para desarrollar úlcerapor estrés, y en 293 pacientes (70,6%) las indicacionesse consideraron incorrectas. Sólo 81 pacientes (19,5%)presentaron indicaciones y dosis correctas de IAG. Seencontró una relación de la prescripción con el ingreso aquirófano y con el uso concomitante de corticoides a dosisbajas. El consumo innecesario de IAG generó un gasto directomensual de US$ 470,42(AU)

Objectives: To evaluate prescription patterns of intravenous ranitidine and omeprazolein pediatric patients hospitalized in a childrenÆs hospital, the adequacy of said prescriptionsand the costs originated by incorrect prescriptions.Patients and Methods: A study of medication usage was designed to observe all patientshospitalized at Hospital de Niños (Córdoba- Argentina) during one month.Results: During the month of study 680 patients were hospitalized, 415 (61%) ofthem received acid-suppressive drugs (ASD). From these, 330 patients (79.5%) did notshow risk factors to develop stress ulcer and indications were considered incorrect in 293patients (70.6%). Only 81 patients (19.5%) showed correct indications and doses of ASD.A relationship was found between prescription and access to the operating room alongwith the concomitant use of corticoid in low doses. The unnecessary consumption of ASDgenerated a direct monthly expenditure of USD 470.42(AU)

Effectiveness of antiretroviral treatment in patients from Pereira and Manizales.

OBJECTIVE: Evaluating the effectiveness of antiretroviral therapy in a sample of Colombian patients diagnosed as having HIV/AIDS and being treated by the Colombian Health Social Security System (CHSSS) METHODS: A descriptive study was conducted among 134 HIV/AIDS patients of any age or gender who had received antiretroviral therapy in the cities of Pereira and Manizales between July 1st 2008 and June 30th 2009. The following factors were assessed from the clinical history of the patients seen in three health insurance companies: viral load, CD4 count, antiretroviral treatment regimens, prescribed daily doses of medications, length of disease evolution, duration of therapy, history of opportunistic diseases, and drug costs. RESULTS: There was male predominance (91 men cf 43 women), mean age beingf 39 years, and an average of 59 months since diagnosis. All treatment regimens were defined by each drug's defined daily dose (DDD). The therapy was effective in 74.5 % of patients. Effectiveness was defined as being viral load < 400 copies/ml. About 79.1 % of patients had had their viral load measured during the last 6 months. Non-adherence to treatment and a history of having acquired 2 other sexually- transmitted infections were associated with an increased risk of uncontrolled HIV infection. The average value of drugs per year per patient was $4,077.2 ± 3,043.8 U.S. dollars/year. CONCLUSIONS: Non-adherence to treatment remains one of the most important issues regarding antiretroviral therapy effectiveness, so programmes intended to control HIV/AIDS must address this problem.

Effectiveness of antiretroviral treatment in patients from Pereira and Manizales / Efectividad del tratamiento antirretroviral en pacientes de Pereira y Manizales

Objective Evaluating the effectiveness of antiretroviral therapy in a sample of Colombian patients diagnosed as having HIV/AIDS and being treated by the Colombian Health Social Security System (CHSSS) Methods A descriptive study was conducted among 134 HIV/AIDS patients of any age or gender who had received antiretroviral therapy in the cities of Pereira and Manizales between July 1st 2008 and June 30th 2009. The following factors were assessed from the clinical history of the patients seen in three health insurance companies: viral load, CD4 count, antiretroviral treatment regimens, prescribed daily doses of medications, length of disease evolution, duration of therapy, history of opportunistic diseases, and drug costs. Results There was male predominance (91 men cf 43 women), mean age beingf 39 years, and an average of 59 months since diagnosis. All treatment regimens were defined by each drug's defined daily dose (DDD). The therapy was effective in 74.5 percent of patients. Effectiveness was defined as being viral load < 400 copies/ml. About 79.1 percent of patients had had their viral load measured during the last 6 months. Non-adherence to treatment and a history of having acquired 2 other sexually- transmitted infections were associated with an increased risk of uncontrolled HIV infection. The average value of drugs per year per patient was $4,077.2 ± 3,043.8 U.S. dollars/year. Conclusions Non-adherence to treatment remains one of the most important issues regarding antiretroviral therapy effectiveness, so programmes intended to control HIV/AIDS must address this problem.

Objetivo Evaluar la efectividad del tratamiento antirretroviral en una muestra de pacientes con diagnóstico de VIH/SIDA en dos ciudades colombianas. Métodos Estudio descriptivo en 134 pacientes en tratamiento para VIH/SIDA de cualquier edad y género en Pereira y Manizales entre 1 de julio de 2008 y 30 de junio de 2009. Se evaluó: carga viral, conteo de linfocitos CD4, esquemas antirretrovirales, dosis diaria prescrita, tiempo evolución de enfermedad, duración de terapia, antecedentes de enfermedades oportunistas, costos de medicamentos. Resultados Predominio masculino (91 hombres vs 43 mujeres), promedio de edad: 39 años y 59 meses de evolución de la enfermedad. Todos recibían esquemas a Dosis Diarias Definidas recomendadas. La terapia era efectiva en 73,6 por ciento de los pacientes (carga viral <400 copias/ml). Se pudo establecer que la falta de adherencia al tratamiento y el antecedente de haber tenido otras 2 infecciones de transmisión sexual se asociaban con mayor riesgo de no controlar la infección por VIH. El valor promedio de los medicamentos por año por paciente fue de US$ 4 077.2 ± 3 043.8 dólares. Conclusiones La falta de adherencia al tratamiento sigue siendo uno de los problemas más importantes para garantizar efectividad, por lo cual los programas de control del VIH/SIDA deben asegurarla.